Myfenax

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Myfenax 250 mg hard capsules 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each capsule contains 250 mg mycophenolate mofetil. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Hard capsule (capsule) 
 
The capsule body is caramel opaque, printed with ‘250’ axially in black ink. 
The capsule cap is light blue opaque printed ‘M’ axially in black ink. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Myfenax 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 Myfenax should be initiated and maintained by appropriately qualified transplant 
specialists. 
 
Posology 
 
Use in renal transplant 
 
Adults 
Oral Myfenax 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). Myfenax 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 
Myfenax 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 Myfenax 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 Myfenax 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 
Intravenous mycophenolate mofetil should be administered for the first 4 days following hepatic 
transplant, with oral Myfenax 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 
Myfenax is not required. There is no basis for Myfenax 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, Myfenax 
capsules should not be opened or crushed to avoid inhalation or direct contact with skin or mucous 
membranes of the powder contained in Myfenax capsules. If such contact occurs, wash thoroughly 
with soap and water; rinse eyes with plain water. 
 



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4.3 Contraindications 
 
Myfenax 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 
Myfenax have been observed (see section 4.8). 
 
Myfenax should not be given to women of childbearing potential who are not using highly effective 
contraception (see section 4.6). 
 
Myfenax treatment should not be initiated in women of child bearing potential without providing a 
pregnancy test result to rule out unintended use in pregnancy (see section 4.6). 
 
Myfenax should not be used during pregnancy unless there is no suitable alternative treatment to 
prevent transplant rejection (see section 4.6). 
 
Myfenax 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 Myfenax, 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 ultraviolet (UV) light should be limited by wearing protective 
clothing and using a sunscreen with a high protection factor. 
 
Infections 
 
Patients treated with immunosuppressants, including Myfenax, 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 mycophenolate mofetil in combination with other immunosuppressants. In some of 
these cases switching mycophenolate mofetil to an alternative immunosuppressant resulted in serum 
IgG levels returning to normal. Patients on mycophenolate mofetil 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 
mycophenolate mofetil in combination with other immunosuppressants. In some of these cases 
switching mycophenolate mofetil 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 Myfenax should be monitored for neutropenia, which may be related to Myfenax 
itself, concomitant medicinal products, viral infections, or some combination of these causes. Patients 
taking Myfenax 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 Myfenax. 
 
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolate 
mofetil in combination with other immunosuppressants. The mechanism for mycophenolate mofetil 
induced PRCA is unknown. PRCA may resolve with dose reduction or cessation of Myfenax therapy. 
Changes to Myfenax 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 Myfenax 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 Myfenax, 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 
 
Mycophenolate mofetil has been associated with an increased incidence of digestive system adverse 
events, including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation. 
Myfenax should be administered with caution in patients with active serious digestive system disease. 
 
Myfenax is an inosine monophosphate dehydrogenase (IMPDH) 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 mycophenolate mofetil (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 mycophenolate mofetil 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, Myfenax 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 mycophenolate. 
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 Myfenax 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. 
 
Excipient 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say 
essentially ‘sodium-free’. 
 
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. 
 



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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 
mycophenolate mofetil. When comparing rates of transplant rejection or rates of graft loss between 
mycophenolate mofetil patients taking PPIs vs. mycophenolate mofetil patients not taking PPIs, no 
significant differences were seen. This data support extrapolation of this finding to all antacids 
because the reduction in exposure when mycophenolate mofetil was co- administered with magnesium 
and aluminium hydroxides is considerably less than when mycophenolate mofetil 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 mycophenolate mofetil. 
 
Cholestyramine 
Following single dose administration of 1.5 g of mycophenolate mofetil to normal healthy subjects 
pre-treated with 4 g three times a day (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 mycophenolate mofetil. 
 
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 mycophenolate mofetil and CsA compared with patients 
receiving sirolimus or belatacept and similar doses of mycophenolate mofetil (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 predose level may not accurately 
represent changes in overall MPA exposure. Therefore, a change in the dose of Myfenax 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 mycophenolate mofetil 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 
mycophenolate mofetil. 
 
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 mycophenolate 
mofetil. 



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Isavuconazole 
An increase of MPA AUC0-∞ by 35% was observed with concomitant administration of isavuconazole. 
 
Telmisartan 
Concomitant administration of telmisartan and mycophenolate mofetil 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 mycophenolate mofetil 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 mofetil and intravenous ganciclovir and the known effects of renal impairment on the 
pharmacokinetics of mycophenolate mofetil (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 mycophenolate mofetil dose adjustment is not required. In patients with renal 
impairment in whom Myfenax and ganciclovir or its prodrugs, e.g. valganciclovir, are co-administered 
the dose recommendations for ganciclovir should be observed and patients monitored carefully. 
 
Oral contraceptives 
The pharmacokinetics and pharmacodynamics of oral contraceptives were unaffected by co-
administration of mycophenolate mofetil (see also section 5.2). 
 
Rifampicin 
In patients not also taking ciclosporin, concomitant administration of mycophenolate mofetil 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 Myfenax 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 
mycophenolate mofetil was concomitantly administered with sevelamer without any clinical 
consequences (i.e. graft rejection). It is recommended, however, to administer Myfenax 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 mycophenolate mofetil with phosphate binders other than sevelamer. 
 
Tacrolimus 
In hepatic transplant patients initiated on mycophenolate mofetil and tacrolimus, the AUC and Cmax 
of MPA, the active metabolite of mycophenolate mofetil, 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 mycophenolate mofetil (1.5 g taken twice a day [BID], morning and 
evening) were administered to hepatic transplant patients taking tacrolimus. However, in renal 
transplant patients, tacrolimus concentration did not appear to be altered by mycophenolate mofetil 
(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. 
 



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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 Fertility, 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 Myfenax 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 
 
Myfenax 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 Myfenax treatment, women of childbearing potential must 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 mycophenolate 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; 



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• 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, Myfenax is contraindicated in breast-feeding 
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 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 health-care professional the potential 
risks of fathering a child. 
 
4.7 Effects on ability to drive and use machines 
 
Mycophenolate mofetil has a moderate influence on the ability to drive and use machines. 
Mycophenolate mofetil 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 mycophenolate mofetil 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 ciclosporine and corticosteroids. 
The types of adverse reactions reported during post-marketing with mycophenolate mofetil are similar 
to those seen in the controlled renal, cardiac and hepatic transplant studies. 
 
Diarrhoea, leucopenia, sepsis and vomiting were among the most common and/or serious adverse drug 
reactions associated with the administration of mycophenolate mofetil in combination with ciclosporin 
and corticosteroids. There is also evidence of a higher frequency of certain types of infections (see 
section 4.4). 
 



