CellCept

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
CellCept 250 mg capsules. 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each capsule contains 250 mg mycophenolate mofetil. 
 
Excipient(s) with known effect 
 
Sodium less than 1 mmol (23 mg) per dose 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Capsules, hard (capsules). 
 
CellCept capsules: oblong, blue/brown, branded with black "CellCept 250" on the capsule cap and 
"Roche" on the capsule body.  
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
CellCept is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute 
transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. 
 
4.2 Posology and method of administration 
 
Treatment with CellCept should be initiated and maintained by appropriately qualified transplant 
specialists. 
 
Posology 
 
Use in renal transplant  
 
Adults 
Oral CellCept should be initiated within 72 hours following transplantation. The recommended dose in 
renal transplant patients is 1 g administered twice daily (2 g daily dose).  
Paediatric population aged 2 to 18 years 
The recommended dose of mycophenolate mofetil is 600 mg/m2 administered orally twice daily (up to 
a maximum of 2 g daily). CellCept capsules should only be prescribed to patients with a body surface 
area of at least 1.25 m2. Patients with a body surface area of 1.25 to 1.5 m2 may be prescribed CellCept 
capsules at a dose of 750 mg twice daily (1.5 g daily dose). Patients with a body surface area greater 
than 1.5 m2 may be prescribed CellCept capsules at a dose of 1 g twice daily (2 g daily dose). As some 
adverse reactions occur with greater frequency in this age group (see section 4.8) compared with 
adults, temporary dose reduction or interruption may be required; these will need to take into account 
relevant clinical factors including severity of reaction. 
 
Paediatric population < 2 years 
There are limited safety and efficacy data in children below the age of 2 years. These are insufficient 
to make dosage recommendations and therefore use in this age group is not recommended. 
 



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Use in cardiac transplant  
 
Adults  
Oral CellCept should be initiated within 5 days following transplantation. The recommended dose in 
cardiac transplant patients is 1.5 g administered twice daily (3 g daily dose).  
 
Paediatric population 
No data are available for paediatric cardiac transplant patients. 
 
Use in hepatic transplant 
 
Adults 
IV CellCept should be administered for the first 4 days following hepatic transplant, with oral 
CellCept initiated as soon after this as it can be tolerated. The recommended oral dose in hepatic 
transplant patients is 1.5 g administered twice daily (3 g daily dose). 
 
Paediatric population 
No data are available for paediatric hepatic transplant patients. 
 
Use in special populations 
 
Elderly 
The recommended dose of 1 g administered twice a day for renal transplant patients and 1.5 g twice a 
day for cardiac or hepatic transplant patients is appropriate for the elderly.  
 
Renal impairment 
In renal transplant patients with severe chronic renal impairment (glomerular filtration rate 
< 25 ml/min/1.73 m2), outside the immediate post-transplant period, doses greater than 1 g 
administered twice a day should be avoided. These patients should also be carefully observed. No dose 
adjustments are needed in patients experiencing delayed renal graft function post-operatively (see 
section 5.2). No data are available for cardiac or hepatic transplant patients with severe chronic renal 
impairment. 
 
Severe hepatic impairment  
No dose adjustments are needed for renal transplant patients with severe hepatic parenchymal disease. 
No data are available for cardiac transplant patients with severe hepatic parenchymal disease. 
 
Treatment during rejection episodes 
Mycophenolic acid (MPA) is the active metabolite of mycophenolate mofetil. Renal transplant 
rejection does not lead to changes in MPA pharmacokinetics; dosage reduction or interruption of 
CellCept is not required. There is no basis for CellCept dose adjustment following cardiac transplant 
rejection. No pharmacokinetic data are available during hepatic transplant rejection.   
 
Paediatric population 
No data are available for treatment of first or refractory rejection in paediatric transplant patients 
 
Method of administration 
 
Oral administration 
 
Precautions to be taken before handling or administering the medicinal product. 
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, CellCept 
capsules should not be opened or crushed to avoid inhalation or direct contact with skin or mucous 
membranes of the powder contained in CellCept capsules. If such contact occurs, wash thoroughly 
with soap and water; rinse eyes with plain water. 
 



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4.3 Contraindications 
 
• CellCept should not be given to patients with hypersensitivity to mycophenolate mofetil, 

mycophenolic acid or to any of the excipients listed in section 6.1. Hypersensitivity reactions to 
CellCept have been observed (see section 4.8).  

 
• CellCept should not be given to women of childbearing potential who are not using highly 

effective contraception (see section 4.6).  
 

• CellCept treatment should not be initiated in women of childbearing potential without providing 
a pregnancy test result to rule out unintended use in pregnancy (see section 4.6). 

 
• CellCept should not be used in pregnancy unless there is no suitable alternative treatment to 

prevent transplant rejection (see section 4.6). 
 

• CellCept should not be given to women who are breastfeeding (see section 4.6). 
 
4.4 Special warnings and precautions for use 
 
Neoplasms 
 
Patients receiving immunosuppressive regimens involving combinations of medicinal products, 
including CellCept, are at increased risk of developing lymphomas and other malignancies, 
particularly of the skin (see section 4.8). The risk appears to be related to the intensity and duration of 
immunosuppression rather than to the use of any specific agent.  
As general advice to minimise the risk for skin cancer, exposure to sunlight and UV light should be 
limited by wearing protective clothing and using a sunscreen with a high protection factor. 
 
Infections 
 
Patients treated with immunosuppressants, including CellCept, are at increased risk for opportunistic 
infections (bacterial, fungal, viral and protozoal), fatal infections and sepsis (see section 4.8). Such 
infections include latent viral reactivation, such as hepatitis B or hepatitis C reactivation and infections 
caused by polyomaviruses (BK virus associated nephropathy, JC virus associated progressive 
multifocal leukoencephalopathy PML). Cases of hepatitis due to reactivation of hepatitis B or hepatitis 
C have been reported in carrier patients treated with immunosuppressants. These infections are often 
related to a high total immunosuppressive burden and may lead to serious or fatal conditions that 
physicians should consider in the differential diagnosis in immunosuppressed patients with 
deteriorating renal function or neurological symptoms. 
 
There have been reports of hypogammaglobulinaemia in association with recurrent infections in 
patients receiving CellCept in combination with other immunosuppressants. In some of these cases, 
switching CellCept to an alternative immunosuppressant resulted in serum IgG levels returning to 
normal. Patients on CellCept who develop recurrent infections should have their serum 
immunoglobulins measured. In cases of sustained, clinically relevant hypogammaglobulinaemia, 
appropriate clinical action should be considered taking into account the potent cytostatic effects that 
mycophenolic acid has on T- and B-lymphocytes. 
 
There have been published reports of bronchiectasis in adults and children who received CellCept in 
combination with other immunosuppressants. In some of these cases, switching CellCept to another 
immunosuppressant resulted in improvement in respiratory symptoms. The risk of bronchiectasis may 
be linked to hypogammaglobulinaemia or to a direct effect on the lung. There have also been isolated 
reports of interstitial lung disease and pulmonary fibrosis, some of which were fatal (see section 4.8). 
It is recommended that patients who develop persistent pulmonary symptoms, such as cough and 
dyspnoea, are investigated. 
 



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Blood and immune system 
 
Patients receiving CellCept should be monitored for neutropenia, which may be related to CellCept 
itself, concomitant medications, viral infections, or some combination of these causes. Patients taking 
CellCept should have complete blood counts weekly during the first month, twice monthly for the 
second and third months of treatment, then monthly through the first year. If neutropenia develops 
(absolute neutrophil count < 1.3 x 103/µl), it may be appropriate to interrupt or discontinue CellCept. 
 
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CellCept in 
combination with other immunosuppressants. The mechanism for mycophenolate mofetil induced 
PRCA is unknown. PRCA may resolve with dose reduction or cessation of CellCept therapy. Changes 
to CellCept therapy should only be undertaken under appropriate supervision in transplant recipients 
in order to minimise the risk of graft rejection (see section 4.8). 
 
Patients receiving CellCept should be instructed to report immediately any evidence of infection, 
unexpected bruising, bleeding or any other manifestation of bone marrow failure. 
 
Patients should be advised that, during treatment with CellCept, vaccinations may be less effective and 
the use of live attenuated vaccines should be avoided (see section 4.5). Influenza vaccination may be 
of value. Prescribers should refer to national guidelines for influenza vaccination. 
 
Gastro-intestinal 
 
CellCept has been associated with an increased incidence of digestive system adverse events, 
including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation. CellCept 
should be administered with caution in patients with active serious digestive system disease.  
 
CellCept is an IMPDH (inosine monophosphate dehydrogenase) inhibitor. Therefore, it should be 
avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-
transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome. 
 
Interactions 
 
Caution should be exercised when switching combination therapy from regimens containing 
immunosuppressants, which interfere with MPA enterohepatic recirculation, e.g. ciclosporin, to others 
devoid of this effect, e.g. tacrolimus, sirolimus, belatacept, or vice versa, as this might result in 
changes of MPA exposure. Drugs which interfere with MPA’s enterohepatic cycle (e.g. 
cholestyramine, antibiotics) should be used with caution due to their potential to reduce the plasma 
levels and efficacy of CellCept (see also section 4.5). Therapeutic drug monitoring of MPA may be 
appropriate when switching combination therapy (e.g. from ciclosporin to tacrolimus or vice versa) or 
to ensure adequate immunosuppression in patients with high immunological risk (e.g. risk of rejection, 
treatment with antibiotics, addition or removal of an interacting medication). 
 
It is recommended that CellCept should not be administered concomitantly with azathioprine because 
such concomitant administration has not been studied. 
 
The risk/benefit ratio of mycophenolate mofetil in combination with sirolimus has not been 
established (see also section 4.5). 
 
Special populations  
 
Elderly patients may be at an increased risk of adverse events such as certain infections (including 
cytomegalovirus tissue invasive disease) and possibly gastrointestinal haemorrhage and pulmonary 
oedema, compared with younger individuals (see section 4.8). 
 



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Teratogenic effects 
 
Mycophenolate is a powerful human teratogen. Spontaneous abortion (rate of 45% to 49%) and 
congenital malformations (estimated rate of 23% to 27%) have been reported following MMF 
exposure during pregnancy. Therefore, CellCept is contraindicated in pregnancy unless there are no 
suitable alternative treatments to prevent transplant rejection. Female patients of childbearing potential 
should be made aware of the risks and follow the recommendations provided in section 4.6 (e.g. 
contraceptive methods, pregnancy testing) prior to, during, and after therapy with CellCept. Physicians 
should ensure that women taking mycophenolate understand the risk of harm to the baby, the need for 
effective contraception, and the need to immediately consult their physician if there is a possibility of 
pregnancy. 
 
Contraception (see section 4.6) 
 
Because of robust clinical evidence showing a high risk of abortion and congenital malformations 
when mycophenolate mofetil is used in pregnancy, every effort to avoid pregnancy during treatment 
should be taken. Therefore, women with childbearing potential must use at least one form of reliable 
contraception (see section 4.3) before starting CellCept therapy, during therapy, and for six weeks 
after stopping the therapy; unless abstinence is the chosen method of contraception. Two 
complementary forms of contraception simultaneously are preferred to minimise the potential for 
contraceptive failure and unintended pregnancy. 
 
For contraception advice for men see section 4.6. 
 
Educational materials 
In order to assist patients in avoiding foetal exposure to mycophenolate and to provide additional 
important safety information, the Marketing Authorisation Holder will provide educational materials 
to healthcare professionals. The educational materials will reinforce the warnings about the 
teratogenicity of mycophenolate, provide advice on contraception before therapy is started and 
guidance on the need for pregnancy testing. Full patient information about the teratogenic risk and the 
pregnancy prevention measures should be given by the physician to women of childbearing potential 
and, as appropriate, to male patients.  
 
Additional precautions 
Patients should not donate blood during therapy or for at least 6 weeks following discontinuation of 
mycophenolate. Men should not donate semen during therapy or for 90 days following discontinuation 
of mycophenolate. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Aciclovir 
Higher aciclovir plasma concentrations were observed when mycophenolate mofetil was administered 
with aciclovir in comparison to the administration of aciclovir alone. The changes in MPAG (the 
phenolic glucuronide of MPA) pharmacokinetics (MPAG increased by 8%) were minimal and are not 
considered clinically significant. Because MPAG plasma concentrations are increased in the presence 
of renal impairment, as are aciclovir concentrations, the potential exists for mycophenolate mofetil and 
aciclovir, or its prodrugs, e.g. valaciclovir, to compete for tubular secretion and further increases in 
concentrations of both substances may occur. 
 
Antacids and proton pump inhibitors (PPIs)  
Decreased MPA exposure has been observed when antacids, such as magnesium and aluminium 
hydroxides, and PPIs, including lansoprazole and pantoprazole, were administered with CellCept. 
When comparing rates of transplant rejection or rates of graft loss between CellCept patients taking 
PPIs vs. CellCept patients not taking PPIs, no significant differences were seen. Theses data support 
extrapolation of this finding to all antacids because the reduction in exposure when CellCept was co-
administered with magnesium and aluminium hydroxides is considerably less than when CellCept was 
co-administered with PPIs. 



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Medicinal products that interfere with enterohepatic recirculation (e.g. cholestyramine, ciclosporin A,  
antibiotics) 
Caution should be used with medicinal products that interfere with enterohepatic recirculation because 
of their potential to reduce the efficacy of CellCept. 
 
Cholestyramine 
Following single dose administration of 1.5 g of mycophenolate mofetil to normal healthy subjects 
pre-treated with 4 g TID of cholestyramine for 4 days, there was a 40% reduction in the AUC of MPA 
(see section 4.4 and section 5.2). Caution should be used during concomitant administration because 
of the potential to reduce efficacy of CellCept. 
 
Ciclosporin A 
Ciclosporin A (CsA) pharmacokinetics are unaffected by mycophenolate mofetil. 
In contrast, if concomitant CsA treatment is stopped, an increase in MPA AUC of around 30% should 
be expected. CsA interferes with MPA enterohepatic recycling, resulting in reduced MPA exposures 
by 30-50% in renal transplant patients treated with CellCept and CsA compared with patients 
receiving sirolimus or belatacept and similar doses of CellCept (see also section 4.4). Conversely, 
changes of MPA exposure should be expected when switching patients from CsA to one of the 
immunosuppressants which does not interfere with MPA’s enterohepatic cycle. 
 
Antibiotics eliminating β-glucuronidase-producing bacteria in the intestine (e.g. aminoglycoside, 
cephalosporin, fluoroquinolone, and penicillin classes of antibiotics) may interfere with MPAG/MPA 
enterohepatic recirculation, thus leading to reduced systemic MPA exposure. Information concerning 
the following antibiotics is available: 
 
Ciprofloxacin or amoxicillin plus clavulanic acid 
Reductions in pre-dose (trough) MPA concentrations of about 50% have been reported in renal 
transplant recipients in the days immediately following commencement of oral ciprofloxacin or 
amoxicillin plus clavulanic acid. This effect tended to diminish with continued antibiotic use and to 
cease within a few days of antibiotic discontinuation. The change in pre-dose level may not accurately 
represent changes in overall MPA exposure. Therefore, a change in the dose of CellCept should not 
normally be necessary in the absence of clinical evidence of graft dysfunction. However, close clinical 
monitoring should be performed during the combination and shortly after antibiotic treatment. 
 
Norfloxacin and metronidazole 
In healthy volunteers, no significant interaction was observed when CellCept was concomitantly 
administered with norfloxacin or metronidazole separately. However, norfloxacin and metronidazole 
combined reduced the MPA exposure by approximately 30% following a single dose of CellCept. 
 
Trimethoprim/sulfamethoxazole 
No effect on the bioavailability of MPA was observed.  
 
Medicinal products that affect glucuronidation (e.g. isavuconazole, telmisartan) 
Concomitant administration of drugs affecting glucuronidation of MPA may change MPA exposure. 
Caution is therefore recommended when administering these drugs concomitantly with CellCept.  
 
Isavuconazole 
An increase of MPA AUC0-∞ by 35% was observed with concomitant administration of 
isavuconazole. 
 
Telmisartan 
Concomitant administration of telmisartan and CellCept resulted in an approximately 30% decrease of 
MPA concentrations. Telmisartan changes MPA’s elimination by enhancing PPAR gamma 
(peroxisome proliferator-activated receptor gamma) expression, which in turn results in an enhanced 
UGT1A9 expression and activity. When comparing rates of transplant rejection, rates of graft loss or 



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adverse event profiles between CellCept patients with and without concomitant telmisartan 
medication, no clinical consequences of the pharmacokinetic drug-drug interaction were seen. 
 
Ganciclovir  
Based on the results of a single dose administration study of recommended doses of oral 
mycophenolate and IV ganciclovir and the known effects of renal impairment on the pharmacokinetics 
of CellCept (see section 4.2) and ganciclovir, it is anticipated that co-administration of these agents 
(which compete for mechanisms of renal tubular secretion) will result in increases in MPAG and 
ganciclovir concentration. No substantial alteration of MPA pharmacokinetics is anticipated and 
CellCept dose adjustment is not required. In patients with renal impairment in whom CellCept and 
ganciclovir or its prodrugs, e.g. valganciclovir, are co-administered, the dose recommendations for 
ganciclovir should be observed and patients should be monitored carefully. 
 
Oral contraceptives 
The pharmacokinetics and pharmacodynamics of oral contraceptives were unaffected by co-
administration of CellCept (see also section 5.2). 
 
Rifampicin 
In patients not also taking ciclosporin, concomitant administration of CellCept and rifampicin resulted 
in a decrease in MPA exposure (AUC0-12h) of 18% to 70%. It is recommended to monitor MPA 
exposure levels and to adjust CellCept doses accordingly to maintain clinical efficacy when rifampicin 
is administered concomitantly. 
 
Sevelamer 
Decrease in MPA Cmax and AUC0-12h by 30% and 25%, respectively, were observed when CellCept 
was concomitantly administered with sevelamer without any clinical consequences (i.e. graft 
rejection). It is recommended, however, to administer CellCept at least one hour before or three hours 
after sevelamer intake to minimise the impact on the absorption of MPA. There are no data on 
CellCept with phosphate binders other than sevelamer. 
 
Tacrolimus 
In hepatic transplant patients initiated on CellCept and tacrolimus, the AUC and Cmax of MPA, the 
active metabolite of CellCept, were not significantly affected by co-administration with tacrolimus. In 
contrast, there was an increase of approximately 20% in tacrolimus AUC when multiple doses of 
CellCept (1.5 g BID) were administered to hepatic transplant patients taking tacrolimus. However, in 
renal transplant patients, tacrolimus concentration did not appear to be altered by CellCept (see also 
section 4.4). 
 
Live vaccines 
Live vaccines should not be given to patients with an impaired immune response. The antibody 
response to other vaccines may be diminished (see also section 4.4). 
 
Paediatric population 
Interaction studies have only been performed in adults. 
 
Potential interaction 
Co-administration of probenecid with mycophenolate mofetil in monkeys raises plasma AUC of 
MPAG by 3-fold. Thus, other substances known to undergo renal tubular secretion may compete with 
MPAG, and thereby raise plasma concentrations of MPAG or the other substance undergoing tubular 
secretion.  
 
4.6 Pregnancy and lactation 
 
Women of childbearing potential 
 
Pregnancy whilst taking mycophenolate must be avoided. Therefore, women of childbearing potential 
must use at least one form of reliable contraception (see section 4.3) before starting CellCept therapy, 



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during therapy, and for six weeks after stopping the therapy, unless abstinence is the chosen method of 
contraception. Two complementary forms of contraception simultaneously are preferred. 
 
Pregnancy 
 
CellCept is contraindicated during pregnancy unless there is no suitable alternative treatment to 
prevent transplant rejection. Treatment should not be initiated without providing a negative pregnancy 
test result to rule out unintended use in pregnancy.  
 
Female patients of reproductive potential must be made aware of the increased risk of pregnancy loss 
and congenital malformations at the beginning of the treatment and must be counselled regarding 
pregnancy prevention and planning. 
 
Before starting CellCept treatment, women of childbearing potential should have two negative serum 
or urine pregnancy tests with a sensitivity of at least 25 mIU/ml in order to exclude unintended 
exposure of the embryo to mycophenolate. It is recommended that the second test should be performed 
8 - 10 days after the first test. For transplants from deceased donors, if it is not possible to perform two 
tests 8 - 10 days apart before treatment starts (because of the timing of transplant organ availability), a 
pregnancy test must be performed immediately before starting treatment and a further test performed 8 
- 10 days later. Pregnancy tests should be repeated as clinically required (e.g. after any gap in 
contraception is reported). Results of all pregnancy tests should be discussed with the patient. Patients 
should be instructed to consult their physician immediately should pregnancy occur. 
 
Mycophenolate is a powerful human teratogen, with an increased risk of spontaneous abortions and 
congenital malformations in case of exposure during pregnancy; 
• Spontaneous abortions have been reported in 45 to 49% of pregnant women exposed to 

mycophenolate mofetil, compared to a reported rate of between 12 and 33% in solid organ 
transplant patients treated with immunosuppressants other than mycophenolate mofetil. 

• Based on literature reports, malformations occurred in 23 to 27% of live births in women 
exposed to mycophenolate mofetil during pregnancy (compared to 2 to 3% of live births in the 
overall population and approximately 4 to 5% of live births in solid organ transplant recipients 
treated with immunosuppressants other than mycophenolate mofetil). 

 
Congenital malformations, including reports of multiple malformations, have been observed post-
marketing in children of patients exposed to CellCept in combination with other immunosuppressants 
during pregnancy. The following malformations were most frequently reported:  
 
• Abnormalities of the ear (e.g. abnormally formed or absent external ear), external auditory canal 

atresia (middle ear); 
• Facial malformations such as cleft lip, cleft palate, micrognathia and hypertelorism of the orbits; 
• Abnormalities of the eye (e.g. coloboma); 
• Congenital heart disease such as atrial and ventricular septal defects; 
• Malformations of the fingers (e.g. polydactyly, syndactyly); 
• Tracheo-oesophageal malformations (e.g. oesophageal atresia); 
• Nervous system malformations such as spina bifida;  
• Renal abnormalities. 

 
In addition, there have been isolated reports of the following malformations: 
• Microphthalmia; 
• Congenital choroid plexus cyst; 
• Septum pellucidum agenesis; 
• Olfactory nerve agenesis. 
 
Studies in animals have shown reproductive toxicity (see section 5.3).  
 



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Breast-feeding 
 
Mycophenolate mofetil has been shown to be excreted in the milk of lactating rats. It is not known 
whether this substance is excreted in human milk. Because of the potential for serious adverse 
reactions to mycophenolate mofetil in breast-fed infants, CellCept is contraindicated in nursing 
mothers (see section 4.3). 
 
Men 
 
Limited clinical evidence does not indicate an increased risk of malformations or miscarriage 
following paternal exposure to mycophenolate mofetil.  
 
MPA is a powerful teratogen. It is not known if MPA is present in semen. Calculations based on 
animal data show that the maximum amount of MPA that could potentially be transferred to woman is 
so low that it would be unlikely to have an effect. Mycophenolate has been shown to be genotoxic in 
animal studies at concentrations exceeding the human therapeutic exposures only by small margins, 
such that the risk of genotoxic effects on sperm cells cannot completely be excluded. 
 
Therefore, the following precautionary measures are recommended: sexually active male patients or 
their female partners are recommended to use reliable contraception during treatment of the male 
patient and for at least 90 days after cessation of mycophenolate mofetil. Male patients of reproductive 
potential should be made aware of and discuss with a qualified healthcare professional the potential 
risks of fathering a child. 
 
4.7 Effects on ability to drive and use machines 
 
CellCept has moderate influence on the ability to drive and use machines.  
CellCept may cause somnolence, confusion, dizziness, tremor or hypotension, and therefore patients 
are advised to use caution when driving or using machines. 
 
4.8 Undesirable effects 
 
Summary of safety profile 
An estimated total of 1557 patients received CellCept during five clinical trials in the prevention of 
acute organ rejection. Of these, 991 were included in the three renal studies, 277 were included in one 
hepatic study, and 289 were included in one cardiac study. Azathioprine was the comparator used in 
the hepatic and cardiac studies and in two of the renal studies whilst the other renal study was placebo-
controlled. Patients in all study arms also received cyclosporine and corticosteroids. The types of 
adverse reactions reported during post-marketing with CellCept are similar to those seen in the 
controlled renal, cardiac and hepatic transplant studies. 
Diarrhoea, leukopenia, sepsis and vomiting were among the most common and/or serious adverse drug 
reactions associated with the administration of CellCept in combination with ciclosporin and 
corticosteroids. There is also evidence of a higher frequency of certain types of infections (see section 
4.4). 
 
Tabulated list of adverse reactions 
The adverse drug reactions (ADRs) from clinical trials and post-marketing experience are listed in 
Table 1, by MedDRA system organ class (SOC) along with their frequencies. The corresponding 
frequency category for each adverse drug reaction is based on the following convention: very common 
(≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) 
and very rare (<1/10,000). Due to the large differences observed in the frequency of certain ADRs 
across the different transplant indications, the frequency is presented separately for renal, hepatic and 
cardiac transplant patients. 
 



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Table 1 Summary of adverse drug reactions occurring in patients treated with CellCept reported 
from clinical trials and post-marketing experience 
 

Adverse drug reaction 
 
(MedDRA) 
 
System Organ Class 

Renal 
transplant 
n = 991 

Hepatic 
transplant 
n = 277 

Cardiac 
transplant 
n = 289 

 
Frequency Frequency Frequency 

Infections and infestations  
Bacterial infections Very Common Very Common Very Common 
Fungal infections Common Very Common Very Common 
Protozoal infections Uncommon Uncommon Uncommon 
Viral infections Very Common Very Common Very Common 
Neoplasms benign, malignant and unspecified (including cysts and polyps)  
Benign neoplasm of skin  Common Common Common 
Lymphoma Uncommon Uncommon Uncommon 
Lymphoproliferative disorder Uncommon Uncommon Uncommon 
Neoplasm Common Common Common 
Skin cancer Common Uncommon Common 
Blood and lymphatic system disorders 
Anemia Very Common Very Common Very Common 
Aplasia pure red cell Uncommon Uncommon Uncommon 
Bone marrow failure Uncommon Uncommon Uncommon 
Ecchymosis Common Common Very Common 
Leukocytosis Common Very Common Very Common 
Leukopenia Very Common Very Common Very Common 
Pancytopenia Common Common Uncommon 
Pseudolymphoma Uncommon Uncommon Common 
Thrombocytopenia Common Very Common Very Common 
Metabolism and nutrition disorders  
Acidosis Common Common Very Common 
Hypercholesterolemia Very Common Common Very Common 
Hyperglycemia Common Very Common Very Common 
Hyperkalemia Common Very Common Very Common 
Hyperlipidemia Common Common Very Common 
Hypocalcemia Common Very Common Common 
Hypokalemia Common Very Common Very Common 
Hypomagnesemia Common Very Common Very Common 
Hypophosphatemia Very Common Very Common Common 
Hyperuricaemia Common Common Very Common 
Gout Common Common Very Common 
Weight decreased Common Common Common 



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Adverse drug reaction 
 
(MedDRA) 
 
System Organ Class 

Renal 
transplant 
n = 991 

Hepatic 
transplant 
n = 277 

Cardiac 
transplant 
n = 289 

Psychiatric disorders  
Confusional state Common Very Common Very Common 
Depression Common Very Common Very Common 
Insomnia Common Very Common Very Common 
Agitation Uncommon Common Very Common 
Anxiety Common Very Common Very Common 
Thinking abnormal Uncommon Common Common 
Nervous system disorders  
Dizziness Common Very Common Very Common 
Headache Very Common Very Common Very Common 
Hypertonia Common Common Very Common 
Paresthesia Common Very Common Very Common 
Somnolence Common Common Very Common 
Tremor Common Very Common Very Common 
Convulsion Common Common Common 
Dysgeusia Uncommon Uncommon Common 
Cardiac disorders  
Tachycardia Common Very Common Very Common 
Vascular disorders   
Hypertension Very Common Very Common Very Common 
Hypotension Common Very Common Very Common 
Lymphocele Uncommon Uncommon Uncommon 
Venous thrombosis Common Common Common 
Vasodilatation Common Common Very Common 
Respiratory, thoracic and mediastinal disorders  
Bronchiectasis Uncommon Uncommon Uncommon 
Cough Very Common Very Common Very Common 
Dyspnea Very Common Very Common Very Common 
Interstitial lung disease Uncommon Very Rare Very Rare 
Pleural effusion Common Very Common Very Common 
Pulmonary fibrosis Very Rare Uncommon Uncommon 
Gastrointestinal disorders 
Abdominal distension Common Very Common Common 
Abdominal pain Very Common Very Common Very Common 
Colitis Common Common Common 
Constipation Very Common Very Common Very Common 
Decreased appetite Common Very Common Very Common 
Diarrhea Very Common Very Common Very Common 
Dyspepsia Very Common Very Common Very Common 
Esophagitis Common Common Common 
Eructation Uncommon Uncommon Common 
Flatulence  Common Very Common Very Common 



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Adverse drug reaction 
 
(MedDRA) 
 
System Organ Class 

Renal 
transplant 
n = 991 

Hepatic 
transplant 
n = 277 

Cardiac 
transplant 
n = 289 

Gastritis  Common Common Common 
Gastrointestinal hemorrhage Common Common Common 
Gastrointestinal ulcer Common Common Common 
Gingival hyperplasia Common Common Common 
Ileus Common Common Common 
Mouth ulceration Common Common Common 
Nausea Very Common Very Common Very Common 
Pancreatitis Uncommon Common Uncommon 
Stomatitis Common Common Common 
Vomiting Very Common Very Common Very Common 
Immune system disorders  
Hypersenstivity Uncommon Common Common 
Hypogammaglobulinaemia Uncommon Very Rare Very Rare 
Hepatobiliary disorders  
Blood alkaline phosphatase 
increased  Common Common Common 
Blood lactate dehydrogenase 
increased  Common Uncommon Very Common 
Hepatic enzyme increased  Common Very Common Very Common 
Hepatitis Common Very Common Uncommon 
Hyperbilirubinaemia Common Very Common Very Common 
Jaundice Uncommon Common Common 
Skin and subcutaneous tissue disorders   
Acne Common Common Very Common 
Alopecia Common Common Common 
Rash Common Very Common Very Common 
Skin hypertrophy Common Common Very Common 
Musculoskeletal and connective tissue disorders  
Arthralgia Common Common Very Common 
Muscular weakness Common Common Very Common 
Renal and urinary disorders 
Blood creatinine increased Common Very Common Very Common 
Blood urea increased Uncommon Very Common Very Common 
Hematuria Very Common Common Common 
Renal impairment Common Very Common Very Common 
    



14 

Adverse drug reaction 
 
(MedDRA) 
 
System Organ Class 

Renal 
transplant 
n = 991 

Hepatic 
transplant 
n = 277 

Cardiac 
transplant 
n = 289 

General disorders and administration site conditions  
Asthenia Very Common Very Common Very Common 
Chills Common Very Common Very Common 
Edema Very Common Very Common Very Common 
Hernia Common Very Common Very Common 
Malaise Common Common Common 
Pain Common Very Common Very Common 
Pyrexia Very Common Very Common Very Common 

 
Note: 991 (2 g /3 g CellCept daily), 289 (3 g CellCept daily) and 277 (2 g IV / 3 g oral CellCept daily) patients were treated 
in Phase III studies for the prevention of rejection in renal, cardiac and hepatic transplantation, respectively. 
 
Description of selected adverse reactions 
 
Malignancies 
Patients receiving immunosuppressive regimens involving combinations of medicinal products, 
including CellCept, are at increased risk of developing lymphomas and other malignancies, 
particularly of the skin (see section 4.4). Three-year safety data in renal and cardiac transplant patients 
did not reveal any unexpected changes in incidence of malignancy compared to the 1-year data. 
Hepatic transplant patients were followed for at least 1 year, but less than 3 years.  
 
Infections 
All patients treated with immunosuppressants are at increased risk of bacterial, viral and fungal 
infections (some of which may lead to a fatal outcome), including those caused by opportunistic 
agents and latent viral reactivation. The risk increases with total immunosuppressive load (see section 
4.4). The most serious infections were sepsis, peritonitis, meningitis, endocarditis, tuberculosis and 
atypical mycobacterial infection. The most common opportunistic infections in patients receiving 
CellCept (2 g or 3 g daily) with other immunosuppressants in controlled clinical trials in renal, cardiac 
and hepatic transplant patients followed for at least 1 year were candida mucocutaneous, CMV 
viraemia/syndrome and Herpes simplex. The proportion of patients with CMV viraemia/syndrome was 
13.5%. Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive 
multifocal leukoencephalopathy (PML), have been reported in patients treated with 
immunosuppressants, including CellCept.  
 
Blood and lymphatic disorders  
Cytopenias, including leukopenia, anemia, thrombocytopenia and pancytopenia, are known risks 
associated with mycophenolate mofetil and may lead or contribute to the occurrence of infections and 
hemorrhages (see section 4.4). Agranulocytosis and neutropenia have been reported; therefore, regular 
monitoring of patients taking CellCept is advised (see section 4.4). There have been reports of aplastic 
anaemia and bone marrow failure in patients treated with CellCept, some of which have been fatal. 
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CellCept (see 
section 4.4). 
Isolated cases of abnormal neutrophil morphology, including the acquired Pelger-Huet anomaly, have 
been observed in patients treated with CellCept. These changes are not associated with impaired 
neutrophil function. These changes may suggest a ‘left shift’ in the maturity of neutrophils in 
haematological investigations, which may be mistakenly interpreted as a sign of infection in 
immunosuppressed patients such as those that receive CellCept. 
 



15 

Gastrointestinal disorders 
The most serious gastrointestinal disorders were ulceration and hemorrhage which are known risks 
associated with mycophenolate mofetil. Mouth, esophageal, gastric, duodenal, and intestinal ulcers 
often complicated by hemorrhage, as well as hematemesis, melena, and hemorrhagic forms of gastritis 
and colitis were commonly reported during the pivotal clinical trials. The most common 
gastrointestinal disorders, however, were diarrhea, nausea and vomiting. Endoscopic investigation of 
patients with CellCept-related diarrhea have revealed isolated cases of intestinal villous atrophy (see 
section 4.4). 
 
Hypersensitivity  
Hypersensitivity reactions, including angioneurotic oedema and anaphylactic reaction, have been 
reported.  
 
Pregnancy, puerperium and perinatal conditions 
Cases of spontaneous abortion have been reported in patients exposed to mycophenolate mofetil, 
mainly in the first trimester, see section 4.6. 
 
Congenital disorders 
Congenital malformations have been observed post-marketing in children of patients exposed to 
CellCept in combination with other immunosuppressants, see section 4.6. 
 
Respiratory, thoracic and mediastinal disorders 
There have been isolated reports of interstitial lung disease and pulmonary fibrosis in patients treated 
with CellCept in combination with other immunosuppressants, some of which have been fatal. There 
have also been reports of bronchiectasis in children and adults. 
 
Immune system disorders 
Hypogammaglobulinaemia has been reported in patients receiving CellCept in combination with other 
immunosuppressants. 
 
General disorders and administration site conditions 
Edema, including peripheral, face and scrotal edema, was reported very commonly during the pivotal 
trials. Musculoskeletal pain such as myalgia, and neck and back pain were also very commonly 
reported. 
 
Special populations 
 
Paediatric population 
The type and frequency of adverse reactions in a clinical study, which recruited 92 paediatric patients 
aged 2 to 18 years who were given 600 mg/m2 mycophenolate mofetil orally twice daily, were 
generally similar to those observed in adult patients given 1 g CellCept twice daily. However, the 
following treatment-related adverse events were more frequent in the paediatric population, 
particularly in children under 6 years of age, when compared to adults: diarrhoea, sepsis, leucopenia, 
anaemia and infection.  
 
Elderly 
Elderly patients (≥ 65 years) may generally be at increased risk of adverse reactions due to 
immunosuppression. Elderly patients receiving CellCept as part of a combination immunosuppressive 
regimen may be at increased risk of certain infections (including cytomegalovirus tissue invasive 
disease) and possibly gastrointestinal haemorrhage and pulmonary oedema, compared to younger 
individuals.  
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 



16 

professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Reports of overdoses with mycophenolate mofetil have been received from clinical trials and during 
post-marketing experience. In many of these cases, no adverse events were reported. In those overdose 
cases in which adverse events were reported, the events fall within the known safety profile of the 
medicinal product. 
 
It is expected that an overdose of mycophenolate mofetil could possibly result in oversuppression of 
the immune system and increase susceptibility to infections and bone marrow suppression (see section 
4.4). If neutropenia develops, dosing with CellCept should be interrupted or the dose reduced (see 
section 4.4). 
 
Haemodialysis would not be expected to remove clinically significant amounts of MPA or MPAG. 
Bile acid sequestrants, such as cholestyramine, can remove MPA by decreasing the enterohepatic 
recirculation of the drug (see section 5.2). 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: immunosuppressive agents ATC code L04AA06 
 
Mechanism of action 
 
Mycophenolate mofetil is the 2-morpholinoethyl ester of MPA. MPA is a potent, selective, 
uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase, and therefore 
inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA. 
Because T- and B-lymphocytes are critically dependent for their proliferation on de novo synthesis of 
purines whereas other cell types can utilise salvage pathways, MPA has more potent cytostatic effects 
on lymphocytes than on other cells.  
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Following oral administration, mycophenolate mofetil undergoes rapid and extensive absorption and 
complete presystemic metabolism to the active metabolite, MPA. As evidenced by suppression of 
acute rejection following renal transplantation, the immunosuppressant activity of CellCept is 
correlated with MPA concentration. The mean bioavailability of oral mycophenolate mofetil, based on 
MPA AUC, is 94% relative to IV mycophenolate mofetil. Food had no effect on the extent of 
absorption (MPA AUC) of mycophenolate mofetil when administered at doses of 1.5 g BID to renal 
transplant patients. However, MPA Cmax was decreased by 40% in the presence of food. 
Mycophenolate mofetil is not measurable systemically in plasma following oral administration.  
 
Distribution 
 
As a result of enterohepatic recirculation, secondary increases in plasma MPA concentration are 
usually observed at approximately 6 - 12 hours post-dose. A reduction in the AUC of MPA of 
approximately 40% is associated with the co-administration of cholestyramine (4 g TID), indicating 
that there is a significant amount of enterohepatic recirculation.  
MPA at clinically relevant concentrations is 97% bound to plasma albumin. 
 

https://www.ema.europa.eu/documents/template-form/appendix-v-adverse-drug-reaction-reporting-details_en.doc


17 

Biotransformation 
 
MPA is metabolised principally by glucuronyl transferase (isoform UGT1A9) to form the inactive 
phenolic glucuronide of MPA (MPAG). In vivo, MPAG is converted back to free MPA via 
enterohepatic recirculation. A minor acylglucuronide (AcMPAG) is also formed. AcMPAG is 
pharmacologically active and is suspected to be responsible for some of MMF’s side effects 
(diarrhoea, leukopenia). 
 
Elimination 
A negligible amount of substance is excreted as MPA (< 1% of the dose) in the urine. Oral 
administration of radiolabelled mycophenolate mofetil results in complete recovery of the 
administered dose with 93% of the administered dose recovered in the urine and 6% recovered in the 
faeces. Most (about 87%) of the administered dose is excreted in the urine as MPAG. 
 
At clinically encountered concentrations, MPA and MPAG are not removed by haemodialysis. 
However, at high MPAG plasma concentrations (> 100 µg/ml), small amounts of MPAG are removed. 
By interfering with enterohepatic recirculation of the drug, bile acid sequestrants such as 
cholestyramine reduce MPA AUC (see section 4.9). 
MPA’s disposition depends on several transporters. Organic anion-transporting polypeptides (OATPs) 
and multidrug resistance-associated protein 2 (MRP2) are involved in MPA’s disposition; OATP 
isoforms, MRP2 and breast cancer resistance protein (BCRP) are transporters associated with the 
glucuronides’ biliary excretion. Multidrug resistance protein 1 (MDR1) is also able to transport MPA, 
but its contribution seems to be confined to the absorption process. In the kidney, MPA and its 
metabolites potently interact with renal organic anion transporters. 
 
In the early post-transplant period (< 40 days post-transplant), renal, cardiac and hepatic transplant 
patients had mean MPA AUCs approximately 30% lower and Cmax approximately 40% lower 
compared to the late post-transplant period (3 - 6 months post-transplant). 
 
Special populations 
 
Renal impairment 
In a single dose study (6 subjects/group), mean plasma MPA AUC observed in subjects with severe 
chronic renal impairment (glomerular filtration rate < 25 ml/min/1.73 m2) were 28 – 75% higher 
relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal 
impairment. The mean single dose MPAG AUC was 3 – 6-fold higher in subjects with severe renal 
impairment than in subjects with mild renal impairment or normal healthy subjects, consistent with the 
known renal elimination of MPAG. Multiple dosing of mycophenolate mofetil in patients with severe 
chronic renal impairment has not been studied. No data are available for cardiac or hepatic transplant 
patients with severe chronic renal impairment. 
 
Delayed renal graft function 
In patients with delayed renal graft function post-transplant, mean MPA AUC0-12h was comparable to 
that seen in post-transplant patients without delayed graft function. Mean plasma MPAG AUC0-12h was 
2 – 3-fold higher than in post-transplant patients without delayed graft function. There may be a 
transient increase in the free fraction and concentration of plasma MPA in patients with delayed renal 
graft function. Dose adjustment of CellCept does not appear to be necessary. 
 
Hepatic impairment 
In volunteers with alcoholic cirrhosis, hepatic MPA glucuronidation processes were relatively 
unaffected by hepatic parenchymal disease. Effects of hepatic disease on this process probably depend 
on the particular disease. However, hepatic disease with predominantly biliary damage, such as 
primary biliary cirrhosis, may show a different effect.  
 
Paediatric population 
Pharmacokinetic parameters were evaluated in 49 paediatric renal transplant patients (aged 2 to 18 
years) given 600 mg/m2 mycophenolate mofetil orally twice daily. This dose achieved MPA AUC 



18 

values similar to those seen in adult renal transplant patients receiving CellCept at a dose of 1 g BID in 
the early and late post-transplant period. MPA AUC values across age groups were similar in the early 
and late post-transplant period. 
 
Elderly 
The pharmacokinetics of mycophenolate mofetil and its metabolites have not been found to be altered 
in the elderly patients (≥ 65 years) when compared to younger transplant patients. 
 
Patients taking oral contraceptives 
A study of the co-administration of CellCept (1 g BID) and combined oral contraceptives containing 
ethinylestradiol (0.02 mg to 0.04 mg) and levonorgestrel (0.05 mg to 0.15 mg), desogestrel (0.15 mg) 
or gestodene (0.05 mg to 0.10 mg) conducted in 18 non-transplant women (not taking other 
immunosuppressants) over 3 consecutive menstrual cycles showed no clinically relevant influence of 
CellCept on the ovulation suppressing action of the oral contraceptives. Serum levels of LH, FSH and 
progesterone were not significantly affected. The pharmacokinetics of oral contraceptives were 
unaffected by co-administration of CellCept (see also section 4.5). 
 
5.3 Preclinical safety data 
 
In experimental models, mycophenolate mofetil was not tumourigenic. The highest dose tested in the 
animal carcinogenicity studies resulted in approximately 2 – 3 times the systemic exposure (AUC or 
Cmax) observed in renal transplant patients at the recommended clinical dose of 2 g/day and 1.3 – 2 
times the systemic exposure (AUC or Cmax) observed in cardiac transplant patients at the recommended 
clinical dose of 3 g/day. 
 
Two genotoxicity assays (in vitro mouse lymphoma assay and in vivo mouse bone marrow 
micronucleus test) showed a potential of mycophenolate mofetil to cause chromosomal aberrations. 
These effects can be related to the pharmacodynamic mode of action, i.e. inhibition of nucleotide 
synthesis in sensitive cells. Other in vitro tests for detection of gene mutation did not demonstrate 
genotoxic activity. 
 
Mycophenolate mofetil had no effect on fertility of male rats at oral doses up to 20 mg/kg/day. The 
systemic exposure at this dose represents 2 – 3 times the clinical exposure at the recommended clinical 
dose of 2 g/day in renal transplant patients and 1.3 – 2 times the clinical exposure at the recommended 
clinical dose of 3 g/day in cardiac transplant patients. In a female fertility and reproduction study 
conducted in rats, oral doses of 4.5 mg/kg/day caused malformations (including anophthalmia, 
agnathia, and hydrocephaly) in the first generation offspring in the absence of maternal toxicity. The 
systemic exposure at this dose was approximately 0.5 times the clinical exposure at the recommended 
clinical dose of 2 g/day for renal transplant patients and approximately 0.3 times the clinical exposure 
at the recommended clinical dose of 3 g/day for cardiac transplant patients. No effects on fertility or 
reproductive parameters were evident in the dams or in the subsequent generation.  
 
In teratology studies in rats and rabbits, foetal resorptions and malformations occurred in rats at 
6 mg/kg/day (including anophthalmia, agnathia, and hydrocephaly) and in rabbits at 90 mg/kg/day 
(including cardiovascular and renal anomalies, such as ectopia cordis and ectopic kidneys, and 
diaphragmatic and umbilical hernia), in the absence of maternal toxicity. The systemic exposure at 
these levels is approximately equivalent to or less than 0.5 times the clinical exposure at the 
recommended clinical dose of 2 g/day for renal transplant patients and approximately 0.3 times the 
clinical exposure at the recommended clinical dose of 3 g/day for cardiac transplant patients (see 
section 4.6). 
 
The haematopoietic and lymphoid systems were the primary organs affected in toxicology studies 
conducted with mycophenolate mofetil in the rat, mouse, dog and monkey. These effects occurred at 
systemic exposure levels that are equivalent to or less than the clinical exposure at the recommended 
dose of 2 g/day for renal transplant recipients. Gastrointestinal effects were observed in the dog at 
systemic exposure levels equivalent to or less than the clinical exposure at the recommended dose. 
Gastrointestinal and renal effects consistent with dehydration were also observed in the monkey at the 



19 

highest dose (systemic exposure levels equivalent to or greater than clinical exposure). The nonclinical 
toxicity profile of mycophenolate mofetil appears to be consistent with adverse events observed in 
human clinical trials, which now provide safety data of more relevance to the patient population (see 
section 4.8). 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
CellCept capsules 
pregelatinised maize starch 
croscarmellose sodium 
polyvidone (K-90) 
magnesium stearate 
 
Capsule shells 
gelatin 
indigo carmine (E132) 
yellow iron oxide (E172) 
red iron oxide (E172) 
titanium dioxide (E171) 
black iron oxide (E172) 
potassium hydroxide 
shellac. 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf-life 
 
3 years. 
 
6.4 Special precautions for storage 
 
Do not store above 25 °C. Store in the original package in order to protect from moisture. 
 
6.5 Nature and contents of container 
 
PVC/aluminium foil blister strips 
CellCept 250 mg capsules:   1 carton contains 100 capsules (in blister packs of 10) 
     1 carton contains 300 capsules (in blister packs of 10) 
     multipacks containing 300 (3 packs of 100) capsules 
 
Not all pack sizes may be marketed 
 
6.6 Special precautions for disposal 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 



20 

7. MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/96/005/001 CellCept (100 capsules) 
EU/1/96/005/003 CellCept (300 capsules) 
EU/1/96/005/007 CellCept (300 (3x100) capsules multipack) 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 14 February 1996 
Date of latest renewal: 13 March 2006 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu/. 

http://www.ema.europa.eu/


21 

1. NAME OF THE MEDICINAL PRODUCT 
 
CellCept 500 mg powder for concentrate for solution for infusion. 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each vial contains the equivalent of 500 mg mycophenolate mofetil (as hydrochloride salt). 
 
Excipient(s) with known effect 
 
Sodium less than 1 mmol (23 mg) per dose 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Powder for concentrate for solution for infusion. 
 
CellCept 500 mg powder for concentrate for solution for infusion must be reconstituted and further 
diluted with glucose intravenous infusion 5% prior to administration to the patient (see section 6.6). 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
CellCept 500 mg powder for concentrate for solution for infusion is indicated in combination with 
ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving 
allogeneic renal or hepatic transplants. 
 
4.2 Posology and method of administration 
 
Treatment with CellCept should be initiated and maintained by appropriately qualified transplant 
specialists. 
 
CAUTION: CELLCEPT I.V. SOLUTION MUST NOT BE ADMINISTERED BY RAPID OR 
BOLUS INTRAVENOUS INJECTION.  
 
Posology  
 
CellCept 500 mg powder for concentrate for solution for infusion is an alternative dosage form to 
CellCept oral forms (capsules, tablets and powder for oral suspension) that may be administered for up 
to 14 days. The initial dose of CellCept 500 mg powder for concentrate for solution for infusion 
should be given within 24 hours following transplantation. 
 
Renal transplant 
The recommended dose in renal transplant patients is 1 g administered twice daily (2 g daily dose).  
 
Hepatic transplant 
The recommended dose of CellCept for infusion in hepatic transplant patients is 1 g administered 
twice daily (2 g daily dose). IV CellCept should continue for the first 4 days following hepatic 
transplant, with oral CellCept initiated as soon after this as it can be tolerated. The recommended dose 
of oral CellCept in hepatic transplant patients is 1.5 g administered twice daily (3 g daily dose). 
 



22 

Use in special populations 
 
Paediatric population 
The safety and efficacy of CellCept for infusion in paediatric patients have not been established. No 
pharmacokinetic data with CellCept for infusion are available for paediatric renal transplant patients. 
No pharmacokinetic data are available for paediatric patients following hepatic transplants. 
 
Elderly 
The recommended dose of 1 g administered twice a day for renal or hepatic transplant patients is 
appropriate for the elderly.  
 
Renal impairment 
In renal transplant patients with severe chronic renal impairment (glomerular filtration rate 
< 25 ml/min/1.73 m2), outside the immediate post-transplant period, doses greater than 1 g 
administered twice a day should be avoided. These patients should also be carefully observed. No dose 
adjustments are needed in patients experiencing delayed renal graft function post-operatively (see 
section 5.2). No data are available for hepatic transplant patients with severe chronic renal impairment. 
 
Severe hepatic impairment 
No dose adjustments are needed for renal transplant patients with severe hepatic parenchymal disease.  
 
Treatment during rejection episodes 
Mycophenolic acid (MPA) is the active metabolite of mycophenolate mofetil. Renal transplant 
rejection does not lead to changes in MPA pharmacokinetics; dosage reduction or interruption of 
CellCept is not required. No pharmacokinetic data are available during hepatic transplant rejection. 
 
Paediatric population 
No data are available for treatment of first or refractory rejection in paediatric transplant patients. 
 
Method of administration 
 
Following reconstitution to a concentration of 6 mg/ml, CellCept 500 mg powder for concentrate for 
solution for infusion must be administered by slow intravenous infusion over a period of 2 hours by 
either a peripheral or a central vein (see section 6.6). 
 
Precautions to be taken before handling or administering the medicinal product 
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, avoid direct 
contact of the dry powder or prepared solutions of CellCept 500 mg powder for concentrate for 
solution for infusion with skin or mucous membranes. If such contact occurs, wash thoroughly with 
soap and water; rinse eyes with plain water. 
 
For instructions on reconstitution and dilution of the medicinal product before administration, see 
section 6.6. 
 
4.3 Contraindications 
 
• CellCept should not be given to patients with hypersensitivity to mycophenolate mofetil, 

mycophenolic acid or to any of the excipients listed in section 6.1. Hypersensitivity reactions to 
CellCept have been observed (see section 4.8). CellCept 500 mg powder for concentrate for 
solution for infusion is contraindicated in patients who are allergic to polysorbate 80.  

 
• CellCept should not be given to women of childbearing potential who are not using highly 

effective contraception (see section 4.6).  
 

• CellCept treatment should not be initiated in women of childbearing potential without providing 
a pregnancy test result to rule out unintended use in pregnancy (see section 4.6). 

 



23 

• CellCept should not to be used in pregnancy unless there is no suitable alternative treatment to 
prevent transplant rejection (see section 4.6).  

 
• CellCept should not be given to women who are breastfeeding (see section 4.6). 
 
4.4 Special warnings and precautions for use 
 
Neoplasms 
 
Patients receiving immunosuppressive regimens involving combinations of medicinal products, 
including CellCept, are at increased risk of developing lymphomas and other malignancies, 
particularly of the skin (see section 4.8). The risk appears to be related to the intensity and duration of 
immunosuppression rather than to the use of any specific agent.  
As general advice to minimise the risk for skin cancer, exposure to sunlight and UV light should be 
limited by wearing protective clothing and using a sunscreen with a high protection factor. 
 
Infections 
 
Patients treated with immunosuppressants, including CellCept, are at increased risk for opportunistic 
infections (bacterial, fungal, viral and protozoal), fatal infections and sepsis (see section 4.8). Such 
infections include latent viral reactivation, such as hepatitis B or hepatitis C reactivation and infections 
caused by polyomaviruses (BK virus-associated nephropathy, JC virus-associated progressive 
multifocal leukoencephalopathy PML). Cases of hepatitis due to reactivation of hepatitis B or hepatitis 
C have been reported in carrier patients treated with immunosuppressants. These infections are often 
related to a high total immunosuppressive burden and may lead to serious or fatal conditions that 
physicians should consider in the differential diagnosis in immunosuppressed patients with 
deteriorating renal function or neurological symptoms. 
 
There have been reports of hypogammaglobulinaemia in association with recurrent infections in 
patients receiving CellCept in combination with other immunosuppressants. In some of these cases, 
switching CellCept to an alternative immunosuppressant resulted in serum IgG levels returning to 
normal. Patients on CellCept who develop recurrent infections should have their serum 
immunoglobulins measured. In cases of sustained, clinically relevant hypogammaglobulinaemia, 
appropriate clinical action should be considered taking into account the potent cytostatic effects that 
mycophenolic acid has on T- and B-lymphocytes. 
 
There have been published reports of bronchiectasis in adults and children who received CellCept in 
combination with other immunosuppressants. In some of these cases, switching CellCept to another 
immunosuppressant resulted in improvement in respiratory symptoms. The risk of bronchiectasis may 
be linked to hypogammaglobulinaemia or to a direct effect on the lung. There have also been isolated 
reports of interstitial lung disease and pulmonary fibrosis, some of which were fatal (see section 4.8). 
It is recommended that patients who develop persistent pulmonary symptoms, such as cough and 
dyspnoea, are investigated. 
 
Blood and immune system 
 
Patients receiving CellCept should be monitored for neutropenia, which may be related to CellCept 
itself, concomitant medications, viral infections, or some combination of these causes. Patients taking 
CellCept should have complete blood counts weekly during the first month, twice monthly for the 
second and third months of treatment, then monthly through the first year. If neutropenia develops 
(absolute neutrophil count < 1.3 x 103/µl) it may be appropriate to interrupt or discontinue CellCept. 
 
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CellCept in 
combination with other immunosuppressants. The mechanism for mycophenolate mofetil induced 
PRCA is unknown. PRCA may resolve with dose reduction or cessation of CellCept therapy. Changes 
to CellCept therapy should only be undertaken under appropriate supervision in transplant recipients 
in order to minimise the risk of graft rejection (see section 4.8). 



24 

 
Patients receiving CellCept should be instructed to report immediately any evidence of infection, 
unexpected bruising, bleeding or any other manifestation of bone marrow failure. 
 
Patients should be advised that, during treatment with CellCept, vaccinations may be less effective, 
and the use of live attenuated vaccines should be avoided (see section 4.5). Influenza vaccination may 
be of value. Prescribers should refer to national guidelines for influenza vaccination. 
 
Gastro-intestinal 
 
CellCept has been associated with an increased incidence of digestive system adverse events, 
including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation. CellCept 
should be administered with caution in patients with active serious digestive system disease.  
 
CellCept is an IMPDH (inosine monophosphate dehydrogenase) inhibitor. Therefore, it should be 
avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyltransferase 
(HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome. 
 
Interactions 
 
Caution should be exercised when switching combination therapy from regimens containing 
immunosuppressants, which interfere with MPA enterohepatic recirculation, e.g. ciclosporin, to others 
devoid of this effect, e.g. tacrolimus, sirolimus, belatacept, or vice versa, as this might result in 
changes of MPA exposure. Drugs which interfere with MPA’s enterohepatic cycle (e.g. 
cholesterolamine, antibiotics) should be used with caution due to their potential to reduce the plasma 
levels and efficacy of CellCept (see also section 4.5). Some degree of enterohepatic recirculation is 
anticipated following intravenous administration of CellCept. Therapeutic drug monitoring of MPA 
may be appropriate when switching combination therapy (e.g. from ciclosporin to tacrolimus or vice 
versa) or to ensure adequate immunosuppression in patients with high immunological risk (e.g. risk of 
rejection, treatment with antibiotics, addition or removal of an interacting medication). 
 
It is recommended that CellCept should not be administered concomitantly with azathioprine because 
such concomitant administration has not been studied. 
 
The risk/benefit ratio of mycophenolate mofetil in combination with sirolimus has not been 
established (see also section 4.5). 
 
Special populations 
 
Elderly patients may be at an increased risk of adverse events such as certain infections (including 
cytomegalovirus tissue invasive disease) and possibly gastrointestinal haemorrhage and pulmonary 
oedema, compared with younger individuals (see section 4.8). 
 
Teratogenic effects 
 
Mycophenolate is a powerful human teratogen. Spontaneous abortion (rate of 45% to 49%) and 
congenital malformations (estimated rate of 23% to 27%) have been reported following MMF 
exposure during pregnancy. Therefore, CellCept is contraindicated in pregnancy unless there are no 
suitable alternative treatments to prevent transplant rejection. Female patients of childbearing potential 
should be made aware of the risks and follow the recommendations provided in section 4.6 (e.g. 
contraceptive methods, pregnancy testing) prior to, during, and after therapy with CellCept. Physicians 
should ensure that women taking mycophenolate understand the risk of harm to the baby, the need for 
effective contraception, and the need to immediately consult their physician if there is a possibility of 
pregnancy. 
 



25 

Contraception (see section 4.6) 
 
Because of robust clinical evidence showing a high risk of abortion and congenital malformations 
when mycophenolate mofetil is used in pregnancy, every effort to avoid pregnancy during treatment 
should be taken. Therefore, women with childbearing potential must use at least one form of reliable 
contraception (see section 4.3) before starting CellCept therapy, during therapy, and for six weeks 
after stopping the therapy, unless abstinence is the chosen method of contraception. Two 
complementary forms of contraception simultaneously are preferred to minimise the potential for 
contraceptive failure and unintended pregnancy. 
 
For contraception advice for men see section 4.6. 
 
Educational materials 
 
In order to assist patients in avoiding foetal exposure to mycophenolate and to provide additional 
important safety information, the Marketing Authorisation Holder will provide educational materials 
to healthcare professionals. The educational materials will reinforce the warnings about the 
teratogenicity of mycophenolate, provide advice on contraception before therapy is started and 
guidance on the need for pregnancy testing. Full patient information about the teratogenic risk and the 
pregnancy prevention measures should be given by the physician to women of childbearing potential 
and, as appropriate, to male patients. 
 
Additional precautions 
Patients should not donate blood during therapy or for at least 6 weeks following discontinuation of 
mycophenolate. Men should not donate semen during therapy or for 90 days following discontinuation 
of mycophenolate. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Aciclovir  
Higher aciclovir plasma concentrations were observed when mycophenolate mofetil was administered 
with aciclovir in comparison to the administration of aciclovir alone. The changes in MPAG (the 
phenolic glucuronide of MPA) pharmacokinetics (MPAG increased by 8%) were minimal and are not 
considered clinically significant. Because MPAG plasma concentrations are increased in the presence 
of renal impairment, as are aciclovir concentrations, the potential exists for mycophenolate mofetil and 
aciclovir, or its prodrugs, e.g. valaciclovir, to compete for tubular secretion, and further increases in 
concentrations of both substances may occur. 
 
Medicinal products that interfere with enterohepatic recirculation (e.g. cholestyramine, ciclosporin A, 
antibiotics) 
Caution should be used with medicinal products that interfere with enterohepatic recirculation because 
of their potential to reduce the efficacy of CellCept. 
 
Cholestyramine 
Following single dose, oral administration of 1.5 g of mycophenolate mofetil to normal healthy 
subjects pre-treated with 4 g TID of cholestyramine for 4 days, there was a 40% reduction in the AUC 
of MPA (see section 4.4, and section 5.2). Caution should be used during concomitant administration 
because of the potential to reduce efficacy of CellCept. 
 



26 

Ciclosporin A 
Ciclosporin A (CsA) pharmacokinetics are unaffected by mycophenolate mofetil. 
In contrast, if concomitant CsA treatment is stopped, an increase in MPA AUC of around 30% should 
be expected. CsA interferes with MPA enterohepatic recycling, resulting in reduced MPA exposures 
by 30 - 50% in renal transplant patients treated with CellCept and CsA compared with patients 
receiving sirolimus or belatacept and similar doses of CellCept (see also section 4.4). Conversely, 
changes of MPA exposure should be expected when switching patients from CsA to one of the 
immunosuppressants which does not interfere with MPA’s enterohepatic cycle. 
 
Antibiotics eliminating -glucuronidase-producing bacteria in the intestine (e.g. aminoglycoside, 
cephalosporin, fluoroquinolone, and penicillin classes of antibiotics) may interfere with MPAG/MPA 
enterohepatic recirculation, thus leading to reduced systemic MPA exposure. Information concerning 
the following antibiotics is available: 
 
Ciprofloxacin or amoxicillin plus clavulanic acid  
Reductions in pre-dose (trough) MPA concentrations of about 50% have been reported in renal 
transplant recipients in the days immediately following commencement of oral ciprofloxacin or 
amoxicillin plus clavulanic acid. This effect tended to diminish with continued antibiotic use and to 
cease within a few days of antibiotic discontinuation. The change in pre-dose level may not accurately 
represent changes in overall MPA exposure. Therefore, a change in the dose of CellCept should not 
normally be necessary in the absence of clinical evidence of graft dysfunction. However, close clinical 
monitoring should be performed during the combination and shortly after antibiotic treatment. 
 
Norfloxacin and metronidazole 
In healthy volunteers, no significant interaction was observed when CellCept was concomitantly 
administered with norfloxacin or metronidazole separately. However, norfloxacin and metronidazole 
combined reduced the MPA exposure by approximately 30% following a single dose of CellCept. 
 
Trimethoprim/sulfamethoxazole 
No effect on the bioavailability of MPA was observed. 
 
Medicinal products that affect glucuronidation (e.g. isavuconazole, telmisartan) 
Concomitant administration of drugs affecting glucuronidation of MPA may change MPA exposure. 
Caution is therefore recommended when administering these drugs concomitantly with CellCept.  
 
Isavuconazole 
An increase of MPA AUC0-∞ by 35% was observed with concomitant administration of 
isavuconazole. 
 
Telmisartan 
Concomitant administration of telmisartan and CellCept resulted in an approximately 30% decrease of 
MPA concentrations. Telmisartan changes MPA’s elimination by enhancing PPAR gamma 
(peroxisome proliferator-activated receptor gamma) expression, which in turn results in an enhanced 
UGT1A9 expression and activity. When comparing rates of transplant rejection, rates of graft loss or 
adverse event profiles between CellCept patients with and without concomitant telmisartan 
medication, no clinical consequences of the pharmacokinetic drug-drug interaction were seen. 
 
Ganciclovir 
Based on the results of a single dose administration study of recommended doses of oral 
mycophenolate and IV ganciclovir and the known effects of renal impairment on the pharmacokinetics 
of CellCept (see section 4.2) and ganciclovir, it is anticipated that co-administration of these agents 
(which compete for mechanisms of renal tubular secretion) will result in increases in MPAG and 
ganciclovir concentration. No substantial alteration of MPA pharmacokinetics is anticipated and 
CellCept dose adjustment is not required. In patients with renal impairment in whom CellCept and 
ganciclovir or its prodrugs, e.g. valganciclovir, are co-administered, the dose recommendations for 
ganciclovir should be observed and patients should be monitored carefully. 
 



27 

Oral contraceptives 
The pharmacokinetics and pharmacodynamics of oral contraceptives were unaffected by co-
administration of CellCept (see also section 5.2). 
 
Rifampicin 
In patients not also taking ciclosporin, concomitant administration of CellCept and rifampicin resulted 
in a decrease in MPA exposure (AUC0-12h) of 18% to 70%. It is recommended to monitor MPA 
exposure levels and to adjust CellCept doses accordingly to maintain clinical efficacy when rifampicin 
is administered concomitantly. 
 
Sevelamer 
Decrease in MPA Cmax and AUC0-12h by 30% and 25%, respectively, were observed when CellCept 
was concomitantly administered with sevelamer without any clinical consequences (i.e. graft 
rejection). It is recommended, however, to administer CellCept at least one hour before or three hours 
after sevelamer intake to minimise the impact on the absorption of MPA. There are no data on 
CellCept with phosphate binders other than sevelamer. 
 
Tacrolimus 
In hepatic transplant patients initiated on CellCept and tacrolimus, the AUC and Cmax of MPA, the 
active metabolite of CellCept, were not significantly affected by co-administration with tacrolimus. In 
contrast, there was an increase of approximately 20% in tacrolimus AUC when multiple doses of 
CellCept (1.5 g BID) were administered to hepatic transplant patients taking tacrolimus. However, in 
renal transplant patients, tacrolimus concentration did not appear to be altered by CellCept (see also 
section 4.4). 
 
Live vaccines 
Live vaccines should not be given to patients with an impaired immune response. The antibody 
response to other vaccines may be diminished (see also section 4.4). 
 
Paediatric population 
Interaction studies have only been performed in adults. 
 
Potential interaction 
Co-administration of probenecid with mycophenolate mofetil in monkeys raises plasma AUC of 
MPAG by 3-fold. Thus, other substances known to undergo renal tubular secretion may compete with 
MPAG, and thereby raise plasma concentrations of MPAG or the other substance undergoing tubular 
secretion.  
 
4.6 Pregnancy and lactation 
 
Women of childbearing potential 
 
Pregnancy whilst taking mycophenolate must be avoided. Therefore, women of childbearing potential 
must use at least one form of reliable contraception (see section 4.3) before starting CellCept therapy, 
during therapy, and for six weeks after stopping the therapy, unless abstinence is the chosen method of 
contraception. Two complementary forms of contraception simultaneously are preferred. 
 
Pregnancy 
 
CellCept is contraindicated during pregnancy unless there is no suitable alternative treatment to 
prevent transplant rejection. Treatment should not be initiated without providing a negative pregnancy 
test result to rule out unintended use in pregnancy.   
 
Female patients of reproductive potential must be made aware of the increased risk of pregnancy loss 
and congenital malformations at the beginning of the treatment and must be counselled regarding 
pregnancy prevention, and planning. 
 



28 

Before starting CellCept treatment, women of childbearing potential should have two negative serum 
or urine pregnancy tests with a sensitivity of at least 25 mIU/ml in order to exclude unintended 
exposure of the embryo to mycophenolate. It is recommended that the second test should be performed 
8 - 10 days after the first test. For transplants from deceased donors, if it is not possible to perform two 
tests 8 - 10 days apart before treatment starts (because of the timing of transplant organ availability), a 
pregnancy test must be performed immediately before starting treatment and a further test performed 8 
- 10 days later. Pregnancy tests should be repeated as clinically required (e.g. after any gap in 
contraception is reported). Results of all pregnancy tests should be discussed with the patient. Patients 
should be instructed to consult their physician immediately should pregnancy occur. 
 