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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 mycophenolate 
mofetil 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 



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Adverse drug reaction 
(MedDRA) 
System Organ Class 

Renal transplant 
n = 991 

Hepatic transplant 
n = 277 

Cardiac transplant 
n = 289 

 Frequency Frequency Frequency 
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 
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 



13 

Adverse drug reaction 
(MedDRA) 
System Organ Class 

Renal transplant 
n = 991 

Hepatic transplant 
n = 277 

Cardiac transplant 
n = 289 

 Frequency Frequency Frequency 
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 tissues 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 

 



14 

Note: 991 (2 g/3 g mycophenolate mofetil daily), 289 (3 g mycophenolate mofetil daily) and 277 (2 g 
IV/3 g oral mycophenolate mofetil 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 mycophenolate mofetil, 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 
mycophenolate mofetil (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, 
cytomegalovirus (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 mycophenolate mofetil. 
 
Blood and lymphatic disorders 
Cytopenias, including leucopenia, 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 mycophenolate mofetil is advised (see section 4.4). There have been 
reports of aplastic anaemia and bone marrow failure in patients treated with mycophenolate mofetil, 
some of which have been fatal. 
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolate 
mofetil (see section 4.4). 
Isolated cases of abnormal neutrophil morphology, including the acquired Pelger-Huet anomaly, have 
been observed in patients treated with mycophenolate mofetil. 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 mycophenolate mofetil. 
 
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 mycophenolate mofetil-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 abortions have been reported in patients exposed to mycophenolate mofetil, 
mainly in the first trimester, see section 4.6. 



15 

 
Congenital disorders 
Congenital malformations have been observed post-marketing in children of patients exposed to 
mycophenolate mofetil 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 mycophenolate mofetil 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 mycophenolate mofetil 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 mycophenolate mofetil 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 Myfenax 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 Myfenax 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). 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


16 

 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: immunosuppressive agents ATC code: LO4A A06 
 
Mechanism of action 
Mycophenolate mofetil is the 2-morpholinoethyl ester of mycophenolic acid (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 mycophenolate 
mofetil is correlated with MPA concentration. The mean bioavailability of oral mycophenolate 
mofetil, based on MPA AUC, is 94% relative to intravenous 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, leucopenia). 
 
Elimination 
 
A negligible amount of substance is excreted as MPA (< 1% of 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). 



17 

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 AUC0-12 h was comparable to 
that seen in post-transplant patients without delayed graft function. Mean plasma MPAG AUC0-12 h 
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 Myfenax 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 mycophenolate mofetil 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 mycophenolate mofetil (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 mycophenolate mofetil on the ovulation suppressing action of the oral 
contraceptives. Serum levels of luteinizing hormone (LH), follicle-stimulating hormone (FSH) and 
progesterone were not significantly affected. The pharmacokinetics of oral contraceptives were 
unaffected by co-administration of mycophenolate mofetil (see also section 4.5). 
 



18 

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 doses. 
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 
 
Capsule content 
Pregelatinised starch (maize) 
Povidone K-30 
Croscarmellose sodium 
Magnesium stearate 
 



19 

Capsule shell 
Cap 
Indigo carmine (E132) 
Titanium dioxide (E171) 
Gelatin 
Body 
Red iron oxide (E172) 
Yellow iron oxide (E172) 
Titanium dioxide (E171) 
Gelatin 
Black ink containing: shellac, black iron oxide (E172), propylene glycol and potassium hydroxide. 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container 
 
Transparent PVC/PVdC-aluminium blisters 
 
Pack sizes of 100, 300 or 100 x 1 and multipacks containing 300 (3 packs of 100) capsules. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
Any unused product or waste material should be disposed of in accordance with local requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5 
2031GA Haarlem 
Netherlands 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/07/438/001 (100 capsules) 
EU/1/07/438/002 (300 capsules) 
EU/1/07/438/006 (100 x 1 capsules) 
EU/1/07/438/009 (300 (3 x 100) capsules) 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 21 February 2008 
Date of first renewal: 19 November 2012 



20 

 
 
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 
 
Myfenax 500 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each tablet contains 500 mg mycophenolate mofetil. 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet (tablet) 
 
Pale purple, oval shaped film-coated tablet, debossed with "M500" on one side and plain on the other 
side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Myfenax 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 Myfenax should be initiated and maintained by appropriately qualified transplant 
specialists. 
 
Posology 
 
Use in renal transplant 
 
Adults 
Oral Myfenax 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). Myfenax 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 dose recommendations and therefore use in this age group is not recommended. 
 
Use in cardiac transplant 
 
Adults 
Oral Myfenax 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). 
 



22 

Paediatric population 
No data are available for paediatric cardiac transplant patients. 
 
Use in hepatic transplant 
 
Adults 
Intravenous mycophenolate mofetil should be administered for the first 4 days following hepatic 
transplant, with oral Myfenax 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; dose reduction or interruption of 
Myfenax is not required. There is no basis for Myfenax 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, Myfenax 
tablets should not be crushed. 
 
4.3 Contraindications 
 
Myfenax 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 
Myfenax have been observed (see section 4.8). 
 
Myfenax should not be given to women of childbearing potential who are not using highly effective 
contraception (see section 4.6). 
 



23 

Myfenax treatment should not be initiated in women of child bearing potential without providing a 
pregnancy test result to rule out unintended use in pregnancy (see section 4.6). 
 
Myfenax should not be used during pregnancy unless there is no suitable alternative treatment to 
prevent transplant rejection (see section 4.6). 
 
Myfenax 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 Myfenax, 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 ultraviolet (UV) light should be limited by wearing protective 
clothing and using a sunscreen with a high protection factor. 
 
Infections 
 
Patients treated with immunosuppressants, including Myfenax, 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 mycophenolate mofetil in combination with other immunosuppressants. In some of 
these cases switching mycophenolate mofetil to an alternative immunosuppressant resulted in serum 
IgG levels returning to normal. Patients on mycophenolate mofetil 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 
mycophenolate mofetil in combination with other immunosuppressants. In some of these cases 
switching mycophenolate mofetil 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 Myfenax should be monitored for neutropenia, which may be related to Myfenax 
itself, concomitant medicinal products, viral infections, or some combination of these causes. Patients 
taking Myfenax 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 Myfenax. 
 
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolate 
mofetil in combination with other immunosuppressants. The mechanism for mycophenolate mofetil 



24 

induced PRCA is unknown. PRCA may resolve with dose reduction or cessation of Myfenax therapy. 
Changes to Myfenax 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 Myfenax 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 Myfenax, 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 
 
Mycophenolate mofetil has been associated with an increased incidence of digestive system adverse 
events, including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation. 
Myfenax should be administered with caution in patients with active serious digestive system disease. 
 
Myfenax is an inosine monophosphate dehydrogenase (IMPDH) 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 mycophenolate mofetil (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 mycophenolate mofetil 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, Myfenax 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 mycophenolate. 
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 Myfenax 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. 
 
Excipient 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say 
essentially ‘sodium-free’. 
 