Mycophenolate is a powerful human teratogen, with an increased risk of spontaneous abortions and 
congenital malformations in case of exposure during pregnancy; 
• Spontaneous abortions have been reported in 45 to 49% of pregnant women exposed to 

mycophenolate mofetil, compared to a reported rate of between 12 and 33% in solid organ 
transplant patients treated with immunosuppressants other than mycophenolate mofetil. 

• Based on literature reports, malformations occurred in 23 to 27% of live births in women 
exposed to mycophenolate mofetil during pregnancy (compared to 2 to 3% of live births in the 
overall population and approximately 4 to 5% of live births in solid organ transplant recipients 
treated with immunosuppressants other than mycophenolate mofetil). 

 
Congenital malformations, including reports of multiple malformations, have been observed post-
marketing in children of patients exposed to CellCept during pregnancy in combination with other 
immunosuppressants. The following malformations were most frequently reported:  
 

• Abnormalities of the ear (e.g. abnormally formed or absent external ear), external auditory 
canal atresia (middle ear); 

• Facial malformations such as cleft lip, cleft palate, micrognathia and hypertelorism of the 
orbits; 

• Abnormalities of the eye (e.g. coloboma); 
• Congenital heart disease such as atrial and ventricular septal defects; 
• Malformations of the fingers (e.g. polydactyly, syndactyly); 
• Tracheo-oesophageal malformations (e.g. oesophageal atresia);  
• Nervous system malformations such as spina bifida; 
• Renal abnormalities. 
 
In addition, there have been isolated reports of the following malformations: 
• Microphthalmia; 
• Congenital choroid plexus cyst; 
• Septum pellucidum agenesis; 
• Olfactory nerve agenesis. 
 
Studies in animals have shown reproductive toxicity (see section 5.3).  
 
Breast-feeding 
 
Mycophenolate mofetil has been shown to be excreted in the milk of lactating rats. It is not known 
whether this substance is excreted in human milk. Because of the potential for serious adverse 
reactions to mycophenolate mofetil in breast-fed infants, CellCept is contraindicated in nursing 
mothers (see section 4.3). 
 
Men 
 
Limited clinical evidence does not indicate an increased risk of malformations or miscarriage 
following paternal exposure to mycophenolate mofetil.  
 
MPA is a powerful teratogen. It is not known if MPA is present in semen. Calculations based on 
animal data show that the maximum amount of MPA that could potentially be transferred to woman is 



29 

so low that it would be unlikely to have an effect. Mycophenolate has been shown to be genotoxic in 
animal studies at concentrations exceeding the human therapeutic exposures only by small margins 
such that the risk of genotoxic effects on sperm cells cannot completely be excluded. 
 
Therefore, the following precautionary measures are recommended: sexually active male patients or 
their female partners are recommended to use reliable contraception during treatment of the male 
patient and for at least 90 days after cessation of mycophenolate mofetil. Male patients of reproductive 
potential should be made aware of and discuss with a qualified healthcare professional the potential 
risks of fathering a child. 
 
4.7 Effects on ability to drive and use machines 
 
CellCept has a moderate influence on the ability to drive and use machines.  
CellCept may cause somnolence, confusion, dizziness, tremor or hypotension, and therefore patients 
are advised to use caution when driving or using machines. 
 
4.8 Undesirable effects 
 
Summary of safety profile 
An estimated total of 1268 patients received CellCept during four clinical trials in the prevention of 
acute organ rejection. Of these, 991 were included in the three renal studies and 277 were included in 
one hepatic study. Azathioprine was the comparator used in the hepatic study and in two of the renal 
studies whilst the other renal study was placebo-controlled. Patients in all study arms also received 
cyclosporine and corticosteroids. The types of adverse reactions reported during post-marketing with 
CellCept are similar to those seen in the controlled renal and hepatic transplant studies. 
 
Diarrhoea, leukopenia, sepsis and vomiting were among the most common and/or serious adverse 
drugs reactions associated with the administration of CellCept in combination with ciclosporin and 
corticosteroids. There is also evidence of a higher frequency of certain types of infections (see section 
4.4).  
 
Tabulated list of adverse reactions 
The adverse drug reactions (ADRs) from clinical trials and post-marketing experience are listed in 
Table 1, by MedDRA system organ class (SOC) along with their frequencies. The corresponding 
frequency category for each adverse drug reaction is based on the following convention: very common 
(≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) 
and very rare (<1/10,000). Due to the large differences observed in the frequency of certain ADRs 
across the different transplant indications, the frequency is presented separately for renal and hepatic 
transplant patients. 
 



30 

Table 1 Summary of adverse drug reactions occurring in patients treated with CellCept reported 
from clinical trials and post-marketing experience 
 

Adverse drug reaction 
 
(MedDRA) 
 
System Organ Class 

Renal 
transplant 
(n = 991) 

Hepatic 
transplant 
(n = 277) 

 
Frequency Frequency 

Infections and infestations  
Bacterial infections Very Common Very Common 
Fungal infections Common Very Common 
Protozoal infections Uncommon Uncommon 
Viral infections Very Common Very Common 
Neoplasms benign, malignant and unspecified (including cysts and polyps)  
Benign neoplasm of skin  Common Common 
Lymphoma Uncommon Uncommon 
Lymphoproliferative disorder Uncommon Uncommon 
Neoplasm Common Common 
Skin cancer Common Uncommon 
Blood and lymphatic system disorders 
Anemia Very Common Very Common 
Aplasia pure red cell Uncommon Uncommon 
Bone marrow failure Uncommon Uncommon 
Ecchymosis Common Common 
Leukocytosis Common Very Common 
Leukopenia Very Common Very Common 
Pancytopenia Common Common 
Pseudolymphoma Uncommon Uncommon 
Thrombocytopenia Common Very Common 
Metabolism and nutrition disorders  
Acidosis Common Common 
Hypercholesterolemia Very Common Common 
Hyperglycemia Common Very Common 
Hyperkalemia Common Very Common 
Hyperlipidemia Common Common 
Hypocalcemia Common Very Common 
Hypokalemia Common Very Common 
Hypomagnesemia Common Very Common 
Hypophosphatemia Very Common Very Common 
Hyperuricaemia Common Common 
Gout Common Common 
Weight decreased Common Common 



31 

Adverse drug reaction 
 
(MedDRA) 
 
System Organ Class 

Renal 
transplant 
(n = 991) 

Hepatic 
transplant 
(n = 277) 

Psychiatric disorders  
Confusional state Common Very Common 
Depression Common Very Common 
Insomnia Common Very Common 
Agitation Uncommon Common 
Anxiety Common Very Common 
Thinking abnormal Uncommon Common 
Nervous system disorders  
Dizziness Common Very Common 
Headache Very Common Very Common 
Hypertonia Common Common 
Paresthesia Common Very Common 
Somnolence Common Common 
Tremor Common Very Common 
Convulsion Common Common 
Dysgeusia Uncommon Uncommon 
Cardiac disorders  
Tachycardia Common Very Common 
Vascular disorders   
Hypertension Very Common Very Common 
Hypotension Common Very Common 
Lymphocele Uncommon Uncommon 
Venous thrombosis Common Common 
Vasodilatation Common Common 
Respiratory, thoracic and mediastinal disorders  
Bronchiectasis Uncommon Uncommon 
Cough Very Common Very Common 
Dyspnea Very Common Very Common 
Interstitial lung disease Uncommon Very Rare 
Pleural effusion Common Very Common 
Pulmonary fibrosis Very Rare Uncommon 
Gastrointestinal disorders 
Abdominal distension Common Very Common 
Abdominal pain Very Common Very Common 
Colitis Common Common 
Constipation Very Common Very Common 
Decreased appetite Common Very Common 
Diarrhea Very Common Very Common 
Dyspepsia Very Common Very Common 
Esophagitis Common Common 
Eructation Uncommon Uncommon 
Flatulence  Common Very Common 



32 

Adverse drug reaction 
 
(MedDRA) 
 
System Organ Class 

Renal 
transplant 
(n = 991) 

Hepatic 
transplant 
(n = 277) 

Gastritis  Common Common 
Gastrointestinal hemorrhage Common Common 
Gastrointestinal ulcer Common Common 
Gingival hyperplasia Common Common 
Ileus Common Common 
Mouth ulceration Common Common 
Nausea Very Common Very Common 
Pancreatitis Uncommon Common 
Stomatitis Common Common 
Vomiting Very Common Very Common 
Immune system disorders  
Hypersenstivity Uncommon Common 
Hypogammaglobulinaemia Uncommon Very Rare 
Hepatobiliary disorders  
Blood alkaline phosphatase increased  Common Common 
Blood lactate dehydrogenase increased  Common Uncommon 
Hepatic enzyme increased  Common Very Common 
Hepatitis Common Very Common 
Hyperbilirubinaemia Common Very Common 
Jaundice Uncommon Common 
Skin and subcutaneous tissue disorders   
Acne Common Common 
Alopecia Common Common 
Rash Common Very Common 
Skin hypertrophy Common Common 
Musculoskeletal and connective tissue disorders  
Arthralgia Common Common 
Muscular weakness Common Common 
Renal and urinary disorders 
Blood creatinine increased Common Very Common 
Blood urea increased Uncommon Very Common 
Hematuria Very Common Common 
Renal impairment Common Very Common 
General disorders and administration site conditions  
Asthenia Very Common Very Common 
Chills Common Very Common 
Edema Very Common Very Common 
Hernia Common Very Common 
Malaise Common Common 
Pain Common Very Common 
Pyrexia Very Common Very Common 

Note: 991 (2 g / 3 g CellCept daily) and 277 (2 g IV / 3 g oral CellCept daily) patients were treated in Phase III studies for the 
prevention of rejection in renal and hepatic transplantation, respectively 



33 

 
Adverse reactions attributable to peripheral venous infusion were phlebitis and thrombosis, both 
observed at 4% in patients treated with CellCept 500 mg powder for concentrate for solution for 
infusion. 
 
Description of selected adverse reactions 
 
Malignancies 
Patients receiving immunosuppressive regimens involving combinations of medicinal products, 
including CellCept, are at increased risk of developing lymphomas and other malignancies, 
particularly of the skin (see section 4.4). Three-year safety data in renal transplant patients did not 
reveal any unexpected changes in incidence of malignancy compared to the 1-year data. Hepatic 
transplant patients were followed for at least 1 year, but less than 3 years.  
 
Infections 
All patients treated with immunosuppressants are at increased risk of bacterial, viral and fungal 
infections (some of which may lead to a fatal outcome), including those caused by opportunistic 
agents and latent viral reactivation. The risk increases with total immunosuppressive load (see section 
4.4). The most serious infections were sepsis, peritonitis, meningitis, endocarditis tuberculosis and 
atypical mycobacterial infection. The most common opportunistic infections in patients receiving 
CellCept (2 g or 3 g daily) with other immunosuppressants in controlled clinical trials in renal and 
hepatic transplant patients followed for at least 1 year were candida mucocutaneous, CMV 
viraemia/syndrome and Herpes simplex. The proportion of patients with CMV viraemia/syndrome was 
13.5%. Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive 
multifocal leukoencephalopathy (PML), have been reported in patients treated with 
immunosuppressants, including CellCept.  
 
Blood and lymphatic disorders  
Cytopenias, including leukopenia, anemia, thrombocytopenia and pancytopenia, are known risks 
associated with mycophenolate mofetil and may lead or contribute to the occurrence of infections and 
hemorrhages (see section 4.4). Agranulocytosis and neutropenia have been reported; therefore, regular 
monitoring of patients taking CellCept is advised (see section 4.4). There have been reports of aplastic 
anaemia and bone marrow failure in patients treated with CellCept, some of which have been fatal.  
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CellCept (see 
section 4.4). 
Isolated cases of abnormal neutrophil morphology, including the acquired Pelger-Huet anomaly, have 
been observed in patients treated with CellCept. These changes are not associated with impaired 
neutrophil function. These changes may suggest a ‘left shift’ in the maturity of neutrophils in 
haematological investigations, which may be mistakenly interpreted as a sign of infection in 
immunosuppressed patients such as those that receive CellCept. 
 
Gastrointestinal disorders 
The most serious gastrointestinal disorders were ulceration and hemorrhage which are known risks 
associated with mycophenolate mofetil. Mouth, esophageal, gastric, duodenal, and intestinal ulcers 
often complicated by hemorrhage, as well as hematemesis, melena, and hemorrhagic forms of gastritis 
and colitis were commonly reported during the pivotal clinical trials. The most common 
gastrointestinal disorders, however, were diarrhea, nausea and vomiting. Endoscopic investigation of 
patients with CellCept-related diarrhea have revealed isolated cases of intestinal villous atrophy (see 
section 4.4). 
 
Hypersensitivity  
Hypersensitivity reactions, including angioneurotic oedema and anaphylactic reaction, have been 
reported. 
 



34 

Pregnancy, puerperium and perinatal conditions 
Cases of spontaneous abortion have been reported in patients exposed to mycophenolate mofetil, 
mainly in the first trimester, see section 4.6. 
 
Congenital disorders 
Congenital malformations have been observed post-marketing in children of patients exposed to 
CellCept in combination with other immunosuppressants, see section 4.6. 
 
Respiratory, thoracic and mediastinal disorders 
There have been isolated reports of interstitial lung disease and pulmonary fibrosis in patients treated 
with CellCept in combination with other immunosuppressants, some of which have been fatal. There 
have also been reports of bronchiectasis in children and adults. 
 
Immune system disorders 
Hypogammaglobulinaemia has been reported in patients receiving CellCept in combination with other 
immunosuppressants. 
 
General disorders and administration site conditions 
Edema, including peripheral, face and scrotal edema, was reported very commonly during the pivotal 
trials. Musculoskeletal pain such as myalgia, and neck and back pain were also very commonly 
reported. 
 
Special populations 
 
Elderly 
Elderly patients (≥ 65 years) may generally be at increased risk of adverse reactions due to 
immunosuppression. Elderly patients receiving CellCept as part of a combination immunosuppressive 
regimen may be at increased risk of certain infections (including cytomegalovirus tissue invasive 
disease) and possibly gastrointestinal haemorrhage and pulmonary oedema, compared to younger 
individuals.  
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Reports of overdoses with mycophenolate mofetil have been received from clinical trials and during 
post-marketing experience. In many of these cases, no adverse events were reported. In those overdose 
cases in which adverse events were reported, the events fall within the known safety profile of the 
medicinal product. 
 
It is expected that an overdose of mycophenolate mofetil could possibly result in oversuppression of 
the immune system and increase susceptibility to infections and bone marrow suppression (see section 
4.4). If neutropenia develops, dosing with CellCept should be interrupted or the dose reduced (see 
section 4.4). 
 
Haemodialysis would not be expected to remove clinically significant amounts of MPA or MPAG. 
Bile acid sequestrants, such as cholestyramine, can remove MPA by decreasing the enterohepatic 
recirculation of the drug (see section 5.2). 
 
 

https://www.ema.europa.eu/documents/template-form/appendix-v-adverse-drug-reaction-reporting-details_en.doc


35 

5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: immunosuppressive agents ATC code L04AA06 
 
Mechanism of action 
 
Mycophenolate mofetil is the 2-morpholinoethyl ester of MPA. MPA is a potent, selective, 
uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase, and therefore 
inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA. 
Because T- and B-lymphocytes are critically dependent for their proliferation on de novo synthesis of 
purines whereas other cell types can utilise salvage pathways, MPA has more potent cytostatic effects 
on lymphocytes than on other cells.  
 
5.2 Pharmacokinetic properties 
 
Distribution 
 
Following intravenous administration, mycophenolate mofetil undergoes rapid and complete 
metabolism to the active metabolite, MPA. The parent substance mycophenolate mofetil can be 
measured systemically during intravenous infusion. MPA at clinically relevant concentrations is 97% 
bound to plasma albumin. 
As a result of enterohepatic recirculation, secondary increases in plasma MPA concentration are 
usually observed at approximately 6 – 12 hours post-dose. A reduction in the AUC of MPA of 
approximately 40% is associated with the co-administration of cholestyramine (4 g TID), indicating 
that there is a significant amount of enterohepatic recirculation.  
 
Biotransformation 
 
MPA is metabolised principally by glucuronyl transferase (isoform UGT1A9) to form the inactive 
phenolic glucuronide of MPA (MPAG). In vivo, MPAG is converted back to free MPA via 
enterohepatic recirculation. A minor acylglucuronide (AcMPAG) is also formed. AcMPAG is 
pharmacologically active and is suspected to be responsible for some of MMF’s side effects 
(diarrhoea, leukopenia). 
 
Elimination 
 
A negligible amount of substance is excreted as MPA (< 1% of the dose) in the urine. Oral 
administration of radiolabelled mycophenolate mofetil results in complete recovery of the 
administered dose, with 93% of the administered dose recovered in the urine and 6% recovered in 
faeces. Most (about 87%) of the administered dose is excreted in the urine as MPAG. 
 
At clinically encountered concentrations, MPA and MPAG are not removed by haemodialysis. 
However, at high MPAG plasma concentrations (> 100 µg/ml), small amounts of MPAG are removed. 
By interfering with enterohepatic recirculation of the drug, bile acid sequestrants such as 
cholestyramine, reduce MPA AUC (see section 4.9). 
MPA’s disposition depends on several transporters. Organic anion-transporting polypeptides (OATPs) 
and multidrug resistance-associated protein 2 (MRP2) are involved in MPA’s disposition; OATP 
isoforms, MRP2 and breast cancer resistance protein (BCRP) are transporters associated with the 
glucuronides’ biliary excretion. Multidrug resistance protein 1 (MDR1) is also able to transport MPA, 
but its contribution seems to be confined to the absorption process. In the kidney, MPA and its 
metabolites potently interact with renal organic anion transporters. 
 
In the early post-transplant period (< 40 days post-transplant), renal, cardiac and hepatic transplant 
patients had mean MPA AUCs approximately 30% lower and Cmax approximately 40% lower 
compared to the late post-transplant period (3 – 6 months post-transplant).  



36 

 
Equivalence with oral dosage forms 
 
MPA AUC values obtained following administration of 1 g BID intravenous CellCept to renal 
transplant patients in the early post-transplant phase are comparable to those observed following 1 g 
BID oral CellCept. In hepatic transplant patients, administration of 1 g BID intravenous CellCept 
followed by 1.5 g BID oral CellCept resulted in MPA AUC values similar to those found in renal 
transplant patients administered 1 g CellCept BID. 
 
Special populations 
 
Renal impairment 
In a single dose study (6 subjects/group), mean plasma MPA AUC observed in subjects with severe 
chronic renal impairment (glomerular filtration rate < 25 ml/min/1.73 m2) were 28 – 75% higher 
relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal 
impairment. The mean single dose MPAG AUC was 3 – 6 fold higher in subjects with severe renal 
impairment than in subjects with mild renal impairment or normal healthy subjects, consistent with the 
known renal elimination of MPAG. Multiple dosing of mycophenolate mofetil in patients with severe 
chronic renal impairment has not been studied. No data are available for hepatic transplant patients 
with severe chronic renal impairment. 
 
Delayed renal graft function 
In patients with delayed renal graft function post-transplant, mean MPA AUC0–12h was comparable to 
that seen in post-transplant patients without delayed graft function. Mean plasma MPAG AUC0-12h was 
2 – 3-fold higher than in post-transplant patients without delayed graft function. There may be a 
transient increase in the free fraction and concentration of plasma MPA in patients with delayed renal 
graft function. Dose adjustment of CellCept does not appear to be necessary. 
 
Hepatic impairment 
In volunteers with alcoholic cirrhosis, hepatic MPA glucuronidation processes were relatively 
unaffected by hepatic parenchymal disease. Effects of hepatic disease on this process probably depend 
on the particular disease. However, hepatic disease with predominantly biliary damage, such as 
primary biliary cirrhosis, may show a different effect.  
 
Elderly 
The pharmacokinetics of mycophenolate mofetil and its metabolites have not been found to be altered 
in the elderly patients (≥ 65 years) when compared to younger transplant patients. 
 
Patients taking oral contraceptives 
A study of the co-administration of CellCept (1 g BID) and combined oral contraceptives containing 
ethinylestradiol (0.02 mg to 0.04 mg) and levonorgestrel (0.05 mg to 0.15 mg), desogestrel (0.15 mg) 
or gestodene (0.05 mg to 0.10 mg) conducted in 18 non-transplant women (not taking other 
immunosuppressants) over 3 consecutive menstrual cycles showed no clinically relevant influence of 
CellCept on the ovulation suppressing action of the oral contraceptives. Serum levels of LH, FSH and 
progesterone were not significantly affected. The pharmacokinetics of oral contraceptives were 
unaffected by co-administration of CellCept (see also section 4.5). 
 
5.3 Preclinical safety data 
 
In experimental models, mycophenolate mofetil was not tumourigenic. The highest dose tested in the 
animal carcinogenicity studies resulted in approximately 2 – 3 times the systemic exposure (AUC or 
Cmax) observed in renal transplant patients at the recommended clinical dose of 2 g/day. 
 
Two genotoxicity assays (in vitro mouse lymphoma assay and in vivo mouse bone marrow 
micronucleus test) showed a potential of mycophenolate mofetil to cause chromosomal aberrations. 
These effects can be related to the pharmacodynamic mode of action, i.e. inhibition of nucleotide 



37 

synthesis in sensitive cells. Other in vitro tests for detection of gene mutation did not demonstrate 
genotoxic activity. 
 
Mycophenolate mofetil had no effect on fertility of male rats at oral doses up to 20 mg/kg/day. The 
systemic exposure at this dose represents 2 – 3 times the clinical exposure at the recommended clinical 
dose of 2 g/day. In a female fertility and reproduction study conducted in rats, oral doses of 
4.5 mg/kg/day caused malformations (including anophthalmia, agnathia, and hydrocephaly) in the first 
generation offspring in the absence of maternal toxicity. The systemic exposure at this dose was 
approximately 0.5 times the clinical exposure at the recommended clinical dose of 2 g/day. No effects 
on fertility or reproductive parameters were evident in the dams or in the subsequent generation.  
 
In teratology studies in rats and rabbits, foetal resorptions and malformations occurred in rats at  
6 mg/kg/day (including anophthalmia, agnathia, and hydrocephaly) and in rabbits at 90 mg/kg/day 
(including cardiovascular and renal anomalies, such as ectopia cordis and ectopic kidneys, and 
diaphragmatic and umbilical hernia), in the absence of maternal toxicity. The systemic exposure at 
these levels is approximately equivalent to or less than 0.5 times the clinical exposure at the 
recommended clinical dose of 2 g/day (see section 4.6). 
 
The haematopoietic and lymphoid systems were the primary organs affected in toxicology studies 
conducted with mycophenolate mofetil in the rat, mouse, dog and monkey. These effects occurred at 
systemic exposure levels that are equivalent to or less than the clinical exposure at the recommended 
dose of 2 g/day. Gastrointestinal effects were observed in the dog at systemic exposure levels 
equivalent to or less than the clinical exposure at the recommended dose. Gastrointestinal and renal 
effects consistent with dehydration were also observed in the monkey at the highest dose (systemic 
exposure levels equivalent to or greater than clinical exposure). The nonclinical toxicity profile of 
mycophenolate mofetil appears to be consistent with adverse events observed in human clinical trials, 
which now provide safety data of more relevance to the patient population (see section 4.8). 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
CellCept 500 mg powder for concentrate for solution for infusion 
polysorbate 80 
citric acid 
hydrochloric acid 
sodium chloride 
 
6.2 Incompatibilities 
 
CellCept 500 mg powder for concentrate for solution for infusion solution should not be mixed or 
administered concurrently via the same catheter with other intravenous medicinal products or infusion 
admixtures. 
 
This medicinal product must not be mixed with other medicinal products except those mentioned in 
section 6.6. 
 
6.3 Shelf-life 
 
Powder for concentrate for solution for infusion: 3 years. 
 
Reconstituted solution and infusion solution: If the infusion solution is not prepared immediately prior 
to administration, the commencement of administration of the infusion solution should be within 
3 hours from reconstitution and dilution of the medicinal product. 
 



38 

6.4 Special precautions for storage 
 
Powder for concentrate for solution for infusion: Do not store above 30 °C. 
 
Reconstituted solution and infusion solution: Store at 15 – 30 °C. 
 
6.5 Nature and contents of container 
 
20 ml type I clear glass vials with grey butyl rubber stopper and aluminium seals with plastic flip-off 
caps. CellCept 500 mg powder for concentrate for solution for infusion is available in packs 
containing 4 vials. 
 
6.6 Special precautions for disposal and other handling 
 
Preparation of Infusion Solution (6 mg/ml) 
 
CellCept 500 mg powder for concentrate for solution for infusion does not contain an antibacterial 
preservative; therefore, reconstitution and dilution of the product must be performed under aseptic 
conditions. 
 
CellCept 500 mg powder for concentrate for solution for infusion must be prepared in two steps: the 
first step is a reconstitution step with glucose intravenous infusion 5% and the second step is a dilution 
step with glucose intravenous infusion 5%. A detailed description of the preparation is given below: 
 
Step 1 
a. Two vials of CellCept 500 mg powder for concentrate for solution for infusion are used for 
preparing each 1 g dose. Reconstitute the content of each vial by injecting 14 ml of glucose 
intravenous infusion 5%. 
 
b. Gently shake the vial to dissolve the medicinal product yielding a slightly yellow solution. 
 
c. Inspect the resulting solution for particulate matter and discolouration prior to further dilution. 
Discard the vial if particulate matter or discolouration is observed.  
 
Step 2 
a. Further dilute the content of the two reconstituted vials (approx. 2 x 15 ml) into 140 ml of 
glucose intravenous infusion 5%. The final concentration of the solution is 6 mg/mL mycophenolate 
mofetil. 
 
b. Inspect the infusion solution for particulate matter or discolouration. Discard the infusion 
solution if particulate matter or discolouration is observed. 
 
If the infusion solution is not prepared immediately prior to administration, the commencement of 
administration of the infusion solution should be within 3 hours from reconstitution and dilution of the 
medicinal product. Keep solutions at 15 – 30°C. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 



39 

 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/96/005/005 CellCept (4 vials) 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 14 February 1996 
Date of latest renewal: 13 March 2006 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu/ 

http://www.ema.europa.eu/


40 

1. NAME OF THE MEDICINAL PRODUCT 
 
CellCept 1 g/5 ml powder for oral suspension. 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each bottle contains 35 g mycophenolate mofetil in 110 g powder for oral suspension. 5 ml of the 
reconstituted suspension contains 1 g of mycophenolate mofetil. 
 
Excipient(s) with known effect 
 
Sodium less than 1 mmol (23 mg) per dose 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Powder for oral suspension. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
CellCept 1 g/5 ml powder for oral suspension is indicated in combination with ciclosporin and 
corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, 
cardiac or hepatic transplants. 
 
4.2 Posology and method of administration 
 
Treatment with CellCept should be initiated and maintained by appropriately qualified transplant 
specialists. 
 
Posology 
 
Use in renal transplant 
 
Adults 
Oral CellCept 1 g/5 ml powder for oral suspension should be initiated within 72 hours following 
transplantation. The recommended dose in renal transplant patients is 1 g administered twice daily (2 g 
daily dose), i.e. 5 ml oral suspension twice daily. 
 
Paediatric population aged 2 to 18 years 
The recommended dose of CellCept 1 g/5 ml powder for oral suspension is 600 mg/m2 administered 
twice daily (up to a maximum of 2 g/10 ml oral suspension daily). As some adverse reactions occur 
with greater frequency in this age group (see section 4.8) compared with adults, temporary dose 
reduction or interruption may be required; these will need to take into account relevant clinical factors 
including severity of reaction. 
 
Paediatric population < 2 years 
There are limited safety and efficacy data in children below the age of 2 years. These are insufficient 
to make dosage recommendations, and therefore use in this age group is not recommended. 
 



41 

Use in cardiac transplant 
 
Adults 
Oral CellCept should be initiated within 5 days following transplantation. The recommended dose in 
cardiac transplant patients is 1.5 g administered twice daily (3 g daily dose). 
 
Paediatric population 
No data are available for paediatric cardiac transplant patients. 
 
Use in hepatic transplant 
 
Adults 
IV CellCept should be administered for the first 4 days following hepatic transplant, with oral 
CellCept initiated as soon after this as it can be tolerated. The recommended oral dose in hepatic 
transplant patients is 1.5 g administered twice daily (3 g daily dose). 
 
Paediatric population 
No data are available for paediatric hepatic transplant patients. 
 
Use in special populations 
 
Elderly 
The recommended dose of 1 g administered twice a day for renal transplant patients and 1.5 g twice a 
day for cardiac or hepatic transplant patients is appropriate for the elderly.  
 
Renal impairment 
In renal transplant patients with severe chronic renal impairment (glomerular filtration rate 
< 25 ml/min/1.73 m2), outside the immediate post-transplant period, doses greater than 1 g 
administered twice a day should be avoided. These patients should also be carefully observed. No dose 
adjustments are needed in patients experiencing delayed renal graft function post-operatively. (see 
section 5.2). No data are available for cardiac or hepatic transplant patients with severe chronic renal 
impairment. 
 
Severe hepatic impairment 
No dose adjustments are needed for renal transplant patients with severe hepatic parenchymal disease. 
No data are available for cardiac transplant patients with severe hepatic parenchymal disease. 
 
Treatment during rejection episodes 
Mycophenolic acid (MPA) is the active metabolite of mycophenolate mofetil. Renal transplant 
rejection does not lead to changes in MPA pharmacokinetics; dosage reduction or interruption of 
CellCept is not required. There is no basis for CellCept dose adjustment following cardiac transplant 
rejection. No pharmacokinetic data are available during hepatic transplant rejection.  
 
Paediatric population 
No data are available for treatment of first or refractory rejection in paediatric transplant patients. 
 
Method of administration 
 
Oral administration. 
Note: If required, CellCept 1 g/5 ml powder for oral suspension can be administered via a nasogastric 
tube with a minimum size of 8 French (minimum 1.7 mm interior diameter). 
 



42 

Precautions to be taken before handling or administering the medicinal product. 
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, avoid 
inhalation or direct contact with skin or mucous membranes of the dry powder as well as direct contact 
of the reconstituted suspension with the skin. If such contact occurs, wash thoroughly with soap and 
water; rinse eyes with plain water. 
 
For instruction on reconstitution of the medicinal product before administration, see section 6.6. 
 
4.3 Contraindications 
 
• CellCept should not be given to patients with hypersensitivity to mycophenolate mofetil, 

mycophenolic acid or to any of the excipients listed in section 6.1. Hypersensitivity reactions to 
CellCept have been observed (see section 4.8).  

 
• CellCept should not be given to women of childbearing potential who are not using highly 

effective contraception (see section 4.6).  
 
• CellCept treatment should not be initiated in women of childbearing potential without providing 

a pregnancy test result to rule out unintended use in pregnancy (see section 4.6). 
 
• CellCept should not be used in pregnancy unless there is no suitable alternative treatment to 

prevent transplant rejection (see section 4.6). 
 
• CellCept should not be given to women who are breastfeeding (see section 4.6). 
 
4.4 Special warnings and precautions for use 
 
Neoplasms 
 
Patients receiving immunosuppressive regimens involving combinations of medicinal products, 
including CellCept, are at increased risk of developing lymphomas and other malignancies, 
particularly of the skin (see section 4.8). The risk appears to be related to the intensity and duration of 
immunosuppression rather than to the use of any specific agent. As general advice to minimise the risk 
for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing 
and using a sunscreen with a high protection factor. 
 
Infections 
 
Patients treated with immunosuppressants, including CellCept, are at increased risk for opportunistic 
infections (bacterial, fungal, viral and protozoal), fatal infections and sepsis (see section 4.8). Such 
infections include latent viral reactivation, such as hepatitis B or hepatitis C reactivation and infections 
caused by polyomaviruses (BK virus-associated nephropathy, JC virus-associated progressive 
multifocal leukoencephalopathy PML). Cases of hepatitis due to reactivation of hepatitis B or hepatitis 
C have been reported in carrier patients treated with immunosuppressants. These infections are often 
related to a high total immunosuppressive burden and may lead to serious or fatal conditions that 
physicians should consider in the differential diagnosis in immunosuppressed patients with 
deteriorating renal function or neurological symptoms. 
 
There have been reports of hypogammaglobulinaemia in association with recurrent infections in 
patients receiving CellCept in combination with other immunosuppressants. In some of these cases 
switching CellCept to an alternative immunosuppressant resulted in serum IgG levels returning to 
normal. Patients on CellCept who develop recurrent infections should have their serum 
immunoglobulins measured. In cases of sustained, clinically relevant hypogammaglobulinaemia, 
appropriate clinical action should be considered taking into account the potent cytostatic effects that 
mycophenolic acid has on T- and B-lymphocytes. 
 



43 

There have been published reports of bronchiectasis in adults and children who received CellCept in 
combination with other immunosuppressants. In some of these cases switching CellCept to another 
immunosuppressant resulted in improvement in respiratory symptoms. The risk of bronchiectasis may 
be linked to hypogammaglobulinaemia or to a direct effect on the lung. There have also been isolated 
reports of interstitial lung disease and pulmonary fibrosis, some of which were fatal (see section 4.8). 
It is recommended that patients who develop persistent pulmonary symptoms, such as cough and 
dyspnoea, are investigated. 
 
Blood and immune system 
 
Patients receiving CellCept should be monitored for neutropenia, which may be related to CellCept 
itself, concomitant medications, viral infections, or some combination of these causes. Patients taking 
CellCept should have complete blood counts weekly during the first month, twice monthly for the 
second and third months of treatment, then monthly through the first year. If neutropenia develops 
(absolute neutrophil count < 1.3 x 103/µl), it may be appropriate to interrupt or discontinue CellCept. 
 
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CellCept in 
combination with other immunosuppressants. The mechanism for mycophenolate mofetil induced 
PRCA is unknown. PRCA may resolve with dose reduction or cessation of CellCept therapy. Changes 
to CellCept therapy should only be undertaken under appropriate supervision in transplant recipients 
in order to minimise the risk of graft rejection (see section 4.8). 
 