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 
mycophenolate mofetil. When comparing rates of transplant rejection or rates of graft loss between 
mycophenolate mofetil patients taking PPIs vs. mycophenolate mofetil patients not taking PPIs, no 
significant differences were seen. This data support extrapolation of this finding to all antacids 
because the reduction in exposure when mycophenolate mofetil was co- administered with magnesium 
and aluminium hydroxides is considerably less than when mycophenolate mofetil was co-administered 
with PPIs. 
 



26 

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 mycophenolate mofetil. 
 
Cholestyramine 
Following single dose administration of 1.5 g of mycophenolate mofetil to normal healthy subjects 
pre-treated with 4 g three times a day (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 mycophenolate mofetil. 
 
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 mycophenolate mofetil and CsA compared with patients 
receiving sirolimus or belatacept and similar doses of mycophenolate mofetil (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 predose level may not accurately 
represent changes in overall MPA exposure. Therefore, a change in the dose of Myfenax 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 mycophenolate mofetil 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 
mycophenolate mofetil. 
 
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 mycophenolate 
mofetil. 
 
Isavuconazole 
An increase of MPA AUC0-∞ by 35% was observed with concomitant administration of isavuconazole. 
 
Telmisartan 
Concomitant administration of telmisartan and mycophenolate mofetil 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 mycophenolate mofetil patients with and without 



27 

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 mofetil and intravenous ganciclovir and the known effects of renal impairment on the 
pharmacokinetics of mycophenolate mofetil (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 Myfenax dose adjustment is not required. In patients with renal impairment in whom 
mycophenolate mofetil and ganciclovir or its prodrugs, e.g. valganciclovir, are co-administered the 
dose recommendations for ganciclovir should be observed and patients monitored carefully. 
 
Oral contraceptives 
The pharmacokinetics and pharmacodynamics of oral contraceptives were unaffected by co-
administration of mycophenolate mofetil (see also section 5.2). 
 
Rifampicin 
In patients not also taking ciclosporin, concomitant administration of mycophenolate mofetil 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 Myfenax 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 
mycophenolate mofetil was concomitantly administered with sevelamer without any clinical 
consequences (i.e. graft rejection). It is recommended, however, to administer Myfenax 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 mycophenolate mofetil with phosphate binders other than sevelamer. 
 
Tacrolimus 
In hepatic transplant patients initiated on mycophenolate mofetil and tacrolimus, the AUC and Cmax 
of MPA, the active metabolite of mycophenolate mofetil, 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 mycophenolate mofetil (1.5 g taken twice a day [BID], morning and 
evening) were administered to hepatic transplant patients taking tacrolimus. However, in renal 
transplant patients, tacrolimus concentration did not appear to be altered by mycophenolate mofetil 
(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. 
 



28 

4.6 Fertility, 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 Myfenax 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 
 
Myfenax 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 Myfenax treatment, women of childbearing potential must 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 mycophenolate 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; 



29 

• 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, Myfenax is contraindicated in breast-feeding 
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 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 health-care professional the potential 
risks of fathering a child. 
 
4.7 Effects on ability to drive and use machines 
 
Mycophenolate mofetil has a moderate influence on the ability to drive and use machines. 
Mycophenolate mofetil 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 mycophenolate mofetil 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 ciclosporine and corticosteroids. 
The types of adverse reactions reported during post-marketing with mycophenolate mofetil are similar 
to those seen in the controlled renal, cardiac and hepatic transplant studies. 
 
Diarrhoea, leucopenia, sepsis and vomiting were among the most common and/or serious adverse drug 
reactions associated with the administration of mycophenolate mofetil 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 



30 

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 mycophenolate 
mofetil 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 
Psychiatric disorders 
Confusional state Common Very common Very common 
Depression Common Very common Very common 
Insomnia Common Very common Very common 



31 

Adverse drug reaction 
(MedDRA) 
System Organ Class 

Renal transplant 
n = 991 

Hepatic transplant 
n = 277 

Cardiac transplant 
n = 289 

 Frequency Frequency Frequency 
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 
Gastritis  Common Common Common 
Gastrointestinal  hemorrhage Common Common Common 
Gastrointestinal ulcer Common Common Common 
Gingival hyperplasia Common Common Common 
Ileus Common Common Common 



32 

Adverse drug reaction 
(MedDRA) 
System Organ Class 

Renal transplant 
n = 991 

Hepatic transplant 
n = 277 

Cardiac transplant 
n = 289 

 Frequency Frequency Frequency 
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 tissues 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 mycophenolate mofetil daily), 289 (3 g mycophenolate mofetil daily) and 277 (2 g 
IV/3 g oral mycophenolate mofetil daily) patients were treated in Phase III studies for the prevention 
of rejection in renal, cardiac and hepatic transplantation, respectively. 
 



33 

Description of selected adverse reactions 
 
Malignancies 
Patients receiving immunosuppressive regimens involving combinations of medicinal products, 
including mycophenolate mofetil, 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 
mycophenolate mofetil (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, 
cytomegalovirus (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 mycophenolate mofetil. 
 
Blood and lymphatic disorders 
Cytopenias, including leucopenia, 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 mycophenolate mofetil is advised (see section 4.4). There have been 
reports of aplastic anaemia and bone marrow failure in patients treated with mycophenolate mofetil, 
some of which have been fatal. 
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolate 
mofetil (see section 4.4). 
Isolated cases of abnormal neutrophil morphology, including the acquired Pelger-Huet anomaly, have 
been observed in patients treated with mycophenolate mofetil. 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 mycophenolate mofetil. 
 
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 mycophenolate mofetil-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 abortions 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 
mycophenolate mofetil in combination with other immunosuppressants, see section 4.6. 



34 

 
Respiratory, thoracic and mediastinal disorders 
There have been isolated reports of interstitial lung disease and pulmonary fibrosis in patients treated 
with mycophenolate mofetil 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 mycophenolate mofetil 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 mycophenolate mofetil 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 Myfenax 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 Myfenax 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). 
 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


35 

5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: immunosuppressive agents ATC code: LO4A A06 
 
Mechanism of action 
Mycophenolate mofetil is the 2-morpholinoethyl ester of mycophenolic acid (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 mycophenolate 
mofetil is correlated with MPA concentration. The mean bioavailability of oral mycophenolate 
mofetil, based on MPA AUC, is 94% relative to intravenous 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, leucopenia). 
 
Elimination 
 
A negligible amount of substance is excreted as MPA (< 1% of 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 



36 

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 AUC0-12 h was comparable to 
that seen in post-transplant patients without delayed graft function. Mean plasma MPAG AUC0-12 h 
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 Myfenax 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 mycophenolate mofetil 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 mycophenolate mofetil (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 mycophenolate mofetil on the ovulation suppressing action of the oral 
contraceptives. Serum levels of luteinizing hormone (LH), follicle-stimulating hormone (FSH) and 
progesterone were not significantly affected. The pharmacokinetics of oral contraceptives were 
unaffected by co-administration of mycophenolate mofetil (see also section 4.5). 
 