Patients receiving CellCept should be instructed to report immediately any evidence of infection, 
unexpected bruising, bleeding or any other manifestation of bone marrow failure. 
 
Patients should be advised, that during treatment with CellCept, vaccinations may be less effective, 
and the use of live attenuated vaccines should be avoided (see section 4.5). Influenza vaccination may 
be of value. Prescribers should refer to national guidelines for influenza vaccination. 
 
Gastro-intestinal 
 
CellCept has been associated with an increased incidence of digestive system adverse events, 
including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation. CellCept 
should be administered with caution in patients with active serious digestive system disease. 
 
CellCept is an IMPDH (inosine monophosphate dehydrogenase) inhibitor. Therefore, it should be 
avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-
transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome. 
 
Interactions 
 
Caution should be exercised when switching combination therapy from regimens containing 
immunosuppressants, which interfere with MPA enterohepatic recirculation, e.g. ciclosporin, to others 
devoid of this effect, e.g. tacrolimus, sirolimus, belatacept, or vice versa, as this might result in 
changes of MPA exposure. Drugs which interfere with MPA’s enterohepatic cycle (e.g. 
cholestyramine, antibiotics) should be used with caution due to their potential to reduce plasma levels 
and efficacy of CellCept (see also section 4.5). Therapeutic drug monitoring of MPA may be 
appropriate when switching combination therapy (e.g. from ciclosporin to tacrolimus or vice versa) or 
to ensure adequate immunosuppression in patients with high immunological risk (e.g. risk of rejection, 
treatment with antibiotics, addition or removal of an interacting medication). 
 
It is recommended that CellCept should not be administered concomitantly with azathioprine because 
such concomitant administration has not been studied. 
 
CellCept 1 g/5 ml powder for oral suspension contains aspartame. Therefore, care should be taken if 
CellCept 1 g/5 ml powder for oral suspension is administered to patients with phenylketonuria (see 
section 6.1) 



44 

 
The risk/benefit ratio of mycophenolate mofetil in combination with sirolimus has not been 
established (see also section 4.5). 
 
This medicinal product contains sorbitol. Patients with rare hereditary problems of fructose intolerance 
should not take this medicine. 
 
Special populations 
 
Elderly patients may be at an increased risk of adverse events such as certain infections (including 
cytomegalovirus tissue invasive disease) and possibly gastrointestinal haemorrhage and pulmonary 
oedema, compared with younger individuals (see section 4.8). 
 
Teratogenic effects 
 
Mycophenolate is a powerful human teratogen. Spontaneous abortion (rate of 45% to 49%) and 
congenital malformations (estimated rate of 23% to 27%) have been reported following MMF 
exposure during pregnancy. Therefore, CellCept is contraindicated in pregnancy unless there are no 
suitable alternative treatments to prevent transplant rejection. Female patients of childbearing potential 
should be made aware of the risks and follow the recommendations provided in section 4.6 (e.g. 
contraceptive methods, pregnancy testing) prior to, during, and after therapy with CellCept. Physicians 
should ensure that women taking mycophenolate understand the risk of harm to the baby, the need for 
effective contraception, and the need to immediately consult their physician if there is a possibility of 
pregnancy. 
 
Contraception (see section 4.6) 
 
Because of robust clinical evidence showing a high risk of abortion and congenital malformations 
when mycophenolate mofetil is used in pregnancy, every effort to avoid pregnancy during treatment 
should be taken. Therefore, women with childbearing potential must use at least one form of reliable 
contraception (see section 4.3) before starting CellCept therapy, during therapy, and for six weeks 
after stopping the therapy, unless abstinence is the chosen method of contraception. Two 
complementary forms of contraception simultaneously are preferred to minimise the potential for 
contraceptive failure and unintended pregnancy. 
 
For contraception advice for men see section 4.6. 
 
Educational materials 
 
In order to assist patients in avoiding foetal exposure to mycophenolate and to provide additional 
important safety information, the Marketing Authorisation Holder will provide educational materials 
to healthcare professionals. The educational materials will reinforce the warnings about the 
teratogenicity of mycophenolate, provide advice on contraception before therapy is started and 
guidance on the need for pregnancy testing. Full patient information about the teratogenic risk and the 
pregnancy prevention measures should be given by the physician to women of childbearing potential 
and, as appropriate, to male patients.  
 
Additional precautions 
Patients should not donate blood during therapy or for at least 6 weeks following discontinuation of 
mycophenolate. Men should not donate semen during therapy or for 90 days following discontinuation 
of mycophenolate. 
 



45 

4.5 Interaction with other medicinal products and other forms of interaction 
 
Aciclovir  
Higher aciclovir plasma concentrations were observed when mycophenolate mofetil was administered 
with aciclovir in comparison to the administration of aciclovir alone. The changes in MPAG (the 
phenolic glucuronide of MPA) pharmacokinetics (MPAG increased by 8%) were minimal and are not 
considered clinically significant. Because MPAG plasma concentrations are increased in the presence 
of renal impairment, as are aciclovir concentrations, the potential exists for mycophenolate mofetil and 
aciclovir, or its prodrugs, e.g. valaciclovir, to compete for tubular secretion and further increases in 
concentrations of both substances may occur. 
 
Antacids and proton pump inhibitors (PPIs) 
Decreased MPA exposure has been observed when antacids, such as magnesium and aluminium 
hydroxides, and PPIs, including lansoprazole and pantoprazole, were administered with CellCept. 
When comparing rates of transplant rejection or rates of graft loss between CellCept patients taking 
PPIs vs. CellCept patients not taking PPIs, no significant differences were seen. These data support 
extrapolation of this finding to all antacids because the reduction in exposure when CellCept was co- 
administered with magnesium and aluminium hydroxides is considerably less than when CellCept was 
co-administered with PPIs. 
 
Medicinal products that interfere with enterohepatic recirculation (e.g. cholestyramine, ciclosporin A,  
antibiotics) 
Caution should be used with medicinal products that interfere with enterohepatic recirculation because 
of their potential to reduce the efficacy of CellCept. 
 
Cholestyramine 
Following single dose administration of 1.5 g of mycophenolate mofetil to normal healthy subjects 
pre-treated with 4 g TID of cholestyramine for 4 days, there was a 40% reduction in the AUC of MPA. 
(see section 4.4, and section 5.2). Caution should be used during concomitant administration because 
of the potential to reduce efficacy of CellCept. 
 
Ciclosporin A 
Ciclosporin A (CsA) pharmacokinetics are unaffected by mycophenolate mofetil. 
In contrast, if concomitant CsA treatment is stopped, an increase in MPA AUC of around 30% should 
be expected. CsA interferes with MPA enterohepatic recycling, resulting in reduced MPA exposures 
by 30 - 50% in renal transplant patients treated with CellCept and CsA compared with patients 
receiving sirolimus or belatacept and similar doses of CellCept (see also section 4.4). Conversely, 
changes of MPA exposure should be expected when switching patients from CsA to one of the 
immunosuppressants which does not interfere with MPA’s enterohepatic cycle. 
 
Antibiotics eliminating β-glucuronidase-producing bacteria in the intestine (e.g. aminoglycoside, 
cephalosporin, fluoroquinolone, and penicillin classes of antibiotics) may interfere with MPAG/MPA 
enterohepatic recirculation, thus leading to reduced systemic MPA exposure. Information concerning 
the following antibiotics is available: 
 
Ciprofloxacin or amoxicillin plus clavulanic acid 
Reductions in pre-dose (trough) MPA concentrations of about 50% have been reported in renal 
transplant recipients in the days immediately following commencement of oral ciprofloxacin or 
amoxicillin plus clavulanic acid. This effect tended to diminish with continued antibiotic use and to 
cease within a few days of antibiotic discontinuation. The change in pre-dose level may not accurately 
represent changes in overall MPA exposure. Therefore, a change in the dose of CellCept should not 
normally be necessary in the absence of clinical evidence of graft dysfunction. However, close clinical 
monitoring should be performed during the combination and shortly after antibiotic treatment. 
 



46 

Norfloxacin and metronidazole 
In healthy volunteers, no significant interaction was observed when CellCept was concomitantly 
administered with norfloxacin or metronidazole separately. However, norfloxacin and metronidazole 
combined reduced the MPA exposure by approximately 30% following a single dose of CellCept. 
 
Trimethoprim/sulfamethoxazole 
No effect on the bioavailability of MPA was observed.  
 
Medicinal products that affect glucuronidation (e.g. isavuconazole, telmisartan) 
Concomitant administration of drugs affecting glucuronidation of MPA may change MPA exposure. 
Caution is therefore recommended when administering these drugs concomitantly with CellCept.  
Isavuconazole 
An increase of MPA AUC0-∞ by 35% was observed with concomitant administration of 
isavuconazole. 
 
Telmisartan 
Concomitant administration of telmisartan and CellCept resulted in an approximately 30% decrease of 
MPA concentrations. Telmisartan changes MPA’s elimination by enhancing PPAR gamma 
(peroxisome proliferator-activated receptor gamma) expression, which in turn results in an enhanced 
UGT1A9 expression and activity. When comparing rates of transplant rejection, rates of graft loss or 
adverse event profiles between CellCept patients with and without concomitant telmisartan 
medication, no clinical consequences of the pharmacokinetic drug-drug interaction were seen. 
 
Ganciclovir 
Based on the results of a single dose administration study of recommended doses of oral 
mycophenolate and IV ganciclovir and the known effects of renal impairment on the pharmacokinetics 
of CellCept (see section 4.2) and ganciclovir, it is anticipated that co-administration of these agents 
(which compete for mechanisms of renal tubular secretion) will result in increases in MPAG and 
ganciclovir concentration. No substantial alteration of MPA pharmacokinetics is anticipated and 
CellCept dose adjustment is not required. In patients with renal impairment in whom CellCept and 
ganciclovir or its prodrugs, e.g. valganciclovir, are co-administered, the dose recommendations for 
ganciclovir should be observed and patients should be monitored carefully. 
 
Oral contraceptives 
The pharmacokinetics and pharmacodynamics of oral contraceptives were unaffected by co-
administration of CellCept (see also section 5.2). 
 
Rifampicin 
In patients not also taking ciclosporin, concomitant administration of CellCept and rifampicin resulted 
in a decrease in MPA exposure (AUC0-12h) of 18% to 70%. It is recommended to monitor MPA 
exposure levels and to adjust CellCept doses accordingly to maintain clinical efficacy when rifampicin 
is administered concomitantly. 
 
Sevelamer 
Decrease in MPA Cmax and AUC0-12h by 30% and 25%, respectively, were observed when CellCept 
was concomitantly administered with sevelamer without any clinical consequences (i.e. graft 
rejection). It is recommended, however, to administer CellCept at least one hour before or three hours 
after sevelamer intake to minimise the impact on the absorption of MPA. There are no data on 
CellCept with phosphate binders other than sevelamer. 
 



47 

Tacrolimus 
In hepatic transplant patients initiated on CellCept and tacrolimus, the AUC and Cmax of MPA, the 
active metabolite of CellCept, were not significantly affected by co-administration with tacrolimus. In 
contrast, there was an increase of approximately 20% in tacrolimus AUC when multiple doses of 
CellCept (1.5 g BID) were administered to hepatic transplant patients taking tacrolimus. However, in 
renal transplant patients, tacrolimus concentration did not appear to be altered by CellCept (see also 
section 4.4). 
 
Live vaccines 
Live vaccines should not be given to patients with an impaired immune response. The antibody 
response to other vaccines may be diminished (see also section 4.4). 
 
Paediatric population 
Interaction studies have only been performed in adults. 
 
Potential interaction 
Co-administration of probenecid with mycophenolate mofetil in monkeys raises plasma AUC of 
MPAG by 3-fold. Thus, other substances known to undergo renal tubular secretion may compete with 
MPAG, and thereby raise plasma concentrations of MPAG or the other substance undergoing tubular 
secretion. 
 
4.6 Pregnancy and lactation 
 
Women of childbearing potential 
 
Pregnancy whilst taking mycophenolate must be avoided. Therefore, women of childbearing potential 
must use at least one form of reliable contraception (see section 4.3) before starting CellCept therapy, 
during therapy, and for six weeks after stopping the therapy, unless abstinence is the chosen method of 
contraception. Two complementary forms of contraception simultaneously are preferred. 
 
Pregnancy 
 
CellCept is contraindicated during pregnancy unless there is no suitable alternative treatment to 
prevent transplant rejection. Treatment should not be initiated without providing a negative pregnancy 
test result to rule out unintended use in pregnancy. 
 
Female patients of reproductive potential must be made aware of the increased risk of pregnancy loss 
and congenital malformations at the beginning of the treatment and must be counselled regarding 
pregnancy prevention and planning.  
 
Before starting CellCept treatment, women of childbearing potential should have two negative serum 
or urine pregnancy tests with a sensitivity of at least 25 mIU/ml in order to exclude unintended 
exposure of the embryo to mycophenolate. It is recommended that the second test should be performed 
8 - 10 days after the first test. For transplants from deceased donors, if it is not possible to perform two 
tests 8 - 10 days apart before treatment starts (because of the timing of transplant organ availability), a 
pregnancy test must be performed immediately before starting treatment and a further test performed 8 
- 10 days later. Pregnancy tests should be repeated as clinically required (e.g. after any gap in 
contraception is reported). Results of all pregnancy tests should be discussed with the patient. Patients 
should be instructed to consult their physician immediately should pregnancy occur.  
 
Mycophenolate is a powerful human teratogen, with an increased risk of spontaneous abortions and 
congenital malformations in case of exposure during pregnancy; 
• Spontaneous abortions have been reported in 45 to 49% of pregnant women exposed to 

mycophenolate mofetil, compared to a reported rate of between 12 and 33% in solid organ 
transplant patients treated with immunosuppressants other than mycophenolate mofetil. 



48 

• Based on literature reports, malformations occurred in 23 to 27% of live births in women 
exposed to mycophenolate mofetil during pregnancy (compared to 2 to 3 % of live births in the 
overall population and approximately 4 to 5% of live births in solid organ transplant recipients 
treated with immunosuppressants other than mycophenolate mofetil). 

 
Congenital malformations, including reports of multiple malformations, have been observed post-
marketing in children of patients exposed to CellCept during pregnancy in combination with other 
immunosuppressants. The following malformations were most frequently reported:  
 
• Abnormalities of the ear (e.g. abnormally formed or absent external ear), external auditory canal 

atresia (middle ear); 
• Facial malformations such as cleft lip, cleft palate, micrognathia and hypertelorism of the orbits; 
• Abnormalities of the eye (e.g. coloboma); 
• Congenital heart disease such as atrial and ventricular septal defects; 
• Malformations of the fingers (e.g. polydactyly, syndactyly); 
• Tracheo-oesophageal malformations (e.g. oesophageal atresia);  
• Nervous system malformations such as spina bifida;  
• Renal abnormalities. 
 
In addition, there have been isolated reports of the following malformations: 
• Microphthalmia; 
• Congenital choroid plexus cyst; 
• Septum pellucidum agenesis; 
• Olfactory nerve agenesis. 
 
Studies in animals have shown reproductive toxicity (see section 5.3).  
 
Breast-feeding 
 
Mycophenolate mofetil has been shown to be excreted in the milk of lactating rats. It is not known 
whether this substance is excreted in human milk. Because of the potential for serious adverse 
reactions to mycophenolate mofetil in breast-fed infants, CellCept is contraindicated in nursing 
mothers (see section 4.3). 
 
Men 
 
Limited clinical evidence does not indicate an increased risk of malformations or miscarriage 
following paternal exposure to mycophenolate mofetil.  
 
MPA is a powerful teratogen. It is not known if MPA is present in semen. Calculations based on 
animal data show that the maximum amount of MPA that could potentially be transferred to woman is 
so low that it would be unlikely to have an effect. Mycophenolate has been shown to be genotoxic in 
animal studies at concentrations exceeding the human therapeutic exposures only by small margins 
such that the risk of genotoxic effects on sperm cells cannot completely be excluded. 
 
Therefore, the following precautionary measures are recommended: sexually active male patients or 
their female partners are recommended to use reliable contraception during treatment of the male 
patient and for at least 90 days after cessation of mycophenolate mofetil. Male patients of reproductive 
potential should be made aware of and discuss with a qualified healthcare professional the potential 
risks of fathering a child. 
 
4.7 Effects on ability to drive and use machines 
 
CellCept has moderate influence on the ability to drive and use machines.  
CellCept may cause somnolence, confusion, dizziness, tremor or hypotension, and therefore patients 
are advised to use caution when driving or using machines. 
 



49 

4.8 Undesirable effects 
 
Summary of safety profile 
An estimated total of 1557 patients received CellCept during five clinical trials in the prevention of 
acute organ rejection. Of these, 991 were included in the three renal studies, 277 were included in one 
hepatic study, and 289 were included in one cardiac study. Azathioprine was the comparator used in 
the hepatic and cardiac studies and in two of the renal studies whilst the other renal study was placebo-
controlled. Patients in all study arms also received cyclosporine and corticosteroids. The types of 
adverse reactions reported during post-marketing with CellCept are similar to those seen in the 
controlled renal, cardiac and hepatic transplant studies. 
 
Diarrhoea, leukopenia, sepsis and vomiting were among the most common and/or serious adverse drug 
reactions associated with the administration of CellCept in combination with ciclosporin and 
corticosteroids. There is evidence of a higher frequency of certain types of infections (see section 4.4). 
 
Tabulated list of adverse reactions 
The adverse drug reactions (ADRs) from clinical trials and post-marketing experience are listed in 
Table 1, by MedDRA system organ class (SOC) along with their frequencies. The corresponding 
frequency category for each adverse drug reaction is based on the following convention: very common 
(≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) 
and very rare (<1/10,000). Due to the large differences observed in the frequency of certain ADRs 
across the different transplant indications, the frequency is presented separately for renal, hepatic and 
cardiac transplant patients.  
 
Table 1 Summary of adverse drug reactions occurring in patients treated with CellCept reported 
from clinical trials and post-marketing experience 
 

Adverse drug reaction 
 
(MedDRA) 
 
System Organ Class 

Renal 
transplant 
n = 991 

Hepatic 
transplant 
n = 277 

Cardiac 
transplant 
n = 289 

 
Frequency Frequency Frequency 

Infections and infestations  
Bacterial infections Very Common Very Common Very Common 
Fungal infections Common Very Common Very Common 
Protozoal infections Uncommon Uncommon Uncommon 
Viral infections Very Common Very Common Very Common 
Neoplasms benign, malignant and unspecified (including cysts and polyps)  
Benign neoplasm of skin  Common Common Common 
Lymphoma Uncommon Uncommon Uncommon 
Lymphoproliferative disorder Uncommon Uncommon Uncommon 
Neoplasm Common Common Common 
Skin cancer Common Uncommon Common 



50 

Adverse drug reaction 
 
(MedDRA) 
 
System Organ Class 

Renal 
transplant 
n = 991 

Hepatic 
transplant 
n = 277 

Cardiac 
transplant 
n = 289 

Blood and lymphatic system disorders 
Anemia Very Common Very Common Very Common 
Aplasia pure red cell Uncommon Uncommon Uncommon 
Bone marrow failure Uncommon Uncommon Uncommon 
Ecchymosis Common Common Very Common 
Leukocytosis Common Very Common Very Common 
Leukopenia Very Common Very Common Very Common 
Pancytopenia Common Common Uncommon 
Pseudolymphoma Uncommon Uncommon Common 
Thrombocytopenia Common Very Common Very Common 
Metabolism and nutrition disorders  
Acidosis Common Common Very Common 
Hypercholesterolemia Very Common Common Very Common 
Hyperglycemia Common Very Common Very Common 
Hyperkalemia Common Very Common Very Common 
Hyperlipidemia Common Common Very Common 
Hypocalcemia Common Very Common Common 
Hypokalemia Common Very Common Very Common 
Hypomagnesemia Common Very Common Very Common 
Hypophosphatemia Very Common Very Common Common 
Hyperuricaemia Common Common Very Common 
Gout Common Common Very Common 
Weight decreased Common Common Common 
Psychiatric disorders  
Confusional state Common Very Common Very Common 
Depression Common Very Common Very Common 
Insomnia Common Very Common Very Common 
Agitation Uncommon Common Very Common 
Anxiety Common Very Common Very Common 
Thinking abnormal Uncommon Common Common 
Nervous system disorders  
Dizziness Common Very Common Very Common 
Headache Very Common Very Common Very Common 
Hypertonia Common Common Very Common 
Paresthesia Common Very Common Very Common 
Somnolence Common Common Very Common 
Tremor Common Very Common Very Common 
Convulsion Common Common Common 
Dysgeusia Uncommon Uncommon Common 
Cardiac disorders  
Tachycardia Common Very Common Very Common 



51 

Adverse drug reaction 
 
(MedDRA) 
 
System Organ Class 

Renal 
transplant 
n = 991 

Hepatic 
transplant 
n = 277 

Cardiac 
transplant 
n = 289 

Vascular disorders   
Hypertension Very Common Very Common Very Common 
Hypotension Common Very Common Very Common 
Lymphocele Uncommon Uncommon Uncommon 
Venous thrombosis Common Common Common 
Vasodilatation Common Common Very Common 
Respiratory, thoracic and mediastinal disorders  
Bronchiectasis Uncommon Uncommon Uncommon 
Cough Very Common Very Common Very Common 
Dyspnea Very Common Very Common Very Common 
Interstitial lung disease Uncommon Very Rare Very Rare 
Pleural effusion Common Very Common Very Common 
Pulmonary fibrosis Very Rare Uncommon Uncommon 
Gastrointestinal disorders 
Abdominal distension Common Very Common Common 
Abdominal pain Very Common Very Common Very Common 
Colitis Common Common Common 
Constipation Very Common Very Common Very Common 
Decreased appetite Common Very Common Very Common 
Diarrhea Very Common Very Common Very Common 
Dyspepsia Very Common Very Common Very Common 
Esophagitis Common Common Common 
Eructation Uncommon Uncommon Common 
Flatulence  Common Very Common Very Common 
Gastritis  Common Common Common 
Gastrointestinal  hemorrhage Common Common Common 
Gastrointestinal ulcer Common Common Common 
Gingival hyperplasia Common Common Common 
Ileus Common Common Common 
Mouth ulceration Common Common Common 
Nausea Very Common Very Common Very Common 
Pancreatitis Uncommon Common Uncommon 
Stomatitis Common Common Common 
Vomiting Very Common Very Common Very Common 
Immune system disorders  
Hypersenstivity Uncommon Common Common 
Hypogammaglobulinaemia Uncommon Very Rare Very Rare 



52 

Adverse drug reaction 
 
(MedDRA) 
 
System Organ Class 

Renal 
transplant 
n = 991 

Hepatic 
transplant 
n = 277 

Cardiac 
transplant 
n = 289 

Hepatobiliary disorders  
Blood alkaline phosphatase 
increased  Common Common Common 
Blood lactate dehydrogenase 
increased  Common Uncommon Very Common 
Hepatic enzyme increased  Common Very Common Very Common 
Hepatitis Common Very Common Uncommon 
Hyperbilirubinaemia Common Very Common Very Common 
Jaundice Uncommon Common Common 
Skin and subcutaneous tissue disorders   
Acne Common Common Very Common 
Alopecia Common Common Common 
Rash Common Very Common Very Common 
Skin hypertrophy Common Common Very Common 
Musculoskeletal and connective tissue disorders  
Arthralgia Common Common Very Common 
Muscular weakness Common Common Very Common 
Renal and urinary disorders 
Blood creatinine increased Common Very Common Very Common 
Blood urea increased Uncommon Very Common Very Common 
Hematuria Very Common Common Common 
Renal impairment Common Very Common Very Common 
General disorders and administration site conditions  
Asthenia Very Common Very Common Very Common 
Chills Common Very Common Very Common 
Edema Very Common Very Common Very Common 
Hernia Common Very Common Very Common 
Malaise Common Common Common 
Pain Common Very Common Very Common 
Pyrexia Very Common Very Common Very Common 

Note: 991 (2 g /3 g CellCept daily), 289 (3 g CellCept daily) and 277 (2 g IV / 3 g oral CellCept daily) patients were treated 
in Phase III studies for the prevention of rejection in renal, cardiac and hepatic transplantation, respectively. 
 
Description of selected adverse reactions 
 
Malignancies 
Patients receiving immunosuppressive regimens involving combinations of medicinal products, 
including CellCept, are at increased risk of developing lymphomas and other malignancies, 
particularly of the skin (see section 4.4). Three-year safety data in renal and cardiac transplant patients 
did not reveal any unexpected changes in incidence of malignancy compared to the 1-year data. 
Hepatic transplant patients were followed for at least 1 year, but less than 3 years.  
 
Infections 
All patients treated with immunosuppressants are at increased risk of bacterial, viral and fungal 
infections (some of which may lead to a fatal outcome), including those caused by opportunistic 
agents and latent viral reactivation. The risk increases with total immunosuppressive load (see section 
4.4). The most serious infections were sepsis, peritonitis, meningitis, endocarditis, tuberculosis and 



53 

atypical mycobacterial infection. The most common opportunistic infections in patients receiving 
CellCept (2 g or 3 g daily) with other immunosuppressants in controlled clinical trials in renal, cardiac 
and hepatic transplant patients followed for at least 1 year were candida mucocutaneous, CMV 
viraemia/syndrome and Herpes simplex. The proportion of patients with CMV viraemia/syndrome was 
13.5%. Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive 
multifocal leukoencephalopathy (PML), have been reported in patients treated with 
immunosuppressants, including CellCept. 
 
Blood and lymphatic disorders  
Cytopenias, including leukopenia, anemia, thrombocytopenia and pancytopenia, are known risks 
associated with mycophenolate mofetil and may lead or contribute to the occurrence of infections and 
hemorrhages (see section 4.4). Agranulocytosis and neutropenia have been reported; therefore, regular 
monitoring of patients taking CellCept is advised (see section 4.4). There have been reports of aplastic 
anaemia and bone marrow failure in patients treated with CellCept, some of which have been fatal.  
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CellCept (see 
section 4.4). 
Isolated cases of abnormal neutrophil morphology, including the acquired Pelger-Huet anomaly, have 
been observed in patients treated with CellCept. These changes are not associated with impaired 
neutrophil function. These changes may suggest a ‘left shift’ in the maturity of neutrophils in 
haematological investigations, which may be mistakenly interpreted as a sign of infection in 
immunosuppressed patients such as those that receive CellCept. 
 
Gastrointestinal disorders 
The most serious gastrointestinal disorders were ulceration and hemorrhage which are known risks 
associated with mycophenolate mofetil. Mouth, esophageal, gastric, duodenal, and intestinal ulcers 
often complicated by hemorrhage, as well as hematemesis, melena, and hemorrhagic forms of gastritis 
and colitis were commonly reported during the pivotal clinical trials. The most common 
gastrointestinal disorders, however, were diarrhea, nausea and vomiting. Endoscopic investigation of 
patients with CellCept-related diarrhea have revealed isolated cases of intestinal villous atrophy (see 
section 4.4). 
 
Hypersensitivity 
Hypersensitivity reactions, including angioneurotic oedema and anaphylactic reaction have been 
reported.  
 
Pregnancy, puerperium and perinatal conditions 
Cases of spontaneous abortion have been reported in patients exposed to mycophenolate mofetil, 
mainly in the first trimester, see section 4.6. 
 
Congenital disorders 
Congenital malformations have been observed post-marketing in children of patients exposed to 
CellCept in combination with other immunosuppressants, see section 4.6. 
 
Respiratory, thoracic and mediastinal disorders 
There have been isolated reports of interstitial lung disease and pulmonary fibrosis in patients treated 
with CellCept in combination with other immunosuppressants, some of which have been fatal. There 
have also been reports of bronchiectasis in children and adults. 
 
Immune system disorders 
Hypogammaglobulinaemia has been reported in patients receiving CellCept in combination with other 
immunosuppressants. 
 
General disorders and administration site conditions 
Edema, including peripheral, face and scrotal edema, was reported very commonly during the pivotal 
trials. Musculoskeletal pain such as myalgia, and neck and back pain were also very commonly 
reported. 



54 

 
Special populations 
 
Paediatric population 
The type and frequency of adverse reactions in a clinical study, which recruited 92 paediatric patients 
aged 2 to 18 years who were given 600 mg/m2 mycophenolate mofetil orally twice daily, were 
generally similar to those observed in adult patients given 1 g CellCept twice daily. However, the 
following treatment-related adverse events were more frequent in the paediatric population, 
particularly in children under 6 years of age, when compared to adults: diarrhoea, sepsis, leukopenia, 
anaemia and infection.  
 
Elderly  
Elderly patients (≥ 65 years) may generally be at increased risk of adverse reactions due to 
immunosuppression. Elderly patients receiving CellCept as part of a combination immunosuppressive 
regimen may be at increased risk of certain infections (including cytomegalovirus tissue invasive 
disease) and possibly gastrointestinal haemorrhage and pulmonary oedema, compared to younger 
individuals.  
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Reports of overdoses with mycophenolate mofetil have been received from clinical trials and during 
post-marketing experience. In many of these cases, no adverse events were reported. In those overdose 
cases in which adverse events were reported, the events fall within the known safety profile of the 
medicinal product. 
 
It is expected that an overdose of mycophenolate mofetil could possibly result in oversuppression of 
the immune system and increase susceptibility to infections and bone marrow suppression (see section 
4.4). If neutropenia develops, dosing with CellCept should be interrupted or the dose reduced (see 
section 4.4). 
 
Haemodialysis would not be expected to remove clinically significant amounts of MPA or MPAG. 
Bile acid sequestrants, such as cholestyramine, can remove MPA by decreasing the enterohepatic 
recirculation of the drug (see section 5.2). 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: immunosuppressive agents ATC code L04AA06 
 
Mechanism of action 
 
Mycophenolate mofetil is the 2-morpholinoethyl ester of MPA. MPA is a potent, selective, 
uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase, and therefore 
inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA. 
Because T- and B-lymphocytes are critically dependent for their proliferation on de novo synthesis of 
purines whereas other cell types can utilise salvage pathways, MPA has more potent cytostatic effects 
on lymphocytes than on other cells.  
 

https://www.ema.europa.eu/documents/template-form/appendix-v-adverse-drug-reaction-reporting-details_en.doc


55 

5.2 Pharmacokinetic properties 
 
Absorption 
 
Following oral administration, mycophenolate mofetil undergoes rapid and extensive absorption and 
complete presystemic metabolism to the active metabolite, MPA. As evidenced by suppression of 
acute rejection following renal transplantation, the immunosuppressant activity of CellCept is 
correlated with MPA concentration. The mean bioavailability of oral mycophenolate mofetil, based on 
MPA AUC, is 94% relative to IV mycophenolate mofetil. Food had no effect on the extent of 
absorption (MPA AUC) of mycophenolate mofetil when administered at doses of 1.5 g BID to renal 
transplant patients. However, MPA Cmax was decreased by 40% in the presence of food. 
Mycophenolate mofetil is not measurable systemically in plasma following oral administration.  
 
Distribution 
 
As a result of enterohepatic recirculation, secondary increases in plasma MPA concentration are 
usually observed at approximately 6 – 12 hours post-dose. A reduction in the AUC of MPA of 
approximately 40% is associated with the co-administration of cholestyramine (4 g TID), indicating 
that there is a significant amount of enterohepatic recirculation. 
MPA at clinically relevant concentrations is 97% bound to plasma albumin. 
 
Biotransformation 
 
MPA is metabolised principally by glucuronyl transferase (isoform UGT1A9) to form the inactive 
phenolic glucuronide of MPA (MPAG). In vivo, MPAG is converted back to free MPA via 
enterohepatic recirculation. A minor acylglucuronide (AcMPAG) is also formed. AcMPAG is 
pharmacologically active and is suspected to be responsible for some of MMF’´s side effects 
(diarrhoea, leukopenia). 
 
Elimination 
 
A negligible amount of substance is excreted as MPA (< 1% of the dose) in the urine. Oral 
administration of radiolabelled mycophenolate mofetil results in complete recovery of the 
administered dose, with 93% of the administered dose recovered in the urine and 6% recovered in the 
faeces. Most (about 87%) of the administered dose is excreted in the urine as MPAG. 
 
At clinically encountered concentrations, MPA and MPAG are not removed by haemodialysis. 
However, at high MPAG plasma concentrations (> 100 µg/ml), small amounts of MPAG are removed. 
By interfering with enterohepatic recirculation of the drug, bile acid sequestrants such as 
cholestyramine, reduce MPA AUC (see section 4.9). 
MPA’s disposition depends on several transporters. Organic anion-transporting polypeptides (OATPs) 
and multidrug resistance-associated protein 2 (MRP2) are involved in MPA’s disposition; OATP 
isoforms, MRP2 and breast cancer resistance protein (BCRP) are transporters associated with the 
glucuronides’ biliary excretion. Multidrug resistance protein 1 (MDR1) is also able to transport MPA, 
but its contribution seems to be confined to the absorption process. In the kidney, MPA and its 
metabolites potently interact with renal organic anion transporters. 
 
In the early post-transplant period (< 40 days post-transplant), renal, cardiac and hepatic transplant 
patients had mean MPA AUCs approximately 30% lower and Cmax approximately 40% lower 
compared to the late post-transplant period (3 – 6 months post-transplant). 
 
Special populations 
 
Renal impairment 
In a single dose study (6 subjects/group), mean plasma MPA AUC observed in subjects with severe 
chronic renal impairment (glomerular filtration rate < 25 ml/min/1.73 m2) were 28 – 75% higher 
relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal 



56 

impairment. The mean single dose MPAG AUC was 3 – 6-fold higher in subjects with severe renal 
impairment than in subjects with mild renal impairment or normal healthy subjects, consistent with the 
known renal elimination of MPAG. Multiple dosing of mycophenolate mofetil in patients with severe 
chronic renal impairment has not been studied. No data are available for cardiac or hepatic transplant 
patients with severe chronic renal impairment. 
 
Delayed renal graft function 
In patients with delayed renal graft function post-transplant, mean MPA AUC0-12h was comparable to 
that seen in post-transplant patients without delayed graft function. Mean plasma MPAG AUC0-12h was 
2 – 3-fold higher than in post-transplant patients without delayed graft function. There may be a 
transient increase in the free fraction and concentration of plasma MPA in patients with delayed renal 
graft function. Dose adjustment of CellCept does not appear to be necessary. 
 
Hepatic impairment 
In volunteers with alcoholic cirrhosis, hepatic MPA glucuronidation processes were relatively 
unaffected by hepatic parenchymal disease. Effects of hepatic disease on this process probably depend 
on the particular disease. However, hepatic disease with predominantly biliary damage, such as 
primary biliary cirrhosis, may show a different effect. 
 
Paediatric population 
Pharmacokinetic parameters were evaluated in 49 paediatric renal transplant patients (aged 2 to 18 
years) given 600 mg/m2 mycophenolate mofetil orally twice daily. This dose achieved MPA AUC 
values similar to those seen in adult renal transplant patients receiving CellCept at a dose of 1 g BID in 
the early and late post-transplant period. MPA AUC values across age groups were similar in the early 
and late post-transplant period. 
 
Elderly  
The pharmacokinetics of mycophenolate mofetil and its metabolites have not been found to be altered 
in the elderly patients (≥ 65 years) when compared to younger patients. 
 
Patients taking oral contraceptives 
A study of the co-administration of CellCept (1 g BID) and combined oral contraceptives containing 
ethinylestradiol (0.02 mg to 0.04 mg) and levonorgestrel (0.05 mg to 0.15 mg), desogestrel (0.15 mg) 
or gestodene (0.05 mg to 0.10 mg) conducted in 18 non-transplant women (not taking other 
immunosuppressants) over 3 consecutive menstrual cycles showed no clinically relevant influence of 
CellCept on the ovulation suppressing action of the oral contraceptives. Serum levels of LH, FSH and 
progesterone were not significantly affected. The pharmacokinetics of oral contraceptives were 
unaffected by co-administration of CellCept (see also section 4.5). 
 
5.3 Preclinical safety data 
 
In experimental models, mycophenolate mofetil was not tumourigenic. The highest dose tested in the 
animal carcinogenicity studies resulted in approximately 2 – 3 times the systemic exposure (AUC or 
Cmax) observed in renal transplant patients at the recommended clinical dose of 2 g/day and 1.3 – 2 
times the systemic exposure (AUC or Cmax) observed in cardiac transplant patients at the recommended 
clinical dose of 3 g/day. 
 
Two genotoxicity assays (in vitro mouse lymphoma assay and in vivo mouse bone marrow 
micronucleus test) showed a potential of mycophenolate mofetil to cause chromosomal aberrations. 
These effects can be related to the pharmacodynamic mode of action, i.e. inhibition of nucleotide 
synthesis in sensitive cells. Other in vitro tests for detection of gene mutation did not demonstrate 
genotoxic activity. 
 
Mycophenolate mofetil had no effect on fertility of male rats at oral doses up to 20 mg/kg/day. The 
systemic exposure at this dose represents 2 – 3 times the clinical exposure at the recommended clinical 
dose of 2 g/day in renal transplant patients and 1.3 – 2 times the clinical exposure at the recommended 
clinical dose of 3 g/day in cardiac transplant patients. In a female fertility and reproduction study 



57 

conducted in rats, oral doses of 4.5 mg/kg/day caused malformations (including anophthalmia, 
agnathia, and hydrocephaly) in the first generation offspring in the absence of maternal toxicity. The 
systemic exposure at this dose was approximately 0.5 times the clinical exposure at the recommended 
clinical dose of 2 g/day for renal transplant patients and approximately 0.3 times the clinical exposure 
at the recommended clinical dose of 3 g/day for cardiac transplant patients. No effects on fertility or 
reproductive parameters were evident in the dams or in the subsequent generation. 
 
In teratology studies in rats and rabbits, foetal resorptions and malformations occurred in rats at 
6 mg/kg/day (including anophthalmia, agnathia, and hydrocephaly) and in rabbits at 90 mg/kg/day 
(including cardiovascular and renal anomalies, such as ectopia cordis and ectopic kidneys, and 
diaphragmatic and umbilical hernia), in the absence of maternal toxicity. The systemic exposure at 
these levels is approximately equivalent to or less than 0.5 times the clinical exposure at the 
recommended clinical dose of 2 g/day for renal transplant patients and approximately 0.3 times the 
clinical exposure at the recommended clinical dose of 3 g/day for cardiac transplant patients (see 
section 4.6). 
 
The haematopoietic and lymphoid systems were the primary organs affected in toxicology studies 
conducted with mycophenolate mofetil in the rat, mouse, dog and monkey. These effects occurred at 
systemic exposure levels that are equivalent to or less than the clinical exposure at the recommended 
dose of 2 g/day for renal transplant recipients. Gastrointestinal effects were observed in the dog at 
systemic exposure levels equivalent to or less than the clinical exposure at the recommended dose. 
Gastrointestinal and renal effects consistent with dehydration were also observed in the monkey at the 
highest dose (systemic exposure levels equivalent to or greater than clinical exposure). The nonclinical 
toxicity profile of mycophenolate mofetil appears to be consistent with adverse events observed in 
human clinical trials, which now provide safety data of more relevance to the patient population (see 
section 4.8). 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
CellCept 1 g/5 ml powder for oral suspension 
sorbitol 
silica, colloidal anhydrous 
sodium citrate 
soybean lecithin 
mixed fruit flavour 
xanthan gum 
aspartame* (E951) 
methyl parahydroxybenzoate (E218) 
citric acid anhydrous 
 
* contains phenylalanine equivalent to 2.78 mg/5 ml of suspension. 
 
6.2 Incompatibilities 
 
This medicinal product must not be mixed with other medicinal products except those mentioned in 
section 6.6. 
 
6.3 Shelf-life 
 
The shelf-life of the powder for oral suspension is 2 years. 
The shelf-life of the reconstituted suspension is 2 months. 
 



58 

6.4 Special precautions for storage 
 
Powder for oral suspension and reconstituted suspension: Do not store above 30 °C. 
 
6.5 Nature and contents of container 
 
Each bottle contains 35 g mycophenolate mofetil in 110 g powder for oral suspension. When 
reconstituted, the volume of the suspension is 175 mL, providing a usable volume of 160 – 165 ml. 
5 ml of the reconstituted suspension contains 1 g of mycophenolate mofetil. 
A bottle adapter and 2 oral dispensers are also provided. 
 
6.6 Special precautions for disposal and other handling 
 
It is recommended that CellCept 1 g/5 ml powder for oral suspension be reconstituted by the 
pharmacist prior to dispensing to the patient. Wearing disposable gloves is recommended during 
reconstitution and when wiping the outer surface of the bottle/cap and the table after reconstitution. 
 
Preparation of suspension 
 
1. Tap the closed bottle several times to loosen the powder. 
2. Measure 94 ml of purified water in a graduated cylinder. 
3. Add approximately half of the total amount of purified water to the bottle and shake the closed 

bottle well for about 1 minute. 
4. Add the remainder of water and shake the closed bottle well for about 1 minute. 
5. Remove child-resistant cap and push bottle adapter into neck of bottle. 
6. Close bottle with child-resistant cap tightly. This will assure the proper seating of the bottle 

adapter in the bottle and child-resistant status of the cap. 
7. Write the date of expiration of the reconstituted suspension on the bottle label. (The shelf-life of 

the reconstituted suspension is two months.) 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/96/005/006 CellCept (1 bottle 110 g) 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 14 February 1996 
Date of latest renewal: 13 March 2006 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu/ 

http://www.ema.europa.eu/


59 

1. NAME OF THE MEDICINAL PRODUCT 
 
CellCept 500 mg film-coated tablets. 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each tablet contains 500 mg mycophenolate mofetil. 
 
Excipient(s) with known effect 
 
Sodium less than 1 mmol (23 mg) per dose 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablets (tablets). 
 
CellCept tablets: lavender-coloured caplet-shaped tablet, engraved with "CellCept 500" on one side 
and "ROCHE" on the other.  
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
CellCept is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute 
transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. 
 
4.2 Posology and method of administration 
 
Treatment with CellCept should be initiated and maintained by appropriately qualified transplant 
specialists. 
 
Posology 
 
Use in renal transplant 
 
Adults 
Oral CellCept should be initiated within 72 hours following transplantation. The recommended dose in 
renal transplant patients is 1 g administered twice daily (2 g daily dose). 
 
Paediatric population aged 2 to 18 years 
The recommended dose of mycophenolate mofetil is 600 mg/m2 administered orally twice daily (up to 
a maximum of 2 g daily). CellCept tablets should only be prescribed to patients with a body surface 
area greater than 1.5 m2, at a dose of 1 g twice daily (2 g daily dose). As some adverse reactions occur 
with greater frequency in this age group (see section 4.8) compared with adults, temporary dose 
reduction or interruption may be required; these will need to take into account relevant clinical factors 
including severity of reaction. 
 
Paediatric population < 2 years 
There are limited safety and efficacy data in children below the age of 2 years. These are insufficient 
to make dosage recommendations and therefore use in this age group is not recommended. 
 



60 

Use in cardiac transplant  
 
Adults 
Oral CellCept should be initiated within 5 days following transplantation. The recommended dose in 
cardiac transplant patients is 1.5 g administered twice daily (3 g daily dose).  
 
Paediatric population 
No data are available for paediatric cardiac transplant patients. 
 
Use in hepatic transplant 
 
Adults 
IV CellCept should be administered for the first 4 days following hepatic transplant, with oral 
CellCept initiated as soon after this as it can be tolerated. The recommended oral dose in hepatic 
transplant patients is 1.5 g administered twice daily (3 g daily dose). 
 
Paediatric population  
No data are available for paediatric hepatic transplant patients. 
 
Use in special populations 
 
Elderly  
The recommended dose of 1 g administered twice a day for renal transplant patients and 1.5 g twice a 
day for cardiac or hepatic transplant patients is appropriate for the elderly. 
 
Renal impairment 
In renal transplant patients with severe chronic renal impairment (glomerular filtration rate 
< 25 ml/min/1.73 m2), outside the immediate post-transplant period, doses greater than 1 g 
administered twice a day should be avoided. These patients should also be carefully observed. No dose 
adjustments are needed in patients experiencing delayed renal graft function post-operatively (see 
section 5.2). No data are available for cardiac or hepatic transplant patients with severe chronic renal 
impairment. 
 
Severe hepatic impairment 
No dose adjustments are needed for renal transplant patients with severe hepatic parenchymal disease. 
No data are available for cardiac transplant patients with severe hepatic parenchymal disease. 
 
Treatment during rejection episodes 
Mycophenolic acid (MPA) is the active metabolite of mycophenolate mofetil. Renal transplant 
rejection does not lead to changes in MPA pharmacokinetics; dosage reduction or interruption of 
CellCept is not required. There is no basis for CellCept dose adjustment following cardiac transplant 
rejection. No pharmacokinetic data are available during hepatic transplant rejection. 
 
Paediatric population 
No data are available for treatment of first or refractory rejection in paediatric transplant patients. 
 
Method of administration 
 
Oral administration. 
 
Precautions to be taken before handling or administering the medicinal product. 
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, CellCept 
tablets should not be crushed. 
 



61 

4.3 Contraindications 
 
• CellCept should not be given to patients with hypersensitivity to mycophenolate mofetil, 

mycophenolic acid or to any of the excipients listed in section 6.1. Hypersensitivity reactions to 
CellCept have been observed (see section 4.8).  

 
• CellCept should not be given to women of childbearing potential who are not using highly 

effective contraception (see section 4.6).  
 

• CellCept treatment should not be initiated in women of childbearing potential without providing 
a pregnancy test result to rule out unintended use in pregnancy (see section 4.6). 

 
• CellCept should not be used during pregnancy unless there is no suitable alternative treatment to 

prevent transplant rejection (see section 4.6). 
 

• CellCept should not be given to women who are breastfeeding (see section 4.6). 
 
4.4 Special warnings and precautions for use 
 
Neoplasms 
 
Patients receiving immunosuppressive regimens involving combinations of medicinal products, 
including CellCept, are at increased risk of developing lymphomas and other malignancies, 
particularly of the skin (see section 4.8). The risk appears to be related to the intensity and duration of 
immunosuppression rather than to the use of any specific agent. As general advice to minimise the risk 
for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing 
and using a sunscreen with a high protection factor. 
 
Infections 
 
Patients treated with immunosuppressants, including CellCept, are at increased risk for opportunistic 
infections (bacterial, fungal, viral and protozoal), fatal infections and sepsis (see section 4.8). Such 
infections include latent viral reactivation, such as hepatitis B or hepatitis C reactivation and infections 
caused by polyomaviruses (BK virus-associated nephropathy, JC virus-associated progressive 
multifocal leukoencephalopathy PML). Cases of hepatitis due to reactivation of hepatitis B or hepatitis 
C have been reported in carrier patients treated with immunosuppressants. These infections are often 
related to a high total immunosuppressive burden and may lead to serious or fatal conditions that 
physicians should consider in the differential diagnosis in immunosuppressed patients with 
deteriorating renal function or neurological symptoms. 
 
There have been reports of hypogammaglobulinaemia in association with recurrent infections in 
patients receiving CellCept in combination with other immunosuppressants. In some of these cases 
switching CellCept to an alternative immunosuppressant resulted in serum IgG levels returning to 
normal. Patients on CellCept who develop recurrent infections should have their serum 
immunoglobulins measured. In cases of sustained, clinically relevant hypogammaglobulinaemia, 
appropriate clinical action should be considered taking into account the potent cytostatic effects that 
mycophenolic acid has on T- and B-lymphocytes. 
 
There have been published reports of bronchiectasis in adults and children who received CellCept in 
combination with other immunosuppressants. In some of these cases switching CellCept to another 
immunosuppressant resulted in improvement in respiratory symptoms. The risk of bronchiectasis may 
be linked to hypogammaglobulinaemia or to a direct effect on the lung. There have also been isolated 
reports of interstitial lung disease and pulmonary fibrosis, some of which were fatal (see section 4.8). 
It is recommended that patients who develop persistent pulmonary symptoms, such as cough and 
dyspnoea, are investigated. 
 



62 

Blood and immune system 
 
Patients receiving CellCept should be monitored for neutropenia, which may be related to CellCept 
itself, concomitant medications, viral infections, or some combination of these causes. Patients taking 
CellCept should have complete blood counts weekly during the first month, twice monthly for the 
second and third months of treatment, then monthly through the first year. If neutropenia develops 
(absolute neutrophil count < 1.3 x 103/µl), it may be appropriate to interrupt or discontinue CellCept. 
 
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CellCept in 
combination with other immunosuppressants. The mechanism for mycophenolate mofetil induced 
PRCA is unknown. PRCA may resolve with dose reduction or cessation of CellCept therapy. Changes 
to CellCept therapy should only be undertaken under appropriate supervision in transplant recipients 
in order to minimise the risk of graft rejection (see section 4.8). 
 
Patients receiving CellCept should be instructed to report immediately any evidence of infection, 
unexpected bruising, bleeding or any other manifestation of bone marrow failure. 
 
Patients should be advised that, during treatment with CellCept, vaccinations may be less effective, 
and the use of live attenuated vaccines should be avoided (see section 4.5). Influenza vaccination may 
be of value. Prescribers should refer to national guidelines for influenza vaccination. 
 
Gastro-intestinal 
 
CellCept has been associated with an increased incidence of digestive system adverse events, 
including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation. CellCept 
should be administered with caution in patients with active serious digestive system disease.  
 
CellCept is an IMPDH (inosine monophosphate dehydrogenase) inhibitor. Therefore, it should be 
avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-
transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome. 
 
Interactions 
 
Caution should be exercised when switching combination therapy from regimens containing 
immunosuppressants, which interfere with MPA enterohepatic recirculation, e.g. ciclosporin, to others 
devoid of this effect, e.g. tacrolimus, sirolimus, belatacept, or vice versa, as this might result in 
changes of MPA exposure. Drugs which interfere with MPA’s enterohepatic cycle (e.g. 
cholestyramine, antibiotics) should be used with caution due to their potential to reduce the plasma 
level and efficacy of CellCept (see also section 4.5). Therapeutic drug monitoring of MPA may be 
appropriate when switching combination therapy (e.g. from ciclosporin to tacrolimus or vice versa) or 
to ensure adequate immunosuppression in patients with high immunological risk (e.g. risk of rejection, 
treatment with antibiotics, addition or removal of an interacting medication). 
 
It is recommended that CellCept should not be administered concomitantly with azathioprine because 
such concomitant administration has not been studied. 
 
The risk/benefit ratio of mycophenolate mofetil in combination with sirolimus has not been 
established (see also section 4.5). 
 
Special populations 
 
Elderly patients may be at an increased risk of adverse events such as certain infections (including 
cytomegalovirus tissue invasive disease) and possibly gastrointestinal haemorrhage and pulmonary 
oedema, compared with younger individuals (see section 4.8). 
 



63 

Teratogenic effects 
 
Mycophenolate is a powerful human teratogen. Spontaneous abortion (rate of 45% to 49%) and 
congenital malformations (estimated rate of 23% to 27%) have been reported following MMF 
exposure during pregnancy. Therefore, CellCept is contraindicated in pregnancy unless there are no 
suitable alternative treatments to prevent transplant rejection. Female patients of childbearing potential 
should be made aware of the risks and follow the recommendations provided in section 4.6 (e.g. 
contraceptive methods, pregnancy testing) prior to, during, and after therapy with CellCept. Physicians 
should ensure that women taking mycophenolate understand the risk of harm to the baby, the need for 
effective contraception, and the need to immediately consult their physician if there is a possibility of 
pregnancy. 
 
Contraception (see section 4.6) 
 
Because of robust clinical evidence showing a high risk of abortion and congenital malformations 
when mycophenolate mofetil is used in pregnancy, every effort to avoid pregnancy during treatment 
should be taken. Therefore, women with childbearing potential must use at least one form of reliable 
contraception (see section 4.3) before starting CellCept therapy, during therapy, and for six weeks 
after stopping the therapy, unless abstinence is the chosen method of contraception. Two 
complementary forms of contraception simultaneously are preferred to minimise the potential for 
contraceptive failure and unintended pregnancy. 
 
For contraception advice for men see section 4.6. 
 
Educational materials 
 
In order to assist patients in avoiding foetal exposure to mycophenolate and to provide additional 
important safety information, the Marketing Authorisation Holder will provide educational materials 
to healthcare professionals. The educational materials will reinforce the warnings about the 
teratogenicity of mycophenolate, provide advice on contraception before therapy is started and 
guidance on the need for pregnancy testing. Full patient information about the teratogenic risk and the 
pregnancy prevention measures should be given by the physician to women of childbearing potential 
and, as appropriate, to male patients.  
 
Additional precautions 
Patients should not donate blood during therapy or for at least 6 weeks following discontinuation of 
mycophenolate. Men should not donate semen during therapy or for 90 days following discontinuation 
of mycophenolate. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Aciclovir 
Higher aciclovir plasma concentrations were observed when mycophenolate mofetil was administered 
with aciclovir in comparison to the administration of aciclovir alone. The changes in MPAG (the 
phenolic glucuronide of MPA) pharmacokinetics (MPAG increased by 8%) were minimal and are not 
considered clinically significant. Because MPAG plasma concentrations are increased in the presence 
of renal impairment, as are aciclovir concentrations, the potential exists for mycophenolate mofetil and 
aciclovir, or its prodrugs, e.g. valaciclovir, to compete for tubular secretion and further increases in 
concentrations of both substances may occur. 
 
Antacids and proton pump inhibitors (PPIs) 
Decreased MPA exposure has been observed when antacids, such as magnesium and aluminium 
hydroxides, and PPIs, including lansoprazole and pantoprazole, were administered with CellCept. 
When comparing rates of transplant rejection or rates of graft loss between CellCept patients taking 
PPIs vs. CellCept patients not taking PPIs, no significant differences were seen. These data support 
extrapolation of this finding to all antacids because the reduction in exposure when CellCept was co- 



64 

administered with magnesium and aluminium hydroxides is considerably less than when CellCept was 
co-administered with PPIs. 
 
Medicinal products that interfere with enterohepatic recirculation (e.g. cholestyramine, ciclosporin A,  
antibiotics) 
Caution should be used with medicinal products that interfere with enterohepatic recirculation because 
of their potential to reduce the efficacy of CellCept. 
 
Cholestyramine 
Following single dose administration of 1.5 g of mycophenolate mofetil to normal healthy subjects 
pre-treated with 4 g TID of cholestyramine for 4 days, there was a 40% reduction in the AUC of MPA 
(see section 4.4 and section 5.2). Caution should be used during concomitant administration because 
of the potential to reduce efficacy of CellCept. 
 
Ciclosporin A 
Ciclosporin A (CsA) pharmacokinetics are unaffected by mycophenolate mofetil. 
In contrast, if concomitant CsA treatment is stopped, an increase in MPA AUC of around 30% should 
be expected. CsA interferes with MPA enterohepatic recycling, resulting in reduced MPA exposures 
by 30 - 50% in renal transplant patients treated with CellCept and CsA compared with patients 
receiving sirolimus or belatacept and similar doses of CellCept (see also section 4.4). Conversely, 
changes of MPA exposure should be expected when switching patients from CsA to one of the 
immunosuppressants which does not interfere with MPA’s enterohepatic cycle. 
 
Antibiotics eliminating -glucuronidase-producing bacteria in the intestine (e.g. aminoglycoside, 
cephalosporin, fluoroquinolone, and penicillin classes of antibiotics) may interfere with MPAG/MPA 
enterohepatic recirculation, thus leading to reduced systemic MPA exposure. Information concerning 
the following antibiotics is available: 
 
Ciprofloxacin or amoxicillin plus clavulanic acid 
Reductions in pre-dose (trough) MPA concentrations of about 50% have been reported in renal 
transplant recipients in the days immediately following commencement of oral ciprofloxacin or 
amoxicillin plus clavulanic acid. This effect tended to diminish with continued antibiotic use and to 
cease within a few days of antibiotic discontinuation. The change in pre-dose level may not accurately 
represent changes in overall MPA exposure. Therefore, a change in the dose of CellCept should not 
normally be necessary in the absence of clinical evidence of graft dysfunction. However, close clinical 
monitoring should be performed during the combination and shortly after antibiotic treatment. 
 
Norfloxacin and metronidazole 
In healthy volunteers, no significant interaction was observed when CellCept was concomitantly 
administered with norfloxacin or metronidazole separately. However, norfloxacin and metronidazole 
combined reduced the MPA exposure by approximately 30% following a single dose of CellCept. 
 
Trimethoprim/sulfamethoxazole 
No effect on the bioavailability of MPA was observed.  
 
Medicinal products that affect glucuronidation (e.g. isavuconazole, telmisartan) 
Concomitant administration of drugs affecting glucuronidation of MPA may change MPA exposure. 
Caution is therefore recommended when administering these drugs concomitantly with CellCept.  
 
Isavuconazole 
An increase of MPA AUC0-∞ by 35% was observed with concomitant administration of 
isavuconazole. 
 



65 

Telmisartan 
Concomitant administration of telmisartan and CellCept resulted in an approximately 30% decrease of 
MPA concentrations. Telmisartan changes MPA’s elimination by enhancing PPAR gamma 
(peroxisome proliferator-activated receptor gamma) expression, which in turn results in an enhanced 
UGT1A9 expression and activity. When comparing rates of transplant rejection, rates of graft loss or 
adverse event profiles between CellCept patients with and without concomitant telmisartan 
medication, no clinical consequences of the pharmacokinetic drug-drug interaction were seen. 
 
Ganciclovir 
Based on the results of a single dose administration study of recommended doses of oral 
mycophenolate and IV ganciclovir and the known effects of renal impairment on the pharmacokinetics 
of CellCept (see section 4.2) and ganciclovir, it is anticipated that co-administration of these agents 
(which compete for mechanisms of renal tubular secretion) will result in increases in MPAG and 
ganciclovir concentration. No substantial alteration of MPA pharmacokinetics is anticipated and 
CellCept dose adjustment is not required. In patients with renal impairment in whom CellCept and 
ganciclovir or its prodrugs, e.g. valganciclovir, are co-administered, the dose recommendations for 
ganciclovir should be observed and patients should be monitored carefully. 
 
Oral contraceptives 
The pharmacokinetics and pharmacodynamics of oral contraceptives were unaffected by co-
administration of CellCept (see also section 5.2). 
 
Rifampicin 
In patients not also taking ciclosporin, concomitant administration of CellCept and rifampicin resulted 
in a decrease in MPA exposure (AUC0-12h) of 18% to 70%. It is recommended to monitor MPA 
exposure levels and to adjust CellCept doses accordingly to maintain clinical efficacy when rifampicin 
is administered concomitantly. 
 
Sevelamer 
Decrease in MPA Cmax and AUC0-12h by 30% and 25%, respectively, were observed when CellCept 
was concomitantly administered with sevelamer without any clinical consequences (i.e. graft 
rejection). It is recommended, however, to administer CellCept at least one hour before or three hours 
after sevelamer intake to minimise the impact on the absorption of MPA. There are no data on 
CellCept with phosphate binders other than sevelamer. 
 
Tacrolimus 
In hepatic transplant patients initiated on CellCept and tacrolimus, the AUC and Cmax of MPA, the 
active metabolite of CellCept, were not significantly affected by co-administration with tacrolimus. In 
contrast, there was an increase of approximately 20% in tacrolimus AUC when multiple doses of 
CellCept (1.5 g BID) were administered to hepatic transplant patients taking tacrolimus. However, in 
renal transplant patients, tacrolimus concentration did not appear to be altered by CellCept (see also 
section 4.4). 
 
Live vaccines 
Live vaccines should not be given to patients with an impaired immune response. The antibody 
response to other vaccines may be diminished (see also 4.4). 
 
Paediatric population 
Interaction studies have only been performed in adults. 
 
Potential interaction 
Co-administration of probenecid with mycophenolate mofetil in monkeys raises plasma AUC of 
MPAG by 3-fold. Thus, other substances known to undergo renal tubular secretion may compete with 
MPAG, and thereby raise plasma concentrations of MPAG or the other substance undergoing tubular 
secretion.  
 



66 

4.6 Pregnancy and lactation 
 
Women of childbearing potential 
 
Pregnancy whilst taking mycophenolate must be avoided. Therefore, women of childbearing potential 
must use at least one form of reliable contraception (see section 4.3) before starting CellCept therapy, 
during therapy, and for six weeks after stopping the therapy, unless abstinence is the chosen method of 
contraception. Two complementary forms of contraception simultaneously are preferred. 
 
Pregnancy 
 
CellCept is contraindicated during pregnancy unless there is no suitable alternative treatment to 
prevent transplant rejection. Treatment should not be initiated without providing a negative pregnancy 
test result to rule out unintended use in pregnancy (see section 4.3). 
 
Female patients of reproductive potential must be made aware of the increased risk of pregnancy loss 
and congenital malformations at the beginning of the treatment and must be counselled regarding 
pregnancy prevention and planning. 
 
Before starting CellCept treatment, women of childbearing potential should have two negative serum 
or urine pregnancy tests with a sensitivity of at least 25 mIU/ml in order to exclude unintended 
exposure of the embryo to mycophenolate. It is recommended that the second test should be performed 
8 - 10 days after the first test. For transplants from deceased donors, if it is not possible to perform two 
tests 8 - 10 days apart before treatment starts (because of the timing of transplant organ availability), a 
pregnancy test must be performed immediately before starting treatment and a further test performed 8 
- 10 days later. Pregnancy tests should be repeated as clinically required (e.g. after any gap in 
contraception is reported. Results of all pregnancy tests should be discussed with the patient. Patients 
should be instructed to consult their physician immediately should pregnancy occur. 
 
Mycophenolate is a powerful human teratogen, with an increased risk of spontaneous abortions and 
congenital malformations in case of exposure during pregnancy; 
• Spontaneous abortions have been reported in 45 to 49% of pregnant women exposed to 

mycophenolate mofetil, compared to a reported rate of between 12 and 33% in solid organ 
transplant patients treated with immunosuppressants other than mycophenolate mofetil. 

• Based on literature reports, malformations occurred in 23 to 27% of live births in women 
exposed to mycophenolate mofetil during pregnancy (compared to 2 to 3% of live births in the 
overall population and approximately 4 to 5% of live births in solid organ transplant recipients 
treated with immunosuppressants other than mycophenolate mofetil). 

 
Congenital malformations, including reports of multiple malformations, have been observed post-
marketing in children of patients exposed to CellCept during pregnancy in combination with other 
immunosuppressants. The following malformations were most frequently reported:  
• Abnormalities of the ear (e.g. abnormally formed or absent external ear), external auditory 

canal atresia (middle ear); 
• Facial malformations such as cleft lip, cleft palate, micrognathia and hypertelorism of the 

orbits; 
• Abnormalities of the eye (e.g. coloboma); 
• Congenital heart disease such as atrial and ventricular septal defects; 
• Malformations of the fingers (e.g. polydactyly, syndactyly); 
• Tracheo-oesophageal malformations (e.g. oesophageal atresia);  
• Nervous system malformations such as spina bifida;  
• Renal abnormalities. 
 
In addition, there have been isolated reports of the following malformations: 
• Microphthalmia; 
• Congenital choroid plexus cyst; 
• Septum pellucidum agenesis; 



67 

• Olfactory nerve agenesis. 
 
Studies in animals have shown reproductive toxicity (see section 5.3).  
 
Breast-feeding 
 
Mycophenolate mofetil has been shown to be excreted in the milk of lactating rats. It is not known 
whether this substance is excreted in human milk. Because of the potential for serious adverse 
reactions to mycophenolate mofetil in breast-fed infants, CellCept is contraindicated in nursing 
mothers (see section 4.3). 
 
Men 
 
Limited clinical evidence does not indicate an increased risk of malformations or miscarriage 
following paternal exposure to mycophenolate mofetil.  
 
MPA is a powerful teratogen. It is not known if MPA is present in semen. Calculations based on 
animal data show that the maximum amount of MPA that could potentially be transferred to woman is 
so low that it would be unlikely to have an effect. Mycophenolate has been shown to be genotoxic in 
animal studies at concentrations exceeding the human therapeutic exposures only by small margins 
such that the risk of genotoxic effects on sperm cells cannot completely be excluded. 
 
Therefore, the following precautionary measures are recommended: sexually active male patients or 
their female partners are recommended to use reliable contraception during treatment of the male 
patient and for at least 90 days after cessation of mycophenolate mofetil. Male patients of reproductive 
potential should be made aware of and discuss with a qualified healthcare professional the potential 
risks of fathering a child. 
 
4.7 Effects on ability to drive and use machines 
 
CellCept has a moderate influence on the ability to drive and use machines.  
CellCept may cause somnolence, confusion, dizziness, tremor or hypotension, and therefore patients 
are advised to use caution when driving or using machines. 
 
4.8 Undesirable effects 
 
Summary of safety profile 
An estimated total of 1557 patients received CellCept during five clinical trials in the prevention of 
acute organ rejection. Of these, 991 were included in the three renal studies, 277 were included in one 
hepatic study, and 289 were included in one cardiac study. Azathioprine was the comparator used in 
the hepatic and cardiac studies and in two of the renal studies whilst the other renal study was placebo-
controlled. Patients in all study arms also received cyclosporine and corticosteroids. The types of 
adverse reactions reported during post-marketing with CellCept are similar to those seen in the 
controlled renal, cardiac and hepatic transplant studies. 
 
Diarrhoea, leukopenia, sepsis and vomiting were among the most common and/or serious adverse drug 
reactions associated with the administration of CellCept in combination with ciclosporin and 
corticosteroids. There is evidence of a higher frequency of certain types of infections (see section 4.4). 
 
Tabulated list of adverse reactions 
The adverse drug reactions (ADRs) from clinical trials and post-marketing experience are listed in 
Table 1, by MedDRA system organ class (SOC) along with their frequencies. The corresponding 
frequency category for each adverse drug reaction is based on the following convention: very common 
(≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) 
and very rare (<1/10,000). Due to the large differences observed in the frequency of certain ADRs 
across the different transplant indications, the frequency is presented separately for renal, hepatic and 
cardiac transplant patients. 