37 

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 doses. 
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 
 
Tablet core 
Microcrystalline cellulose 
Povidone K-30 
Magnesium stearate 
Croscarmellose sodium 
 



38 

Tablet coat 
Hypromellose (HPMC 2910) 
Titanium dioxide (E171) 
Macrogol (PEG 400) 
Talc 
Indigo carmine aluminium lake (E132) 
Iron oxide black (E172) 
Iron oxide red (E172) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container 
 
Transparent PVC/PVdC-aluminium blisters 
 
Pack sizes of 50, 100, 150, 50 x 1 or 100 x 1 and multipacks containing 150 (3 packs of 50) tablets. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
Any unused product or waste material should be disposed of in accordance with local requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5 
2031GA Haarlem 
Netherlands 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/07/438/003 (50 tablets) 
EU/1/07/438/004 (150 tablets) 
EU/1/07/438/005 (50 x 1 tablets) 
EU/1/07/438/007 (100 tablets) 
EU/1/07/438/008 (100 x 1 tablets) 
EU/1/07/438/010 (150 (3 x 50) tablets) 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 21 February 2008 
Date of first renewal: 19 November 2012 
 



39 

 
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 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

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 



41 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturers responsible for batch release 
 
Teva Pharmaceutical Works Private Limited Company 
Pallagi út 13. 
Debrecen H-4042 
Hungary 
 
Teva Operations Poland Sp. Z.o.o. 
Mogilska 80 Str. 
31-546 Krakow 
Poland 
 
TEVA UK Ltd  
Brampton Road 
Hampden Park 
Eastbourne 
East Sussex 
BN22 9AG 
United Kingdom 
 
Pharmachemie B.V. 
Swensweg 5 
2031 GA Haarlem  
The Netherlands 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
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 
 



42 

• 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 
Myfenax, the contraceptive requirements for both male and female patients and what to do in case of 
pregnancy during treatment with Myfenax. 
 
The MAH shall ensure that in each MS where Myfenax is marketed, all healthcare professionals and 
patients who are expected to prescribe, dispense or use Myfenax are provided with the following 
educational package: 
• Physician educational material 
• Patient information pack 
 
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 minimize 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 



43 

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. 
 
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. 
  



44 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



45 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



46 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Myfenax 250 mg hard 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 
300 capsules 
100 x 1 capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
Read the package leaflet 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 
 
Myfenax capsules should be handled with care. 
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 
 
 
 



47 

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

 
Any unused product or waste material should be disposed of in accordance with local requirements. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5 
2031GA Haarlem 
Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/07/438/001 (100 capsules) 
EU/1/07/438/002 (300 capsules) 
EU/1/07/438/006 (100 x 1 capsules) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Myfenax 250 mg capsules 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
  



48 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Myfenax 250 mg hard 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 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
Read the package leaflet 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 
 
Myfenax capsules should be handled with care. 
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 
 
 
 



49 

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

 
Any unused product or waste material should be disposed of in accordance with local requirements. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5 
2031GA Haarlem 
Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/07/438/009 300 capsules (3 packs of 100) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Myfenax 250 mg capsules 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
  



50 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Myfenax 250 mg hard 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 
Component of a multipack, not to be sold separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
Read the package leaflet 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 
 
Myfenax capsules should be handled with care. 
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 
 
 
 



51 

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

 
Any unused product or waste material should be disposed of in accordance with local requirements. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5 
2031GA Haarlem 
Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/07/438/009 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Myfenax 250 mg capsules 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
 
 
  



52 

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



53 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Myfenax 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 
100 tablets 
150 tablets 
50 x 1 tablets 
100 x 1 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
Read the package leaflet 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 
 
Myfenax film-coated tablets should be handled with care. 
Do not crush the tablets. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 



54 

 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Any unused product or waste material should be disposed of in accordance with local requirements. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5 
2031GA Haarlem 
Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/07/438/003 (50 tablets) 
EU/1/07/438/004 (150 tablets) 
EU/1/07/438/005 (50 x 1 tablets) 
EU/1/07/438/007 (100 tablets) 
EU/1/07/438/008 (100 x 1 tablets) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Myfenax 500 mg film-coated tablets 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 
  



55 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Myfenax 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) tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
Read the package leaflet 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 
 
Myfenax film-coated tablets should be handled with care. 
Do not crush the tablets. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
 



56 

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

 
Any unused product or waste material should be disposed of in accordance with local requirements. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5 
2031GA Haarlem 
Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/07/438/010 150 tablets (3 packs of 50) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Myfenax 500 mg film-coated tablets 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
  



57 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Myfenax 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 
Component of a multipack, not to be sold separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
Read the package leaflet 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 
 
Myfenax film-coated tablets should be handled with care. 
Do not crush the tablets. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
 



58 

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

 
Any unused product or waste material should be disposed of in accordance with local requirements. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5 
2031GA Haarlem 
Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/07/438/010 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Myfenax 500 mg film-coated tablets 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
 
 
  



59 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER FOIL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Myfenax 500 mg film-coated tablets 
mycophenolate mofetil 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
  



60 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 



61 

Package leaflet: Information for the user 
 

Myfenax 250 mg hard 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, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
 
What is in this leaflet 
1. What Myfenax is and what it is used for 
2. What you need to know before you take Myfenax 
3. How to take Myfenax 
4. Possible side effects 
5. How to store Myfenax 
6. Contents of the pack and other information 
 
 
1. What Myfenax is and what it is used for 
 
Myfenax is a medicine that is used to suppress immune activity. 
 
The active substance in this medicine is called mycophenolate mofetil. 
 
Myfenax is used to prevent your body rejecting a transplanted kidney, heart or liver. It is used in 
combination with other medicines with a similar function (i.e. ciclosporin and corticosteroids). 
 
 
2. What you need to know before you take Myfenax 
 
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, contraception and breast-feeding”. 
 
Do not take Myfenax, 
• if you are allergic 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. 
• 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 Myfenax. 
 



62 

Warnings and precautions 
Talk to your doctor straight away before starting treatment with Myfenax: 
• if you experience any evidence of infection (e.g. fever, sore throat), unexpected bruising and/or 

bleeding. 
• if you have or ever have had any problems with your digestive system, e.g. stomach ulcers. 
• if you are planning to become pregnant, or if you get pregnant while you or your partner are taking 

Myfenax. 
 
Myfenax reduces your body’s defence mechanism. Because of this, there is an increased risk of skin 
cancer. Therefore you should limit your exposure to sunlight and ultraviolet (UV) light by wearing 
appropriate protective clothing and using a sunscreen with a high protection factor. 
 
You must not donate blood during treatment with Myfenax and for at least 6 weeks after stopping 
treatment. Men must not donate semen during treatment with Myfenax and for at least 90 days after 
stopping treatment. 
 
Children and adolescents 
Myfenax is used in children and adolescents (aged 2 to 18) to prevent a body rejecting a transplanted 
kidney. 
Myfenax should not be used in children and adolescents (aged 2 to 18) for heart or liver 
transplantation. 
Myfenax should not be used at all in children under 2 years old. 
 
Other medicines and Myfenax 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
If you answer yes to any of the following questions talk to your doctor before you start to take 
Myfenax: 
• Are you taking any medicines containing: 

o azathioprine or other immunosuppressive agents (which are sometimes given to patients after a 
transplant operation), 

o cholestyramine (used to treat patients with high blood cholesterol), 
o rifampicin (antibiotic), 
o antacids or proton pump inhibitors (used for acid problem in your stomach such as indigestion), 
o phosphate binders (used in patients with chronic kidney failure to reduce the absorption of 

phosphate), 
o antibiotics (used to treat bacterial infections), 
o isavuconazole (used to treat fungal infections), 
o telmisartan (used to treat high blood pressure) 
o or any other medicines (including those you can buy without a prescription) that your doctor 

does not know about? 
• Do you need to receive vaccines (live vaccines)? Your doctor will have to advise you what is 

indicated for you. 
 
Pregnancy, contraception and breast-feeding 
 
Contraception in women taking Myfenax 
If you are a woman who could become pregnant you must use an effective method of contraception 
with Myfenax. This includes: 
• Before you start taking Myfenax 
• During your entire treatment with Myfenax 
• For 6 weeks after you stop taking Myfenax. 
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. 



63 

 
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 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 Myfenax 
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 Myfenax. 
 
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 Myfenax 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 Myfenax if you are breast-feeding. This is because small amounts of the medicine can 
pass into the mother’s milk. 
 
Driving and using machines 
Myfenax 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. 
 



64 

Myfenax contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially 
‘sodium-free’. 
 
 
3. How to take Myfenax 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure. 
 
Your treatment is started and monitored by a doctor who is specialised in transplants. 
 
The usual way to take Myfenax is as follows: 
 
Kidney Transplant 
 
Adults 
The first dose will be given within 72 hours after the transplant operation. The recommended daily 
dose is 8 capsules (2 g of the active ingredient) taken as 2 separate doses. This means taking 4 
capsules in the morning then 4 capsules in the evening. 
 
Children and adolescents (aged 2 to 18) 
The dose given will vary depending on the size of the child. Your doctor will decide the most 
appropriate dose based on body surface area (height and weight). The recommended dose is 
600 mg/m2 taken twice a day. 
 
Heart Transplant 
 
Adults 
The first dose will be given within 5 days following the transplant operation. The recommended daily 
dose is 12 capsules (3 g of the active ingredient) taken as 2 separate doses. This means taking 6 
capsules in the morning then 6 capsules in the evening. 
 
Children 
There is no information for the use of Myfenax in children with a heart transplant. 
 
Liver Transplant 
 
Adults 
The first dose of oral Myfenax will be given to you at least 4 days after the transplant operation and 
when you are able to swallow oral medicines. The recommended daily dose is 12 capsules (3 g of the 
active ingredient) taken as 2 separate doses. This means taking 6 capsules in the morning then 
6 capsules in the evening. 
 
Children 
There is no information for the use of Myfenax in children with a liver transplant. 
 
Method and route of administration 
Swallow your capsules whole with a glass of water. You can take them with or without food. Do not 
break or crush them and do not take any capsules that have broken open or split. Avoid contact with 
any powder that spills out from damaged capsules. If a capsule breaks open accidentally, wash any 
powder from your skin with soap and water. If any powder gets into your eyes or mouth, rinse 
thoroughly with plenty of plain, fresh water. 
 
Treatment will continue for you as long as you need immunosuppression to prevent your body from 
rejecting your transplanted organ. 
 



65 

If you take more Myfenax than you should 
It is important not to take too many capsules. Contact your nearest hospital Accident and Emergency 
department or a doctor for advice if you have swallowed more capsules than you have been told to 
take or if you think a child has swallowed any. 
 
If you forget to take Myfenax 
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 forgotten dose. 
 
If you stop taking Myfenax 
Do not stop taking Myfenax because you feel better. It is important to take the medicine for as long as 
the doctor has told you to. Stopping your treatment with Myfenax may increase the chance of rejection 
of your transplanted organ. Do not stop taking your medicine unless your doctor tells you to. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine 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). 
• you have black or bloody stool or if you vomit blood or dark particles that look like coffee 

grounds. These may be signs of bleeding in the stomach or intestines. 
 
The frequency of certain side effects is dependent on the transplanted organ, i.e. some side effects can 
occur more or less often depending on whether this medicinal product is being taken to prevent your 
body from rejecting a transplanted heart or a transplanted kidney. For the sake of clarity each side 
effect is always listed under its highest frequency. 
 
Other side effects 
 
Very common (may affect more than 1 in 10 people) 
• bacterial, viral and/or fungal infections 
• serious infection which may affect the whole body 
• decrease in the number of white blood cells, platelets or red blood cells, which can result in 

increased risk of infections, bruising, bleeding, breathlessness and weakness 
• bleeding underneath the skin 
• increase in the number of white blood cells 
• too much acid in the body 
• high level of cholesterol and/or lipids in the blood 
• high level of sugar in the blood 
• high level of potassium in the blood, low level of potassium, magnesium, calcium and/or phosphate 

in the blood 
• high level of uric acid in the blood, gout 
• feeling restless, abnormalities of thought, perception and levels of awareness, depression, feeling 

anxious, difficulty in sleeping 
• increased tension of the muscles, shaking, sleepiness, feeling dizzy, headache, tingling, pricking or 

numbness 
• faster heart beat 



66 

• low/high blood pressure, widening of blood vessels 
• accumulation of fluid in the lung, shortness of breath, cough 
• bloated belly 
• vomiting, stomach pain, diarrhoea, feeling sick 
• constipation, indigestion, wind (flatulence) 
• decreased appetite 
• changes in different laboratory parameters 
• inflammation of the liver, yellowing of the skin and whites of the eyes 
• growth of the skin, rash, acne 
• muscle weakness 
• joint pain 
• kidney problems 
• blood in the urine 
• fever, feeling of coldness, pain, feeling weak and feeble 
• fluid retention in the body 
• part of an internal organ or tissue bulging through a weak spot in the abdominal muscles 
• muscle pain, neck and back pain 
 
Common (may affect up to 1 in 10 people) 
• skin cancer, non-cancerous growth of the skin 
• abnormal and excessive growth of tissue 
• decrease in the number of all blood cells 
• benign enlargement of the lymph nodes, inflammatory changes of the skin (pseudolymphoma) 
• decreased weight 
• abnormal thinking 
• fit 
• distortion of the sense of taste 
• blood clot that forms within a vein 
• inflammation of the tissue that lines the inner wall of the abdomen and covers most of the 

abdominal organs 
• bowel blockage 
• inflammation of the colon which causes abdominal pain or diarrhoea (sometimes caused by 

cytomegalovirus), ulcer of the mouth and/or stomach and/or duodenum, inflammation of the 
stomach, oesophagus and/or mouth and lips 

• belching 
• hair loss 
• feeling unwell 
• overgrowth of the gum tissue 
• inflammation of the pancreas, which causes severe pain in the abdomen and back 
 
Uncommon (may affect up to 1 in 100 people) 
• protozoal infections 
• proliferation of the lymphatic tissue, including malignant tumours 
• insufficient production of red blood cells 
• serious diseases of the bone marrow 
• accumulation of lymphatic fluid within the body 
• 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. 