68 

 
Table 1 Summary of adverse drug reactions occurring in patients treated with CellCept  
reported from clinical trials and post-marketing experience 
 

Adverse drug reaction 
 
(MedDRA) 
 
System Organ Class 

Renal 
transplant 
n = 991 

Hepatic 
transplant 
n = 277 

Cardiac 
transplant 
n = 289 

 
Frequency Frequency Frequency 

Infections and infestations  
Bacterial infections Very Common Very Common Very Common 
Fungal infections Common Very Common Very Common 
Protozoal infections Uncommon Uncommon Uncommon 
Viral infections Very Common Very Common Very Common 
Neoplasms benign, malignant and unspecified (including cysts and polyps)  
Benign neoplasm of skin  Common Common Common 
Lymphoma Uncommon Uncommon Uncommon 
Lymphoproliferative disorder Uncommon Uncommon Uncommon 
Neoplasm Common Common Common 
Skin cancer Common Uncommon Common 
Blood and lymphatic system disorders 
Anemia Very Common Very Common Very Common 
Aplasia pure red cell Uncommon Uncommon Uncommon 
Bone marrow failure Uncommon Uncommon Uncommon 
Ecchymosis Common Common Very Common 
Leukocytosis Common Very Common Very Common 
Leukopenia Very Common Very Common Very Common 
Pancytopenia Common Common Uncommon 
Pseudolymphoma Uncommon Uncommon Common 
Thrombocytopenia Common Very Common Very Common 
Metabolism and nutrition disorders  
Acidosis Common Common Very Common 
Hypercholesterolemia Very Common Common Very Common 
Hyperglycemia Common Very Common Very Common 
Hyperkalemia Common Very Common Very Common 
Hyperlipidemia Common Common Very Common 
Hypocalcemia Common Very Common Common 
Hypokalemia Common Very Common Very Common 
Hypomagnesemia Common Very Common Very Common 
Hypophosphatemia Very Common Very Common Common 
Hyperuricaemia Common Common Very Common 
Gout Common Common Very Common 
Weight decreased Common Common Common 



69 

Adverse drug reaction 
 
(MedDRA) 
 
System Organ Class 

Renal 
transplant 
n = 991 

Hepatic 
transplant 
n = 277 

Cardiac 
transplant 
n = 289 

Psychiatric disorders  
Confusional state Common Very Common Very Common 
Depression Common Very Common Very Common 
Insomnia Common Very Common Very Common 
Agitation Uncommon Common Very Common 
Anxiety Common Very Common Very Common 
Thinking abnormal Uncommon Common Common 
Nervous system disorders  
Dizziness Common Very Common Very Common 
Headache Very Common Very Common Very Common 
Hypertonia Common Common Very Common 
Paresthesia Common Very Common Very Common 
Somnolence Common Common Very Common 
Tremor Common Very Common Very Common 
Convulsion Common Common Common 
Dysgeusia Uncommon Uncommon Common 
Cardiac disorders  
Tachycardia Common Very Common Very Common 
Vascular disorders   
Hypertension Very Common Very Common Very Common 
Hypotension Common Very Common Very Common 
Lymphocele Uncommon Uncommon Uncommon 
Venous thrombosis Common Common Common 
Vasodilatation Common Common Very Common 
Respiratory, thoracic and mediastinal disorders  
Bronchiectasis Uncommon Uncommon Uncommon 
Cough Very Common Very Common Very Common 
Dyspnea Very Common Very Common Very Common 
Interstitial lung disease Uncommon Very Rare Very Rare 
Pleural effusion Common Very Common Very Common 
Pulmonary fibrosis Very Rare Uncommon Uncommon 
Gastrointestinal disorders 
Abdominal distension Common Very Common Common 
Abdominal pain Very Common Very Common Very Common 
Colitis Common Common Common 
Constipation Very Common Very Common Very Common 
Decreased appetite Common Very Common Very Common 
Diarrhea Very Common Very Common Very Common 
Dyspepsia Very Common Very Common Very Common 
Esophagitis Common Common Common 
Eructation Uncommon Uncommon Common 
Flatulence  Common Very Common Very Common 



70 

Adverse drug reaction 
 
(MedDRA) 
 
System Organ Class 

Renal 
transplant 
n = 991 

Hepatic 
transplant 
n = 277 

Cardiac 
transplant 
n = 289 

Gastritis  Common Common Common 
Gastrointestinal hemorrhage Common Common Common 
Gastrointestinal ulcer Common Common Common 
Gingival hyperplasia Common Common Common 
Ileus Common Common Common 
Mouth ulceration Common Common Common 
Nausea Very Common Very Common Very Common 
Pancreatitis Uncommon Common Uncommon 
Stomatitis Common Common Common 
Vomiting Very Common Very Common Very Common 
Immune system disorders  
Hypersenstivity Uncommon Common Common 
Hypogammaglobulinaemia Uncommon Very Rare Very Rare 
Hepatobiliary disorders  
Blood alkaline phosphatase 
increased  Common Common Common 
Blood lactate dehydrogenase 
increased  Common Uncommon Very Common 
Hepatic enzyme increased  Common Very Common Very Common 
Hepatitis Common Very Common Uncommon 
Hyperbilirubinaemia Common Very Common Very Common 
Jaundice Uncommon Common Common 
Skin and subcutaneous tissue disorders   
Acne Common Common Very Common 
Alopecia Common Common Common 
Rash Common Very Common Very Common 
Skin hypertrophy Common Common Very Common 
Musculoskeletal and connective tissue disorders  
Arthralgia Common Common Very Common 
Muscular weakness Common Common Very Common 
Renal and urinary disorders 
Blood creatinine increased Common Very Common Very Common 
Blood urea increased Uncommon Very Common Very Common 
Hematuria Very Common Common Common 
Renal impairment Common Very Common Very Common 
General disorders and administration site conditions  
Asthenia Very Common Very Common Very Common 
Chills Common Very Common Very Common 
Edema Very Common Very Common Very Common 
Hernia Common Very Common Very Common 
Malaise Common Common Common 
Pain Common Very Common Very Common 
Pyrexia Very Common Very Common Very Common 



71 

Note: 991 (2 g / 3 g CellCept daily), 289 (3 g CellCept daily) and 277 (2 g IV / 3 g oral CellCept daily) patients were treated in 
Phase III studies for the prevention of rejection in renal, cardiac and hepatic transplantation, respectively. 

 
Description of selected adverse reactions 
 
Malignancies 
Patients receiving immunosuppressive regimens involving combinations of medicinal products, 
including CellCept, are at increased risk of developing lymphomas and other malignancies, 
particularly of the skin (see section 4.4). Three-year safety data in renal and cardiac transplant patients 
did not reveal any unexpected changes in incidence of malignancy compared to the 1-year data. 
Hepatic transplant patients were followed for at least 1 year, but less than 3 years.  
 
Infections 
All patients treated with immunosuppressants are at increased risk of bacterial, viral and fungal 
infections (some of which may lead to a fatal outcome), including those caused by opportunistic 
agents and latent viral reactivation. The risk increases with total immunosuppressive load (see section 
4.4). The most serious infections were sepsis, peritonitis, meningitis, endocarditis, tuberculosis and 
atypical mycobacterial infection. The most common opportunistic infections in patients receiving 
CellCept (2 g or 3 g daily) with other immunosuppressants in controlled clinical trials in renal, cardiac 
and hepatic transplant patients followed for at least 1 year were candida mucocutaneous, CMV 
viraemia/syndrome and Herpes simplex. The proportion of patients with CMV viraemia/syndrome was 
13.5%. Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive 
multifocal leukoencephalopathy (PML), have been reported in patients treated with 
immunosuppressants, including CellCept. 
 
Blood and lymphatic disorders  
Cytopenias, including leukopenia, anemia, thrombocytopenia and pancytopenia, are known risks 
associated with mycophenolate mofetil and may lead or contribute to the occurrence of infections and 
hemorrhages (see section 4.4). Agranulocytosis and neutropenia have been reported; therefore, regular 
monitoring of patients taking CellCept is advised (see section 4.4). There have been reports of aplastic 
anaemia and bone marrow failure in patients treated with CellCept, some of which have been fatal. 
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CellCept (see section 
4.4). 
Isolated cases of abnormal neutrophil morphology, including the acquired Pelger-Huet anomaly, have 
been observed in patients treated with CellCept. These changes are not associated with impaired 
neutrophil function. These changes may suggest a ‘left shift’ in the maturity of neutrophils in 
haematological investigations, which may be mistakenly interpreted as a sign of infection in 
immunosuppressed patients such as those that receive CellCept. 
 
Gastrointestinal disorders 
The most serious gastrointestinal disorders were ulceration and hemorrhage which are known risks 
associated with mycophenolate mofetil. Mouth, esophageal, gastric, duodenal, and intestinal ulcers 
often complicated by hemorrhage, as well as hematemesis, melena, and hemorrhagic forms of gastritis 
and colitis were commonly reported during the pivotal clinical trials. The most common 
gastrointestinal disorders, however, were diarrhea, nausea and vomiting. Endoscopic investigation of 
patients with CellCept-related diarrhea have revealed isolated cases of intestinal villous atrophy (see 
section 4.4). 
 
Hypersensitivity 
Hypersensitivity reactions, including angioneurotic oedema and anaphylactic reaction have been 
reported.  
 
Pregnancy, puerperium and perinatal conditions 
Cases of spontaneous abortion have been reported in patients exposed to mycophenolate mofetil, 
mainly in the first trimester, see section 4.6. 
 



72 

Congenital disorders 
Congenital malformations have been observed post-marketing in children of patients exposed to 
CellCept in combination with other immunosuppressants, see section 4.6. 
 
Respiratory, thoracic and mediastinal disorders 
There have been isolated reports of interstitial lung disease and pulmonary fibrosis in patients treated 
with CellCept in combination with other immunosuppressants, some of which have been fatal. There 
have also been reports of bronchiectasis in children and adults. 
 
Immune system disorders 
Hypogammaglobulinaemia has been reported in patients receiving CellCept in combination with other 
immunosuppressants. 
 
General disorders and administration site conditions 
Edema, including peripheral, face and scrotal edema, was reported very commonly during the pivotal 
trials. Musculoskeletal pain such as myalgia, and neck and back pain were also very commonly 
reported. 
 
Special populations 
 
Paediatric population  
The type and frequency of adverse reactions in a clinical study, which recruited 92 paediatric patients 
aged 2 to 18 years who were given 600 mg/m2 mycophenolate mofetil orally twice daily, were 
generally similar to those observed in adult patients given 1 g CellCept twice daily. However, the 
following treatment-related adverse events were more frequent in the paediatric population, 
particularly in children under 6 years of age, when compared to adults: diarrhoea, sepsis, leukopenia, 
anaemia and infection.  
 
Elderly  
Elderly patients (≥ 65 years) may generally be at increased risk of adverse reactions due to 
immunosuppression. Elderly patients receiving CellCept as part of a combination immunosuppressive 
regimen, may be at increased risk of certain infections (including cytomegalovirus tissue invasive 
disease) and possibly gastrointestinal haemorrhage and pulmonary oedema, compared to younger 
individuals.  
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose  
 
Reports of overdoses with mycophenolate mofetil have been received from clinical trials and during 
post-marketing experience. In many of these cases, no adverse events were reported. In those overdose 
cases in which adverse events were reported, the events fall within the known safety profile of the 
medicinal product. 
 
It is expected that an overdose of mycophenolate mofetil could possibly result in oversuppression of 
the immune system and increase susceptibility to infections and bone marrow suppression (see section 
4.4). If neutropenia develops, dosing with CellCept should be interrupted or the dose reduced (see 
section 4.4). 
 
Haemodialysis would not be expected to remove clinically significant amounts of MPA or MPAG. 
Bile acid sequestrants, such as cholestyramine, can remove MPA by decreasing the enterohepatic 
recirculation of the drug (see section 5.2). 

https://www.ema.europa.eu/documents/template-form/appendix-v-adverse-drug-reaction-reporting-details_en.doc


73 

 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: immunosuppressive agents ATC code L04AA06 
 
Mechanism of action 
 
Mycophenolate mofetil is the 2-morpholinoethyl ester of MPA. MPA is a potent, selective, 
uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase, and therefore 
inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA. 
Because T- and B-lymphocytes are critically dependent for their proliferation on de novo synthesis of 
purines whereas other cell types can utilise salvage pathways, MPA has more potent cytostatic effects 
on lymphocytes than on other cells.  
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Following oral administration, mycophenolate mofetil undergoes rapid and extensive absorption and 
complete presystemic metabolism to the active metabolite, MPA. As evidenced by suppression of 
acute rejection following renal transplantation, the immunosuppressant activity of CellCept is 
correlated with MPA concentration. The mean bioavailability of oral mycophenolate mofetil, based on 
MPA AUC, is 94% relative to IV mycophenolate mofetil. Food had no effect on the extent of 
absorption (MPA AUC) of mycophenolate mofetil when administered at doses of 1.5 g BID to renal 
transplant patients. However, MPA Cmax was decreased by 40% in the presence of food. 
Mycophenolate mofetil is not measurable systemically in plasma following oral administration.  
 
Distribution 
 
As a result of enterohepatic recirculation, secondary increases in plasma MPA concentration are 
usually observed at approximately 6 – 12 hours post-dose. A reduction in the AUC of MPA of 
approximately 40% is associated with the co-administration of cholestyramine (4 g TID), indicating 
that there is a significant amount of enterohepatic recirculation.  
MPA at clinically relevant concentrations is 97% bound to plasma albumin. 
 
Biotransformation 
 
MPA is metabolised principally by glucuronyl transferase (isoform UGT1A9) to form the inactive 
phenolic glucuronide of MPA (MPAG). In vivo, MPAG is converted back to free MPA via 
enterohepatic recirculation. A minor acylglucuronide (AcMPAG) is also formed. AcMPAG is 
pharmacologically active and is suspected to be responsible for some of MMF’s side effects 
(diarrhoea, leukopenia). 
 
Elimination 
 
A negligible amount of substance is excreted as MPA (< 1% of the dose) in the urine. Oral 
administration of radiolabelled mycophenolate mofetil results in complete recovery of the 
administered dose with 93% of the administered dose recovered in the urine and 6% recovered in the 
faeces. Most (about 87%) of the administered dose is excreted in the urine as MPAG. 
 
At clinically encountered concentrations, MPA and MPAG are not removed by haemodialysis. 
However, at high MPAG plasma concentrations (> 100 µg/ml), small amounts of MPAG are removed. 
By interfering with enterohepatic recirculation of the drug, bile acid sequestrants such as 
cholestyramine, reduce MPA AUC (see section 4.9). 



74 

MPA’s disposition depends on several transporters. Organic anion-transporting polypeptides (OATPs) 
and multidrug resistance-associated protein 2 (MRP2) are involved in MPA’s disposition; OATP 
isoforms, MRP2 and breast cancer resistance protein (BCRP) are transporters associated with the 
glucuronides’ biliary excretion. Multidrug resistance protein 1 (MDR1) is also able to transport MPA, 
but its contribution seems to be confined to the absorption process. In the kidney, MPA and its 
metabolites potently interact with renal organic anion transporters. 
 
In the early post-transplant period (< 40 days post-transplant), renal, cardiac and hepatic transplant 
patients had mean MPA AUCs approximately 30% lower and Cmax approximately 40% lower 
compared to the late post-transplant period (3 – 6 months post-transplant). 
 
Special populations 
 
Renal impairment 
In a single dose study (6 subjects/group), mean plasma MPA AUC observed in subjects with severe 
chronic renal impairment (glomerular filtration rate < 25 ml/min/1.73 m2) were 28 – 75% higher 
relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal 
impairment. The mean single dose MPAG AUC was 3 – 6-fold higher in subjects with severe renal 
impairment than in subjects with mild renal impairment or normal healthy subjects, consistent with the 
known renal elimination of MPAG. Multiple dosing of mycophenolate mofetil in patients with severe 
chronic renal impairment has not been studied. No data are available for cardiac or hepatic transplant 
patients with severe chronic renal impairment. 
 
Delayed renal graft function 
In patients with delayed renal graft function post-transplant, mean MPA AUC0-12h was comparable to 
that seen in post-transplant patients without delayed graft function. Mean plasma MPAG AUC 0-12h 
was 2 – 3-fold higher than in post-transplant patients without delayed graft function. There may be a 
transient increase in the free fraction and concentration of plasma MPA in patients with delayed renal 
graft function. Dose adjustment of CellCept does not appear to be necessary. 
 
Hepatic impairment 
In volunteers with alcoholic cirrhosis, hepatic MPA glucuronidation processes were relatively 
unaffected by hepatic parenchymal disease. Effects of hepatic disease on this process probably depend 
on the particular disease. However, hepatic disease with predominantly biliary damage, such as 
primary biliary cirrhosis, may show a different effect.  
 
Paediatric population  
Pharmacokinetic parameters were evaluated in 49 paediatric renal transplant patients (aged 2 to 18 
years) given 600 mg/m2 mycophenolate mofetil orally twice daily. This dose achieved MPA AUC 
values similar to those seen in adult renal transplant patients receiving CellCept at a dose of 1 g BID in 
the early and late post-transplant period. MPA AUC values across age groups were similar in the early 
and late post-transplant period. 
 
Elderly   
The pharmacokinetics of mycophenolate mofetil and its metabolites have not been found to be altered 
in the elderly patients (≥ 65 years) when compared to younger transplant patients. 
 
Patients taking oral contraceptives 
A study of the co-administration of CellCept (1 g BID) and combined oral contraceptives containing 
ethinylestradiol (0.02 mg to 0.04 mg) and levonorgestrel (0.05 mg to 0.15 mg), desogestrel (0.15 mg) 
or gestodene (0.05 mg to 0.10 mg) conducted in 18 non-transplant women (not taking other 
immunosuppressants) over 3 consecutive menstrual cycles showed no clinically relevant influence of 
CellCept on the ovulation suppressing action of the oral contraceptives. Serum levels of LH, FSH and 
progesterone were not significantly affected. The pharmacokinetics of oral contraceptives were 
unaffected by co-administration of CellCept (see also section 4.5). 
 



75 

5.3 Preclinical safety data 
 
In experimental models, mycophenolate mofetil was not tumourigenic. The highest dose tested in the 
animal carcinogenicity studies resulted in approximately 2 – 3 times the systemic exposure (AUC or 
Cmax) observed in renal transplant patients at the recommended clinical dose of 2 g/day and 1.3 – 2 
times the systemic exposure (AUC or Cmax) observed in cardiac transplant patients at the 
recommended clinical dose of 3 g/day. 
 
Two genotoxicity assays (in vitro mouse lymphoma assay and in vivo mouse bone marrow 
micronucleus test) showed a potential of mycophenolate mofetil to cause chromosomal aberrations. 
These effects can be related to the pharmacodynamic mode of action, i.e. inhibition of nucleotide 
synthesis in sensitive cells. Other in vitro tests for detection of gene mutation did not demonstrate 
genotoxic activity. 
 
Mycophenolate mofetil had no effect on fertility of male rats at oral doses up to 20 mg/kg/day. The 
systemic exposure at this dose represents 2 – 3 times the clinical exposure at the recommended clinical 
dose of 2 g/day in renal transplant patients and 1.3 – 2 times the clinical exposure at the recommended 
clinical dose of 3 g/day in cardiac transplant patients. In a female fertility and reproduction study 
conducted in rats, oral doses of 4.5 mg/kg/day caused malformations (including anophthalmia, 
agnathia, and hydrocephaly) in the first generation offspring in the absence of maternal toxicity. The 
systemic exposure at this dose was approximately 0.5 times the clinical exposure at the recommended 
clinical dose of 2 g/day for renal transplant patients and approximately 0.3 times the clinical exposure 
at the recommended clinical dose of 3 g/day for cardiac transplant patients. No effects on fertility or 
reproductive parameters were evident in the dams or in the subsequent generation.  
 
In teratology studies in rats and rabbits, foetal resorptions and malformations occurred in rats at  
6 mg/kg/day (including anophthalmia, agnathia, and hydrocephaly) and in rabbits at 90 mg/kg/day 
(including cardiovascular and renal anomalies, such as ectopia cordis and ectopic kidneys, and 
diaphragmatic and umbilical hernia), in the absence of maternal toxicity. The systemic exposure at 
these levels is approximately equivalent to or less than 0.5 times the clinical exposure at the 
recommended clinical dose of 2 g/day for renal transplant patients and approximately 0.3 times the 
clinical exposure at the recommended clinical dose of 3 g/day for cardiac transplant patients (see 
section 4.6). 
 
The haematopoietic and lymphoid systems were the primary organs affected in toxicology studies 
conducted with mycophenolate mofetil in the rat, mouse, dog and monkey. These effects occurred at 
systemic exposure levels that are equivalent to or less than the clinical exposure at the recommended 
dose of 2 g/day for renal transplant recipients. Gastrointestinal effects were observed in the dog at 
systemic exposure levels equivalent to or less than the clinical exposure at the recommended dose. 
Gastrointestinal and renal effects consistent with dehydration were also observed in the monkey at the 
highest dose (systemic exposure levels equivalent to or greater than clinical exposure). The nonclinical 
toxicity profile of mycophenolate mofetil appears to be consistent with adverse events observed in 
human clinical trials, which now provide safety data of more relevance to the patient population (see 
section 4.8). 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
CellCept tablets 
microcrystalline cellulose 
polyvidone (K-90) 
croscarmellose sodium  
magnesium stearate 
 



76 

Tablet coating 
hydroxypropyl methylcellulose 
hydroxypropyl cellulose 
titanium dioxide (E171) 
polyethylene glycol 400 
indigo carmine aluminium lake (E132) 
red iron oxide (E172) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf-life 
 
3 years. 
 
6.4 Special precautions for storage 
 
Do not store above 30 °C. Keep the blister in the outer carton in order to protect from light.  
 
6.5 Nature and contents of container 
 
PVC/aluminium foil blister strips 
CellCept 500 mg film-coated tablets:  1 carton contains 50 tablets (in blister packs of 10) 
     multipacks containing 150 (3 packs of 50) tablets 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/96/005/002 CellCept (50 tablets) 
EU/1/96/005/004 CellCept (150 (3x50) tablets multipack) 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 14 February 1996 
Date of latest renewal: 13 March 2006 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu/  

http://www.ema.europa.eu/


77 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 



78 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacture(s) responsible for batch release 
 
- CellCept 500 mg powder for concentrate for solution for infusion 
- CellCept 1 g/5 ml powder for oral suspension: 
 
Roche Pharma AG, Emil-Barell-Str. 1, 79639 Grenzach-Wyhlen, Germany.  
 
Name and address of the manufacturer(s) responsible for batch release 
 
- CellCept 250 mg capsules 
- CellCept 500 mg film-coated tablets 
 
Roche Pharma AG, Emil-Barell-Str. 1, 79639 Grenzach-Wyhlen, Germany. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product 
Characteristics, section 4.2) 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
• Periodic safety update reports (PSURs) 
 

The requirements for submission of PSURs for this medicinal product are set out in the list of Union 
reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 
subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE 

USE OF THE MEDICINAL PRODUCT 
 
• Risk management plan (RMP)  
 
Not applicable. 
 
• Additional risk minimisation measures  
 
The Marketing Authorisation Holder (MAH) must agree about the content and format of the 
educational programme and a follow-up pregnancy questionnaire, including communication media, 
distribution modalities, and any other aspects of the programme, with the National Competent 
Authority.  
 
The educational programme is aimed at ensuring that the health professionals and patients are aware 
of the teratogenicity and mutagenicity, the need for pregnancy tests before starting therapy with 
CellCept, the contraceptive requirements for both male and female patients and what to do in case of 
pregnancy during treatment with CellCept.  
 
The MAH shall ensure that in each MS where CellCept is marketed, all healthcare professionals and 
patients who are expected to prescribe, dispense or use CellCept are provided with the following 
educational package: 
 ·        Physician educational material  
·         Patient information pack  
 



79 

The health professional educational material should contain:  
·         The Summary of Product Characteristics  
·         Guide for healthcare professionals  
 
The patient information pack should contain:  
·         The Package Leaflet  
·         Guide for patients  
 
The educational materials shall contain the following key elements: 
  
Separate guides for healthcare professionals and patients should be provided. For patients, the text 
should be appropriately separated for men and women. The following areas should be covered in these 
guides:  
 
• An introduction in each guide will inform the reader that the purpose of the guide is to tell 
them that a foetal exposure must be avoided and how to minimise the risk of birth defects and 
miscarriage associated with mycophenolate mofetil. It will explain that although this guide is very 
important it does not provide full information on mycophenolate mofetil and that the SmPC 
(healthcare professionals) and package leaflet (patients) supplied with the medicine must also be read 
carefully.  
 
• Background information on mycophenolate mofetil teratogenicity and mutagenicity in 
humans. This section will provide important background information concerning the teratogenicity 
and mutagenicity of mycophenolate mofetil. It will provide details about the nature and magnitude of 
the risk, in line with the information provided in the SmPC. The information provided in this section 
will facilitate a correct understanding of the risk and explain the rationale for the following pregnancy 
prevention measures. Guides should also mention that patients should not to give this drug to any 
other person.  
 
• Counselling of patients: This section will emphasise the importance of a thorough, informative 
and ongoing dialogue between patient and healthcare professional about the pregnancy risks 
associated with mycophenolate mofetil and the relevant minimisation strategies including alternative 
treatment choices, if applicable. The need to plan a pregnancy will be highlighted.  
 
• The need to avoid foetal exposure: Contraceptive requirements for patients of reproductive 
potential prior to, during and after treatment with mycophenolate mofetil. Contraceptive requirements 
for sexually active male patients (including vasectomised men) and female patients of childbearing 
potential will be explained. The need for contraception prior to, during and after treatment with 
mycophenolate mofetil, including details of the duration of time for which contraception must be 
continued after cessation of therapy, will be clearly stated.  
 
In addition, the text relating to women should explain the pregnancy test requirements prior to and 
during therapy with mycophenolate mofetil; including the advice for two negative pregnancy tests 
prior to starting therapy and the importance of the timing of these tests. The need for subsequent 
pregnancy tests during treatment will also be explained.  
 
• Advice that patients should not donate blood during therapy or for at least 6 weeks following 
discontinuation of mycophenolate. Furthermore, men should not donate semen during therapy or for 
90 days following discontinuation of mycophenolate. 
 
• Advice on action if a pregnancy occurs or is suspected during or shortly after being treated 
with mycophenolate mofetil. Patients will be informed that they should not stop taking mycophenolate 
mofetil but must contact their doctor immediately. It will be explained that the correct course of 
action, based on an assessment of the individual benefit-risk, will be determined on a case-by-case 
basis through a discussion between the treating physician and the patient. 
 



80 

In addition, a pregnancy follow-up questionnaire including details of exposure during pregnancy, 
including timing and dose; duration of therapy, before and during pregnancy; concomitant drugs; 
known teratogenic risks and full details of congenital malformations should be agreed to with the 
national competent authorities. 
 
  



81 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



82 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



83 

 PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
CellCept 250 mg capsules 
mycophenolate mofetil 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each capsule contains 250 mg mycophenolate mofetil. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
100 capsules, hard 
300 capsules, hard 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use 
For oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Capsules should be handled with caution 
Do not open or crush the capsules and breathe the powder inside the capsules or allow it to touch your 
skin 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25 °C 
Store in the original package in order to protect from moisture 
 
 



84 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/96/005/001 100 capsules, hard 
EU/1/96/005/003 300 capsules, hard 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
cellcept 250 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
  



85 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON FOR THE MULTIPACK (INCLUDING BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
CellCept 250 mg capsules 
mycophenolate mofetil 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each capsule contains 250 mg mycophenolate mofetil. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack: 300 (3 packs of 100) capsules, hard  
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use 
For oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Capsules should be handled with caution 
Do not open or crush the capsules and breathe the powder inside the capsules or allow it to touch your 
skin 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25 °C 
Store in the original package in order to protect from moisture 
 
 



86 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/96/005/007 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
cellcept 250 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
  



87 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
CellCept 250 mg capsules 
mycophenolate mofetil 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each capsule contains 250 mg mycophenolate mofetil. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
100 capsules, hard. Component of a multipack, can’t be sold separately 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use 
For oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Capsules should be handled with caution 
Do not open or crush the capsules and breathe the powder inside the capsules or allow it to touch your 
skin 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25 °C 
Store in the original package in order to protect from moisture 
 
 



88 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/96/005/007 
 
 
13. BATCH NUMBER 
 
Lot  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
  



89 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER FOIL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
CellCept 250 mg capsules 
mycophenolate mofetil 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH. 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
  



90 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
CellCept 500 mg powder for concentrate for solution for infusion 
mycophenolate mofetil 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each vial contains the equivalent of 500 mg mycophenolate mofetil as the hydrochloride salt. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains polysorbate 80, citric acid, hydrochloric acid and sodium chloride. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
4 vials  
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use 
For intravenous infusion only 
Reconstitute and dilute before use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Avoid skin contact with infusion solution 
 
 
8. EXPIRY DATE 
 
EXP 
Shelf life after reconstitution: 3 hours 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C 
 
 



91 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/96/005/005 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
  



92 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
CellCept 500 mg powder for concentrate for solution for infusion 
mycophenolate mofetil 
 
 
2. METHOD OF ADMINISTRATION 
 
For intravenous infusion only 
Read the package leaflet before use 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
 
6. OTHER 
 
  



93 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
CellCept 1 g/5 ml powder for oral suspension 
mycophenolate mofetil 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each bottle contains 35 g mycophenolate mofetil in 110 g powder for oral suspension 
5 ml suspension contains 1 g mycophenolate mofetil when reconstituted. 
The usable volume of the reconstituted suspension is 160 - 165 ml. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains aspartame (E951) and methyl parahydroxybenzoate (E218). 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder for oral suspension 
1 bottle, 1 bottle adapter and 2 oral dispensers 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use 
For oral use after reconstitution 
 
Shake bottle well before use 
 
It is recommended that the suspension be reconstituted by the pharmacist prior to dispensing to 
the patient  
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Do not breathe the powder before reconstitution or allow it to touch your skin 
Avoid skin contact with the reconstituted suspension 
 
 
8. EXPIRY DATE 
 
EXP 
Shelf life after reconstitution: 2 months 



94 

 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/96/005/006 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
cellcept 1 g/5 ml 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
  



95 

 
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING  
 
BOTTLE LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
CellCept 1 g/5 ml powder for oral suspension 
mycophenolate mofetil 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each bottle contains 35 g mycophenolate mofetil in 110 g powder for oral suspension 
5 ml suspension contains 1 g mycophenolate mofetil when reconstituted. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains aspartame (E951) and methyl parahydroxybenzoate (E218). 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder for oral suspension 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use 
For oral use after reconstitution 
 
Shake bottle well before use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Do not breathe the powder before reconstitution or allow it to touch your skin 
Avoid skin contact with the reconstituted suspension 
 
 
8. EXPIRY DATE 
 
EXP 
Shelf life after reconstitution: 2 months 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30 °C 



96 

 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/96/005/006 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 
  



97 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
CellCept 500 mg film-coated tablets 
mycophenolate mofetil 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 500 mg mycophenolate mofetil. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
50 tablets  
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use 
For oral use 
Do not crush the tablets 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 Tablets should be handled with caution 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30 °C  
Keep the blister in outer carton in order to protect from light 
 
 



98 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/96/005/002 
 
 
13. BATCH NUMBER 
 
Lot  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
cellcept 500 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
  



99 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON FOR MULTIPACK (INCLUDING BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
CellCept 500 mg film-coated tablets 
mycophenolate mofetil 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 500 mg mycophenolate mofetil. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack: 150 (3 packs of 50) film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use 
For oral use 
Do not crush the tablets 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
  Tablets should be handled with caution 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30 °C 
Keep the blister in outer carton in order to protect from light 
 
 



100 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/96/005/004 
 
 
13. BATCH NUMBER 
 
Lot  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
cellcept 500 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
  



101 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
CellCept 500 mg film-coated tablets 
mycophenolate mofetil 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 500 mg mycophenolate mofetil. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
50 film-coated tablets. Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use 
For oral use 
Do not crush the tablets 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 Tablets should be handled with caution 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30 °C 
Keep the blister in outer carton in order to protect from light 
 
 



102 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/96/005/004 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 
  



103 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER FOIL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
CellCept 500 mg tablets 
mycophenolate mofetil 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
  



104 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 
 

  



105 

Package Leaflet: Information for the user 
 

CellCept 250 mg capsules 
mycophenolate mofetil 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
 
• Keep this leaflet. You may need to read it again. 
• If you have any further questions, ask your doctor or pharmacist. 
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What CellCept is and what it is used for 
2. What you need to know before you take CellCept 
3. How to take CellCept 
4. Possible side effects 
5. How to store CellCept 
6. Content of the pack and other information 
 
 
1. What CellCept is and what it is used for 
 
The full name of your medicine is CellCept 250 mg capsules.  
• In this leaflet the shorter name CellCept is used. 
CellCept contains mycophenolate mofetil.  
• This belongs to a group of medicines called “immunosuppressants”.  
CellCept is used to prevent your body rejecting a transplanted organ. 
• A kidney, heart or liver.  
CellCept should be used together with other medicines: 
• Ciclosporin and corticosteroids. 
 
 
2. What you need to know before you take CellCept 
 
WARNING 
Mycophenolate causes birth defects and miscarriage. If you are a woman who could become pregnant, 
you must provide a negative pregnancy test before starting treatment and must follow the 
contraception advice given to you by your doctor. 
 
Your doctor will speak to you and give you written information, particularly on the effects of 
mycophenolate on unborn babies. Read the information carefully and follow the instructions. 
If you do not fully understand these instructions, please ask your doctor to explain them again before 
you take mycophenolate. See also further information in this section under “Warnings and 
precautions” and “Pregnancy and breast-feeding”. 
 
Do not take CellCept: 
• If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the 

other ingredients of this medicine (listed in section 6) 
• If you are a woman who could be pregnant and you have not provided a negative pregnancy 

test before your first prescription, as mycophenolate causes birth defects and miscarriage. 
• If you are pregnant or planning to become pregnant or think you may be pregnant 



106 

• If you are not using effective contraception (see Pregnancy, contraception and breast-feeding). 
• If you are breast-feeding. 
Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or 
pharmacist before taking CellCept. 
 
Warnings and precautions  
Talk to your doctor straight away before starting treatment with CellCept: 
• If you have a sign of infection such as a fever or sore throat 
• If you have any unexpected bruising or bleeding 
• If you have ever had a problem with your digestive system such as a stomach ulcer 
• If you are planning to become pregnant or if you get pregnant while you or your partner are 
taking CellCept 
If any of the above apply to you (or you are not sure), talk to your doctor straight away before starting 
treatment with CellCept. 
 
The effect of sunlight 
CellCept reduces your body’s defences. As a result, there is an increased risk of skin cancer. Limit the 
amount of sunlight and UV light you get. Do this by: 
• wearing protective clothing that also covers your head, neck, arms and legs 
• using a sunscreen with a high protection factor. 
 
Other medicines and CellCept 
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This 
includes medicines obtained without a prescription, such as herbal medicines. This is because 
CellCept can affect the way some other medicines work. Also other medicines can affect the way 
CellCept works. 
In particular, tell your doctor or pharmacist if you are taking any of the following medicines before 
you start CellCept: 
• azathioprine or other medicines that suppress your immune system – given after a transplant 

operation 
• cholestyramine – used to treat high cholesterol 
• rifampicin – an antibiotic used to prevent and treat infections such as tuberculosis (TB) 
• antacids or proton pump inhibitors – used for acid problems in your stomach such as indigestion 
• phosphate binders – used by people with chronic kidney failure to reduce how much phosphate 

gets absorbed into their blood 
• antibiotics – used to treat bacterial infections  
• isavuconazole – used to treat fungal infections 
• telmisartan – used to treat high blood pressure 

 
Vaccines 
If you need to have a vaccine (a live vaccine) while taking CellCept, talk to your doctor or pharmacist 
first. Your doctor will have to advise you on what vaccines you can have. 
 
You must not donate blood during treatment with CellCept and for at least 6 weeks after stopping 
treatment. Men must not donate semen during treatment with CellCept and for at least 90 days after 
stopping treatment. 
 
CellCept with food and drink 
Taking food and drink has no effect on your treatment with CellCept. 
 
Pregnancy, contraception and breast-feeding 
 
Contraception in women taking CellCept 
If you are a woman who could become pregnant, you must use an effective method of contraception 
with CellCept. This includes: 
• Before you start taking CellCept 



107 

• During your entire treatment with CellCept  
• For 6 weeks after you stop taking CellCept. 
Talk to your doctor about the most suitable contraception for you. This will depend on your individual 
situation. Two forms of contraception are preferable as this will reduce the risk of unintended 
pregnancy. Contact your doctor as soon as possible, if you think your contraception may not 
have been effective or if you have forgotten to take your contraceptive pill. 
 
You are a woman who is not capable of becoming pregnant if any of the following applies to you: 
• You are post-menopausal, i.e. at least 50 years old and your last period was more than a year 

ago (if your periods have stopped because you have had treatment for cancer, then there is still a 
chance you could become pregnant) 

• Your fallopian tubes and both ovaries have been removed by surgery (bilateral salpingo-
oophorectomy) 

• Your womb (uterus) has been removed by surgery (hysterectomy) 
• Your ovaries no longer work (premature ovarian failure, which has been confirmed by a 

specialist gynaecologist) 
• You were born with one of the following rare conditions that make pregnancy impossible: the 

XY genotype, Turner’s syndrome or uterine agenesis 
• You are a child or teenager who has not started having periods. 
 
Contraception in men taking CellCept 
The available evidence does not indicate an increased risk of malformations or miscarriage if the 
father takes mycophenolate. However, a risk cannot be completely excluded. As a precaution you or 
your female partner are recommended to use reliable contraception during treatment and for 90 days 
after you stop taking CellCept.  
 
If you are planning to have a child, talk to your doctor about the potential risks and alternative 
therapies. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. Your doctor will talk to you about 
the risks in case of pregnancy and the alternatives you can take to prevent rejection of your transplant 
organ if: 
• You plan to become pregnant. 
• You miss or think you have missed a period, or you have unusual menstrual bleeding, or suspect 

you are pregnant. 
• You have sex without using an effective method of contraception. 
If you do become pregnant during the treatment with mycophenolate, you must inform your doctor 
immediately. However, keep taking CellCept until you see him or her. 
 
Pregnancy 
Mycophenolate causes a very high frequency of miscarriage (50%) and of severe birth defects (23 - 
27%) in the unborn baby. Birth defects that have been reported include anomalies of ears, of eyes, of 
face (cleft lip/palate), of development of fingers, of heart, oesophagus (tube that connects the throat 
with the stomach), kidneys and nervous system (for example spina bifida (where the bones of the 
spine are not properly developed). Your baby may be affected by one or more of these. 
 
If you are a woman who could become pregnant, you must provide a negative pregnancy test before 
starting treatment and must follow the contraception advice given to you by your doctor. Your doctor 
may request more than one test to ensure you are not pregnant before starting treatment. 
 
Breast-feeding 
Do not take CellCept if you are breast-feeding. This is because small amounts of the medicine can 
pass into the mother’s milk. 
 



108 

Driving and using machines 
CellCept has a moderate influence on your ability to drive or use any tools or machines. If you feel 
drowsy, numb or confused, talk to your doctor or nurse and do not drive or use any tools or machines 
until you feel better. 
 
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say 
essentially ‘sodium-free’. 
 
 
3. How to take CellCept 
 
Always take CellCept exactly as your doctor has told you. You should check with your doctor or 
pharmacist if you are not sure.  
 
How much to take 
The amount you take depends on the type of transplant you have had. The usual doses are shown 
below. Treatment will continue for as long as you need to prevent you from rejecting your transplant 
organ. 
 
Kidney transplant 
Adults 
• The first dose is given within 3 days of the transplant operation. 
• The daily dose is 8 capsules (2 g of the medicine) taken as 2 separate doses.  
• Take 4 capsules in the morning and then 4 capsules in the evening. 
Children (aged 2 to 18 years) 
• The dose given will vary depending on the size of the child.  
• Your doctor will decide the most appropriate dose based on your child’s height and weight 

(body surface area – measured as square metres or “m2”). The recommended dose is 600 mg/m² 
taken twice a day. 

 
Heart transplant 
Adults 
• The first dose is given within 5 days of the transplant operation. 
• The daily dose is 12 capsules (3 g of the medicine) taken as 2 separate doses.  
• Take 6 capsules in the morning and then 6 capsules in the evening. 
Children 
• There is no information for the use of CellCept in children with a heart transplant. 
 
Liver transplant 
Adults 
• The first dose of oral CellCept will be given to you at least 4 days after the transplant operation 

and when you are able to swallow oral medicines. 
• The daily dose is 12 capsules (3 g of the medicine) taken as 2 separate doses.  
• Take 6 capsules in the morning and then 6 capsules in the evening.  
Children 
• There is no information for the use of CellCept in children with a liver transplant. 
 
Taking the medicine 
Swallow your capsules whole with a glass of water 
• Do not break or crush them 
• Do not take any capsules that have broken open or split. 
 
Take care not to let any powder from inside a broken capsule get into your eyes or mouth. 
• If this happens, rinse with plenty of plain water. 
 



109 

Take care not to let any powder from inside a broken capsule get onto your skin.  
• If this happens, wash the area thoroughly with soap and water. 
 
If you take more CellCept than you should 
If you take more CellCept than you should, talk to a doctor or go to a hospital straight away. Also do 
this if someone else accidentally takes your medicine. Take the medicine pack with you. 
 
If you forget to take CellCept 
If you forget to take your medicine at any time, take it as soon as you remember. Then continue to take 
it at the usual times. Do not take a double dose to make up for a missed dose. 
 
If you stop taking CellCept 
Do not stop taking CellCept unless your doctor tells you to. If you stop your treatment you may 
increase the chance of rejection of your transplant organ.  
If you have any further questions on the use of this product, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, CellCept can cause side effects, although not everybody gets them. 
 
Talk to a doctor straight away if you notice any of the following serious side effects – you 
may need urgent medical treatment: 
• you have a sign of infection such as a fever or sore throat 
• you have any unexpected bruising or bleeding 
• you have a rash, swelling of your face, lips, tongue or throat, with difficulty breathing - you 
may be having a serious allergic reaction to the medicine (such as anaphylaxis, angioeodema). 
 
Usual problems 
Some of the more usual problems are diarrhoea, fewer white cells or red cells in your blood, infection 
and vomiting. Your doctor will do regular blood tests to check for any changes in: 
• the number of your blood cells or signs of infections 
  
Children may be more likely than adults to have some side effects. These include diarrhoea, infections, 
fewer white cells and fewer red cells in the blood. 
 
Fighting infections 
CellCept reduces your body’s defences. This is to stop you rejecting your transplant. As a result, your 
body will not be as good as normal at fighting infections. This means you may catch more infections 
than usual. This includes infections of the brain, skin, mouth, stomach and gut, lungs and urinary 
system.  
 
Lymph and skin cancer 
As can happen in patients taking this type of medicine (immune-suppressants), a very small number of 
CellCept patients have developed cancer of the lymphoid tissues and skin.  
 
General unwanted effects 
You may get general side effects affecting your body as a whole. These include serious allergic 
reactions (such as anaphylaxis, angioeodema), fever, feeling very tired, difficulty sleeping, pains (such 
as stomach, chest, joint or muscle), headache, flu symptoms and swelling.  
 
Other unwanted effects may include: 
Skin problems such as:  
• acne, cold sores, shingles, skin growth, hair loss, rash, itching. 
 



110 

Urinary problems such as:  
• blood in the urine. 
 
Digestive system and mouth problems such as:  
• swelling of the gums and mouth ulcers, 
• inflammation of the pancreas, colon or stomach,  
• gastrointestinal disorders including bleeding, 
• liver disorder,  
• diarrhea, constipation, feeling sick (nausea), indigestion, loss of appetite, flatulence. 
 
Nervous system problems such as:  
• feeling dizzy, drowsy or numb,  
• tremor, muscle spasms, convulsions,  
• feeling anxious or depressed, changes in your mood or thoughts. 
 
Heart and blood vessel problems such as: 
• change in blood pressure, accelerated heartbeat widening of blood vessels. 
 
Lung problems such as:  
• pneumonia, bronchitis,  
• shortness of breath, cough, which can be due to bronchiectasis (a condition in which the lung 

airways are abnormally dilated) or pulmonary fibrosis (scarring of the lung). Talk to your doctor 
if you develop a persistent cough or breathlessness.  

• fluid on the lungs or inside the chest, 
• sinus problems. 
 
Other problems such as:  
• weight loss, gout, high blood sugar, bleeding, bruising.  
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects, you can help provide more information on the safety 
of this medicine. 
 
 
5. How to store CellCept 
 
• Keep this medicine out of the sight and reach of children. 
• Do not use this medicine after the expiry date stated on the carton after EXP. 
• Do not store above 25°C.  
• Store in the original package in order to protect from moisture. 
• Do not throw away any medicines  via wastewater or household waste. Ask your pharmacist 

how to throw away medicines you no longer use. These measures will help protect the 
environment. 

 
 
6. Contents of the pack and other information  
 
What CellCept contains 
• The active substance is mycophenolate mofetil. 
• The other ingredients are:  
• CellCept capsules: pregelatinised maize starch, croscarmellose sodium, polyvidone (K-90), 

magnesium stearate 
• Capsule shell: gelatin, indigo carmine (E132), yellow iron oxide (E172), red iron oxide (E172), 

titanium dioxide (E171), black iron oxide (E172), potassium hydroxide, shellac. 

https://www.ema.europa.eu/documents/template-form/appendix-v-adverse-drug-reaction-reporting-details_en.doc


111 

 
What CellCept looks like and contents of the pack 
• CellCept capsules are oblong-shaped with one end blue and the other end brown. They have 

“CellCept 250” printed in black on the capsule cap and “Roche” printed in black on the capsule 
body. 

• They are available as a carton of 100 or 300 capsules (both in blister packs of 10) or as a 
multipack containing 300 (3 packs of 100) capsules. 

 
Marketing Authorisation Holder 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
Manufacturing Authorisation Holder responsible for batch release: 
Roche Pharma AG, Emil-Barell-Str. 1, 79639 Grenzach Wyhlen, Germany. 
 
For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder: 
 
België/Belgique/Belgien 
N.V. Roche S.A. 
Tél/Tel: +32 (0) 2 525 82 11 
 

Lietuva 
UAB “Roche Lietuva” 
Tel: +370 5 2546799 
 

България 
Рош България ЕООД 
Тел: +359 2 818 44 44 
 

Luxembourg/Luxemburg 
(Voir/siehe Belgique/Belgien) 
 

Česká republika 
Roche s. r. o. 
Tel: +420 - 2 20382111 
 

Magyarország 
Roche (Magyarország) Kft. 
Tel: +36 - 23 446 800 
 

Danmark 
Roche a/s 
Tlf: +45 - 36 39 99 99 
 

Malta 
(See Ireland) 
 

Deutschland 
Roche Pharma AG 
Tel: +49 (0) 7624 140 
 

Nederland 
Roche Nederland B.V. 
Tel: +31 (0) 348 438050 
 

Eesti 
Roche Eesti OÜ 
Tel: + 372 - 6 177 380 
 

Norge 
Roche Norge AS 
Tlf: +47 - 22 78 90 00 
 

Ελλάδα 
Roche (Hellas) A.E.  
Τηλ: +30 210 61 66 100 
 

Österreich 
Roche Austria GmbH 
Tel: +43 (0) 1 27739 
 

España 
Roche Farma S.A. 
Tel: +34 - 91 324 81 00 
 

Polska 
Roche Polska Sp.z o.o. 
Tel: +48 - 22 345 18 88 
 

France 
Roche 
Tél: +33 (0)1 47 61 40 00 
 

Portugal 
Roche Farmacêutica Química, Lda 
Tel: +351 - 21 425 70 00 
 



112 

Hrvatska 
Roche d.o.o. 
Tel: + 385 1 47 22 333 
 

România 
Roche România S.R.L. 
Tel: +40 21 206 47 01 
 

Ireland 
Roche Products (Ireland) Ltd. 
Tel: +353 (0) 1 469 0700 
 

Slovenija 
Roche farmacevtska družba d.o.o. 
Tel: +386 - 1 360 26 00 
 

Ísland  
Roche a/s 
c/o Icepharma hf 
Sími: +354 540 8000 
 

Slovenská republika  
Roche Slovensko, s.r.o. 
Tel: +421 - 2 52638201 
 

Italia 
Roche S.p.A. 
Tel: +39 - 039 2471 

Suomi/Finland 
Roche Oy  
Puh/Tel: +358 (0) 10 554 500 
 

Kύπρος  
Γ.Α.Σταμάτης & Σια Λτδ. 
Τηλ: +357 - 22 76 62 76 
 

Sverige 
Roche AB 
Tel: +46 (0) 8 726 1200 
 

Latvija 
Roche Latvija SIA 
Tel: +371 - 6 7039831 
 

United Kingdom 
Roche Products Ltd. 
Tel: +44 (0) 1707 366000 
 

 
This leaflet was last revised in {MM/YYYY} 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency website:  
http://www.ema.europa.eu  

  

http://www.ema.europa.eu/


113 

Package leaflet: Information for the user 
 

CellCept 500 mg powder for concentrate for solution for infusion 
mycophenolate mofetil 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
 
• Keep this leaflet. You may need to read it again. 
• If you have any further questions, ask your doctor or nurse. 
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects 

not listed in this leaflet. See section 4. 
 
What is in this leaflet:  
 
1. What CellCept is and what it is used for 
2. What you need to know before you take CellCept 
3. How to take CellCept 
4. Possible side effects 
5. How to store CellCept 
6. Contents of the pack and other information 
7. Making up the medicine 
 
 
1. What CellCept is and what it is used for 
 
The full name of your medicine is CellCept 500 mg powder for concentrate for solution for infusion.  
• In this leaflet the shorter name CellCept is used. 
CellCept contains mycophenolate mofetil.  
• This belongs to a group of medicines called “immunosuppressants”.  
CellCept is used to prevent your body rejecting a transplanted organ. 
• A kidney or liver.  
CellCept should be used together with other medicines: 
• Ciclosporin and corticosteroids. 
 
 
2. What you need to know before you take CellCept  
 
WARNING 
Mycophenolate causes birth defects and miscarriage. If you are a woman who could become pregnant, 
you must provide a negative pregnancy test before starting treatment and must follow the 
contraception advice given to you by your doctor. 
 
Your doctor will speak to you and give you written information, particularly on the effects of 
mycophenolate on unborn babies. Read the information carefully and follow the instructions. 
If you do not fully understand these instructions, please ask your doctor to explain them again before 
you take mycophenolate. See also further information in this section under “Warnings and 
precautions” and “Pregnancy and breast-feeding”. 
 
Do not take CellCept: 
• If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid, polysorbate 

80 or any of the other ingredients in this medicine (listed in section 6) 
• If you are a woman who could be pregnant and you have not provided a negative pregnancy test 

before your first prescription, as mycophenolate causes birth defects and miscarriage. 



114 

• If you are pregnant or planning to become pregnant or think you may be pregnant 
• If you are not using effective contraception (see Pregnancy, contraception and breast-feeding). 
• If you are breast-feeding. 
Do not have this medicine if any of the above applies to you. If you are not sure, talk to your doctor or 
nurse before having CellCept. 
 
Warnings and precautions  
Talk to your doctor or nurse straight away before starting treatment with CellCept: 
• If you have a sign of infection such as a fever or sore throat 
• If you have any unexpected bruising or bleeding 
• If you have ever had a problem with your digestive system such as a stomach ulcer 
• If you are planning to become pregnant or if you get pregnant while you or your partner are taking 

CellCept. 
If any of the above apply to you (or you are not sure), talk to your doctor or nurse straight away before 
starting treatment with CellCept. 
 
The effect of sunlight 
CellCept reduces your body’s defences. As a result, there is an increased risk of skin cancer. Limit the 
amount of sunlight and UV light you get. Do this by: 
• wearing protective clothing that also covers your head, neck, arms and legs 
• using a sunscreen with a high protection factor. 
 
Other medicines and CellCept  
Please tell your doctor or nurse if you are taking or have recently taken any other medicines. This 
includes medicines obtained without a prescription, such as herbal medicines. This is because 
CellCept can affect the way some other medicines work. Also other medicines can affect the way 
CellCept works. 
 
In particular, tell your doctor or nurse if you are taking any of the following medicines before you start 
CellCept: 
• azathioprine or other medicines that suppress your immune system – given after a transplant 

operation 
• cholestyramine – used to treat high cholesterol 
• rifampicin – an antibiotic used to prevent and treat infections such as tuberculosis (TB) 
• phosphate binders – used by people with chronic kidney failure to reduce how much phosphate 

gets absorbed into their blood. 
• antibiotics – used to treat bacterial infections  
• isavuconazole – used to treat fungal infections 
• telmisartan – used to treat high blood pressure 
 
Vaccines 
If you need to have a vaccine (a live vaccine) while having CellCept, talk to your doctor or pharmacist 
first. Your doctor will have to advise you on what vaccines you can have. 
 
You must not donate blood during treatment with CellCept and for at least 6 weeks after stopping 
treatment. Men must not donate semen during treatment with CellCept and for at least 90 days after 
stopping treatment. 
Pregnancy, contraception and breast-feeding 
 
Contraception in women taking CellCept 
If you are a woman who could become pregnant, you must use an effective method of contraception 
with CellCept. This includes: 
• Before you start taking CellCept 
• During your entire treatment with CellCept  
• For 6 weeks after you stop taking CellCept. 



115 

Talk to your doctor about the most suitable contraception for you. This will depend on your individual 
situation. Two forms of contraception are preferable as this will reduce the risk of unintended 
pregnancy. Contact your doctor as soon as possible, if you think your contraception may not 
have been effective or if you have forgotten to take your contraceptive pill. 
 
You are a woman who is not capable of becoming pregnant if any of the following applies to you: 
• You are post-menopausal, i.e. at least 50 years old and your last period was more than a year 

ago (if your periods have stopped because you have had treatment for cancer, then there is still a 
chance you could become pregnant) 

• Your fallopian tubes and both ovaries have been removed by surgery (bilateral                            
salpingo-oophorectomy) 

• Your womb (uterus) has been removed by surgery (hysterectomy) 
• Your ovaries no longer work (premature ovarian failure, which has been confirmed by a 

specialist gynaecologist) 
• You were born with one of the following rare conditions that make pregnancy impossible: the 

XY genotype, Turner’s syndrome or uterine agenesis 
• You are a child or teenager who has not started having periods. 
 
Contraception in men taking CellCept 
The available evidence does not indicate an increased risk of malformations or miscarriage if the 
father takes mycophenolate. However, a risk cannot be completely excluded. As a precaution, you or 
your female partner are recommended to use reliable contraception during treatment and for 90 days 
after you stop taking CellCept.  
 
If you are planning to have a child, talk to your doctor about the potential risks and alternative 
therapies. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. Your doctor will talk to you about 
the risks in case of pregnancy and the alternatives you can take to prevent rejection of your transplant 
organ if: 
• You plan to become pregnant. 
• You miss or think you have missed a period, or you have unusual menstrual bleeding, or   

suspect you are pregnant. 
• You have sex without using an effective method of contraception. 
If you do become pregnant during the treatment with mycophenolate, you must inform your doctor 
immediately. However, keep taking CellCept until you see him or her. 
 
Pregnancy 
Mycophenolate causes a very high frequency of miscarriage (50%) and of severe birth defects (23-
27 %) in the unborn baby. Birth defects which have been reported include anomalies of ears, of eyes, 
of face (cleft lip/palate), of development of fingers, of heart, oesophagus (tube that connects the throat 
with the stomach), kidneys and nervous system (for example spina bifida (where the bones of the 
spine are not properly developed). Your baby may be affected by one or more of these. 
 
If you are a woman who could become pregnant, you must provide a negative pregnancy test before 
starting treatment and must follow the contraception advice given to you by your doctor. Your doctor 
may request more than one test to ensure you are not pregnant before starting treatment. 
 
Breast-feeding 
Do not take CellCept if you are breast-feeding. This is because small amounts of the medicine can 
pass into the mother’s milk. 
 



116 

Driving and using machines 
CellCept has a moderate influence on your ability to drive or use any tools or machines. If you feel 
drowsy, numb or confused, talk to your doctor or nurse and do not drive or use any tools or machines 
until you feel better. 
 
This medicine contains less than 1  mmol sodium (23  mg) per dose, that is to say 
essentially ‘sodium-free’. 
 
 
3. How to take CellCept 
 
CellCept is usually given by a doctor or nurse in hospital. It is given as a slow drip (infusion) into a 
vein.  
 
How much to take 
The amount you take depends on the type of transplant you have had. The usual doses are shown 
below. Treatment will continue for as long as you need to prevent you from rejecting your transplant 
organ. 
 
Kidney transplant 
Adults 
• The first dose is given within 24 hours of the transplant operation. 
• The daily dose is 2 g of the medicine taken as 2 separate doses.  
• This will be given as 1 g in the morning and then 1 g in the evening. 
 
Liver transplant 
Adults 
• The first dose is given to you as soon as possible after the transplant operation. 
• You will have the medicine for at least 4 days. 
• The daily dose is 2 g of the medicine taken as 2 separate doses.  
• This will be given as 1 g in the morning and then 1 g in the evening. 
• When you are able to swallow, you will be given this medicine by mouth. 
 
Making up the medicine 
The medicine comes as a powder. This needs mixing with glucose before using. Your doctor or nurse 
will make up the medicine and give it to you. They will follow the instructions under section 7 
“Making up the medicine”. 
 
If you take more CellCept than you should 
If you think that you have had too much medicine, talk to your doctor or nurse straight away. 
 
If you forget to take CellCept 
If a dose of CellCept is missed, this will be given to you as soon as possible. Your treatment will then 
continue at the normal times. 
 
If you stop taking CellCept 
Do not stop having CellCept unless your doctor tells you to. If you stop your treatment you may 
increase the chance of rejection of your transplant organ.  
 
If you have any further questions on the use of this medicine, ask your doctor or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, CellCept can cause side effects, although not everybody gets them. 



117 

 
Talk to a doctor or nurse straight away if you notice any of the following serious side 
effects – you may need urgent medical treatment: 
• you have a sign of infection such as a fever or sore throat 
• you have any unexpected bruising or bleeding 
• you have a rash, swelling of your face, lips, tongue or throat, with difficulty breathing - you may 

be having a serious allergic reaction to the medicine (such as anaphylaxis, angioeodema). 
 
Usual problems 
Some of the more usual problems are diarrhoea, fewer white cells or red cells in your blood, infection 
and vomiting. Your doctor will do regular blood tests to check for any changes in: 
• the number of your blood cells or signs of infections. 
 
Fighting infections 
CellCept reduces your body’s defences. This is to stop you rejecting your transplant. As a result, your 
body will not be as good as normal at fighting infections. This means you may catch more infections 
than usual. This includes infections of the brain, skin, mouth, stomach and gut, lungs and urinary 
system.  
 
Lymph and skin cancer 
As can happen in patients having this type of medicine (immune-suppressants), a very small number 
of CellCept patients have developed cancer of the lymphoid tissues and skin.  
 
General unwanted effects 
You may get general side effects affecting your body as a whole. These include serious allergic 
reactions (such as anaphylaxis, angioeodema), fever, feeling very tired, difficulty sleeping, pains (such 
as stomach, chest, joint or muscle), headache, flu symptoms and swelling.  
 
Other unwanted effects may include: 
Skin problems such as:  
• acne, cold sores, skin growth, shingles, hair loss, rash, itching. 
 
Urinary problems such as:  
• blood in the urine. 
 
Digestive system and mouth problems such as:  
• swelling of the gums and mouth ulcers, 
• inflammation of the pancreas, colon or stomach,  
• gastrointestinal disorders including bleeding, 
•  liver disorders,  
• diarrhea, constipation, feeling sick (nausea), indigestion, loss of appetite, flatulence. 
 
Nervous system problems such as:  
• feeling drowsy or numb,  
• tremor, muscle spasms convulsions,  
• feeling anxious or depressed, changes in your mood or thoughts. 
 
Heart and blood vessel problems such as: 
• change in blood pressure, blood clots, accelerated heartbeat 
• pain, redness and swelling of the blood vessels where you had the infusion. 
 
Lung problems such as:  
• pneumonia, bronchitis,  
• shortness of breath, cough, which can be due to bronchiectasis (a condition in which the lung 

airways are abnormally dilated) or pulmonary fibrosis (scarring of the lung). Talk to your 
doctor if you develop a persistent cough or breathlessness  



118 

•  fluid on the lungs or inside the chest, 
• sinus problems. 
 
Other problems such as:  
• weight loss, gout, high blood sugar, bleeding, bruising.  
 
Reporting of side effects 
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not 
listed in this leaflet. You can also report side effects directly via the national reporting system listed in 
Appendix V. By reporting side effects, you can help provide more information on the safety of this 
medicine. 
 
 
5. How to store CellCept  
 
• Keep this medicine out of the sight and reach of children. 
• Do not use this medicine after the expiry date which is stated on the carton and vial label after 
EXP. 
• Powder for concentrate for solution for infusion: do not store above 30°C.  
• Reconstituted solution and the diluted solution: store between 15°C and 30°C. 
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist 
how to throw away  medicines no longer required. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What CellCept contains 
• The active substance is mycophenolate mofetil. 
• The other ingredients are: polysorbate 80, citric acid, hydrochloric acid, sodium chloride. 
 
What CellCept looks like and contents of the pack 
• CellCept is provided in a 20 ml type I clear glass vial with a grey butyl rubber stopper and 

aluminium seal with a plastic flip-off cap. 
• It is available in packs of 4 vials. 
 
 
7. Making up the medicine 
 
Method and route of administration 
CellCept 500 mg powder for concentrate for solution for infusion does not contain an antibacterial 
preservative; therefore, reconstitution and dilution of the product must be performed under aseptic 
conditions. 
 
The contents of CellCept 500 mg powder for concentrate for solution for infusion vials must be 
reconstituted with 14 ml of glucose intravenous infusion 5% each. A further dilution with glucose 
intravenous infusion 5% is required to a final concentration of 6 mg/ml. This means that to prepare a 
1 g dose of mycophenolate mofetil the content of 2 reconstituted vials (approx. 2 x 15 mL) must be 
further diluted into 140 ml glucose intravenous infusion 5% solution. If the infusion solution is not 
prepared immediately prior to administration, the commencement of administration of the infusion 
solution should be within 3 hours from reconstitution and dilution of the medicinal product. 
 
Take care not to let the made-up medicine get into your eyes. 
∙ If this happens, rinse your eyes with plain water. 
Take care not to let the made-up medicine get on your skin.  
∙ If this happens, wash the area thoroughly with soap and water.  

https://www.ema.europa.eu/documents/template-form/appendix-v-adverse-drug-reaction-reporting-details_en.doc


119 

CellCept 500 mg powder for concentrate for solution for infusion must be given as an intravenous (IV) 
infusion. The infusion flow rate should be controlled to equate to a 2-hour period of administration.  
 
CellCept IV solution should never be administered by rapid or bolus intravenous injection. 
 
Marketing Authorisation Holder 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
Manufacturing Authorisation Holder responsible for batch release: 
Roche Pharma AG, Emil-Barell-Str. 1, 79639 Grenzach Wyhlen, Germany. 
 
For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder: 
 
België/Belgique/Belgien 
N.V. Roche S.A. 
Tél/Tel: +32 (0) 2 525 82 11 
 

Lietuva 
UAB “Roche Lietuva” 
Tel: +370 5 2546799 
 

България 
Рош България ЕООД 
Тел: +359 2 818 44 44 
 

Luxembourg/Luxemburg 
(Voir/siehe Belgique/Belgien) 
 

Česká republika 
Roche s. r. o. 
Tel: +420 - 2 20382111 
 

Magyarország 
Roche (Magyarország) Kft. 
Tel: +36 - 23 446 800 
 

Danmark 
Roche a/s 
Tlf: +45 - 36 39 99 99 
 

Malta 
(See Ireland) 
 

Deutschland 
Roche Pharma AG 
Tel: +49 (0) 7624 140 
 

Nederland 
Roche Nederland B.V. 
Tel: +31 (0) 348 438050 
 

Eesti 
Roche Eesti OÜ 
Tel: + 372 - 6 177 380 
 

Norge 
Roche Norge AS 
Tlf: +47 - 22 78 90 00 
 

Ελλάδα 
Roche (Hellas) A.E.  
Τηλ: +30 210 61 66 100 
 

Österreich 
Roche Austria GmbH 
Tel: +43 (0) 1 27739 
 

España 
Roche Farma S.A. 
Tel: +34 - 91 324 81 00 
 

Polska 
Roche Polska Sp.z o.o. 
Tel: +48 - 22 345 18 88 
 

France 
Roche 
Tél: +33 (0)1 47 61 40 00 
 

Portugal 
Roche Farmacêutica Química, Lda 
Tel: +351 - 21 425 70 00 
 



120 

Hrvatska 
Roche d.o.o. 
Tel: + 385 1 47 22 333 
 

România 
Roche România S.R.L. 
Tel: +40 21 206 47 01 
 

Ireland 
Roche Products (Ireland) Ltd. 
Tel: +353 (0) 1 469 0700 
 

Slovenija 
Roche farmacevtska družba d.o.o. 
Tel: +386 - 1 360 26 00 
 

Ísland  
Roche a/s 
c/o Icepharma hf 
Sími: +354 540 8000 
 

Slovenská republika  
Roche Slovensko, s.r.o. 
Tel: +421 - 2 52638201 
 

Italia 
Roche S.p.A. 
Tel: +39 - 039 2471 

Suomi/Finland 
Roche Oy  
Puh/Tel: +358 (0) 10 554 500 
 

Kύπρος  
Γ.Α.Σταμάτης & Σια Λτδ. 
Τηλ: +357 - 22 76 62 76 
 

Sverige 
Roche AB 
Tel: +46 (0) 8 726 1200 
 

Latvija 
Roche Latvija SIA 
Tel: +371 - 6 7039831 
 

United Kingdom 
Roche Products Ltd. 
Tel: +44 (0) 1707 366000 
 

 
This leaflet was last revised in {MM/YYYY} 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency website:  
http://www.ema.europa.eu  
 
 

  

http://www.ema.europa.eu/


121 

Package leaflet: Information for the user 
 

CellCept 1 g/5 ml powder for oral suspension 
mycophenolate mofetil 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
 
• Keep this leaflet. You may need to read it again. 
• If you have any further questions, ask your doctor or pharmacist. 
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their symptoms are the same as yours 
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet: 
  
1. What CellCept is and what it is used for 
2. What you need to know before you take CellCept 
3. How to take CellCept 
4. Possible side effects 
5. How to store CellCept 
6. Contents of the pack and other information 
7. Making-up the medicine 
 
 
1. What CellCept is and what it is used for 
 
The full name of your medicine is CellCept 1 g/5 ml powder for oral suspension. 
• In this leaflet the shorter name CellCept is used. 
CellCept contains mycophenolate mofetil. 
• This belongs to a group of medicines called “immuno-suppressants”. 
CellCept is used to prevent your body rejecting a transplanted organ. 
• A kidney, heart or liver.  
CellCept should be used together with other medicines: 
• Ciclosporin and corticosteroids. 
 
 
2. What you need to know before you take CellCept  
 
WARNING 
Mycophenolate causes birth defects and miscarriage. If you are a woman who could become pregnant, 
you must provide a negative pregnancy test before starting treatment and must follow the 
contraception advice given to you by your doctor. 
 
Your doctor will speak to you and give you written information, particularly on the effects of 
mycophenolate on unborn babies. Read the information carefully and follow the instructions. 
 
If you do not fully understand these instructions, please ask your doctor to explain them again before 
you take mycophenolate. See also further information in this section under “Warnings and 
precautions” and “Pregnancy and breast-feeding”. 
 
Do not take CellCept: 
• If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the 

other ingredients in this medicine (listed in section 6) 
• If you are a woman who could be pregnant and you have not provided a negative pregnancy test 

before your first prescription, as mycophenolate causes birth defects and miscarriage. 



122 

• If you are pregnant or planning to become pregnant or think you may be pregnant 
• If you are not using effective contraception (see Pregnancy, contraception and breast-feeding). 
• If you are breast-feeding. 
Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or 
pharmacist before taking CellCept. 
 
Warnings and precautions  
Talk to your doctor straight away before starting treatment with CellCept: 
• If you have a sign of infection such as a fever or sore throat  
• If you have any unexpected bruising or bleeding 
• If you have ever had a problem with your digestive system such as a stomach ulcer 
• If you have a rare problem with your metabolism called “phenylketonuria” which runs in 

families 
• If you are planning to become pregnant or if you get pregnant while you or your partner are 

taking CellCept. 
If any of the above apply to you (or you are not sure), talk to your doctor straight away before starting 
treatment with CellCept. 
 
The effect of sunlight 
CellCept reduces your body’s defences. As a result, there is an increased risk of skin cancer. Limit the 
amount of sunlight and UV light you get. Do this by: 
• wearing protective clothing that covers your head, neck, arms and legs 
• using a sunscreen with a high protection factor. 
 