• decrease in the amount of antibodies in the blood 
• severe reduction in the number of certain white blood cells (possible symptoms are fever, sore 

throat, frequent infections) (agranulocytosis) 
 



67 

Not known (frequency cannot be estimated from the available data) 
• alterations of the inner wall of the small intestine (intestinal villous atrophy) 
• serious inflammation of the membrane that covers the brain and spinal cord 
• serious inflammation of the heart and its valves 
• bacterial infections usually resulting in a serious lung disorder (tuberculosis, atypical mycobacterial 

infection) 
• serious disease of the kidney (BK virus associated nephropathy) 
• serious disease of the central nervous system (JC virus associated progressive multifocal 

leucoencephalopathy) 
• decrease in the number of certain white blood cells (neutropenia) 
• change of the shape of certain white blood cells 
 
Do not stop taking your medicine unless you have discussed this with your doctor first. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist 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 Myfenax 
 
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 blister and carton after EXP. The 
expiry date refers to the last day of that month. 
 
This medicine does not require any special storage conditions. 
 
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 to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Myfenax contains 
 
• The active substance is mycophenolate mofetil. 

Each capsule contains 250 mg mycophenolate mofetil. 
• The other ingredients are: 

Capsule content 
Pregelatinised maize starch 
Povidone K-30 
Croscarmellose sodium 
Magnesium stearate 
Capsule shells 
Cap 
Indigo carmine (E132) 
Titanium dioxide (E171) 
Gelatin 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


68 

Body 
Red iron oxide (E172) 
Yellow iron oxide (E172) 
Titanium dioxide (E171) 
Gelatin 
Black ink containing: shellac, black iron oxide (E172), propylene glycol and potassium hydroxide 

 
What Myfenax looks like and contents of the pack 
 
Hard capsules 
Body: caramel opaque, printed ‘250’ axially in black ink. 
Cap: light blue opaque printed ‘M’ axially in black ink. 
 
Myfenax 250 mg hard capsules are available in PVC/PVdC-aluminium blisters in pack sizes of 100, 
300 or 100 x 1 capsules and in multipacks containing 300 (3 packs of 100) capsules. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder 
Teva B.V. 
Swensweg 5 
2031GA Haarlem 
Netherlands 
 
Manufacturers 
Teva Pharmaceutical Works Private Limited Company 
Pallagi út 13. 
Debrecen H-4042 
Hungary 
 
Teva Operations Poland Sp. Z.o.o. 
Mogilska 80 Str. 
31-546 Krakow 
Poland 
 
Teva UK Ltd 
Brampton Road 
Hampden Park 
Eastbourne, East Sussex 
BN22 9AG UK 
 
Pharmachemie B.V. 
Swensweg 5 
2031 GA Haarlem 
The Netherlands 
 
For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder: 
 
België/Belgique/Belgien 
Teva Pharma Belgium N.V./S.A./AG 
Tél/Tel: +32 38207373 
 

Lietuva 
UAB Teva Baltics 
Tel: +370 52660203 
 



69 

България 
Актавис ЕАД 
Тел: +359 24899585 
 

Luxembourg/Luxemburg 
Teva Pharma Belgium N.V./S.A./AG 
Belgique/Belgien 
Tél/Tel: +32 38207373 
 

Česká republika 
Teva Pharmaceuticals CR, s.r.o. 
Tel: +420 251007111 
 

Magyarország 
Teva Gyógyszergyár Zrt. 
Tel: +36 12886400 
 

Danmark 
Teva Denmark A/S 
Tlf: +45 44985511 
 

Malta 
Teva Pharmaceuticals Ireland 
L-Irlanda 
Tel: +353 19127700 
 

Deutschland 
TEVA GmbH 
Tel: +49 73140208 
 

Nederland 
Teva Nederland B.V. 
Tel: +31 8000228400 
 

Eesti 
UAB Teva Baltics Eesti filiaal 
Tel: +372 6610801 
 

Norge 
Teva Norway AS 
Tlf: +47 66775590 
 

Ελλάδα 
Specifar Α.Β.Ε.Ε. 
Τηλ: +30 2118805000 
 

Österreich 
ratiopharm Arzneimittel Vertriebs-GmbH 
Tel: +43 1970070 
 

España 
Teva Pharma, S.L.U. 
Tel: +34 913873280 
 

Polska 
Teva Pharmaceuticals Polska Sp. z o.o. 
Tel: +48 223459300 
 

France 
Teva Santé 
Tél: +33 155917800 
 

Portugal 
Teva Pharma - Produtos Farmacêuticos, Lda. 
Tel: +351 214767550 
 

Hrvatska 
Pliva Hrvatska d.o.o. 
Tel: +385 13720000 
 

România 
Teva Pharmaceuticals S.R.L. 
Tel: +40 212306524 
 

Ireland 
Teva Pharmaceuticals Ireland 
Tel: +353 19127700 
 

Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 15890390 
 

Ísland 
Alvogen ehf. 
Sími: +354 5222900 

Slovenská republika 
TEVA Pharmaceuticals Slovakia s.r.o. 
Tel: +421 257267911 
 

Italia 
Teva Italia S.r.l. 
Tel: +39 028917981 
 

Suomi/Finland 
Teva Finland Oy 
Puh/Tel: +358 201805900 
 

Κύπρος 
Specifar Α.Β.Ε.Ε. 
Ελλάδα 
Τηλ: +30 2118805000 
 

Sverige 
Teva Sweden AB 
Tel: +46 42121100 
 



70 

Latvija 
UAB Teva Baltics filiāle Latvijā 
Tel: +371 67323666 
 

United Kingdom 
Teva UK Limited 
Tel: +44 1977628500 
 

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

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


71 

Package leaflet: Information for the user 
 

Myfenax 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, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
 
What is in this leaflet 
1. What Myfenax is and what it is used for 
2. What you need to know before you take Myfenax 
3. How to take Myfenax 
4. Possible side effects 
5. How to store Myfenax 
6. Contents of the pack and other information 
 
 
1. What Myfenax is and what it is used for 
 
Myfenax is a medicine that is used to suppress immune activity. 
 
The active substance in this medicine is called mycophenolate mofetil. 
 
Myfenax is used to prevent your body rejecting a transplanted kidney, heart or liver. It is used in 
combination with other medicines with a similar function (i.e. ciclosporin and corticosteroids). 
 
 
2. What you need to know before you take Myfenax 
 
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, contraception and breast-feeding”. 
 
Do not take Myfenax, 
• if you are allergic 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. 
• 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 Myfenax. 
 



72 

Warnings and precautions 
Talk to your doctor straight away before starting treatment with Myfenax: 
• if you experience any evidence of infection (e.g. fever, sore throat), unexpected bruising and/or 

bleeding. 
• if you have or ever have had any problems with your digestive system, e.g. stomach ulcers. 
• if you are planning to become pregnant, or if you get pregnant while you or your partner are taking 

Myfenax. 
 
Myfenax reduces your body’s defence mechanism. Because of this, there is an increased risk of skin 
cancer. Therefore you should limit your exposure to sunlight and ultraviolet (UV) light by wearing 
appropriate protective clothing and using a sunscreen with a high protection factor. 
 
You must not donate blood during treatment with Myfenax and for at least 6 weeks after stopping 
treatment. Men must not donate semen during treatment with Myfenax and for at least 90 days after 
stopping treatment. 
 
Children and adolescents 
Myfenax is used in children and adolescents (aged 2 to 18) to prevent a body rejecting a transplanted 
kidney. 
Myfenax should not be used in children and adolescents (aged 2 to 18) for heart or liver 
transplantation. 
Myfenax should not be used at all in children under 2 years old. 
 
Other medicines and Myfenax 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
If you answer yes to any of the following questions talk to your doctor before you start to take 
Myfenax: 
• Are you taking any medicines containing: 

o azathioprine or other immunosuppressive agents (which are sometimes given to patients after a 
transplant operation), 

o cholestyramine (used to treat patients with high blood cholesterol), 
o rifampicin (antibiotic), 
o antacids or proton pump inhibitors (used for acid problem in your stomach such as indigestion), 
o phosphate binders (used in patients with chronic kidney failure to reduce the absorption of 

phosphate), 
o antibiotics (used to treat bacterial infections), 
o isavuconazole (used to treat fungal infections), 
o telmisartan (used to treat high blood pressure) 
o or any other medicines (including those you can buy without a prescription) that your doctor 

does not know about? 
• Do you need to receive vaccines (live vaccines)? Your doctor will have to advise you what is 

indicated for you. 
 
Pregnancy, contraception and breast-feeding 
 
Contraception in women taking Myfenax 
If you are a woman who could become pregnant you must use an effective method of contraception 
with Myfenax. This includes: 
• Before you start taking Myfenax 
• During your entire treatment with Myfenax 
• For 6 weeks after you stop taking Myfenax. 
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. 



73 

 
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 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 Myfenax 
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 Myfenax. 
 
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 Myfenax 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 Myfenax if you are breast-feeding. This is because small amounts of the medicine can 
pass into the mother’s milk. 
 
Driving and using machines 
Myfenax 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. 
 



74 

Myfenax contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say 
essentially ‘sodium-free’. 
 
 
3. How to take Myfenax 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure. 
 
Your treatment is started and monitored by a doctor who is specialised in transplants. 
 
The usual way to take Myfenax is as follows: 
 
Kidney Transplant 
 
Adults 
The first dose will be given within 72 hours after the transplant operation. The recommended daily 
dose is 4 tablets (2 g of the active ingredient) taken as 2 separate doses. This means taking 2 tablets in 
the morning then 2 tablets in the evening. 
 
Children and adolescents (aged 2 to 18) 
The dose given will vary depending on the size of the child. Your doctor will decide the most 
appropriate dose based on body surface area (height and weight). The recommended dose is 
600 mg/m2 taken twice a day. 
 
Heart Transplant 
 
Adults 
The first dose will be given within 5 days following the transplant operation. The recommended daily 
dose is 6 tablets (3 g of the active ingredient) taken as 2 separate doses. This means taking 3 tablets in 
the morning then 3 tablets in the evening. 
 
Children 
There is no information for the use of Myfenax in children with a heart transplant. 
 
Liver Transplant 
 
Adults 
The first dose of oral Myfenax will be given to you at least 4 days after the transplant operation and 
when you are able to swallow oral medicines. The recommended daily dose is 6 tablets (3 g of the 
active ingredient) taken as 2 separate doses. This means taking 3 tablets in the morning then 3 tablets 
in the evening. 
 
Children 
There is no information for the use of Myfenax in children with a liver transplant. 
 
Method and route of administration 
Swallow your tablets whole with a glass of water. You can take them with or without food. Do not 
break or crush them. 
 
Treatment will continue for you as long as you need immunosuppression to prevent your body from 
rejecting your transplanted organ. 
 



75 

If you take more Myfenax than you should 
It is important not to take too many tablets. Contact your nearest hospital Accident and Emergency 
department or a doctor for advice if you have swallowed more tablets than you have been told to take 
or if you think a child has swallowed any. 
 
If you forget to take Myfenax 
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 forgotten dose. 
 
If you stop taking Myfenax 
Do not stop taking Myfenax because you feel better. It is important to take the medicine for as long as 
the doctor has told you to. Stopping your treatment with Myfenax may increase the chance of rejection 
of your transplanted organ. Do not stop taking your medicine unless your doctor tells you to. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine 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). 
• you have black or bloody stool or if you vomit blood or dark particles that look like coffee 

grounds. These may be signs of bleeding in the stomach or intestines. 
 
The frequency of certain side effects is dependent on the transplanted organ, i.e. some side effects can 
occur more or less often depending on whether this medicinal product is being taken to prevent your 
body from rejecting a transplanted heart or a transplanted kidney. For the sake of clarity each side 
effect is always listed under its highest frequency. 
 
Other side effects 
 
Very common (may affect more than 1 in 10 people) 
• bacterial, viral and/or fungal infections 
• serious infection which may affect the whole body 
• decrease in the number of white blood cells, platelets or red blood cells, which can result in 

increased risk of infections, bruising, bleeding, breathlessness and weakness 
• bleeding underneath the skin 
• increase in the number of white blood cells 
• too much acid in the body 
• high level of cholesterol and/or lipids in the blood 
• high level of sugar in the blood 
• high level of potassium in the blood, low level of potassium, magnesium, calcium and/or phosphate 

in the blood 
• high level of uric acid in the blood, gout 
• feeling restless, abnormalities of thought, perception and levels of awareness, depression, feeling 

anxious, difficulty in sleeping 
• increased tension of the muscles, shaking, sleepiness, feeling dizzy, headache, tingling, pricking or 

numbness 
• faster heart beat 



76 

• low/high blood pressure, widening of blood vessels 
• accumulation of fluid in the lung, shortness of breath, cough 
• bloated belly 
• vomiting, stomach pain, diarrhoea, feeling sick 
• constipation, indigestion, wind (flatulence) 
• decreased appetite 
• changes in different laboratory parameters 
• inflammation of the liver, yellowing of the skin and whites of the eyes 
• growth of the skin, rash, acne 
• muscle weakness 
• joint pain 
• kidney problems 
• blood in the urine 
• fever, feeling of coldness, pain, feeling weak and feeble 
• fluid retention in the body 
• part of an internal organ or tissue bulging through a weak spot in the abdominal muscles 
• muscle pain, neck and back pain 
 
Common (may affect up to 1 in 10 people) 
• skin cancer, non-cancerous growth of the skin 
• abnormal and excessive growth of tissue 
• decrease in the number of all blood cells 
• benign enlargement of the lymph nodes, inflammatory changes of the skin (pseudolymphoma) 
• decreased weight 
• abnormal thinking 
• fit 
• distortion of the sense of taste 
• blood clot that forms within a vein 
• inflammation of the tissue that lines the inner wall of the abdomen and covers most of the 

abdominal organs 
• bowel blockage 
• inflammation of the colon which causes abdominal pain or diarrhoea (sometimes caused by 

cytomegalovirus), ulcer of the mouth and/or stomach and/or duodenum, inflammation of the 
stomach, oesophagus and/or mouth and lips 

• belching 
• hair loss 
• feeling unwell 
• overgrowth of the gum tissue 
• inflammation of the pancreas, which causes severe pain in the abdomen and back 
 
Uncommon (may affect up to 1 in 100 people) 
• protozoal infections 
• proliferation of the lymphatic tissue, including malignant tumours 
• insufficient production of red blood cells 
• serious diseases of the bone marrow 
• accumulation of lymphatic fluid within the body 
• 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. 

• decrease in the amount of antibodies in the blood 
• severe reduction in the number of certain white blood cells (possible symptoms are fever, sore 

throat, frequent infections) (agranulocytosis) 
 



77 

Not known (frequency cannot be estimated from the available data) 
• alterations of the inner wall of the small intestine (intestinal villous atrophy) 
• serious inflammation of the membrane that covers the brain and spinal cord 
• serious inflammation of the heart and its valves 
• bacterial infections usually resulting in a serious lung disorder (tuberculosis, atypical mycobacterial 

infection) 
• serious disease of the kidney (BK virus associated nephropathy) 
• serious disease of the central nervous system (JC virus associated progressive multifocal 

leucoencephalopathy) 
• decrease in the number of certain white blood cells (neutropenia) 
• change of the shape of certain white blood cells 
 
Do not stop taking your medicine unless you have discussed this with your doctor first. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist 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 Myfenax 
 
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 blister and carton after EXP. The 
expiry date refers to the last day of that month. 
 
This medicine does not require any special storage conditions. 
 
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 to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Myfenax contains 
 
• The active substance is mycophenolate mofetil. 

Each tablet contains 500 mg of mycophenolate mofetil. 
• The other ingredients are: 

Tablet core 
Microcrystalline cellulose 
Povidone K-30 
Magnesium stearate 
Croscarmellose sodium 
Tablet coat 
Hypromellose (HPMC 2910) 
Titanium dioxide (E171) 
Macrogol (PEG 400) 
Talc 
Indigo carmine aluminium lake (E132) 
Iron oxide black (E172) 
Iron oxide red (E172) 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


78 

What Myfenax looks like and contents of the pack 
 
Film-coated tablets 
Pale purple, oval shaped film-coated tablet, debossed with "M500" on one side and plain on the other 
side. 
 
Myfenax 500 mg film-coated tablets are available in PVC/PVdC-aluminium blisters in pack sizes of 
50, 100, 150, 50 x 1 or 100 x 1 tablets and in multipacks containing 150 (3 packs of 50) tablets. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder 
Teva B.V. 
Swensweg 5 
2031GA Haarlem 
Netherlands 
 
Manufacturers 
Teva Pharmaceutical Works Private Limited Company 
Pallagi út 13. 
Debrecen H-4042 
Hungary 
 
Teva Operations Poland Sp. Z.o.o. 
Mogilska 80 Str. 
31-546 Krakow 
Poland 
 
Teva UK Ltd 
Brampton Road 
Hampden Park 
Eastbourne, East Sussex 
BN22 9AG, UK 
 
Pharmachemie B.V. 
Swensweg 5 
2031 GA Haarlem 
The Netherlands 
 
For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder: 
 
België/Belgique/Belgien 
Teva Pharma Belgium N.V./S.A./AG 
Tél/Tel: +32 38207373 
 

Lietuva 
UAB Teva Baltics 
Tel: +370 52660203 
 

България 
Актавис ЕАД 
Тел: +359 24899585 
 

Luxembourg/Luxemburg 
Teva Pharma Belgium N.V./S.A./AG 
Belgique/Belgien 
Tél/Tel: +32 38207373 
 

Česká republika 
Teva Pharmaceuticals CR, s.r.o. 
Tel: +420 251007111 
 

Magyarország 
Teva Gyógyszergyár Zrt. 
Tel: +36 12886400 
 



79 

Danmark 
Teva Denmark A/S 
Tlf: +45 44985511 
 

Malta 
Teva Pharmaceuticals Ireland 
L-Irlanda 
Tel: +353 19127700 
 

Deutschland 
TEVA GmbH 
Tel: +49 73140208 
 

Nederland 
Teva Nederland B.V. 
Tel: +31 8000228400 
 

Eesti 
UAB Teva Baltics Eesti filiaal 
Tel: +372 6610801 
 

Norge 
Teva Norway AS 
Tlf: +47 66775590 
 

Ελλάδα 
Specifar Α.Β.Ε.Ε. 
Τηλ: +30 2118805000 
 

Österreich 
ratiopharm Arzneimittel Vertriebs-GmbH 
Tel: +43 1970070 
 

España 
Teva Pharma, S.L.U. 
Tel: +34 913873280 
 

Polska 
Teva Pharmaceuticals Polska Sp. z o.o. 
Tel: +48 223459300 
 

France 
Teva Santé 
Tél: +33 155917800 
 

Portugal 
Teva Pharma - Produtos Farmacêuticos, Lda. 
Tel: +351 214767550 
 

Hrvatska 
Pliva Hrvatska d.o.o. 
Tel: +385 13720000 
 

România 
Teva Pharmaceuticals S.R.L. 
Tel: +40 212306524 
 

Ireland 
Teva Pharmaceuticals Ireland 
Tel: +353 19127700 
 

Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 15890390 
 

Ísland 
Alvogen ehf. 
Sími: +354 5222900 

Slovenská republika 
TEVA Pharmaceuticals Slovakia s.r.o. 
Tel: +421 257267911 
 

Italia 
Teva Italia S.r.l. 
Tel: +39 028917981 
 

Suomi/Finland 
Teva Finland Oy 
Puh/Tel: +358 201805900 
 

Κύπρος 
Specifar Α.Β.Ε.Ε. 
Ελλάδα 
Τηλ: +30 2118805000 
 

Sverige 
Teva Sweden AB 
Tel: +46 42121100 
 

Latvija 
UAB Teva Baltics filiāle Latvijā 
Tel: +371 67323666 
 

United Kingdom 
Teva UK Limited 
Tel: +44 1977628500 
 

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

http://www.emea.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	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
	A. LABELLING
	B. PACKAGE LEAFLET