Other medicines and CellCept:  
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This 
includes medicines obtained without a prescription, such as herbal medicines. This is because 
CellCept can affect the way some other medicines work. Also, other medicines can affect the way 
CellCept works. 
 
In particular, tell your doctor or pharmacist if you are taking any of the following medicines before 
you start CellCept: 
• azathioprine or other medicines that suppress your immune system - given after a transplant 

operation 
• cholestyramine - used to treat high cholesterol 
• rifampicin - an antibiotic used to prevent and treat infections such as tuberculosis (TB) 
• antacids or proton pump inhibitors - used for acid problems in your stomach such as indigestion 
• phosphate binders - used by people with chronic kidney failure to reduce how much phosphate 

gets absorbed into their blood. 
• antibiotics – used to treat bacterial infections  
• isavuconazole – used to treat fungal infections 
• telmisartan – used to treat high blood pressure 
 
Vaccines 
If you need to have a vaccine (a live vaccine) while taking CellCept, talk to your doctor or pharmacist 
first. Your doctor will have to advise you on which vaccines you can have. 
 
You must not donate blood during treatment with CellCept and for at least 6 weeks after stopping 
treatment. Men must not donate semen during treatment with CellCept and for at least 90 days after 
stopping treatment. 
 
CellCept with food and drink 
Taking food and drink has no effect on your treatment with CellCept. 
 



123 

Pregnancy, contraception and breast-feeding 
 
Contraception in women taking CellCept 
If you are a woman who could become pregnant, you must use an effective method of contraception 
with CellCept. This includes: 
• Before you start taking CellCept 
• During your entire treatment with CellCept  
• For 6 weeks after you stop taking CellCept. 
Talk to your doctor about the most suitable contraception for you. This will depend on your individual 
situation. Two forms of contraception are preferable as this will reduce the risk of unintended 
pregnancy. Contact your doctor as soon as possible, if you think your contraception may not 
have been effective or if you have forgotten to take your contraceptive pill. 
 
You are a woman who is not capable of becoming pregnant if any of the following applies to you: 
• You are post-menopausal, i.e. at least 50 years old and your last period was more than a year 

ago (if your periods have stopped because you have had treatment for cancer, then there is still a 
chance you could become pregnant) 

• Your fallopian tubes and both ovaries have been removed by surgery (bilateral                            
salpingo-oophorectomy) 

• Your womb (uterus) has been removed by surgery (hysterectomy) 
• Your ovaries no longer work (premature ovarian failure, which has been confirmed by a 

specialist gynaecologist) 
• You were born with one of the following rare conditions that make pregnancy impossible: the 

XY genotype, Turner’s syndrome or uterine agenesis 
• You are a child or teenager who has not started having periods. 
 
Contraception in men taking CellCept 
The available evidence does not indicate an increased risk of malformations or miscarriage if the 
father takes mycophenolate. However, a risk cannot be completely excluded. As a precaution, you or 
your female partner are recommended to use reliable contraception during treatment and for 90 days 
after you stop taking CellCept.  
 
If you are planning to have a child, talk to your doctor about the potential risks and alternative 
therapies. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. Your doctor will talk to you about 
the risks in case of pregnancy and the alternatives you can take to prevent rejection of your transplant 
organ if: 
• You plan to become pregnant. 
• You miss or think you have missed a period, or you have unusual menstrual bleeding, or 

suspect you are pregnant. 
• You have sex without using an effective method of contraception. 
If you do become pregnant during the treatment with mycophenolate, you must inform your doctor 
immediately. However, keep taking CellCept until you see him or her. 
 
Pregnancy 
Mycophenolate causes a very high frequency of miscarriage (50%) and of severe birth defects (23 - 
27 %) in the unborn baby. Birth defects which have been reported include anomalies of ears, of eyes, 
of face (cleft lip/palate), of development of fingers, of heart, oesophagus (tube that connects the throat 
with the stomach), kidneys and nervous system (for example spina bifida (where the bones of the 
spine are not properly developed). Your baby may be affected by one or more of these. 
 
If you are a woman who could become pregnant, you must provide a negative pregnancy test before 
starting treatment and must follow the contraception advice given to you by your doctor. Your doctor 
may request more than one test to ensure you are not pregnant before starting treatment. 



124 

 
Breast-feeding 
Do not take CellCept if you are breast-feeding. This is because small amounts of the medicine can 
pass into the mother’s milk. 
 
Driving and using machines 
CellCept has a moderate influence on your ability to drive or use any tools or machines. If you feel 
drowsy, numb or confused, talk to your doctor or nurse and do not drive or use any tools or machines 
until you feel better. 
 
Important information about some of the ingredients of CellCept 
• CellCept contains aspartame. If you have a rare problem with your metabolism called 

“phenylketonuria”, talk to your doctor before you start taking this medicine. 
• CellCept contains sorbitol (a type of sugar). If you have been told by your doctor that you 

cannot tolerate or digest some sugars, talk to your doctor before taking this medicine. 
 
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say 
essentially ‘sodium-free’. 
 
 
3. How to take CellCept 
 
Always take CellCept exactly as your doctor has told you. You should check with your doctor or 
pharmacist if you are not sure. 
 
How much to take 
The amount you take depends on the type of transplant you have had. The usual doses are shown 
below. Treatment will continue for as long as you need to prevent you from rejecting your transplant 
organ. 
 
Kidney transplant 
Adults 
• The first dose is given within 3 days of the transplant operation.  
• The daily dose is 10 ml suspension (2 g of the medicine) taken as 2 separate doses.  
• Take 5 ml suspension in the morning and then 5 ml suspension in the evening. 

Children (aged 2 to 18 years) 
• The dose given will vary depending on the size of the child.  
• Your doctor will decide the most appropriate dose based on your child’s height and weight 

(body surface area – measured as square metres or “m²”). The recommended dose is 
600 mg/m² taken twice a day. 

 
Heart transplant 
Adults 
• The first dose is given within 5 days of the transplant operation.  
• The daily dose is 15 ml suspension (3 g of the medicine) taken as 2 separate doses.  
• Take 7.5 ml suspension in the morning and then 7.5 ml suspension in the evening. 
Children 
• There is no information for the use of CellCept in children with a heart transplant. 
 
Liver transplant 
Adults 
• The first dose of oral CellCept will be given to you at least 4 days after the transplant operation 

and when you are able to swallow oral medications.  
• The daily dose is 15 ml suspension (3 g of the medicine) taken as 2 separate doses.  
• Take 7.5 ml suspension in the morning and then 7.5 ml suspension in the evening.  

Children 



125 

• There is no information for the use of CellCept in children with a liver transplant. 
 
Making up the medicine 
The medicine comes as a powder. This needs mixing with purified water before using. Your 
pharmacist will normally make up the medicine for you. If you need to do it yourself, see section 7 
“Making up the medicine” 
 
Taking the medicine 
You need to use the dispenser and bottle adapter supplied with the medicine to measure the dose. 
Try not to inhale the dry powder. Also, try not to get it on your skin, inside your mouth or nose. 
Take care not to let the made-up medicine get into your eyes. 
• If this happens, rinse your eyes with plain water. 
Take care not to let the made-up medicine get onto your skin.  
• If this happens, wash the area thoroughly with soap and water. 

 
 
1. Shake the closed bottle well for about 5 seconds before each use. 
2. Take off the child safety bottle cap. 
3. Take the dispenser and push the plunger completely down toward the tip of the dispenser.  
4. Then put the tip of the dispenser firmly into the opening of the bottle adapter. 
5. Turn the whole thing upside down (bottle and dispenser – see picture below). 

 
 
6. Pull the plunger out slowly. 
• Keep pulling it out until the desired amount of medicine is in the dispenser. 
7. Turn the whole thing back round the right way. 
• Holding onto the body of the dispenser, carefully pull the dispenser out of the bottle adapter. 
The bottle adapter should stay in the bottle. 
• Put the end of the dispenser directly into your mouth and swallow the medicine.  
• Do not mix the medicine with any other liquid when you swallow it. Close the bottle with the 

child safety bottle cap after each use. 
• Immediately after use – take the dispenser to pieces and rinse it under running tap water. Allow 

it to dry in the air before using it again. Do not use solvent-containing wipes for cleaning. Do 
not use cloths or wipes for drying. 

 



126 

If you take more CellCept than you should 
If you take more CellCept than you should, talk to a doctor or go to a hospital straight away. Also do 
this if someone else accidentally takes your medicine. Take the medicine pack with you. 
 
If you forget to take CellCept 
If you forget to take your medicine at any time, take it as soon as you remember. Then continue to take 
it at the usual times. Do not take a double dose to make up for a missed dose.  
 
If you stop taking CellCept 
Do not stop taking CellCept unless your doctor tells you to. If you stop your treatment you may 
increase the chance of rejection of your transplant organ. 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, CellCept can cause side effects, although not everybody gets them. 
 
Talk to a doctor straight away if you notice any of the following serious side effects – you 
may need urgent medical treatment: 
• you have a sign of infection such as a fever or sore throat 
• you have any unexpected bruising or bleeding 
• you have a rash, swelling of your face, lips, tongue or throat, with difficulty breathing – you 

may be having a serious allergic reaction to the medicine (such as anaphylaxis, angioeodema). 
 
Usual problems 
Some of the more usual problems are diarrhoea, fewer white cells or red cells in your blood, infection 
and vomiting. Your doctor will do regular blood tests to check for any changes in: 
• the number of your blood cells or signs of infections. 
 
Children may be more likely than adults to have some side effects. These include diarrhoea, infections, 
fewer white cells and fewer red cells in the blood. 
 
Fighting infections 
CellCept reduces your body’s defences. This is to stop you rejecting your transplant. As a result, your 
body will not be as good as normal at fighting infections. This means you may catch more infections 
than usual. This includes infections of the brain, skin, mouth, stomach and gut, lungs and urinary 
system.  
 
Lymph and skin cancer 
As can happen in patients taking this type of medicine (immune-suppressants), a very small number of 
CellCept patients have developed cancer of the lymphoid tissues and skin.  
 
General unwanted effects 
You may get general side effects affecting your body as a whole. These include serious allergic 
reactions (such as anaphylaxis, angioeodema), fever, feeling very tired, difficulty sleeping, pains (such 
as stomach, chest, joint or muscle), headache, flu symptoms and swelling.  
 
Other unwanted effects may include: 
Skin problems such as:  
• acne, cold sores, shingles, skin growth, hair loss, rash, itching. 
 
Urinary problems such as: 
• blood in the urine. 
 



127 

Digestive system and mouth problems such as: 
• swelling of the gums and mouth ulcers, 
• inflammation of the pancreas, colon or stomach, 
• gastrointestinal disorders including bleeding, 
•  liver disorders, 
• diarrhea, constipation, feeling sick (nausea), indigestion, loss of appetite, flatulence. 
 
Nervous system problems such as: 
• feeling dizzy, drowsy or numb, 
• tremor, muscle spasms, convulsions, 
• feeling anxious or depressed, changes in your mood or thoughts. 
 
Heart and blood vessel problems such as: 
• change in blood pressure, accelerated heartbeat, widening of blood vessels.  
 
Lung problems such as: 
• pneumonia, bronchitis, 
• shortness of breath, cough, which can be due to bronchiectasis (a condition in which the lung 

airways are abnormally dilated) or pulmonary fibrosis (scarring of the lung). Talk to your doctor 
if you develop a persistent cough or breathlessness  

• fluid on the lungs or inside the chest, 
• sinus problems. 
 
Other problems such as: 
• weight loss, gout, high blood sugar, bleeding, bruising. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not 
listed in this leaflet. You can also report side effects directly via the national reporting system listed in 
Appendix V. By reporting side effects, you can help provide more information on the safety of this 
medicine. 
 
 
5. How to store CellCept 
 
• Keep this medicine out of the sight and reach of children. 
• Do not use this medicine after the expiry date which is stated on the carton and bottle label after 

EXP. 
• The shelf-life of the reconstituted suspension is two months. Do not use the suspension past this 

expiry date. 
• Powder for oral suspension: do not store above 30°C.  
• Reconstituted suspension: do not store above 30°C. 
• Do not throw away any medicines  via wastewater or household waste. Ask your pharmacist 

how to throw away medicines no longer required. These measures will help protect the 
environment. 

 
 
6. Contents of the pack and other information 
 
What CellCept contains 
 
• The active substance is mycophenolate mofetil. 
• The other ingredients are sorbitol, colloidal anhydrous silica, sodium citrate, soybean lecithin, 

mixed fruit flavour, xanthan gum, aspartame* (E951), methyl parahydroxybenzoate (E218), 
citric acid anhydrous. 

 * contains phenylalanine equivalent to 2.78 mg/5 ml of suspension. 
 

https://www.ema.europa.eu/documents/template-form/appendix-v-adverse-drug-reaction-reporting-details_en.doc


128 

What CellCept looks like and contents of the pack 
• Each bottle of 110 g powder for oral suspension contains 35 g of mycophenolate mofetil. 

Reconstitute with 94 ml of purified water. When reconstituted, the volume of the suspension is 
175 ml, providing a usable volume of 160 – 165 ml. 5 ml of the reconstituted suspension 
contain 1 g of mycophenolate mofetil. 

• A bottle adapter and 2 oral dispensers are also provided. 
 
 
7. Making up the medicine 
 
Your pharmacist will normally make up the medicine for you. If you need to do it yourself, follow the 
steps below: 
Try not to inhale the dry powder. Also try not to get it on your skin, inside your mouth or nose. 
Take care not to let the made-up medicine get into your eyes. 
• If this happens, rinse your eyes with plain water. 
Take care not to let the made-up medicine get on your skin.  
• If this happens, wash the area thoroughly with soap and water. 
 
1. Tap the bottom of the closed bottle several times to loosen the powder. 
2. Measure 94 ml of purified water in a measuring cylinder. 
3. Add about half of the total amount of purified water to the bottle. 
• Then shake the closed bottle well for about 1 minute. 
4. Add the rest of the water. 
• Then shake the closed bottle well for about another minute. 
5. Take off the child safety bottle cap and push the bottle adapter into the neck of the bottle. 
6. Then, tightly close the bottle with the child safety bottle cap. 
• This will make sure that the bottle adapter and child safety bottle cap are in the right position. 
7. Write the expiry date of the made-up medicine on the bottle label.  
• The made-up medicine can be used for 2 months. 
 
Marketing Authorisation Holder 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
Manufacturing Authorisation Holder responsible for batch release: 
Roche Pharma AG, Emil-Barell-Str. 1, 79639 Grenzach Wyhlen, Germany. 
 
For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder: 
 
België/Belgique/Belgien 
N.V. Roche S.A. 
Tél/Tel: +32 (0) 2 525 82 11 
 

Lietuva 
UAB “Roche Lietuva” 
Tel: +370 5 2546799 
 

България 
Рош България ЕООД 
Тел: +359 2 818 44 44 
 

Luxembourg/Luxemburg 
(Voir/siehe Belgique/Belgien) 
 

Česká republika 
Roche s. r. o. 
Tel: +420 - 2 20382111 
 

Magyarország 
Roche (Magyarország) Kft. 
Tel: +36 - 23 446 800 
 



129 

Danmark 
Roche a/s 
Tlf: +45 - 36 39 99 99 
 

Malta 
(See Ireland) 
 

Deutschland 
Roche Pharma AG 
Tel: +49 (0) 7624 140 
 

Nederland 
Roche Nederland B.V. 
Tel: +31 (0) 348 438050 
 

Eesti 
Roche Eesti OÜ 
Tel: + 372 - 6 177 380 
 

Norge 
Roche Norge AS 
Tlf: +47 - 22 78 90 00 
 

Ελλάδα 
Roche (Hellas) A.E.  
Τηλ: +30 210 61 66 100 
 

Österreich 
Roche Austria GmbH 
Tel: +43 (0) 1 27739 
 

España 
Roche Farma S.A. 
Tel: +34 - 91 324 81 00 
 

Polska 
Roche Polska Sp.z o.o. 
Tel: +48 - 22 345 18 88 
 

France 
Roche 
Tél: +33 (0)1 47 61 40 00 
 

Portugal 
Roche Farmacêutica Química, Lda 
Tel: +351 - 21 425 70 00 
 

Hrvatska 
Roche d.o.o. 
Tel: + 385 1 47 22 333 
 

România 
Roche România S.R.L. 
Tel: +40 21 206 47 01 
 

Ireland 
Roche Products (Ireland) Ltd. 
Tel: +353 (0) 1 469 0700 
 

Slovenija 
Roche farmacevtska družba d.o.o. 
Tel: +386 - 1 360 26 00 
 

Ísland  
Roche a/s 
c/o Icepharma hf 
Sími: +354 540 8000 
 

Slovenská republika  
Roche Slovensko, s.r.o. 
Tel: +421 - 2 52638201 

Italia 
Roche S.p.A. 
Tel: +39 - 039 2471 

Suomi/Finland 
Roche Oy  
Puh/Tel: +358 (0) 10 554 500 
 

Kύπρος  
Γ.Α.Σταμάτης & Σια Λτδ. 
Τηλ: +357 - 22 76 62 76 
 

Sverige 
Roche AB 
Tel: +46 (0) 8 726 1200 
 

Latvija 
Roche Latvija SIA 
Tel: +371 - 6 7039831 
 

United Kingdom 
Roche Products Ltd. 
Tel: +44 (0) 1707 366000 
 

 
This leaflet was last revised in {MM/YYYY} 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site:  
http://www.ema.europa.eu  

  

http://www.ema.europa.eu/


130 

Package leaflet: Information for the user 
 

CellCept 500 mg film-coated tablets 
mycophenolate mofetil 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
 
• Keep this leaflet. You may need to read it again. 
• If you have any further questions, ask your doctor or pharmacist. 
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What in this leaflet:  
 
1. What CellCept is and what it is used for 
2. What you need to know before you take CellCept 
3. How to take CellCept 
4. Possible side effects 
5. How to store CellCept 
6. Contents of the pack and other information 
 
 
1. What CellCept is and what it is used for 
 
The full name of your medicine is CellCept 500 mg film-coated tablets.  
• In this leaflet the shorter name CellCept is used. 
CellCept contains mycophenolate mofetil.  
• This belongs to a group of medicines called “immunosuppressants”.  
CellCept is used to prevent your body rejecting a transplanted organ. 
• A kidney, heart or liver.  
CellCept should be used together with other medicines: 
• Ciclosporin and corticosteroids. 
 
 
2. What you need to know before you take CellCept  
 
WARNING 
Mycophenolate causes birth defects and miscarriage. If you are a woman who could become pregnant, 
you must provide a negative pregnancy test before starting treatment and must follow the 
contraception advice given to you by your doctor. 
 
Your doctor will speak to you and give you written information, particularly on the effects of 
mycophenolate on unborn babies. Read the information carefully and follow the instructions. 
 
If you do not fully understand these instructions, please ask your doctor to explain them again before 
you take mycophenolate. See also further information in this section under “Warnings and 
precautions” and “Pregnancy and breast-feeding”. 
 
Do not take CellCept: 
• If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the 

other ingredients in this medicine (listed in section 6) 
• If you are a woman who could be pregnant and you have not provided a negative pregnancy test 

before your first prescription, as mycophenolate causes birth defects and miscarriage. 



131 

• If you are pregnant or planning to become pregnant or think you may be pregnant 
• If you are not using effective contraception (see Pregnancy, contraception and breast-feeding). 
• If you are breast-feeding. 
Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or 
pharmacist before taking CellCept. 
 
Warnings and precautions 
Talk to your doctor straight away before starting treatment with CellCept: 
• If you have a sign of infection such as a fever or sore throat 
• If you have any unexpected bruising or bleeding 
• If you have ever had a problem with your digestive system such as a stomach ulcer 
• If you are planning to become pregnant or if you get pregnant while you or partner are taking 
CellCept. 
If any of the above apply to you (or you are not sure), talk to your doctor straight away before starting 
treatment with CellCept. 
 
The effect of sunlight 
CellCept reduces your body’s defences. As a result, there is an increased risk of skin cancer. Limit the 
amount of sunlight and UV light you get. Do this by: 
• wearing protective clothing that also covers your head, neck, arms and legs 
• using a sunscreen with a high protection factor. 
 
Other medicines and CellCept 
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This 
includes medicines obtained without a prescription, such as herbal medicines. This is because 
CellCept can affect the way some other medicines work. Also other medicines can affect the way 
CellCept works. 
In particular, tell your doctor or pharmacist if you are taking any of the following medicines before 
you start CellCept: 
• azathioprine or other medicines that suppress your immune system – given after a transplant 

operation 
• cholestyramine – used to treat high cholesterol 
• rifampicin – an antibiotic used to prevent and treat infections such as tuberculosis (TB) 
• antacids or proton pump inhibitors – used for acid problems in your stomach such as indigestion 
• phosphate binders – used by people with chronic kidney failure to reduce how much phosphate 

gets absorbed into their blood. 
• antibiotics – used to treat bacterial infections  
• isavuconazole – used to treat fungal infections 
• telmisartan – used to treat high blood pressure 
 
Vaccines 
If you need to have a vaccine (a live vaccine) while taking CellCept, talk to your doctor or pharmacist 
first. Your doctor will have to advise you on what vaccines you can have. 
 
You must not donate blood during treatment with CellCept and for at least 6 weeks after stopping 
treatment. Men must not donate semen during treatment with CellCept and for at least 90 days after 
stopping treatment. 
 
CellCept with food and drink 
Taking food and drink has no effect on your treatment with CellCept. 
 



132 

Pregnancy, contraception and breast-feeding 
 
Contraception in women taking CellCept 
If you are a woman who could become pregnant, you must use an effective method of contraception 
with CellCept. This includes: 
• Before you start taking CellCept 
• During your entire treatment with CellCept  
• For 6 weeks after you stop taking CellCept. 
Talk to your doctor about the most suitable contraception for you. This will depend on your individual 
situation. Two forms of contraception are preferable as this will reduce the risk of unintended 
pregnancy. Contact your doctor as soon as possible, if you think your contraception may not 
have been effective or if you have forgotten to take your contraceptive pill. 
 
You are a woman who is not capable of becoming pregnant if any of the following applies to you: 
• You are post-menopausal, i.e. at least 50 years old and your last period was more than a year 

ago (if your periods have stopped because you have had treatment for cancer, then there is still a 
chance you could become pregnant) 

• Your fallopian tubes and both ovaries have been removed by surgery (bilateral                            
salpingo-oophorectomy) 

• Your womb (uterus) has been removed by surgery (hysterectomy) 
• Your ovaries no longer work (premature ovarian failure, which has been confirmed by a 

specialist gynaecologist) 
• You were born with one of the following rare conditions that make pregnancy impossible: the 

XY genotype, Turner’s syndrome or uterine agenesis 
• You are a child or teenager who has not started having periods. 
 
Contraception in men taking CellCept 
The available evidence does not indicate an increased risk of malformations or miscarriage if the 
father takes mycophenolate. However, a risk cannot be completely excluded. As a precaution you or 
your female partner are recommended to use reliable contraception during treatment and for 90 days 
after you stop taking CellCept.  
 
If you are planning to have a child, talk to your doctor about the potential risks and alternative 
therapies. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. Your doctor will talk to you about 
the risks in case of pregnancy and the alternatives you can take to prevent rejection of your transplant 
organ if: 
• You plan to become pregnant. 
• You miss or think you have missed a period, or you have unusual menstrual bleeding, or suspect 

you are pregnant. 
• You have sex without using an effective method of contraception. 
If you do become pregnant during the treatment with mycophenolate, you must inform your doctor 
immediately. However, keep taking CellCept until you see him or her. 
 
Pregnancy 
Mycophenolate causes a very high frequency of miscarriage (50%) and of severe birth defects (23 - 
27 %) in the unborn baby. Birth defects which have been reported include anomalies of ears, of eyes, 
of face (cleft lip/palate), of development of fingers, of heart, oesophagus (tube that connects the throat 
with the stomach), kidneys and nervous system (for example spina bifida (where the bones of the 
spine are not properly developed). Your baby may be affected by one or more of these. 
 
If you are a woman who could become pregnant, you must provide a negative pregnancy test before 
starting treatment and must follow the contraception advice given to you by your doctor. Your doctor 
may request more than one test to ensure you are not pregnant before starting treatment. 



133 

 
Breast-feeding 
Do not take CellCept if you are breast-feeding. This is because small amounts of the medicine can 
pass into the mother’s milk. 
 
Driving and using machines 
CellCept has a moderate influence on your ability to drive or use any tools or machines. If you feel 
drowsy, numb or confused, talk to your doctor or nurse and do not drive or use any tools or machines 
until you feel better. 
 
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say 
essentially ‘sodium-free’. 
 
 
3. How to take CellCept 
 
Always take CellCept exactly as your doctor has told you. You should check with your doctor or 
pharmacist if you are not sure.  
 
How much to take 
The amount you take depends on the type of transplant you have had. The usual doses are shown 
below. Treatment will continue for as long as you need to prevent you from rejecting your transplant 
organ. 
 
Kidney transplant 
Adults 
• The first dose is given within 3 days of the transplant operation. 
• The daily dose is 4 tablets (2 g of the medicine) taken as 2 separate doses.  
• Take 2 tablets in the morning and then 2 tablets in the evening. 

Children (aged 2 to 18 years) 
• The dose given will vary depending on the size of the child.  
• Your doctor will decide the most appropriate dose based on your child’s height and weight 

(body surface area – measured as square metres or “m2”). The recommended dose is 600 mg/m2 
taken twice a day. 

 
Heart transplant 
Adults 
• The first dose is given within 5 days of the transplant operation. 
• The daily dose is 6 tablets (3 g of the medicine) taken as 2 separate doses.  
• Take 3 tablets in the morning and then 3 tablets in the evening. 
Children 
• There is no information for the use of CellCept in children with a heart transplant. 
 
Liver transplant 
Adults 
• The first dose of oral CellCept will be given to you at least 4 days after the transplant 

operation and when you are able to swallow oral medicines. 
• The daily dose is 6 tablets (3 g of the medicine) taken as 2 separate doses.  
• Take 3 tablets in the morning and then 3 tablets in the evening.  
Children 
• There is no information for the use of CellCept in children with a liver transplant. 
 
Taking the medicine 
• Swallow your tablets whole with a glass of water. 
• Do not break or crush them. 
 



134 

If you take more CellCept than you should 
If you take more CellCept than you should, talk to a doctor or go to a hospital straight away. Also do 
this if someone else accidentally takes your medicine. Take the medicine pack with you. 
 
If you forget to take CellCept 
If you forget to take your medicine at any time, take it as soon as you remember. Then continue to take 
it at the usual times. Do not take a double dose to make up for a missed dose. 
 
If you stop taking CellCept 
Do not stop taking CellCept unless your doctor tells you to. If you stop your treatment you may 
increase the chance of rejection of your transplanted organ.  
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, CellCept can cause side effects, although not everybody gets them. 
 
Talk to a doctor straight away if you notice any of the following serious side effects – you 
may need urgent medical treatment: 
• you have a sign of infection such as a fever or sore throat 
• you have any unexpected bruising or bleeding 
• you have a rash, swelling of your face, lips, tongue or throat, with difficulty breathing - you may 

be having a serious allergic reaction to the medicine (such as anaphylaxis, angioeodema). 
 
Usual problems 
Some of the more usual problems are diarrhoea, fewer white cells or red cells in your blood, infection 
and vomiting. Your doctor will do regular blood tests to check for any changes in: 
• the number of your blood cells or signs of infections. 
 
Children may be more likely than adults to have some side effects. These include diarrhoea, infections, 
fewer white cells and fewer red cells in the blood. 
 
Fighting infections 
CellCept reduces your body’s defences. This is to stop you rejecting your transplant. As a result, your 
body will not be as good as normal at fighting infections. This means you may catch more infections 
than usual. This includes infections of the brain, skin, mouth, stomach and gut, lungs and urinary 
system.  
 
Lymph and skin cancer 
As can happen in patients taking this type of medicine (immune-suppressants), a very small number of 
CellCept patients have developed cancer of the lymphoid tissues and skin.  
 
General unwanted effects 
You may get general side effects affecting your body as a whole. These include serious allergic 
reactions (such as anaphylaxis, angioeodema), fever, feeling very tired, difficulty sleeping, pains (such 
as stomach, chest, joint or muscle), headache, flu symptoms and swelling.  
 
Other unwanted effects may include: 
Skin problems such as:  
• acne, cold sores, shingles, skin growth hair loss, rash, itching. 
 
Urinary problems such as:  
• blood in the urine. 
 



135 

Digestive system and mouth problems such as:  
• swelling of the gums and mouth ulcers, 
• inflammation of the pancreas, colon or stomach,  
• gastrointestinal disorders including bleeding, 
• liver disorders  
• diarrhea, constipation, feeling sick (nausea), indigestion, loss of appetite, flatulence. 
 
Nervous system problems such as:  
• feeling dizzy, drowsy or numb,  
• tremor, muscle spasms, convulsions,  
• feeling anxious or depressed, changes in your mood or thoughts. 
 
Heart and blood vessel problems such as: 
• change in blood pressure, accelerated heartbeat, widening of blood vessels. 
 
Lung problems such as:  
• pneumonia, bronchitis,  
• shortness of breath, cough, which can be due to bronchiectasis (a condition in which the lung 

airways are abnormally dilated) or pulmonary fibrosis (scarring of the lung). Talk to your doctor 
if you develop a persistent cough or breathlessness,fluid on the lungs or inside the chest, 

• sinus problems. 
 
Other problems such as:  
• weight loss, gout, high blood sugar, bleeding, bruising.  
 
Reporting of side effects 
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not 
listed in this leaflet. You can also report side effects directly via the national reporting system listed in 
Appendix V. By reporting side effects, you can help provide more information on the safety of this 
medicine. 
 
 
5. How to store CellCept 
 
• Keep this medicine out of the sight and reach of children. 
• Do not use this medicine  after the expiry date which is stated on the carton after EXP. 
• Do not store above 30°C.  
• Keep in outer carton in order to protect from light. 
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist 
how to throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What CellCept film coated tablet contains 
• The active substance is mycophenolate mofetil. 
• The other ingredients are: 
• CellCept tablets: microcrystalline cellulose, polyvidone (K-90), croscarmellose sodium, 

magnesium stearate 
• tablet coating: hydroxypropyl methycellulose, hydroxypropyl cellulose, titanium dioxide 

(E171), polyethylene glycol 400, indigo carmine aluminium lake (E132), red iron oxide (E172). 
 
What CellCept looks like and contents of the pack 
• CellCept tablets are lavender-coloured and caplet-shaped. They have “CellCept 500” engraved 

on one side and “ROCHE” on the other. 
• They are available as packs of 50 (in blister packs of 10) or Multipacks containing 150 (3 packs 

of 50) tablets. 

https://www.ema.europa.eu/documents/template-form/appendix-v-adverse-drug-reaction-reporting-details_en.doc


136 

 
Marketing Authorisation Holder 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
Manufacturing Authorisation Holder responsible for batch release: 
Roche Pharma AG, Emil-Barell-Str. 1, 79639 Grenzach Wyhlen, Germany. 
 
For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder: 
 
België/Belgique/Belgien 
N.V. Roche S.A. 
Tél/Tel: +32 (0) 2 525 82 11 
 

Lietuva 
UAB “Roche Lietuva” 
Tel: +370 5 2546799 
 

България 
Рош България ЕООД 
Тел: +359 2 818 44 44 
 

Luxembourg/Luxemburg 
(Voir/siehe Belgique/Belgien) 
 

Česká republika 
Roche s. r. o. 
Tel: +420 - 2 20382111 
 

Magyarország 
Roche (Magyarország) Kft. 
Tel: +36 - 23 446 800 
 

Danmark 
Roche a/s 
Tlf: +45 - 36 39 99 99 
 

Malta 
(See Ireland) 
 

Deutschland 
Roche Pharma AG 
Tel: +49 (0) 7624 140 
 

Nederland 
Roche Nederland B.V. 
Tel: +31 (0) 348 438050 
 

Eesti 
Roche Eesti OÜ 
Tel: + 372 - 6 177 380 
 

Norge 
Roche Norge AS 
Tlf: +47 - 22 78 90 00 
 

Ελλάδα 
Roche (Hellas) A.E.  
Τηλ: +30 210 61 66 100 
 

Österreich 
Roche Austria GmbH 
Tel: +43 (0) 1 27739 
 

España 
Roche Farma S.A. 
Tel: +34 - 91 324 81 00 
 

Polska 
Roche Polska Sp.z o.o. 
Tel: +48 - 22 345 18 88 
 

France 
Roche 
Tél: +33 (0)1 47 61 40 00 
 

Portugal 
Roche Farmacêutica Química, Lda 
Tel: +351 - 21 425 70 00 
 

Hrvatska 
Roche d.o.o. 
Tel: + 385 1 47 22 333 
 

România 
Roche România S.R.L. 
Tel: +40 21 206 47 01 
 

Ireland 
Roche Products (Ireland) Ltd. 
Tel: +353 (0) 1 469 0700 
 

Slovenija 
Roche farmacevtska družba d.o.o. 
Tel: +386 - 1 360 26 00 
 



137 

Ísland  
Roche a/s 
c/o Icepharma hf 
Sími: +354 540 8000 
 

Slovenská republika  
Roche Slovensko, s.r.o. 
Tel: +421 - 2 52638201 
 

Italia 
Roche S.p.A. 
Tel: +39 - 039 2471 

Suomi/Finland 
Roche Oy  
Puh/Tel: +358 (0) 10 554 500 
 

Kύπρος  
Γ.Α.Σταμάτης & Σια Λτδ. 
Τηλ: +357 - 22 76 62 76 
 

Sverige 
Roche AB 
Tel: +46 (0) 8 726 1200 
 

Latvija 
Roche Latvija SIA 
Tel: +371 - 6 7039831 
 

United Kingdom 
Roche Products Ltd. 
Tel: +44 (0) 1707 366000 
 

 
This leaflet was last revised in {MM/YYYY} 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency website:  
http://www.ema.europa.eu  
 

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET