Imnovid

1 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 



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This medicinal product is subject to additional monitoring. This will allow quick identification of new 

safety information. Healthcare professionals are asked to report any suspected adverse reactions. See 
section 4.8 for how to report adverse reactions. 

 

 

1. NAME OF THE MEDICINAL PRODUCT 
 

Imnovid 1 mg hard capsules 

Imnovid 2 mg hard capsules 

Imnovid 3 mg hard capsules 

Imnovid 4 mg hard capsules 

 
 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

Imnovid 1 mg hard capsules 

 
Each hard capsule contains 1 mg of pomalidomide. 

 

Imnovid 2 mg hard capsules 

 

Each hard capsule contains 2 mg of pomalidomide. 
 

Imnovid 3 mg hard capsules 

 

Each hard capsule contains 3 mg of pomalidomide. 

 
Imnovid 4 mg hard capsules 

 

Each hard capsule contains 4 mg of pomalidomide. 

 

For the full list of excipients, see section 6.1. 

 
 

3. PHARMACEUTICAL FORM 

 

Hard capsule 

 
Imnovid 1 mg hard capsules 

 

Dark blue opaque cap and yellow opaque body, imprinted “POML” in white ink and “1 mg” in black ink, 

size 4 gelatin hard capsule. 

 
Imnovid 2 mg hard capsules 

 

Dark blue opaque cap and orange opaque body, imprinted “POML 2 mg” in white ink, size 2 gelatin hard 

capsule. 

 



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Imnovid 3 mg hard capsules 

 
Dark blue opaque cap and green opaque body, imprinted “POML 3 mg” in white ink, size 2 gelatin hard 

capsule. 

 

Imnovid 4 mg hard capsules 

 
Dark blue opaque cap and blue opaque body, imprinted “POML 4 mg” in white ink, size 2 gelatin hard 

capsule. 

 

 

4. CLINICAL PARTICULARS 

 
4.1 Therapeutic indications 

 

Imnovid in combination with bortezomib and dexamethasone is indicated in the treatment of adult 

patients with multiple myeloma who have received at least one prior treatment regimen including 

lenalidomide. 
 

Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed 

and refractory multiple myeloma who have received at least two prior treatment regimens, including both 

lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy. 

 
4.2 Posology and method of administration 

 

Treatment must be initiated and monitored under the supervision of physicians experienced in the 

management of multiple myeloma. 

 

Dosing is continued or modified based upon clinical and laboratory findings (see section 4.4). 
 

Posology 

 

• Pomalidomide in combination with bortezomib and dexamethasone 
The recommended starting dose of Imnovid is 4 mg orally once daily on Days 1 to 14 of repeated 21-day 
cycles. 

 

Pomalidomide is administered in combination with bortezomib and dexamethasone, as shown in Table 1. 

The recommended starting dose of bortezomib is 1.3 mg/m2 intravenous or subcutaneous once daily, on 

the days shown in Table 1. The recommended dose of dexamethasone is 20 mg orally once daily, on the 
days shown in Table 1. 

 

Treatment with pomalidomide combined with bortezomib and dexamethasone should be given until 

disease progression or until unacceptable toxicity occurs. 

 



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Table 1. Recommended dosing scheme for Imnovid in combination with bortezomib and 

dexamethasone 

Cycle 1-8 Day (of 21-day cycle)   

  1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 

Pomalidomide (4 mg) • • • • • • • • • • • • • •               

Bortezomib (1.3 mg/m2) •     •       •     •                     

Dexamethasone (20 mg) * • •   • •     • •   • •                   

                                              

Cycle 9 onwards Day (of 21-day cycle)   

  1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 

Pomalidomide (4 mg) • • • • • • • • • • • • • •               

Bortezomib (1.3 mg/m2) •             •                           

Dexamethasone (20 mg) * • •           • •                         

* For patients > 75 years of age, see Special populations. 

 
Pomalidomide dose modification or interruption 

To initiate a new cycle of pomalidomide, the neutrophil count must be  1 x 109/l and the platelet count 

must be  50 x 109/l. 

 

Instructions on dose interruptions or reductions for pomalidomide related adverse reactions are outlined in 

the Table 2 and dose levels are defined in Table 3 below: 
 

Table 2. Pomalidomide dose modification instructions∞ 

Toxicity Dose modification 

Neutropenia* 

ANC** < 0.5 x 109/l or febrile neutropenia 
(fever ≥38.5°C and ANC <1 x 109/l) 

Interrupt pomalidomide treatment for 

remainder of cycle. Follow CBC*** weekly.  

ANC return to ≥ 1 x 109/l  Resume pomalidomide treatment at one dose 

level lower than previous dose. 

 

For each subsequent drop < 0.5 x 109/l  Interrupt pomalidomide treatment. 

 

ANC return to ≥ 1 x 109/l  Resume pomalidomide treatment at one dose 

level lower than the previous dose. 
 

Thrombocytopenia 

Platelet count < 25 x 109/l 

Interrupt pomalidomide treatment for 

remainder of cycle. Follow CBC*** weekly. 

Platelet count return to ≥ 50 x 109/l Resume pomalidomide treatment at one dose 

level lower than previous dose. 

For each subsequent drop < 25 x 109/l Interrupt pomalidomide treatment. 

 

Platelet count return to ≥ 50 x 109/l Resume pomalidomide treatment at one dose 

level lower than the previous dose. 

 



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Rash 

Rash = Grade 2-3 

 

Consider dose interruption or discontinuation 
of pomalidomide treatment. 

Rash = Grade 4 or blistering (including 

angioedema, exfoliative or bullous rash or if 

Stevens-Johnson syndrome (SJS), Toxic 

Epidermal Necrolysis (TEN) or Drug Reaction 

with Eosinophilia and Systemic Symptoms 

(DRESS) is suspected) 

Permanently discontinue treatment (see section 

4.4). 

Other 

Other ≥ Grade 3 pomalidomide-related adverse 

events 

Interrupt pomalidomide treatment for 

remainder of cycle. Resume at one dose level 

lower than previous dose at next cycle (adverse 

event must be resolved or improved to ≤ Grade 
2 before restarting dosing). 

 
∞ Dose modification instructions in this table are applicable to pomalidomide in combination with bortezomib and dexamethasone and to 

pomalidomide in combination with dexamethasone. 
*In case of neutropenia, the physician should consider the use of growth factors. **ANC – Absolute Neutrophil Count; ***CBC – Complete 

Blood Count. 
 

Table 3. Pomalidomide dose reduction∞ 

Dose level Oral pomalidomide dose 

Starting dose 4 mg 

Dose level -1 3 mg 

Dose level -2 2 mg 

Dose level -3 1 mg 

∞Dose reduction in this table is applicable to pomalidomide in combination with bortezomib and dexamethasone and to pomalidomide in 

combination with dexamethasone. 

 

If adverse reactions occur after dose reductions to 1 mg, then the medicinal product should be 

discontinued. 

 
Strong CYP1A2 inhibitors 

If strong inhibitors of CYP1A2 (e.g. ciprofloxacin, enoxacin and fluvoxamine) are co-administered with 

pomalidomide, reduce the dose of pomalidomide by 50% (see sections 4.5 and 5.2). 

 

Bortezomib dose modification or interruption 
For instructions on dose interruptions or reductions for bortezomib related adverse reactions, physicians 

should refer to bortezomib Summary of Product Characteristics (SmPC). 

 

Dexamethasone dose modification or interruption 

Instructions on dose interruptions or reductions for low-dose dexamethasone related adverse reactions are 

outlined in Tables 4 and 5 below. However, dose interruption or resumption decisions are at the 
physician’s discretion per Summary of Product Characteristics (SmPC).  

 



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Table 4. Dexamethasone dose modification instructions 

Toxicity Dose Modification 

Dyspepsia = Grade 1-2 Maintain dose and treat with histamine (H2) 

blockers or equivalent. Decrease by one dose level 

if symptoms persist. 

Dyspepsia ≥ Grade 3 Interrupt dose until symptoms are controlled. Add 

H2 blocker or equivalent and resume at one dose 

level lower than previous dose. 

Oedema ≥ Grade 3 Use diuretics as needed and decrease dose by one 

dose level. 

Confusion or mood alteration ≥ Grade 2 Interrupt dose until symptoms resolve. Resume at 

one dose level lower than previous dose. 

Muscle weakness ≥ Grade 2 Interrupt dose until muscle weakness ≤ Grade 1. 

Resume at one dose level lower than previous dose.  

Hyperglycaemia ≥ Grade 3 Decrease dose by one dose level. Treat with insulin 

or oral hypoglycaemic agents as needed. 

Acute pancreatitis Discontinue dexamethasone from treatment 

regimen. 

Other ≥ Grade 3 dexamethasone-related adverse 

events 

Stop dexamethasone dosing until the adverse event 

resolves to ≤ Grade 2. Resume at one dose level 

lower than previous dose. 

 

If recovery from toxicities is prolonged beyond 14 days, then the dose of dexamethasone will be resumed 

at one dose level lower than the previous dose. 
 

Table 5. Dexamethasone dose reduction 

Dose Level 

≤ 75 years old 

Dose (Cycle 1-8: Days 1, 2, 4, 5, 8, 9, 11, 

12 of a 21-day cycle 

Cycle ≥ 9: Days 1, 2, 8, 9 of a 21-day 

cycle) 

> 75 years old 

Dose (Cycle 1-8: Days 1, 2, 4, 5, 8, 9, 

11, 12 of a 21-day cycle 

Cycle ≥ 9: Days 1, 2, 8, 9 of a 21-day 

cycle) 

Starting Dose 20 mg 10 mg 

Dose Level -1 12 mg 6 mg 

Dose Level -2 8 mg 4 mg 



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Dexamethasone should be discontinued if the patient is unable to tolerate 8 mg if ≤ 75 years old or 4 mg 
if > 75 years old. 

 

In case of permanent discontinuation of any component of the treatment regimen, continuation of the 

remaining medicinal products is at the physician’s discretion.  

 

• Pomalidomide in combination with dexamethasone 
The recommended starting dose of Imnovid is 4 mg orally once daily on Days 1 to 21 of repeated 28-day 

cycles. 

 

The recommended dose of dexamethasone is 40 mg orally once daily on Days 1, 8, 15 and 22 of each 28-

day treatment cycle. 
 

Treatment with pomalidomide combined with dexamethasone should be given until disease progression 

or until unacceptable toxicity occurs. 

 

Pomalidomide dose modification or interruption 
Instructions for dose interruptions or reductions for pomalidomide related adverse reactions are outlined 

in Table 2 and 3.  

 

Dexamethasone dose modification or interruption 

Instructions for dose modification for dexamethasone related adverse reactions are outlined in Table 4. 
Instructions for dose reduction for dexamethasone related adverse reactions are outlined in Table 6 below. 

However, dose interruption / resumption decisions are at physician’s discretion per the current Summary 

of Product Characteristics (SmPC). 

 

Table 6. Dexamethasone dose reduction 

Dose Level 

≤ 75 years old 

Days 1, 8, 15 and 22 of each 28-day 

treatment cycle 

> 75 years old 

Days 1, 8, 15 and 22 of each 28-day 

treatment cycle 

Starting Dose 40 mg 20 mg 

Dose Level -1 20 mg 12 mg 

Dose Level -2  10mg 8 mg 

 

Dexamethasone should be discontinued if the patient is unable to tolerate 10 mg if ≤ 75 years old or 8 mg 

if > 75 years old. 

 
Special populations 

 

Elderly 

• Pomalidomide in combination with bortezomib and dexamethasone 
No dose adjustment is required for pomalidomide.  
 

For information on bortezomib given in combination with Imnovid, refer to the respective current SmPC. 

 



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For patients >75 years of age, the starting dose of dexamethasone is: 

• For Cycles 1 to 8: 10 mg once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 of each 21-day cycle  
• For Cycles 9 and onwards: 10 mg once daily on Days 1, 2, 8 and 9 of each 21-day cycle. 
 

• Pomalidomide in combination with dexamethasone 
No dose adjustment is required for pomalidomide.  

 
For patients > 75 years of age, the starting dose of dexamethasone is: 

• 20 mg once daily on days 1, 8, 15 and 22 of each 28-day treatment cycle. 
 

 

Hepatic impairment 
Patients with serum total bilirubin > 1.5 x ULN (upper limit of normal range) were excluded from clinical 
studies. Hepatic impairment has a modest effect on the pharmacokinetics of pomalidomide (see 

section 5.2). No adjustment of the starting dose of pomalidomide is required for patients with hepatic 

impairment as defined by the Child-Pugh criteria. However, patients with hepatic impairment should be 

carefully monitored for adverse reactions and dose reduction or interruption of pomalidomide should be 

used as needed. 
 

Renal impairment 

No dose adjustment of pomalidomide is required for patients with renal impairment. On haemodialysis 

days, patients should take their pomalidomide dose following haemodialysis.  

 
Paediatric population 

There is no relevant use of pomalidomide in children aged 0-17 years for the indication of multiple 

myeloma. 

 

Method of administration 
 

Oral use. 

Imnovid hard capsules should be taken orally at the same time each day. The capsules should not be 

opened, broken or chewed (see section 6.6). The capsules should be swallowed whole, preferably with 

water, with or without food. If the patient forgets to take a dose of pomalidomide on one day, then the 

patient should take the normal prescribed dose as scheduled on the next day. Patients should not adjust 
the dose to make up for a missing dose on previous days. 

 

It is recommended to press only on one end of the capsule to remove it from the blister thereby reducing 

the risk of capsule deformation or breakage. 

 
For information on other medicinal products given in combination with Imnovid, refer to the respective 

current SmPC. 

 

4.3 Contraindications 

 

• Pregnancy. 

• Women of childbearing potential, unless all the conditions of the pregnancy prevention programme 
are met (see sections 4.4 and 4.6). 

• Male patients unable to follow or comply with the required contraceptive measures (see 
section 4.4). 

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 



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For information on other medicinal products given in combination with Imnovid, refer to the respective 
current SmPC. 

 

4.4 Special warnings and precautions for use 

 

Teratogenicity 
 

Pomalidomide must not be taken during pregnancy, since a teratogenic effect is expected. Pomalidomide 

is structurally related to thalidomide. Thalidomide is a known human teratogen that causes severe 

life-threatening birth defects. Pomalidomide was found to be teratogenic in both rats and rabbits when 

administered during the period of major organogenesis (see section 5.3). 

  
The conditions of the Pregnancy Prevention Programme must be fulfilled for all patients unless there is 

reliable evidence that the patient does not have childbearing potential.  

 

Criteria for women of non-childbearing potential 

 
A female patient or a female partner of a male patient is considered of non-childbearing potential if she 

meets at least one of the following criteria: 

• Age ≥ 50 years and naturally amenorrhoeic for ≥ 1 year (amenorrhoea following cancer therapy or 
during breast-feeding does not rule out childbearing potential) 

• Premature ovarian failure confirmed by a specialist gynaecologist 
• Previous bilateral salpingo-oophorectomy, or hysterectomy 

• XY genotype, Turner syndrome, uterine agenesis. 
 

Counselling 

 

For women of childbearing potential, pomalidomide is contraindicated unless all of the following are met: 

• She understands the expected teratogenic risk to the unborn child 

• She understands the need for effective contraception, without interruption, at least 4 weeks before 
starting treatment, throughout the entire duration of treatment, and at least 4 weeks after the end of 

treatment 

• Even if a woman of childbearing potential has amenorrhoea she must follow all the advice on 
effective contraception 

• She should be capable of complying with effective contraceptive measures 

• She is informed and understands the potential consequences of pregnancy and the need to rapidly 
consult if there is a risk of pregnancy 

• She understands the need to commence the treatment as soon as pomalidomide is dispensed 
following a negative pregnancy test 

• She understands the need and accepts to undergo pregnancy testing at least every 4 weeks except in 
case of confirmed tubal sterilisation 

• She acknowledges that she understands the hazards and necessary precautions associated with the 
use of pomalidomide. 

 
The prescriber must ensure that for women of childbearing potential: 

• The patient complies with the conditions of the Pregnancy Prevention Programme, including 
confirmation that she has an adequate level of understanding 

• The patient has acknowledged the aforementioned conditions. 
 



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For male patients taking pomalidomide, pharmacokinetic data has demonstrated that pomalidomide is 

present in human semen during treatment. As a precaution, and taking into account special populations 
with potentially prolonged elimination time such as hepatic impairment, all male patients taking 

pomalidomide must meet the following conditions: 

• He understands the expected teratogenic risk if engaged in sexual activity with a pregnant woman 
or a woman of childbearing potential 

• He understands the need for the use of a condom if engaged in sexual activity with a pregnant 
woman or a woman of childbearing potential not using effective contraception, throughout 

treatment duration, during dose interruption and for 7 days after dose interruptions and/or cessation 

of treatment. This includes vasectomised males who should wear a condom if engaged in sexual 

activity with a pregnant woman or a woman of childbearing potential as seminal fluid may still 

contain pomalidomide in the absence of spermatozoa. 

• He understands that if his female partner becomes pregnant whilst he is taking pomalidomide or 
7 days after he has stopped taking pomalidomide, he should inform his treating physician 

immediately and that it is recommended to refer the female partner to a physician specialised or 

experienced in teratology for evaluation and advice. 

 

Contraception 
 

Women of childbearing potential must use at least one effective method of contraception for at least 

4 weeks before therapy, during therapy, and until at least 4 weeks after pomalidomide therapy and even in 

case of dose interruption unless the patient commits to absolute and continuous abstinence confirmed on a 

monthly basis. If not established on effective contraception, the patient must be referred to an 
appropriately trained health care professional for contraceptive advice in order that contraception can be 

initiated. 

 

The following can be considered to be examples of suitable methods of contraception: 

• Implant 
• Levonorgestrel-releasing intrauterine system 

• Medroxyprogesterone acetate depot 

• Tubal sterilisation 

• Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two 
negative semen analyses 

• Ovulation inhibitory progesterone-only pills (i.e. desogestrel) 
 

Because of the increased risk of venous thromboembolism in patients with multiple myeloma taking 

pomalidomide and dexamethasone, combined oral contraceptive pills are not recommended (see also 

section 4.5). If a patient is currently using combined oral contraception the patient should switch to one of 

the effective methods listed above. The risk of venous thromboembolism continues for 4-6 weeks after 
discontinuing combined oral contraception. The efficacy of contraceptive steroids may be reduced during 

cotreatment with dexamethasone (see section 4.5). 

 

Implants and levonorgestrel-releasing intrauterine systems are associated with an increased risk of 
infection at the time of insertion and irregular vaginal bleeding. Prophylactic antibiotics should be 

considered particularly in patients with neutropenia. 

 

Insertion of copper-releasing intrauterine devices is not recommended due to the potential risks of 

infection at the time of insertion and menstrual blood loss which may compromise patients with severe 

neutropenia or severe thrombocytopenia. 



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Pregnancy testing 
 

According to local practice, medically supervised pregnancy tests with a minimum sensitivity of 

25 mIU/mL must be performed for women of childbearing potential as outlined below. This requirement 

includes women of childbearing potential who practice absolute and continuous abstinence. Ideally, 

pregnancy testing, issuing a prescription and dispensing should occur on the same day. Dispensing of 
pomalidomide to women of childbearing potential should occur within 7 days of the prescription. 

 

Prior to starting treatment 

A medically supervised pregnancy test should be performed during the consultation, when pomalidomide 

is prescribed, or in the 3 days prior to the visit to the prescriber once the patient had been using effective 

contraception for at least 4 weeks. The test should ensure the patient is not pregnant when she starts 
treatment with pomalidomide. 

 

Follow-up and end of treatment 

A medically supervised pregnancy test should be repeated at least every 4 weeks, including at least 

4 weeks after the end of treatment, except in the case of confirmed tubal sterilisation. These pregnancy 
tests should be performed on the day of the prescribing visit or in the 3 days prior to the visit to the 

prescriber. 

 

Additional precautions 

 
Patients should be instructed never to give this medicinal product to another person and to return any 

unused capsules to their pharmacist at the end of treatment. 

 

Patients should not donate blood, semen or sperm during treatment (including during dose interruptions) 

and for 7 days following discontinuation of pomalidomide. 

 
Educational materials, prescribing and dispensing restrictions 

 

In order to assist patients in avoiding foetal exposure to pomalidomide, the Marketing Authorisation 

Holder will provide educational material to health care professionals to reinforce the warnings about the 

expected teratogenicity of pomalidomide, to provide advice on contraception before therapy is started, 
and to provide guidance on the need for pregnancy testing. The prescriber must inform the patient about 

the expected teratogenic risk and the strict pregnancy prevention measures as specified in the Pregnancy 

Prevention Programme and provide patients with appropriate patient educational brochure, patient card 

and/or equivalent tool in accordance with the national implemented patient card system. A national 

controlled distribution system has been implemented in collaboration with each National Competent 
Authority. The controlled distribution system includes the use of a patient card and/or equivalent tool for 

prescribing and /or dispensing controls, and the collection of detailed data relating to the indication in 

order to monitor the off-label use within the national territory. Ideally, pregnancy testing, issuing a 

prescription and dispensing should occur on the same day. Dispensing of pomalidomide to women of 

childbearing potential should occur within 7 days of the prescription and following a medically 

supervised negative pregnancy test result. Prescriptions for women of childbearing potential can be for a 
maximum duration of 4 weeks, and prescriptions for all other patients can be for a maximum duration of 

12 weeks. 

 

Haematological events 

 
Neutropenia was the most frequently reported Grade 3 or 4 haematological adverse reaction in patients 



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with relapsed/refractory multiple myeloma, followed by anaemia and thrombocytopenia. Patients should 

be monitored for haematological adverse reactions, especially neutropenia. Patients should be advised to 
report febrile episodes promptly. Physicians should observe patients for signs of bleeding including 

epistaxes, especially with use of concomitant medicinal products known to increase the risk of bleeding 

(see section 4.8). Complete blood counts should be monitored at baseline, weekly for the first 8 weeks 

and monthly thereafter. A dose modification may be required (see section 4.2). Patients may require use 

of blood product support and /or growth factors. 
 

Thromboembolic events 

 

Patients receiving pomalidomide either in combination with bortezomib and dexamethasone or in 

combination with dexamethasone have developed venous thromboembolic events (predominantly deep 

vein thrombosis and pulmonary embolism) and arterial thrombotic events  (myocardial infarction and 
cerebrovascular accident). Patients with known risk factors for thromboembolism – including prior 

thrombosis – should be closely monitored. Action should be taken to try to minimise all modifiable risk 

factors (e.g. smoking, hypertension, and hyperlipidaemia). Patients and physicians are advised to be 

observant for the signs and symptoms of thromboembolism. Patients should be instructed to seek medical 

care if they develop symptoms such as shortness of breath, chest pain, arm or leg swelling.  Anti-
coagulation therapy (unless contraindicated) is recommended, (such as acetylsalicylic acid, warfarin, 

heparin or clopidogrel), especially in patients with additional thrombotic risk factors. A decision to take 

prophylactic measures should be made after a careful assessment of the individual patient’s underlying 

risk factors. In clinical studies, patients received prophylactic acetylsalicylic acid or alternative anti-

thrombotic therapy. The use of erythropoietic agents carries a risk of thrombotic events including 
thromboembolism. Therefore, erythropoietic agents, as well as other agents that may increase the risk of 

thromboembolic events, should be used with caution. 

 

Peripheral neuropathy 

 

Patients with ongoing ≥ Grade 2 peripheral neuropathy were excluded from clinical studies with 
pomalidomide. Appropriate caution should be exercised when considering the treatment of such patients 

with pomalidomide. 

 

Significant cardiac dysfunction 

 
Patients with significant cardiac dysfunction (congestive heart failure [NY Heart Association Class  III 

or IV]; myocardial infarction within 12 months of starting study; unstable or poorly controlled angina 

pectoris) were excluded from clinical studies with pomalidomide. Cardiac events, including congestive 

cardiac failure, pulmonary oedema and atrial fibrillation (see section 4.8), have been reported, mainly in 

patients with pre-existing cardiac disease or cardiac risk factors. Appropriate caution should be exercised 
when considering the treatment of such patients with pomalidomide, including periodic monitoring for 

signs or symptoms of cardiac events. 

 

Tumour lysis syndrome 

 

Patients at greatest risk of tumour lysis syndrome are those with high tumour burden prior to treatment. 
These patients should be monitored closely and appropriate precautions taken. 

 

Second primary malignancies 

 

Second primary malignancies, such as non-melanoma skin cancer, have been reported in patients 
receiving pomalidomide (see section 4.8). Physicians should carefully evaluate patients before and during 



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treatment using standard cancer screening for occurrence of second primary malignancies and institute 

treatment as indicated. 
 

Allergic reactions and severe skin reactions 

 

Angioedema and severe dermatologic reactions including SJS, TEN and DRESS have been reported with 

the use of pomalidomide (see section 4.8). Patients should be advised of the signs and symptoms of these 
reactions by their prescribers and should be told to seek medical attention immediately if they develop 

these symptoms. Pomalidomide must be discontinued for exfoliative or bullous rash, or if SJS, TEN or 

DRESS is suspected, and should not be resumed following discontinuation for these reactions. Patients 

with a prior history of serious allergic reactions associated with thalidomide or lenalidomide were 

excluded from clinical studies. Such patients may be at higher risk of hypersensitivity reactions and 

should not receive pomalidomide. Pomalidomide interruption or discontinuation should be considered for 
Grade 2-3 skin rash. Pomalidomide must be discontinued permanently for angioedema. 

 

Dizziness and confusion 

 

Dizziness and confusional state have been reported with pomalidomide. Patients must avoid situations 
where dizziness or confusion may be a problem and not to take other medicinal products that may cause 

dizziness or confusion without first seeking medical advice. 

 

Interstitial lung disease (ILD) 

 
ILD and related events, including cases of pneumonitis, have been observed with pomalidomide. Careful 

assessment of patients with an acute onset or unexplained worsening of pulmonary symptoms should be 

performed to exclude ILD. Pomalidomide should be interrupted pending investigation of these symptoms 

and if ILD is confirmed, appropriate treatment should be initiated. Pomalidomide should only be resumed 

after a thorough evaluation of the benefits and the risks. 

 
Hepatic disorders 

 

Markedly elevated levels of alanine aminotransferase and bilirubin have been observed in patients treated 

with pomalidomide (see section 4.8). There have also been cases of hepatitis that resulted in 

discontinuation of pomalidomide. Regular monitoring of liver function is recommended for the first 
6 months of treatment with pomalidomide and as clinically indicated thereafter.  

 

Infections 

 

Reactivation of hepatitis B has been reported rarely in patients receiving pomalidomide in combination 
with dexamethasone who have previously been infected with the hepatitis B virus (HBV). Some of these 

cases have progressed to acute hepatic failure, resulting in discontinuation of pomalidomide. Hepatitis B 

virus status should be established before initiating treatment with pomalidomide. For patients who test 

positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is 

recommended. Caution should be exercised when pomalidomide in combination with dexamethasone is 

used in patients previously infected with HBV, including patients who are anti-HBc positive but HBsAg 
negative. These patients should be closely monitored for signs and symptoms of active HBV infection 

throughout therapy. 

 



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Sodium content 

 
This medicinal product contains less than 1 mmol sodium (23 mg) per capsule, i.e. essentially 

‘sodium-free’. 

 

For information on other medicinal products given in combination with Imnovid, refer to the respective 

current SmPC. 

 

4.5 Interaction with other medicinal products and other forms of interaction 
 

Effect of pomalidomide on other medicinal products 

 

Pomalidomide is not anticipated to cause clinically relevant pharmacokinetic drug-drug interactions due 

to P450 isoenzyme inhibition or induction or transporter inhibition when co-administered with substrates 
of these enzymes or transporters. The potential for such drug-drug interactions, including the potential 

impact of pomalidomide on the pharmacokinetics of combined oral contraceptives, has not been evaluated 

clinically (see section 4.4 Teratogenicity). 

 

Effect of other medicinal products on pomalidomide 
 

Pomalidomide is partly metabolised by CYP1A2 and CYP3A4/5. It is also a substrate for P-glycoprotein. 

Co-administration of pomalidomide with the strong CYP3A4/5 and P-gp inhibitor ketoconazole, or the 

strong CYP3A4/5 inducer carbamazepine, had no clinically relevant effect on exposure to pomalidomide.  

Co-administration of the strong CYP1A2 inhibitor fluvoxamine with pomalidomide in the presence of 

ketoconazole, increased mean exposure to pomalidomide by 107% with a 90% confidence interval [91% 
to 124%] compared to pomalidomide plus ketoconazole. In a second study to evaluate the contribution of 

a CYP1A2 inhibitor alone to metabolism changes, co-administration of fluvoxamine alone with 

pomalidomide increased mean exposure to pomalidomide by 125% with a 90% confidence interval [98% 

to 157%] compared to pomalidomide alone. If strong inhibitors of CYP1A2 (e.g. ciprofloxacin, enoxacin 

and fluvoxamine) are co-administered with pomalidomide, reduce the dose of pomalidomide by 50%. 
 

Dexamethasone 

 

Co-administration of multiple doses of up to 4 mg pomalidomide with 20 mg to 40 mg dexamethasone (a 

weak to moderate inducer of several CYP enzymes including CYP3A) to patients with multiple myeloma 
had no effect on the pharmacokinetics of pomalidomide compared with pomalidomide administered 

alone. 

 

The effect of dexamethasone on warfarin is unknown. Close monitoring of warfarin concentration is 

advised during treatment. 

 
For information on other medicinal products given in combination with Imnovid, refer to the respective 

current SmPC.  
 

4.6 Fertility, pregnancy and lactation 

 
Women of childbearing potential / Contraception in males and females 

 

Women of childbearing potential should use effective method of contraception. If pregnancy occurs in a 

woman treated with pomalidomide, treatment must be stopped and the patient should be referred to a 



15 

physician specialised or experienced in teratology for evaluation and advice. If pregnancy occurs in a 

partner of a male patient taking pomalidomide, it is recommended to refer the female partner to a 
physician specialised or experienced in teratology for evaluation and advice. Pomalidomide is present in 

human semen. As a precaution, all male patients taking pomalidomide should use condoms throughout 

treatment duration, during dose interruption and for 7 days after cessation of treatment if their partner is 

pregnant or of childbearing potential and has no contraception (see sections 4.3 and 4.4). 

 
Pregnancy 

 

A teratogenic effect of pomalidomide in humans is expected. Pomalidomide is contraindicated during 

pregnancy and in women of childbearing potential, except when all the conditions for pregnancy 

prevention have been met, see section 4.3 and section 4.4. 

 
Breast-feeding 

 

It is unknown whether pomalidomide is excreted in human milk. Pomalidomide was detected in milk of 

lactating rats following administration to the mother. Because of the potential for adverse reactions in 

breastfed infants from pomalidomide, a decision must be made whether to discontinue breast-feeding or 
to discontinue the medicinal product, taking into account the benefit of breast-feeding for the child and 

the benefit of the therapy for the woman. 

 

Fertility 

 
Pomalidomide was found to impact negatively on fertility and be teratogenic in animals.  Pomalidomide 

crossed the placenta and was detected in foetal blood following administration to pregnant rabbits , see 

section 5.3. 

 

4.7 Effects on ability to drive and use machines 

 
Pomalidomide has minor or moderate influence on the ability to drive and use machines.  Fatigue, 

depressed level of consciousness, confusion, and dizziness have been reported with the use of 

pomalidomide. If affected, patients should be instructed not to drive cars, use machines or perform 

hazardous tasks while being treated with pomalidomide. 

 
4.8 Undesirable effects 

 

Summary of the safety profile 

 

• Pomalidomide in combination with bortezomib and dexamethasone 
The most commonly reported blood and lymphatic system disorders were neutropenia (46.8%), 

thrombocytopenia (36.7%) and anaemia (28.4%). The most frequently reported adverse reaction was 

peripheral sensory neuropathy (47.8%). The most commonly reported Grade 3 or 4 adverse reactions 

were blood and lymphatic system disorders including neutropenia (41.7%), thrombocytopenia (27.3%) 

and anaemia (14.0%). The most commonly reported serious adverse reaction was pneumonia (11.5%). 
Other serious adverse reactions reported included pyrexia (4.0%), lower respiratory tract infection (2.9%), 

pulmonary embolism (2.9%), influenza (2.9%), and acute kidney injury (2.9%).  

  

• Pomalidomide in combination with dexamethasone 
The most commonly reported adverse reactions in clinical studies have been blood and lymphatic system 

disorders including anaemia (45.7%), neutropenia (45.3%) and thrombocytopenia (27%); in general 
disorders and administration site conditions including fatigue (28.3%), pyrexia (21%) and oedema 



16 

peripheral (13%); and in infections and infestations including pneumonia (10.7%). Peripheral neuropathy 

adverse reactions were reported in 12.3% of patients and venous embolic or thrombotic (VTE) adverse 
reactions were reported in 3.3% of patients. The most commonly reported Grade 3 or 4 adverse reactions 

were in the blood and lymphatic system disorders including neutropenia (41.7%), anaemia (27%) and 

thrombocytopenia (20.7%); in infections and infestations including pneumonia (9%); and in general 

disorders and administration site conditions including fatigue (4.7%), pyrexia (3%) and oedema 

peripheral (1.3%). The most commonly reported serious adverse reaction was pneumonia (9.3%). Other 
serious adverse reactions reported included febrile neutropenia (4.0%), neutropenia (2.0%), 

thrombocytopenia (1.7%) and VTE adverse reactions (1.7 %). 

 

Adverse reactions tended to occur more frequently within the first 2 cycles of treatment with 

pomalidomide. 

 
Tabulated list of adverse reactions 

 

• Pomalidomide in combination with bortezomib and dexamethasone 
In randomised study CC-4047-MM-007, 278 patients received pomalidomide, bortezomib and 

dexamethasone (Pom+Btz+Dex arm). See section 4.2 for dosing information.  
 

The adverse reactions observed in patients treated with pomalidomide in combination with bortezomib 

and dexamethasone are listed in Table 7 by system organ class (SOC) and frequency for all adverse 

reactions and for Grade 3 or 4 adverse reactions.  

 
Frequencies for Pom+Btz+Dex (any grade) are defined in accordance with current guidance, as: very 

common (≥1/10), common (≥1/100 to <1/10); and uncommon (≥1/1,000 to <1/100). 

 



17 

Table 7. All Adverse Reactions (ADRs) reported in clinical trial MM-007 in patients treated with 

pomalidomide in combination with bortezomib and dexamethasone. 

System Organ Class/ 

Preferred Term 

All Adverse Reactions  

/Frequency  

Grade 3−4 Adverse Reactions  

/Frequency  

Infections and 

infestations  

 

Very Common 

Pneumonia 

Bronchitis 

Upper respiratory tract infection 

Viral upper respiratory tract infection 

 

Common 

Sepsis 

Septic shock 

Clostridium difficile colitis 

Respiratory tract infection 

Lower respiratory tract infection 

Lung infection  

Influenza 

Bronchiolitis 

Urinary tract infection 

Very Common 

Pneumonia 

 

Common 

Sepsis 

Septic shock 

Clostridium difficile colitis 

Bronchitis 

Upper respiratory tract infection 

Respiratory tract infection 

Lower respiratory tract infection 

Lung infection  

Influenza 

Bronchiolitis 

Urinary tract infection 

 

Neoplasms benign, 

malignant and 

unspecified (incl cysts 

and polyps) 

Common 

Basal cell carcinoma  

 

 

Blood and lymphatic 

system disorders  

 

Very Common 

Neutropenia  

Thrombocytopenia 

Leucopenia  

Anaemia 

 

Common 

Febrile neutropenia 

Lymphopenia 

Very Common 

Neutropenia 

Thrombocytopenia 

Anaemia 

 

Common 

Febrile neutropenia 

Leucopenia 

Lymphopenia 



18 

System Organ Class/ 

Preferred Term 

All Adverse Reactions  

/Frequency  

Grade 3−4 Adverse Reactions  

/Frequency  

Metabolism and 

nutrition disorders  

Very Common 

Hypokalaemia 

Hyperglycaemia 

 

Common 

Hypomagnesaemia 

Hypocalcaemia 

Hypophosphataemia 

Hyperkalaemia 

Hypercalcaemia 

Common 

Hypokalaemia  

Hyperglycaemia 

Hypomagnaesaemia 

Hypocalcaemia 

Hypophosphataemia 

Hyperkalaemia 

Hypercalcaemia 

 

Psychiatric disorders  Very Common 

Insomnia 

 

Common 

Depression 

Common 

Depression 

Insomnia 

 

Nervous system 

disorders  

 

Very Common 

Peripheral sensory neuropathy 

Dizziness 

Tremor 

 

Common 

Syncope 

Peripheral sensorimotor neuropathy 

Paraesthesia 

Dysgeusia 

Common 

Syncope 

Peripheral sensory neuropathy 

Peripheral sensorimotor neuropathy 

 

Uncommon 

Dizziness 

Tremor 

 

 

Eye disorders Common 

Cataract 

Common 

Cataract 

Cardiac disorders Common 

Atrial fibrillation 

Common 

Atrial fibrillation 

Vascular disorders  Common 

Deep vein thrombosis 

Hypotension 

Hypertension 

Common 

Hypotension 

Hypertension 

 

Uncommon 

Deep vein thrombosis  



19 

System Organ Class/ 

Preferred Term 

All Adverse Reactions  

/Frequency  

Grade 3−4 Adverse Reactions  

/Frequency  

Respiratory, thoracic 

and mediastinal 

disorders  

Very Common 

Dyspnoea 

Cough 

 

Common 

Pulmonary embolism 

Common 

Pulmonary embolism  

Dyspnoea 

 

 

Gastrointestinal 

disorders  

 

Very Common 

Diarrhoea 

Vomiting 

Nausea 

Constipation 

 

Common 

Abdominal pain 

Abdominal pain upper  

Stomatitis 

Dry mouth 

Abdominal distension 

Common 

Diarrhoea 

Vomiting 

Abdominal pain 

Constipation 

 

Uncommon 

Abdominal pain upper  

Stomatitis 

Nausea 

Abdominal distension 

 

Skin and subcutaneous 

tissue disorders  

Common 

Rash  

Common 

Rash 

Musculoskeletal and 
connective tissue 

disorders  

Very Common 

Muscular weakness 

Back pain 

 

Common 

Bone pain 

Muscle spasms  

Common 

Muscular weakness 

Back pain 

 

Uncommon 

Bone pain  

 

Renal and urinary 

disorders  

 

Common 

Acute kidney injury 

Chronic kidney injury 

Urinary retention 

Common 

Acute kidney injury 

Chronic kidney injury 

Urinary retention 

General disorders and 

administration site 

conditions  

 

Very Common 

Fatigue  

Pyrexia  

Oedema peripheral 

 

Common 

Non-cardiac chest pain 

Oedema 

Common 

Fatigue  

Pyrexia 

Non-cardiac chest pain 

Oedema peripheral 

Oedema 



20 

System Organ Class/ 

Preferred Term 

All Adverse Reactions  

/Frequency  

Grade 3−4 Adverse Reactions  

/Frequency  

Investigations Common 

Alanine aminotransferase increased 

Weight decreased 

Common 

Weight decreased 

 

Uncommon 

Alanine aminotransferase increased 

Injury, poisoning and 
procedural 

complications 

Common 

Fall 

Uncommon 

Fall 

 

Tabulated list of adverse reactions 

 

• Pomalidomide in combination with dexamethasone 
In randomised study CC-4047-MM-003, 302 patients with relapsed and refractory multiple myeloma 
were exposed to 4 mg pomalidomide administered once daily for 21 days of each 28–day cycle in 

combination with a weekly low dose of dexamethasone. 

 

The adverse reactions observed in patients treated with pomalidomide plus dexamethasone are listed 

below in Table 8 by system organ class (SOC) and frequency for all adverse reactions (ADRs) and for 
Grade 3 or 4 adverse reactions. 

 

The frequencies of adverse reactions are those reported in the pomalidomide plus dexamethasone arm of 

study CC-4047-MM-003 (n = 302). Within each SOC and frequency grouping, adverse reactions are 

presented in order of decreasing seriousness. Frequencies are defined in accordance with current 

guidance, as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); and uncommon (≥ 1/1,000 to < 1/100). 

Table 8. ADRs reported in clinical study MM-003 in patients treated with pomalidomide in 

combination with dexamethasone. 

 

System Organ Class/ 

Preferred Term 
All ADRs/Frequency  Grade 3−4 ADRs/Frequency  

Infections and 

infestations  

 

Very Common 

Pneumonia (bacterial, viral and 

fungal infections, including 
opportunistic infections) 

 

Common 

Neutropenic sepsis 

Bronchopneumonia 

Bronchitis  
Respiratory tract infection 

Upper respiratory tract infection 

Nasopharyngitis 

Herpes zoster 

 
 

Common 

Neutropenic sepsis 

Pneumonia (bacterial, viral and fungal 
infections, including opportunistic 

infections)  

Bronchopneumonia 

Respiratory tract infection 

Upper respiratory tract infection 

 
Uncommon 

Bronchitis 

Herpes zoster 

 

 



21 

System Organ Class/ 

Preferred Term 
All ADRs/Frequency  Grade 3−4 ADRs/Frequency  

Neoplasms benign, 

malignant and 

unspecified (incl cysts 

and polyps) 

Uncommon 
Basal cell carcinoma of the skin, 

Squamous cell carcinoma of the skin 

Uncommon 
Basal cell carcinoma of the skin, 

Squamous cell carcinoma of the skin 

Blood and lymphatic 

system disorders 

 

Very Common 

Neutropenia 
Thrombocytopenia 

Leucopenia 

Anaemia 

 

Common 
Febrile neutropenia 

Very Common 

Neutropenia 
Thrombocytopenia 

Anaemia 

 

Common 

Febrile neutropenia 
Leucopenia 

Metabolism and 

nutrition disorders  

Very Common 
Decreased appetite 

 

Common 

Hyperkalaemia 

Hyponatraemia 
 

 

 

Common 
Hyperkalaemia 

Hyponatraemia 

 

 

Uncommon 
Decreased appetite 

 

Psychiatric disorders  Common 

Confusional state 

Common 

Confusional state 

Nervous system 

disorders 

 

Common 

Depressed level of consciousness 

Peripheral sensory neuropathy 

Dizziness 
Tremor 

 

 

Common 

Depressed level of consciousness 

 

Uncommon 
Peripheral sensory neuropathy 

Dizziness 

Tremor 

 

Ear and labyrinth 

disorders 

Common 

Vertigo 

Common 

Vertigo 

Vascular disorders  Common 

Deep vein thrombosis 

Uncommon 

Deep vein thrombosis 

Respiratory, thoracic 

and mediastinal 

disorders 

Very Common 

Dyspnoea 

Cough 

 

Common 
Pulmonary embolism 

 

Common 

Dyspnoea 

 

Uncommon 

Pulmonary embolism 
Cough 

 



22 

System Organ Class/ 

Preferred Term 
All ADRs/Frequency  Grade 3−4 ADRs/Frequency  

Gastrointestinal 

disorders 

 

Very Common 
Diarrhoea 

Nausea 

Constipation 

 

Common 

Vomiting 
Gastrointestinal haemorrhage 

Common 
Diarrhoea 

Vomiting 

Constipation 

 

Uncommon 

Nausea 
Gastrointestinal haemorrhage 

Hepatobiliary disorders Uncommon 

Hyperbilirubinaemia 

 

Uncommon 

Hyperbilirubinaemia 

Skin and subcutaneous 

tissue disorders 

Common 

Rash 

Pruritus 

 
 

Common 

Rash 

 

 

Musculoskeletal and 

connective tissue 

disorders  

Very Common 
Bone pain 

Muscle spasms 

 

Common 
Bone pain 

 

Uncommon 

Muscle spasms 

Renal and urinary 

disorders 

 

Common 

Renal failure 

Urinary retention 

Common 

Renal failure 

 
Uncommon 

Urinary retention 

Reproductive system 

and breast disorders 

Common 

Pelvic pain 

Common 

Pelvic pain 

General disorders and 
administration site 

conditions 

Very Common 

Fatigue 
 Pyrexia 

Oedema peripheral 

Common 

Fatigue 
 Pyrexia 

Oedema peripheral 

Investigations Common 

Neutrophil count decreased 

White blood cell count decreased 

Platelet count decreased 

Alanine aminotransferase increased 

Common 

Neutrophil count decreased 

White blood cell count decreased 

Platelet count decreased 

Alanine aminotransferase increased 

 

Tabulated list of post-marketing adverse reactions 

 

In addition to the above adverse reactions identified from the pivotal clinical trials, the following Table 9 

is derived from data gathered from post-marketing surveillance.  
 



23 

Table 9. ADRs reported in post-marketing use in patients treated with pomalidomide. 

System Organ Class/ 

Preferred Term 

All Adverse Reactions  

/Frequency  

Grade 3−4 Adverse Reactions  

/Frequency  

Infections and 

infestations  

Not Known 

Hepatitis B reactivation 

Not Known 

Hepatitis B reactivation 

Blood and lymphatic 

system disorders  

Common 

Pancytopenia 

Common 

Pancytopenia 

Metabolism and 

nutrition disorders  

Common 

Hyperuricaemia 

 

Uncommon 
Tumour lysis syndrome 

Common 

Hyperuricaemia 

 

Uncommon 
Tumour lysis syndrome 

Nervous system 

disorders  

 

Common 

Intracranial haemorrhage 

 

Uncommon 

Cerebrovascular accident 

 

 

 

Uncommon 

Cerebrovascular accident 

Intracranial haemorrhage 

Cardiac disorders Common 

Cardiac failure 

Atrial fibrillation 

Myocardial infarction 

Common 

Cardiac failure 

Atrial fibrillation 

 

Uncommon 

Myocardial infarction 

Immune system 

disorders  
Common 

Angioedema 

Urticaria 

Uncommon 

Angioedema 

Urticaria 

Respiratory, thoracic 

and mediastinal 

disorders 

Common 

Epistaxis 

Interstitial lung disease 

Uncommon 

Epistaxis 

Interstitial lung disease 

Hepatobiliary disorders  Uncommon 

Hepatitis 

 

 

Skin and subcutaneous 

tissue disorders 
Not Known 

Drug Reaction with Eosinophilia and 

Systemic Symptoms 

Toxic Epidermal Necrolysis 

Stevens-Johnson Syndrome 

Not Known 

Drug Reaction with Eosinophilia and 

Systemic Symptoms 

Toxic Epidermal Necrolysis 

Stevens-Johnson Syndrome 

Investigations Common 

Blood uric acid increased 

Uncommon 

Blood uric acid increased 

 

Description of selected adverse reactions 

 



24 

Teratogenicity 

Pomalidomide is structurally related to thalidomide. Thalidomide is a known human teratogenic active 
substance that causes severe life-threatening birth defects. Pomalidomide was found to be teratogenic in 

both rats and rabbits when administered during the period of major organogenesis (see sections 4.6 

and 5.3). If pomalidomide is taken during pregnancy, a teratogenic effect of pomalidomide in humans is 

expected (see section 4.4). 

 
Neutropenia and thrombocytopenia 

In patients receiving combination therapy with pomalidomide in clinical studies, neutropenia occurred in 

up to 46.8% of patients (41.7% Grade 3 or 4). Neutropenia did not lead to pomalidomide discontinuation 

in any patient and was infrequently serious.  

 

Febrile neutropenia (FN) was reported in 3.2-6.7% of patients and was serious in 1.8-4.0% of patients 
(see section 4.2 and 4.4). 

 

In patients receiving combination therapy with pomalidomide in clinical studies, thrombocytopenia 

occurred in 27.0-36.7% of patients. Thrombocytopenia was Grade 3 or 4 in 20.7-27.3% of patients, led to 

pomalidomide discontinuation in 0.7% of patients and was serious in 0.4-1.7% of patients (see 
sections 4.2 and 4.4). 

 

Neutropenia and thrombocytopenia tended to occur more frequently within the first 2 cycles of treatment 

with pomalidomide. 

 
Infection 

Infection was the most common non haematological toxicity. 

 

In patients receiving combination therapy with pomalidomide in clinical studies,  infection occurred in 

55.0-80.2% of patients (24.0-30.9% Grade 3 or 4). Upper respiratory tract infection and pneumonia were 

the most frequently occurring infections. Fatal infections (Grade 5) occurred in 2.7-4.0% of patients. 
Infections led to pomalidomide discontinuation in 2.0-2.9% of patients. 

 

Thromboembolic events 

Prophylaxis with acetylsalicylic acid (and other anticoagulants in high risk patients) was mandatory for all 

patients in clinical studies. Anticoagulation therapy (unless contraindicated) is recommended (see 
section 4.4). 

 

In patients receiving combination therapy with pomalidomide in clinical studies, venous thromboembolic 

events (VTE) occurred in 3.3-11.5% of patients (1.3-5.4% Grade 3 or 4). VTE was reported as serious in 

1.7-4.3% of patients, no fatal reactions were reported, and VTE was associated with pomalidomide 
discontinuation in up to 1.8% of patients. 

 

Peripheral neuropathy 

• Pomalidomide in combination with bortezomib and dexamethasone 
Patients with ongoing peripheral neuropathy ≥ Grade 2 with pain within 14 days prior to randomisation 
were excluded from clinical trials. Peripheral neuropathy occurred in 55.4 % of patients (10.8% Grade 3; 

0.7% Grade 4). Exposure-adjusted rates were comparable across treatment arms. Approximately 30% of 

the patients experiencing peripheral neuropathy had a history of neuropathy at baseline. Peripheral 

neuropathy led to discontinuation of bortezomib in approximately 12.9% of patients, pomalidomide in 

1.8% and dexamethasone in 2.2 - 8.9% of patients, respectively. Refer also to the bortezomib SmPC. 

 



25 

• Pomalidomide in combination with dexamethasone 
Patients with ongoing peripheral neuropathy ≥ Grade 2 were excluded from clinical studies. Peripheral 
neuropathy occurred in 12.3% of patients (1.0% Grade 3 or 4). No peripheral neuropathy reactions were 

reported as serious, and peripheral neuropathy led to dose discontinuation in 0.3% of patients (see 

section 4.4). 

 

Haemorrhage 
Haemorrhagic disorders have been reported with pomalidomide, especially in patients with risk factors 

such as concomitant medicinal products that increase susceptibility to bleeding. Haemorrhagic events  

have included epistaxis, intracranial haemorrhage and gastrointestinal haemorrhage.  

 

Allergic reactions and severe skin reactions 

Angioedema and severe cutaneous reactions including SJS, TEN and DRESS has been reported with the 
use of pomalidomide. Patients with a history of severe rash associated with lenalidomide or thalidomide 

should not receive pomalidomide (see section 4.4).  

 

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 

 
Pomalidomide doses as high as 50 mg as a single dose in healthy volunteers, and 10 mg as once-daily 

multiple doses in multiple myeloma patients have been studied without reported serious adverse reactions 

related to overdose. In studies, pomalidomide was found to be removed by haemodialysis. 

 

In the event of overdose, supportive care is advised. 

 
 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1  Pharmacodynamic properties 

 
Pharmacotherapeutic group: Immunosuppressants, Other immunosuppressants, ATC code: L04AX06 

 

Mechanism of action 

 

Pomalidomide has direct anti-myeloma tumoricidal activity, immunomodulatory activities and inhibits 
stromal cell support for multiple myeloma tumour cell growth. Specifically, pomalidomide inhibits 

proliferation and induces apoptosis of haematopoietic tumour cells.  Additionally, pomalidomide inhibits 

the proliferation of lenalidomide-resistant multiple myeloma cell lines and synergises with 

dexamethasone in both lenalidomide-sensitive and lenalidomide-resistant cell lines to induce tumour cell 

apoptosis. Pomalidomide enhances T cell- and natural killer (NK) cell-mediated immunity and inhibits 
production of pro-inflammatory cytokines (e.g., TNF-α and IL-6) by monocytes. Pomalidomide also 

inhibits angiogenesis by blocking the migration and adhesion of endothelial cells.  

 

Pomalidomide binds directly to the protein cereblon (CRBN), which is part of an E3 ligase complex that 

includes deoxyribonucleic acid (DNA) damage-binding protein 1(DDB1), cullin 4 (CUL4), and regulator 

of cullins-1 (Roc1), and can inhibit the auto-ubiquitination of CRBN within the complex. E3 ubiquitin 

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


26 

ligases are responsible for the poly-ubiquitination of a variety of substrate proteins, and may partially 

explain the pleiotropic cellular effects observed with pomalidomide treatment.  
 

In the presence of pomalidomide in vitro, substrate proteins Aiolos and Ikaros are targeted for 

ubiquitination and subsequent degradation leading to direct cytotoxic and immunomodulatory effects. In 

vivo, pomalidomide therapy led to reduction in the levels of Ikaros in patients with relapsed lenalidomide-

refractory multiple myeloma. 
 

Clinical efficacy and safety 

 

• Pomalidomide in combination with bortezomib and dexamethasone 
The efficacy and safety of pomalidomide in combination with bortezomib and low-dose dexamethasone 

(Pom+Btz+LD-Dex) was compared with bortezomib and low-dose dexamethasone (Btz+LD-Dex) in a 
Phase III multi-centre, randomised, open-label study (CC-4047-MM-007), in previously treated adult 

patients with multiple myeloma, who had received at least one prior regimen, including lenalidomide and 

have demonstrated disease progression on or after the last therapy. A total of 559 patients were enrolled 

and randomised in the study: 281 in the Pom+Btz+LD-Dex arm and 278 in the Btz+LD-Dex arm. 54% of 

patients were male with median age for the overall population of 68 years (min, max: 27, 89 years). 
Approximately 70% of patients were refractory to lenalidomide (71.2% in Pom+Btz+LD-Dex, 68.7 % in 

Btz+LD-Dex). Approximately 40% of patients were in 1st relapse and approximately 73% of patients 

received bortezomib as prior treatment. 

 

Patients in the Pom+Btz+LD-Dex arm were administered 4 mg pomalidomide orally on Days 1 to 14 of 
each 21-day cycle. Bortezomib (1.3 mg/m2/dose) was administered to patients in both study arms on Days 

1, 4, 8 and 11 of a 21-day cycle for Cycles 1 to 8; and on Days 1 and 8 of a 21-day cycle for Cycles 9 and 

onwards. Low-dose dexamethasone (20 mg/day [≤ 75 years old] or 10 mg/day [> 75 years old]) was 

administered to patients in both study arms on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle for Cycles 

1 to 8; and on Days 1, 2, 8 and 9 of each subsequent 21-day cycle from Cycles 9 onwards. Doses were 

reduced and treatment was temporarily interrupted or stopped as needed to manage toxicity (see section 
4.2).  

 

The primary efficacy endpoint was Progression Free Survival (PFS) assessed by an Independent 

Response Adjudication Committee (IRAC) according to the IMWG criteria using the intent to treat 

population (ITT). After a median follow-up of 15.9 months, median PFS time was 11.20 months (95% 
CI: 9.66, 13.73) in the Pom+Btz+LD-Dex arm. In the Btz+LD-Dex arm, median PFS time was 7.1 

months (95% CI: 5.88, 8.48).  

 

Summary of overall efficacy data are presented in Table 10 using a cut-off date of 26 Oct 2017. Kaplan-

Meier curve for PFS for the ITT population is provided in Figure 1.  
 

Table 10. Summary of overall efficacy data 

 Pom+Btz+LD-Dex 

(N = 281) 

Btz+LD-Dex 

(N = 278) 

PFS (months)  

Mediana time (95% CI) b 11.20 (9.66, 13.73) 7.10 (5.88, 8.48) 

HR c (95% CI), p-valued 0.61 (0.49, 0.77), <0.0001 

ORR, n (%) 82.2 % 50.0% 

sCR 9 (3.2) 2 (0.7) 



27 

CR 35 (12.5) 9 (3.2) 

VGPR 104 (37.0) 40 (14.4) 

PR 83 (29.5) 88 (31.7) 

OR (95% CI) e, p-valuef 5.02 (3.35, 7.52), <0.001 

DoR (months)  

Mediana time (95% CI) b 13.7 (10.94, 18.10) 10.94 (8.11, 14.78) 

HRc (95% CI)  0.76 (0.56, 1.02) 

Btz = bortezomib; CI = Confidence interval; CR = Complete response; DoR = Duration of response; HR = Hazard Ratio; LD-Dex = low-dose 

dexamethasone; OR = Odds ratio; ORR = Overall response rate; PFS = Progression free survival; POM = pomalidomide; PR = Partial Response; 
sCR = Stringent complete response VGPR = Very good partial response. 
a The median is based on the Kaplan-Meier estimate. 
b 95% CI about the median. 
c Based on Cox proportional hazards model.  
d The p-value is based on a stratified log-rank test. 
e Odds ratio is for Pom+Btz+LD-Dex:Btz+LD-Dex. 
f The p-value is based on a CMH test, stratified by age (<=75 vs >75), Prior number of antimyeloma regimens (1 vs >1), and Beta-2 

microglobulin at screening (< 3.5 mg/L versus ≥ 3.5 mg/L — ≤ 5.5 mg/L versus > 5.5 mg/L). 

 

The median duration of treatment was 8.8 months (12 treatment cycles) in the Pom+Btz+LD-Dex arm 

and 4.9 months (7 treament cycles) in the Btz+LD-Dex arm. 
 

The PFS advantage was more pronounced in patients who received only one prior line of therapy. In 

patients who received 1 prior antimyeloma line, median PFS time was 20.73 months (95% CI: 15.11, 

27.99) in the Pom + Btz + LD-Dex arm and 11.63 months (95% CI: 7.52, 15.74) in the Btz + LD-Dex 

arm. A 46% risk reduction was observed with Pom + Btz + LD-Dex treatment (HR = 0.54, 95% CI: 0.36, 
0.82). 

 

 

Figure 1. Progression Free Survival Based on IRAC Review of Response by IMWG Criteria 

(Stratified Log Rank Test) (ITT Population). 

 



28 

Data cutoff: 26 Oct 2017 

 

As per an interim analysis for Overall Survival (OS), using a cut-off of 15 September 2018 (median 

follow-up period of 26.2 months), median OS time from Kaplan-Meier estimates was 40.5 months for the 

Pom + Btz + LD-Dex arm and 30.5 months for the Btz + LD-Dex arm; HR = 0.91, 95% CI: 0.70, 1.18, 

with an overall event rate of 43.3%. 
 

• Pomalidomide in combination with dexamethasone 
 

The efficacy and safety of pomalidomide in combination with dexamethasone were evaluated in a Phase 

III multi-centre, randomised, open-label study (CC-4047-MM-003), where pomalidomide plus low-dose 
dexamethasone therapy (Pom+LD-Dex) was compared to high-dose dexamethasone alone (HD-Dex) in 

previously treated adult patients with relapsed and refractory multiple myeloma, who have received at 

least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated 

disease progression on the last therapy. A total of 455 patients were enrolled in the study: 302 in the 

Pom+LD-Dex arm and 153 in the HD-Dex arm. The majority of patients were male (59%) and white 
(79%); the median age for the overall population was 64 years (min, max: 35, 87 years). 

 

Patients in the Pom+LD-Dex arm were administered 4 mg pomalidomide orally on days 1 to 21 of each 

28-day cycle. LD-Dex (40 mg) was administered once per day on days 1, 8, 15 and 22 of a 28-day cycle. 

For the HD-Dex arm, dexamethasone (40 mg) was administered once per day on days 1 through 4, 

9 through 12, and 17 through 20 of a 28-day cycle. Patients > 75 years of age started treatment with 
20 mg dexamethasone. Treatment continued until patients had disease progression. 

 

The primary efficacy endpoint was progression free survival by International Myeloma Working Group 

(IMWG criteria). For the intention to treat (ITT) population, median PFS time by Independent Review 

Adjudication Committee (IRAC) review based on IMWG criteria was 15.7 weeks (95% CI: 13.0, 20.1) in 
the Pom + LD-Dex arm; the estimated 26-week event-free survival rate was 35.99% (±3.46%). In the 

HD-Dex arm, median PFS time was 8.0 weeks (95% CI: 7.0, 9.0); the estimated 26-week event-free 

survival rate was 12.15% (±3.63%). 

 

PFS was evaluated in several relevant subgroups: gender, race, ECOG performance status, stratification 
factors (age, disease population, prior anti-myeloma therapies [2, > 2]), selected parameters of prognostic 

significance (baseline beta-2 microglobulin level, baseline albumin levels, baseline renal impairment, and 

cytogenetic risk), and exposure and refractoriness to prior anti-myeloma therapies. Regardless of the 

subgroup evaluated, PFS was generally consistent with that observed in the ITT population for both 

treatment groups. 
 

PFS is summarised in Table 11 for the ITT population. Kaplan-Meier curve for PFS for the ITT 

population is provided in Figure 2. 

 

Table 11. Progression Free Survival Time by IRAC Review Based on IMWG Criteria (Stratified 

Log Rank Test) (ITT Population) 

 

Pom+LD-Dex 

(N=302) 

HD-Dex 

(N=153) 

Progression free survival (PFS), N 302 (100.0) 153 (100.0) 

Censored, n (%) 138 (45.7) 50 (32.7) 

Progressed/Died, n (%) 164 (54.3) 103 (67.3) 



29 

Progression Free Survival Time (weeks)   

Mediana 15.7 8.0 

Two sided 95% CIb [13.0, 20.1] [7.0, 9.0] 

Hazard Ratio (Pom+LD-Dex:HD-Dex) 2-Sided 

95% CI c 

0.45 [0.35,0.59] 

Log-Rank Test Two sided P-Value d <0.001 

Note: CI=Confidence interval; IRAC=Independent Review Adjudication Committee; NE = Not Estimable. 
a The median is based on Kaplan-Meier estimate. 
b 95% confidence interval about the median progression free survival time.  
c Based on Cox proportional hazards model comparing the hazard functions associated with treatment  groups, stratified by age 

(≤75 vs >75),diseases population (refractory to both lenalidomide and bortezomib vs not refractory to both active substances), and prior 
number of anti myeloma therapy (=2 vs >2).  
d The p-value is based on a stratified log-rank test with the same stratification factors as the above Cox model. 
Data cutoff: 07 Sep 2012 

Figure 2. Progression Free Survival Based on IRAC Review of Response by IMWG Criteria 

(Stratified Log Rank Test) (ITT Population) 

 

Data cutoff: 07 Sep 2012 

 

Overall Survival was the key secondary study endpoint. A total of 226 (74.8%) of the Pom + LD-Dex 

patients and 95 (62.1%) of the HD-Dex patients were alive as of the cutoff date (07 Sep 2012). Median 
OS time from Kaplan-Meier estimates has not been reached for the Pom + LD-Dex, but would be 

expected to be at least 48 weeks, which is the lower boundary of the 95% CI. Median OS time for the 

HD-Dex arm was 34 weeks (95% CI: 23.4, 39.9). The 1-year event free rate was 52.6% (± 5.72%) for the 

Pom + LD-Dex arm and 28.4% (± 7.51%) for the HD-Dex arm. The difference in OS between the two 

treatment arms was statistically significant (p < 0.001). 
 

0 13 26 39 52 65 

HD - DEX 

POM+LD - DEX 

1.0 

0.8 

0.6 

0.4 

0.2 

0.0 

Progression Free Survival (weeks) 

POM+LD-DEX vs HD-DEX 

Logrank p-value = < 0.001 (2-sided) 
HR (95% CI) 0.45 (0.35, 0.59) 

Events: POM+LD-DEX=164/302 HD-DEX=103/153  

 

P
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30 

Overall survival is summarised in Table 12 for the ITT population. Kaplan-Meier curve for OS for the 
ITT population is provided in Figure 3. 

 

Based on the results of both PFS and OS endpoints, the Data Monitoring Committee established for this 
study recommended that the study be completed and patients in the HD-Dex arm be crossed over to the 

Pom + LD-Dex arm. 

 

Table 12. Overall Survival: ITT Population 

 

Statistics Pom+LD-Dex 

(N=302) 

HD-Dex 

(N=153) 

 N 302 (100.0) 153 (100.0) 

Censored n (%) 226 (74.8) 95 (62.1) 

Died n (%) 76 (25.2) 58 (37.9) 

Survival Time (weeks) Mediana NE 34.0 

 Two sided 95% CIb [48.1, NE] [23.4, 39.9] 

Hazard Ratio (Pom+LD-Dex:HD-Dex) [Two sided 95% CIc] 0.53[0.37, 0.74] 

Log-Rank Test Two sided P-Valued <0.001 

Note: CI=Confidence interval. NE = Not Estimable.  
a The median is based on Kaplan-Meier estimate. 
b 95% confidence interval about the median overall survival time.  
c Based on Cox proportional hazards model comparing the hazard functions associated with treatment groups.  
d The p-value is based on an unstratified log-rank test. 

Data cutoff: 07 Sep 2012 

 



31 

Figure 3. Kaplan-Meier Curve of Overall Survival (ITT Population) 

cutoff: 07 Sep 2012 

 
5.2 Pharmacokinetic properties 

 

Absorption 

 

Pomalidomide is absorbed with a maximum plasma concentration (Cmax) occurring between 2 and 3 hours 

and is at least 73% absorbed following administration of single oral dose. The systemic exposure (AUC) 
of pomalidomide increases in an approximately linear and dose proportional manner. Following multiple 

doses, pomalidomide has an accumulation ratio of 27 to 31% on AUC. 

 

Coadministration with a high-fat and high-calorie meal slows the rate of absorption, decreasing mean 

plasma Cmax by approximately 27%, but has minimal effect on the overall extent of absorption with an 8% 
decrease in mean AUC. Therefore, pomalidomide can be administered without regard to food intake. 

 

Distribution 

 

Pomalidomide has a mean apparent volume of distribution (Vd/F) between 62 and 138 L at steady state.  
Pomalidomide is distributed in semen of healthy subjects at a concentration of approximately 67% of 

plasma level at 4 hours post-dose (approximately Tmax) after 4 days of once daily dosing at 2 mg. In vitro 

binding of pomalidomide enantiomers to proteins in human plasma ranges from 12% to 44% and is not 

concentration dependent. 

 

HD - DEX 
POM+LD - DEX 

Overall Survival (week) 

POM+LD-DEX vs HD-DEX 

Logrank p-value = < 0.001 (2-sided) 

HR (95% CI)  0.53 (0.37, 0.74) 

KM median: POM+LD-DEX=NE       [48.1, NE] 

KM median: HD-DEX   =   34.0[23.4, 39.9] 

Events: POM+LD-DEX=75/284 HD-DEX=56/139  

 

  
 

 
  

1.0 

0.8 

0.6 

0.4 

0.2 

0.0 

0 13 26 39 52 65 

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32 

Biotransformation 

 
Pomalidomide is the major circulating component (approximately 70% of plasma radioactivity) in vivo in 

healthy subjects who received a single oral dose of [14C]-pomalidomide (2 mg). No metabolites were 

present at >10% relative to parent or total radioactivity in plasma. 

 

The predominant metabolic pathways of excreted radioactivity are hydroxylation with subsequent 
glucuronidation, or hydrolysis. In vitro, CYP1A2 and CYP3A4 were identified as the primary enzymes 

involved in the CYP-mediated hydroxylation of pomalidomide, with additional minor contributions from 

CYP2C19 and CYP2D6. Pomalidomide is also a substrate of P-glycoprotein in vitro. Co-administration 

of pomalidomide with the strong CYP3A4/5 and P-gp inhibitor ketoconazole, or the strong CYP3A4/5 

inducer carbamazepine, had no clinically relevant effect on exposure to pomalidomide.  Co-administration 

of the strong CYP1A2 inhibitor fluvoxamine with pomalidomide in the presence of ketoconazole, 
increased mean exposure to pomalidomide by 107% with a 90% confidence interval [91% to 124%] 

compared to pomalidomide plus ketoconazole. In a second study to evaluate the contribution of a 

CYP1A2 inhibitor alone to metabolism changes, co-administration of fluvoxamine alone with 

pomalidomide increased mean exposure to pomalidomide by 125% with a 90% confidence interval [98% 

to 157%] compared to pomalidomide alone. If strong inhibitors of CYP1A2 (e.g. ciprofloxacin, enoxacin 
and fluvoxamine) are co-administered with pomalidomide, reduce the dose of pomalidomide to 50%. 

Administration of pomalidomide in smokers, with smoking tobacco known to induce the CYP1A2 

isoform, had no clinically relevant effect on exposure to pomalidomide compared to that exposure to 

pomalidomide observed in non-smokers. 

 
Based on in vitro data, pomalidomide is not an inhibitor or inducer of cytochrome P-450 isoenzymes, and 

does not inhibit any drug transporters that were studied. Clinically relevant drug-drug interactions are not 

anticipated when pomalidomide is coadministered with substrates of these pathways. 

 

Elimination 

 
Pomalidomide is eliminated with a median plasma half-life of approximately 9.5 hours in healthy subjects 

and approximately 7.5 hours in patients with multiple myeloma. Pomalidomide has a mean total body 

clearance (CL/F) of approximately 7-10 L/hr. 

 

Following a single oral administration of [14C] -pomalidomide (2 mg) to healthy subjects, approximately 
73% and 15% of the radioactive dose was eliminated in urine and faeces, respectively, with 

approximately 2% and 8% of the dosed radiocarbon eliminated as pomalidomide in urine and faeces. 

 

Pomalidomide is extensively metabolised prior to excretion, with the resulting metabolites eliminated 

primarily in the urine. The 3 predominant metabolites in urine (formed via hydrolysis or hydroxylation 
with subsequent glucuronidation) account for approximately 23%, 17%, and 12%, respectively, of the 

dose in the urine. 

 

CYP dependent metabolites account for approximately 43% of the total excreted radioactivity, while non-

CYP dependent hydrolytic metabolites account for 25%, and excretion of unchanged pomalidomide 

accounted for 10% (2% in urine and 8% in faeces). 
 

Population Pharmacokinetics (PK) 

 

Based on population PK analysis using a two-compartment model, healthy subjects and MM patients had 

comparable apparent clearance (CL/F) and apparent central volume of distribution (V2/F). In peripheral 
tissues, pomalidomide was preferentially taken up by tumors with apparent peripheral distribution 



33 

clearance (Q/F) and apparent peripheral volume of distribution (V3/F) 3.7-fold and 8-fold higher, 

respectively, than that of healthy subjects. 
 

Paediatric population 

 

No data are available on administration of pomalidomide to paediatric patients (< 18 years of age). 

 
Elderly 

 

Based on population pharmacokinetic analyses in healthy subjects and multiple myeloma patients, no 

significant influence of age (19-83 years) on oral clearance of pomalidomide was observed. In clinical 

studies, no dose adjustment was required in elderly (> 65 years) patients exposed to pomalidomide (see 

section 4.2). 
 

Renal impairment 

 

Population pharmacokinetic analyses showed that the pomalidomide pharmacokinetic parameters were 

not remarkably affected in renally impaired patients (defined by creatinine clearance or estimated 
glomerular filtration rate [eGFR]) compared to patients with normal renal function 

(CrCl ≥60 mL/minute). Mean normalised AUC exposure to pomalidomide was 98.2% with a 

90% confidence interval [77.4% to 120.6%] in moderate renal impairment patients (eGFR ≥30 to 

≤45 mL/minute/1.73 m2) compared to patients with normal renal function. Mean normalised AUC 

exposure to pomalidomide was 100.2% with a 90% confidence interval [79.7% to 127.0%] in severe renal 
impairment patients not requiring dialysis (CrCl <30 or eGFR <30 mL/minute/1.73 m2) compared to 

patients with normal renal function. Mean normalised AUC exposure to pomalidomide increased by 

35.8% with a 90% CI [7.5% to 70.0%] in severe renal impairment patients requiring dialysis 

(CrCl <30mL/minute requiring dialysis) compared to patients with normal renal function. The mean 

changes in exposure to pomalidomide in each of these renal impairment groups are not of a magnitude 

that requires dosage adjustments.  
 

Hepatic impairment 

 

The pharmacokinetic parameters were modestly changed in hepatically impaired patients (defined by 

Child-Pugh criteria) compared to healthy subjects. Mean exposure to pomalidomide increased by 51% 
with a 90% confidence interval [9% to 110%] in mildly hepatically impaired patients compared to healthy 

subjects. Mean exposure to pomalidomide increased by 58% with a 90% confidence interval [13% to 

119%] in moderately hepatically impaired patients compared to healthy subjects. Mean exposure to 

pomalidomide increased by 72% with a 90% confidence interval [24% to 138%] in severely hepatically 

impaired patients compared to healthy subjects. The mean increases in exposure to pomalidomide in each 
of these impairment groups are not of a magnitude for which adjustments in schedule or dose are required 

(see section 4.2). 

 

5.3 Preclinical safety data 

 

Repeat-dose toxicology studies 
 

In rats, chronic administration of pomalidomide at doses of 50, 250, and 1000 mg/kg/day for 6 months 

was well tolerated. No adverse findings were noted up to 1000 mg/kg/day (175-fold exposure ratio 

relative to a 4 mg clinical dose).  

 



34 

In monkeys, pomalidomide was evaluated in repeat-dose studies of up to 9 months in duration. In these 

studies, monkeys exhibited greater sensitivity to pomalidomide effects than rats.  The primary toxicities 
observed in monkeys were associated with the haematopoietic/lymphoreticular systems. In the 9-month 

study in monkeys with doses of 0.05, 0.1, and 1 mg/kg/day, morbidity and early euthanasia of 6 animals 

were observed at the dose of 1 mg/kg/day and were attributed to immunosuppressive effects 

(staphylococcal infection, decreased peripheral blood lymphocytes, chronic inflammation of the large 

intestine, histologic lymphoid depletion, and hypocellularity of bone marrow) at high exposures of 
pomalidomide (15-fold exposure ratio relative to a 4 mg clinical dose). These immunosuppressive effects 

resulted in early euthanasia of 4 monkeys due to poor health condition (watery stool, inappetence, 

reduced food intake, and weight loss); histopathologic evaluation of these animals showed chronic 

inflammation of the large intestine and villous atrophy of the small intestine. Staphylococcal infection 

was observed in 4 monkeys; 3 of these animals responded to antibiotic treatment and 1 died without 

treatment. In addition, findings consistent with acute myelogenous leukemia led to euthanasia of 1 
monkey; clinical observations and clinical pathology and/or bone marrow alterations observed in this 

animal were consistent with immunosuppression. Minimal or mild bile duct proliferation with associated 

increases in ALP and GGT were also observed at 1 mg/kg/day. Evaluation of recovery animals indicated 

that all treatment-related findings were reversible after 8 weeks of dosing cessation, except for 

proliferation of intrahepatic bile ducts observed in 1 animal in the 1 mg/kg/day group. The No Observed 
Adverse Effect Level (NOAEL) was 0.1 mg/kg/day (0.5-fold exposure ratio relative to a 4 mg clinical 

dose). 

 

Genotoxicity/carcinogenicity 

 
Pomalidomide was not mutagenic in bacterial and mammalian mutation assays, and did not induce 

chromosomal aberrations in human peripheral blood lymphocytes or micronuclei formation in 

polychromatic erythrocytes in bone marrow of rats administered doses up to 2000 mg/kg/day. 

Carcinogenicity studies have not been conducted. 

 

Fertility and early embryonic development 
 

In a fertility and early embryonic development study in rats, pomalidomide was administered to males 

and females at dosages of 25, 250, and 1000 mg/kg/day. Uterine examination on Gestation Day 13 

showed a decrease in mean number of viable embryos and an increase in postimplantation loss at all 

dosage levels. Therefore, the NOAEL for these observed effects was < 25 mg/kg/day (AUC 24h was 
39960 ng•h/mL (nanogram•hour/millilitres) at this lowest dose tested, and the exposure ratio was 99-fold 

relative to a 4 mg clinical dose). When treated males on this study were mated with untreated females, all 

uterine parameters were comparable to the controls. Based on these results, the observed effects were 

attributed to the treatment of females. 

 
Embryo-foetal development  

 

Pomalidomide was found to be teratogenic in both rats and rabbits when administered during the period 

of major organogenesis. In the rat embryofoetal developmental toxicity study, malformations of absence 

of urinary bladder, absence of thyroid gland, and fusion and misalignment of lumbar and thoracic 

vertebral elements (central and/or neural arches) were observed at all dosage levels (25, 250, and 
1000 mg/kg/day).  

 

There was no maternal toxicity observed in this study. Therefore, the maternal NOAEL was 

1000 mg/kg/day, and the NOAEL for developmental toxicity was < 25 mg/kg/day (AUC24h was 

34340 ng•h/mL on Gestation Day 17 at this lowest dose tested, and the exposure ratio was 85-fold 
relative to a 4 mg clinical dose). In rabbits, pomalidomide at dosages ranging from 10 to 250 mg/kg 



35 

produced embryo-foetal developmental malforma tions. Increased cardiac anomalies were seen at all 

doses with significant increases at 250 mg/kg/day. At 100 and 250 mg/kg/day, there were slight increases 
in post-implantation loss and slight decreases in fetal body weights. At 250 mg/kg/day, fetal 

malformations included limb anomalies (flexed and/or rotated fore- and/or hindlimbs, unattached or 

absent digit) and associated skeletal malformations (not ossified metacarpal, misaligned phalanx and 

metacarpal, absent digit, not ossified phalanx, and short not ossified or bent tibia); moderate dilation of 

the lateral ventricle in the brain; abnormal placement of the right subclavian artery; absent intermediate 
lobe in the lungs; low-set kidney; altered liver morphology; incompletely or not ossified pelvis; an 

increased average for supernumerary thoracic ribs and a reduced average for ossified tarsals.  Slight 

reduction in maternal body weight gain, significant reduction in triglycerides, and significant dec rease in 

absolute and relative spleen weights were observed at 100 and 250 mg/kg/day. The maternal NOAEL was 

10 mg/kg/day, and the developmental NOAEL was <10 mg/kg/day (AUC24h was 418 ng•h/mL on 

Gestation Day 19 at this lowest dose tested, which was similar to that obtained from a 4 mg clinical dose). 
 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 
 

Capsule contents 

 

Mannitol (E421) 

Starch, pregelatinised 
Sodium stearyl fumarate 

 

Capsule shell 

 

Imnovid 1 mg hard capsules 

Gelatin 
Titanium dioxide (E171) 

Indigotine (E132) 

Yellow iron oxide (E172) 

White and black ink 

 
Imnovid 2 mg hard capsules 

Gelatin 

Titanium dioxide (E171) 

Indigotine (E132) 

Yellow iron oxide (E172) 
Erythrosin (E127) 

White ink 

 

Imnovid 3 mg hard capsules 

Gelatin 

Titanium dioxide (E171) 
Indigotine (E132) 

Yellow iron oxide (E172) 

White ink 

 



36 

Imnovid 4 mg hard capsules 

Gelatin 
Titanium dioxide (E171) 

Indigotine (E132) 

Brilliant blue FCF (E133) 

White ink 

 
Printing ink 

 

Imnovid 1 mg hard capsules 

White ink  

Shellac 

Titanium dioxide (E171) 
Simeticone 

Propylene glycol (E1520) 

Ammonium hydroxide (E527) 

 

Black ink  
Shellac 

Iron oxide black (E172) 

Propylene glycol (E1520)  

Ammonium hydroxide (E527) 

 
Imnovid 2 mg hard capsules, Imnovid 3 mg hard capsules, Imnovid 4 mg hard capsules 

White ink 

Shellac 

Titanium dioxide (E171) 

Simeticone 

Propylene glycol (E1520) 
Ammonium hydroxide (E527) 

 

6.2 Incompatibilities 

 

Not applicable. 
 

6.3 Shelf life 

 

4 years. 

 
6.4 Special precautions for storage 

 

This medicinal product does not require any special storage conditions. 

 

6.5 Nature and contents of container 

 
The capsules are packaged in Polyvinyl chloride (PVC)/ polychlorotrifluoroethylene (PCTFE) blisters 

with push through aluminium foil.  

 

Pack size of 14 or 21 capsules. 

Not all pack size may be marketed. 
 



37 

6.6 Special precautions for disposal and other handling 

 
Capsules should not be opened or crushed. If powder from pomalidomide makes contact with the skin, 

the skin should be washed immediately and thoroughly with soap and water. If pomalidomide makes 

contact with the mucous membranes, they should be thoroughly flushed with water. 

 

Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. Unused medicinal product should be returned to the pharmacist at the end of treatment. 

 

 

7. MARKETING AUTHORISATION HOLDER 

 

Celgene Europe B.V. 
Winthontlaan 6 N 

3526 KV Utrecht  

Netherlands 

 

 
8. MARKETING AUTHORISATION NUMBER(S)  

 

Imnovid 1 mg hard capsules 

 

EU/1/13/850/001 
EU/1/13/850/005 

 

 

Imnovid 2 mg hard capsules 

 

EU/1/13/850/002 
EU/1/13/850/006 

 

Imnovid 3 mg hard capsules 

 

EU/1/13/850/003 
EU/1/13/850/007 

 

Imnovid 4 mg hard capsules 

 

EU/1/13/850/004 
EU/1/13/850/008 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 05 August 2013 
Date of latest renewal: 11 July 2018 

 

 

10. DATE OF REVISION OF THE TEXT 

 
 



38 

 

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/


39 

 
 

 

 

 

 

 
 

 

 

 

 
 

 

 

 

 
 

 

 

 

 

  

ANNEX II 

A. MANUFACTURER 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 



40 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturer responsible for batch release 

 

Celgene Distribution B.V. 

Winthontlaan 6 N 

3526 KV Utrecht  

Netherlands 

 

 

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 
 

The requirements for submission of periodic safety update reports 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) 
 

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 

agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent 
updates of the RMP. 

An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of an 

important (pharmacovigilance or risk minimisation) milestone being reached.  

 

• Additional risk minimisation measures  
 

1. The MAH shall agree the details of a controlled distribution system with the National Competent 

Authorities and must implement such programme nationally to ensure that: 

• Prior to launch, all doctors who intend to prescribe pomalidomide and all pharmacists who may 
dispense pomalidomide receive a Direct Healthcare Professional Communication as described 

below. 

• Prior to prescribing (where appropriate, and in agreement with the National Competent Authority, 
dispensing) all healthcare professionals who intend to prescribe (and dispense) pomalidomide are 

provided with a physician information pack containing the following: 



41 

o Educational Health Care Professional’s kit 
o Educational brochures for patients 
o Patient cards 
o Summary of Product Characteristics (SmPC) and Package Leaflet and Labelling. 

2. The MAH shall implement a pregnancy prevention programme (PPP) in each Member State. 

Details of the PPP should be agreed with the National Competent Authorities in each Member State 

and put in place prior to the marketing of the product. 
3. The MAH should agree the final text of the Direct Healthcare Professional Communication and the 

physician information pack contents with the National Competent Authority in each Member State 

and ensure that the materials contain the key elements as described below. 

4. The MAH should agree on the implementation of the patient card system in each Member State.   

 
 

Key elements to be included 

 

Direct Healthcare Professional Communications (Prior to Launch) 

 
The Direct Healthcare Professional Communication shall consist of two parts: 

• A core text as agreed by the CHMP. 

• National specific requirements agreed with the National Competent Authority regarding: 
o Distribution of the product 
o To ensure that all appropriate measures have been performed prior to pomalidomide being 

dispensed 
 

The Educational Healthcare Professional’s Kit 

 

The Educational Health Care Professional’s Kit shall contain the following elements: 

• Brief background on pomalidomide and its licensed indication 
• Maximum duration of prescription 

o 4 weeks for women with childbearing potential 
o 12 weeks for men and women without childbearing potential 

• The need to avoid foetal exposure due to teratogenicity of pomalidomide in animals and the 
expected teratogenic effect of pomalidomide in humans  

• Obligations of the health care professional in relation to the prescribing of pomalidomide 
o Need to provide comprehensive advice and counselling to patients 
o That patients should be capable of complying with the requirements for the safe use of 

pomalidomide 

o Need to provide patients with appropriate patient educational brochure and patient card 
• Safety advice relevant to all patients 

o Description and management of thrombocytopenia including incidence rates from clinical 
studies 

o Description and management of cardiac failure 
o Disposal of unwanted medicine 
o Local country specific arrangements for a prescription for pomalidomide to be dispensed 

• Description of the PPP and categorisation of patients based on sex and childbearing potential 
o Algorithm for implementation of PPP 
o Definition of women of childbearing potential (WCBP) and actions the physician should 

take if unsure 

• Safety advice for women of childbearing potential 
o The need to avoid foetal exposure 
o Description of the PPP 
o Need for effective contraception (even if woman has amenorrhoea) and definition of 

effective contraception 



42 

▪ Pregnancy test regime 
▪ Advice on suitable tests 
▪ Before commencing treatment 
▪ During treatment based on method of contraception 
▪ After finishing treatment 

o Need to stop pomalidomide immediately upon suspicion of pregnancy 
o Need to tell treating doctor immediately upon suspicion of pregnancy 

• Safety advice for men 
o The need to avoid foetal exposure 
o The need to use condoms if sexual partner is pregnant or a WCBP and has no 

contraception (even if man has had a vasectomy) 

▪ During pomalidomide treatment 
▪ For one week following final dose 

o That he should not donate semen or sperm during therapy (including during dose 
interruptions) and for 7 days after discontinuation of pomalidomide treatment 

o That if his partner becomes pregnant whilst he is taking pomalidomide or shortly after he 
has stopped taking pomalidomide he should inform his treating doctor immediately 

• Requirements in the event of pregnancy 
o Instructions to stop pomalidomide immediately upon suspicion of pregnancy if female 

patients 

o Need to refer to physician specialised or experienced in dealing with teratology and its 
diagnosis for evaluation and advice 

o Local contact details for reporting of any suspected pregnancy 
o Pregnancy reporting form 

• Patient confirmation form ensuring that patients receive the appropriate counselling concerning the 
treatment, contraceptive methods and pregnancy prevention appropriate for their sex and childbearing 

status 

• Adverse event reporting forms 
 

Educational Brochures for patients 

 

The Educational brochures for patients should be of 3 types: 

• Brochure for women patients of childbearing potential and their partners 
• Brochure for women patients who are not of childbearing potential 

• Brochure for male patients 
 

All patient brochures should contain the following elements: 

• That pomalidomide is teratogenic in animals and is expected to be teratogenic in humans 
• That pomalidomide may cause thrombocytopenia and the need for regular blood tests  

• Description of the patient card and its necessity 

• Disposal of unwanted medicine 

• Guidance on handling pomalidomide for patients, caregivers and family members 

• National or other applicable specific arrangements for a prescription for pomalidomide to be 
dispensed 

• That the patient should not give pomalidomide to any other person 

• That the patient should not donate blood during therapy (including during dose interruptions) and for 
7 days after discontinuation of pomalidomide treatment 

• That the patient should tell their doctor about any adverse events 
 

The following information should also be provided in the appropriate brochure: 

 



43 

Brochure for women patients with childbearing potential 

• The need to avoid foetal exposure 

• Description of the PPP 

• Need for effective contraception and definition of effective contraception 

• Pregnancy test regime 
o Before commencing treatment 
o During treatment (including dose interruptions), at least every 4 weeks except in case of 

confirmed tubal sterilisation 

o After finishing treatment 

• The need to stop pomalidomide immediately upon suspicion of pregnancy 

• The need to contact their doctor immediately upon suspicion of pregnancy 
 
Brochure for male patients 

• The need to avoid fetal exposure 

• The need to use condoms if sexual partner is pregnant or a WCBP and has no contraception (even if 
man has had vasectomy) 

o During pomalidomide treatment (including dose interruptions) 
o For 7 days following final dose 

• That if his partner becomes pregnant he should inform his treating doctor immediately 

• That he should not donate semen or sperm during therapy (including during dose interruptions) and 
for 7 days after discontinuation of pomalidomide treatment 

 

Patient Card 

 

The patient card shall contain the following elements: 

• Verification that appropriate counselling has taken place 

• Documentation of childbearing potential status  

• Pregnancy test dates and results 
 

• Obligation to conduct post-authorisation measures 

 

The MAH shall complete, within the stated timeframe, the below measures: 

 

Description Due date 

• To conduct a non-interventional post-authorisation registry of patients 

treated with pomalidomide for relapsed and refractory multiple myeloma 

to monitor the incidence of adverse drug reactions in the “real world 

situation” and to monitor the implementation and compliance of the 

Celgene PPP and controlled distribution system on a country basis in 

agreement with the relevant National Competent Authority (ie., 

monitoring of Patient Card completion). 

Final clinical study 

report: 

31 August 2023 

• Post-authorisation efficacy study (PAES) MM-007: In order to further 

investigate the efficacy of pomalidomide in combination with bortezomib 

and dexamethasone for the treatment of adult patients with multiple 

myeloma who have received at least one prior treatment regimen 

including lenalidomide, the MAH should submit the final analysis of OS 

from the phase 3, randomized, open label study MM-007. 

30 September 2021 



44 

 
 

 

 

 

 

 
 

 

 

 

 
 

 

 

 

 
 

 

 

 

 

 
ANNEX III 

 

 

LABELLING AND PACKAGE LEAFLET 



45 

 
 

 

 

 

 

 
 

 

 

 

 
 

 

 

 

 
 

 

 

 

 

 

A. LABELLING 



46 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 

Imnovid 1 mg hard capsules 
 

pomalidomide 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each hard capsule contains 1 mg of pomalidomide. 

 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

14 hard capsules. 

21 hard capsules. 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

 
For oral use 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

WARNING: Risk of severe birth defects. Do not use while pregnant or breast-feeding.  

You must follow the Imnovid Pregnancy Prevention Programme. 
 

 

8. EXPIRY DATE 

 
EXP 

 

 



47 

9. SPECIAL STORAGE CONDITIONS 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Unused medicinal product should be returned to the pharmacist. 

 
 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Celgene Europe B.V.  
Winthontlaan 6 N 

3526 KV Utrecht  

Netherlands 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/13/850/005 (Pack size of 14 hard capsules) 

EU/1/13/850/001 (Pack size of 21 hard capsules) 

 
 

13. BATCH NUMBER 

 

Lot 
 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Imnovid 1 mg  

 
 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2 D bar code carrying the unique identifier 
 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 



48 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 

BLISTER 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Imnovid 1 mg hard capsules 

 
pomalidomide 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Celgene Europe B.V. 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 



49 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 

Imnovid 2 mg hard capsules 
 

pomalidomide 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each hard capsule contains 2 mg of pomalidomide. 

 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

14 hard capsules. 

21 hard capsules.  

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

 
For oral use 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

WARNING: Risk of severe birth defects. Do not use while pregnant or breast-feeding.  

You must follow the Imnovid Pregnancy Prevention Programme. 
 

 

8. EXPIRY DATE 

 
EXP 

 

 



50 

9. SPECIAL STORAGE CONDITIONS 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Unused medicinal product should be returned to the pharmacist. 

 
 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Celgene Europe B.V.  
Winthontlaan 6 N 

3526 KV Utrecht  

Netherlands 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/13/850/006 (Pack size of 14 hard capsules) 

EU/1/13/850/002 (Pack size of 21 hard capsules) 

 
 

13. BATCH NUMBER 

 

Lot 
 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Imnovid 2 mg  

 
 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2 D bar code carrying the unique identifier 
 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 



51 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 

Imnovid 2 mg hard capsules 
 

pomalidomide 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Celgene Europe B.V. 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 
 

5. OTHER 

 



52 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 

Imnovid 3 mg hard capsules 
 

pomalidomide 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each hard capsule contains 3 mg of pomalidomide. 

 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

14 hard capsules.  

21 hard capsules.  

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

 
For oral use 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

WARNING: Risk of severe birth defects. Do not use while pregnant or breast-feeding.  

You must follow the Imnovid Pregnancy Prevention Programme. 
 

 

8. EXPIRY DATE 

 
EXP 

 

 



53 

9. SPECIAL STORAGE CONDITIONS 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Unused medicinal product should be returned to the pharmacist. 

 
 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Celgene Europe B.V.  
Winthontlaan 6 N 

3526 KV Utrecht  

Netherlands 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/13/850/007 (Pack size of 14 hard capsules) 

EU/1/13/850/003 (Pack size of 21 hard capsules) 

 
 

13. BATCH NUMBER 

 

Lot 
 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Imnovid 3 mg  

 
 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2 D bar code carrying the unique identifier 
 

  

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 



54 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 

Imnovid 3 mg hard capsules 
 

pomalidomide 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Celgene Europe B.V. 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 
 

5. OTHER 

 



55 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 

Imnovid 4 mg hard capsules 
 

pomalidomide 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each hard capsule contains 4 mg of pomalidomide. 

 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

14 hard capsules. 

21 hard capsules.  

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

 
For oral use 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

WARNING: Risk of severe birth defects. Do not use while pregnant or breast-feeding.  

You must follow the Imnovid Pregnancy Prevention Programme. 
 

 

8. EXPIRY DATE 

 
EXP 

 

 



56 

9. SPECIAL STORAGE CONDITIONS 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

Unused medicinal product should be returned to the pharmacist. 

 
 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Celgene Europe B.V.  
Winthontlaan 6 N 

3526 KV Utrecht  

Netherlands 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/13/850/008 (Pack size of 14 hard capsules) 

EU/1/13/850/004 (Pack size of 21 hard capsules) 

 
 

13. BATCH NUMBER 

 

Lot 
 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Imnovid 4 mg  

 
 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2 D bar code carrying the unique identifier 
 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 



57 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 
 

1. NAME OF THE MEDICINAL PRODUCT 

 

Imnovid 4 mg hard capsules 
 

pomalidomide 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Celgene Europe B.V. 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 
 

5. OTHER 

 



 

58 

 

 
 

 

 

 

 
 

 

 

 

 

 
 

 

 

 

 
 

 

 

 

 

B. PACKAGE LEAFLET 

 
 

 

 

 

 

 
 

 

 

 

 
 

 

 

 

 
 

 

 

 



 

59 

Package leaflet: Information for the patient 

 
Imnovid 1 mg hard capsules 

Imnovid 2 mg hard capsules 

Imnovid 3 mg hard capsules 

Imnovid 4 mg hard capsules 

pomalidomide 
 

This medicine is subject to additional monitoring. This will allow quick identification of new safety 

information. You can help by reporting any side effects you may get. See the end of section 4 for how to 

report side effects. 

 

Imnovid is expected to cause severe birth defects and may lead to the death of an unborn baby.  

• Do not take this medicine if you are pregnant or could become pregnant. 

• You must follow the contraception advice described in this leaflet.  

 

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, pharmacist or nurse. 
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 

• If you get any side effects, talk to your doctor, pharmacist or nurse.  

• This includes any possible side effects not listed in this leaflet.  See section 4. 
 
What is in this leaflet 

 

1. What Imnovid is and what it is used for 

2. What you need to know before you take Imnovid 

3. How to take Imnovid 
4. Possible side effects 

5. How to store Imnovid 

6. Contents of the pack and other information 

 

 

1. What Imnovid is and what it is used for 
 

What Imnovid is 

Imnovid contains the active substance ‘pomalidomide’. This medicine is related to thalidomide and 

belongs to a group of medicines which affect the immune system (the body’s natural defences). 

 
What Imnovid is used for 

Imnovid is used to treat adults with a type of cancer called ‘multiple myeloma’. 

 

Imnovid is either used with: 

• two other medicines - called ‘bortezomib’ (a type of chemotherapy medicine) and 
‘dexamethasone’ (an anti-inflammatory medicine) in people who have had at least one other 

treatment - including lenalidomide.  

 

Or 



 

60 

•  one other medicine - called ‘dexamethasone’ in people whose myeloma has become worse, 
despite having at least two other treatments - including lenalidomide and bortezomib. 

 

What is multiple myeloma 

Multiple myeloma is a type of cancer which affects a certain type of white blood cell (called the ‘plasma 

cell’). These cells grow out of control and accumulate in the bone marrow. This results in damage to the 

bones and kidneys. 
 

Multiple myeloma generally cannot be cured. However, treatment can reduce the signs and symptoms of 

the disease, or make them disappear for a period of time. When this happens, it is called ‘response’. 

 

How Imnovid works 

Imnovid works in a number of different ways: 

• by stopping the myeloma cells developing 

• by stimulating the immune system to attack the cancer cells 

• by stopping the formation of blood vessels supplying the cancer cells. 
 

The benefit of using Imnovid with bortezomib and dexamethasone 
When Imnovid is used with bortezomib and dexamethasone, in people who have had at least one other 

treatment, it can stop multiple myeloma getting worse: 

• On average, Imnovid when used with bortezomib and dexamethasone stopped multiple myeloma 
from coming back for up to 11 months - compared with 7 months for those patients who only 

used bortezomib and dexamethasone. 
 

The benefit of using Imnovid with dexamethasone  

When Imnovid is used with dexamethasone, in people who have had at least two other treatments,  it can 

stop multiple myeloma getting worse: 

• On average, Imnovid when used with dexamethasone stopped multiple myeloma from coming back 
for up to 4 months - compared with 2 months for those patients who used only dexamethasone. 

 

 

2. What you need to know before you take Imnovid 

 

Do not take Imnovid: 

• if you are pregnant or think you may be pregnant or are planning to become pregnant – this is 
because Imnovid is expected to be harmful to an unborn child. (Men and women taking this 

medicine must read the section “Pregnancy, contraception and breast-feeding – information for 

women and men” below). 

• if you are able to become pregnant, unless you follow all the necessary measures to prevent you 
from becoming pregnant (see “Pregnancy, contraception and breast-feeding – information for 

women and men”). If you are able to become pregnant, your doctor will record with each 

prescription that the necessary measures have been taken and will provide you with this 

confirmation. 

• if you are allergic to pomalidomide or any of the other ingredients of this medicine (listed in 
section 6). If you think you may be allergic, ask your doctor for advice. 

 

If you are uncertain whether any of the conditions above apply to you, talk to your doctor, pharmacist or 

nurse before taking Imnovid. 

 



 

61 

Warnings and precautions 

Talk to your doctor, pharmacist or nurse before taking Imnovid if: 

• you have ever had blood clots in the past. During the treatment with Imnovid you have an increased 
risk of getting blood clots in your veins and arteries. Your doctor may recommend you take 

additional treatments (e.g. warfarin) or lower the dose of Imnovid to reduce the chance that you get 

blood clots.  

• you have ever had an allergic reaction such as rash, itching, swelling, feeling dizzy or trouble 
breathing while taking related medicines called ‘thalidomide’ or ‘lenalidomide’.  

• you have had a heart attack, have heart failure, have difficulty breathing, or if you smoke, have 
high blood pressure or high cholesterol levels. 

• you have a high total amount of tumour throughout the body, including your bone marrow. This 
could lead to a condition where the tumours break down and cause unusual levels of chemicals in 
the blood which can lead to kidney failure. You may also experience an uneven heartbeat. This 

condition is called tumour lysis syndrome. 

• you have or have had neuropathy (nerve damage causing tingling or pain in your hands or feet). 

• you have or have ever had hepatitis B infection. Treatment with Imnovid may cause the hepatitis B 
virus to become active again in patients who carry the virus, resulting in a recurrence of the 

infection. Your doctor should check whether you have ever had hepatitis B infection. 

• you experience or have experienced in the past a combination of any of the following symptoms: 
rash on face or extended rash, red skin, high fever, flu-like symptoms, enlarged lymph nodes (signs 

of severe skin reaction called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) 

or drug hypersensitivity syndrome, Toxic Epidermal Necrolysis (TEN) or Stevens-Johnson 

Syndrome (SJS). See also section 4 “Possible side effects”).  
 

It is important to note that patients with multiple myeloma treated with pomalidomide may develop 

additional types of cancer, therefore your doctor should carefully evaluate the benefit and risk when you 

are prescribed this medicine. 

 
At the end of the treatment you should return all unused capsules to the pharmacist. 

 

Pregnancy, contraception and breast-feeding – information for women and men 

The following must be followed as stated in the Imnovid Pregnancy Prevention Programme. 

Women and men taking Imnovid must not become pregnant or father a child. This is because 
pomalidomide is expected to harm the unborn baby. You and your partner should use effective methods 

of contraception while taking this medicine. 

 

Women 

Do not take Imnovid if you are pregnant, think you may be pregnant or are planning to become pregnant. 

This is because this medicine is expected to harm the unborn baby. Before starting the treatment, you 
should tell your doctor if you are able to become pregnant, even if you think this is unlikely.  

 

If you are able to become pregnant: 

• you must use effective methods of contraception for at least 4 weeks before starting treatment, for 
the whole time you are taking treatment, and until at least 4 weeks after stopping treatment. Talk to 
your doctor about the best method of contraception for you. 

• each time your doctor writes a prescription for you, he will ensure you understand the necessary 
measures that have to be taken to prevent pregnancy. 

• your doctor will arrange pregnancy tests before treatment, at least every 4 weeks during treatment, 
and at least 4 weeks after the treatment has finished. 

 



 

62 

If you become pregnant despite the prevention measures: 

• you must stop the treatment immediately and talk to your doctor straight away. 
 

Breast-feeding 

It is not known if Imnovid passes into human breast milk. Tell your doctor if you are breast-feeding or 

intend to breast-feed. Your doctor will advise if you should stop or continue breast-feeding. 

 
Men 

Imnovid passes into human semen. 

 

• If your partner is pregnant or able to become pregnant, you must use condoms for the whole time 
you are taking treatment and for 7 days after the end of treatment. 

• If your partner becomes pregnant while you are taking Imnovid, tell your doctor straight away. 
Your partner should also tell her doctor straight away. 

 

You should not donate semen or sperm during treatment and for 7 days after the end of treatment. 

 

Blood donation and blood tests 

You should not donate blood during treatment and for 7 days after the end of treatment. 

Before and during the treatment with Imnovid you will have regular blood tests. This is because your 

medicine may cause a fall in the number of blood cells that help fight infection (white cells) and in the 

number of cells that help to stop bleeding (platelets). 
 

Your doctor should ask you to have a blood test: 

• before treatment 

• every week for the first 8 weeks of treatment 

• at least every month after that for as long as you are taking Imnovid. 
 

As a result of these tests, your doctor may change your dose of Imnovid or stop your treatment. The 

doctor may also change the dose or stop the medicine because of your general health.  

 

Children and adolescents  
Imnovid is not recommended for use in children and young people under 18 years. 

 

Other medicines and Imnovid 

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other 

medicines. This is because Imnovid can affect the way some other medicines work. Also some other 
medicines can affect the way Imnovid works. 

 

In particular, tell your doctor, pharmacist or nurse before taking Imnovid if you are taking any of the 

following medicines: 

• some antifungals such as ketaconazole 

• some antibiotics (for example ciprofloxacin, enoxacin) 
• certain antidepressants such as fluvoxamine. 

 

Driving and using machines 

Some people feel tired, dizzy, faint, confused or less alert when taking Imnovid. If this happens to you, do 

not drive or operate tools or machinery. 
 



 

63 

Imnovid contains sodium 

This medicine contains less than 1 mmol sodium (23 mg) per capsule, therefore it is considered 
essentially ‘sodium-free’. 

 

 

3. How to take Imnovid 

 
Imnovid must be given to you by a doctor with experience in treating multiple myeloma. 

 

Always take your medicines exactly as your doctor has told you. Check with your doctor, pharmacist or 

nurse if you are not sure. 

 

When to take Imnovid with other medicines 
 

Imnovid with bortezomib and dexamethasone 

• See the leaflets that come with bortezomib and dexamethasone for further information on their use 
and effects. 

• Imnovid, bortezomib and dexamethasone are taken in ‘treatment cycles’. Each cycle lasts 21 days 
(3 weeks). 

• Look at the chart below to see what to take on each day of the 3-week cycle:  
o Each day, look down the chart and find the correct day to see which medicines to take.  
o Some days, you take all 3 medicines, some days just 2 or 1 medicines, and some days none 

at all. 
IMN: Imnovid; BOR: Bortezomib; DEX: Dexamethasone 

 

Cycle 1 to 8 

    

Cycle 9 and onwards 

 

      

 Medicine name    Medicine name 

Day IMN BOR DEX   Day IMN BOR DEX 

1 √ √ √   1 √ √ √ 

2 √  √   2 √  √ 

3 √     3 √   

4 √ √ √   4 √   

5 √  √   5 √   

6 √     6 √   

7 √     7 √   

8 √ √ √   8 √ √ √ 

9 √  √   9 √  √ 

10 √     10 √   

11 √ √ √   11 √   

12 √  √   12 √   

13 √     13 √   

14 √     14 √   

15      15    

16      16    

17      17    

18      18    

19      19    

20      20    

21      21    



 

64 

 

• After completing each 3-week cycle, start a new one. 
 

Imnovid with dexamethasone only 

• See the leaflet that comes with dexamethasone for further information on its use and effects. 
 

• Imnovid and dexamethasone are taken in ‘treatment cycles’. Each cycle lasts 28 days (4 weeks). 
• Look at the chart below to see what to take on each day of the 4-week cycle:  

o Each day, look down the chart and find the correct day to see which medicines to take.  
o Some days, you take both medicines, some days just 1 medicine, and some days none at all.  

 

IMN: Imnovid; DEX: Dexamethasone 
 

 Medicine name 

Day IMN DEX 

1 √ √ 

2 √  

3 √  

4 √  

5 √  

6 √  

7 √  

8 √ √ 

9 √  

10 √  

11 √  

12 √  

13 √  

14 √  

15 √ √ 

16 √  

17 √  

18 √  

19 √  

20 √  

21 √       

22  √ 

23   

24   

25   

26   

27   

28        

 

• After completing each 4-week cycle, start a new one. 
 



 

65 

How much Imnovid to take with other medicines 

 
Imnovid with bortezomib and dexamethasone 

• The recommended starting dose of Imnovid is 4 mg per day.  

• The recommended starting dose of bortezomib will be worked out by your doctor and based on 
your height and weight (1.3 mg/m2 body surface area).  

• The recommended starting dose of dexamethasone is 20 mg per day. However, if you are over 75, 
the recommended starting dose is 10 mg per day. 

 

Imnovid with dexamethasone only 

• The recommended dose of Imnovid is 4 mg per day. 

• The recommended starting dose of dexamethasone is 40 mg per day. However, if you are over 75, 
the recommended starting dose is 20 mg per day. 

 

 

Your doctor may need to reduce the dose of Imnovid, bortezomib or dexamethasone or stop one or more 

of these medicines based on the results of your blood tests, your general condition, other medic ines you 

may be taking (e.g. ciprofloxacin, enoxacin and fluvoxamine) and if you experience side effects 
(especially rash or swelling) from treatment. 

 

If you suffer from liver or kidney problems your doctor will check your condition very carefully whilst 

you are receiving this medicine. 

 
How to take Imnovid 

• Do not break, open or chew the capsules. If powder from a broken Imnovid capsule makes contact 
with the skin, wash the skin immediately and thoroughly with soap and water.  

• Swallow the capsules whole, preferably with water. 

• You can take the capsules either with or without food. 
• Take Imnovid at about the same time each day. 
 

To remove the capsule from the blister, press only one end of the capsule out to push it through the foil. 

Do not apply pressure on the centre of the capsule as this can cause it to break.  

 

 
 
Your doctor will advise you of how and when to take Imnovid if you have kidney problems and are 

receiving dialysis treatment. 

 



 

66 

Duration of the treatment with Imnovid 

You should continue the cycles of treatment until your doctor tells you to stop. 

 

If you take more Imnovid than you should 
If you take more Imnovid than you should, talk to a doctor or go to a hospital straight away. Take the 

medicine pack with you. 

 

If you forget to take Imnovid 

If you forget to take Imnovid on a day when you should, take your next capsule as normal the next day. 

Do not increase the number of capsules you take to make up for not taking Imnovid the previous day. 
 

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. 

 

Serious side effects 

 
Stop taking Imnovid and see a doctor straight away if you notice any of the following serious side 

effects – you may need urgent medical treatment: 

 

• Fever, chills, sore throat, cough, mouth ulcers or any other signs of infection (due to less white 
blood cells, which fight infection).  

• Bleeding or bruising without a cause, including nosebleeds and bleeding from the bowels or 
stomach (due to effects on blood cells called ‘platelets’).  

• Rapid breathing, rapid pulse, fever and chills, passing very little to no urine, nausea and vomiting, 
confusion, unconsciousness (due to infection of blood called sepsis or septic shock). 

• Severe, persistent or bloody diarrhoea (possibly with stomach pain or fever) caused by bacteria 
called Clostridium difficile. 

• Chest pain, or leg pain and swelling, especially in your lower leg or calves (caused by blood clots).  

• Shortness of breath (from serious chest infection, inflammation of the lung, heart failure or blood 
clot). 

• Swelling of face, lips, tongue and throat, which may cause difficulty breathing (due to a serious 
type of allergic reaction called angioedema). 

• Certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma), which can cause 
changes in the appearance of your skin or growths on your skin. If you notice any changes to your 

skin whilst taking Imnovid, tell your doctor as soon as possible. 

• Recurrence of hepatitis B infection, which can cause yellowing of the skin and eyes, dark brown-
coloured urine, right-sided abdominal pain, fever and feeling nauseous or being sick. Tell your 
doctor straightaway if you notice any of these symptoms. 

 

Stop taking Imnovid and see a doctor straight away if you notice any of the serious side effects listed 

above – you may need urgent medical treatment. 

 
 

Other side effects 

Very common (may affect more than 1 in 10 people): 

• Shortness of breath (dyspnoea). 



 

67 

• Infections of the lungs (pneumonia and bronchitis). 

• Infections of the nose, sinuses and throat, caused by bacteria or viruses. 

• Low red blood cells, which may cause anaemia leading to tiredness and weakness. 

• Low blood levels of potassium (hypokalaemia), which may cause weakness, muscle cramps, 
muscle aches, palpitations, tingling or numbness, dyspnoea, mood changes. 

• High blood levels of sugar. 

• Loss of appetite. 
• Constipation, diarrhoea or nausea. 

• Being sick (vomiting). 

• Lack of energy. 

• Difficulty in falling asleep or staying asleep. 

• Dizziness, tremor.  
• Muscle spasm, muscle weakness. 

• Bone pain, back pain. 

• Numbness, tingling or burning sensation to the skin, pains in hands or feet (peripheral sensory 
neuropathy). 

• Swelling of the body, including swelling of the arms or legs. 
 

Common (may affect up to 1 in 10 people): 

• Fall. 
• Bleeding within the skull. 

• Decreased ability to move or feel (sensation) in your hands, arms, feet and legs because of nerve 
damage (peripheral sensorimotor neuropathy). 

• Numbness, itching, and a feeling of pins and needles on your skin (paraesthesia). 

• A spinning feeling in your head, making it difficult to stand up and move normally. 

• Swelling caused by fluid. 

• Hives (urticaria). 
• Rashes. 

• Itchy skin. 

• Shingles. 

• A fast and irregular heartbeat (atrial fibrillation). 

• Heart attack (chest pain spreading to the arms, neck, jaw, feeling sweaty and breathless, feeling 
sick or vomiting). 

• Chest pain, chest infection. 

• Increased blood pressure. 

• A fall in the number of red and white blood cells and platelets at the same time (pancytopenia) , 
which will make you more prone to bleeding and bruising. You may feel tired and weak, and short 
of breath and you are also more likely to get infections. 

• Decreased number of lymphocytes (one type of white blood cells) often caused by infection 
(lymphopenia). 

• Low blood levels of magnesium (hypomagnesaemia), which may cause tiredness, generalised 
weakness, muscle cramps, irritability and may result in low blood levels of calcium 
(hypocalcaemia), which may cause numbness and, or tingling of hands, feet, or lips, muscle 

cramps, muscle weakness, light-headedness, confusion. 



 

68 

• Low blood level of phosphate (hypophosphataemia), which may cause muscle weakness and 
irritability or confusion. 

• High blood level of calcium (hypercalcaemia), which may cause slowing reflexes and skeletal 
muscle weaknesses. 

• High blood levels of potassium, which may cause abnormal heart rhythm. 

• Low blood levels of sodium, which may cause tiredness and confusion, muscle twitching, fits 
(epileptic seizures) or coma. 

• High blood levels of uric acid, which may cause a form of arthritis called gout. 

• Low blood pressure, which may cause dizziness or fainting. 

• Flu-like symptoms (influenza). 
• Sore or dry mouth. 

• Changes in the way things taste. 

• Abdominal pain, swollen abdomen. 

• Feeling confused. 

• Feeling down (depressed mood). 

• Loss of consciousness, fainting. 

• Clouding of your eye (cataract). 

• Damage to the kidney. 

• Inability to pass urine. 

• Abnormal liver test. 
• Urinary tract infection, which may cause a burning sensation when passing urine, or a need to pass 

urine more often. 

• Pain in the pelvis. 

• Weight loss. 
 
Uncommon (may affect up to 1 in 100 people): 

• Stroke. 

• Inflammation of the liver (hepatitis) which can cause itchy skin, yellowing of the skin and the 
whites of the eyes (jaundice), pale coloured stools, dark coloured urine and abdominal pain. 

• The breakdown of cancer cells resulting in the release of toxic compounds into the bloodstream 
(tumour lysis syndrome). This can result in kidney problems. 

 

Not known (frequency cannot be estimated from the available data): 

• Widespread rash, high body temperature, enlarged lymph nodes and other body organs involvement 
(Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug 
hypersensitivity syndrome, Toxic Epidermal Necrolysis or Stevens-Johnson Syndrome). Stop using 

pomalidomide if you develop these symptoms and contact your doctor or seek medical attention 

immediately. See also section 2. 

 

 

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. 

 

 

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


 

69 

5. How to store Imnovid 

 
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 use Imnovid if you notice any damage or signs of tampering to medicine packaging. 

 

Do not throw away any medicines via wastewater or household waste. Any unused medicine should be 

returned to the pharmacist at the end of treatment. These measures will help protect the environment. 
 

 

6. Contents of the pack and other information 

 

What Imnovid contains 

• The active substance is pomalidomide. 

• The other ingredients are mannitol (E421), starch, pregelatinised, and sodium stearyl fumarate. 
 

Imnovid 1 mg hard capsule: 

• Each capsule contains 1 mg of pomalidomide. 

• The capsule shell contains: gelatin, titanium dioxide (E171), indigotine (E132) and yellow iron 
oxide (E172) and white and black ink. 

• The printing ink contains: shellac, titanium dioxide (E171), simeticone, propylene glycol (E1520) 
and ammonium hydroxide (E527) (white ink) and shellac, iron oxide black (E172), propylene 

glycol (E1520) and ammonium hydroxide (E527) (black ink). 

 

Imnovid 2 mg hard capsule: 

• Each capsule contains 2 mg of pomalidomide. 

• The capsule shell contains: gelatin, titanium dioxide (E171), indigotine (E132), yellow iron oxide 
(E172), erythrosin (E127) and white ink. 

• The printing ink contains: white ink - shellac, titanium dioxide (E171), simeticone, propylene 
glycol (E1520) and ammonium hydroxide (E527). 

 

Imnovid 3 mg hard capsule: 

• Each capsule contains 3 mg of pomalidomide. 

• The capsule shell contains: gelatin, titanium dioxide (E171), indigotine (E132), yellow iron oxide 
(E172) and white ink. 

• The printing ink contains: white ink - shellac, titanium dioxide (E171), simeticone, propylene 
glycol (E1520) and ammonium hydroxide (E527). 

 

Imnovid 4 mg hard capsule: 

• Each capsule contains 4 mg of pomalidomide. 

• The capsule shell contains: gelatin, titanium dioxide (E171), indigotine (E132), brilliant blue FCF 
(E133), and white ink. 

• The printing ink contains: white ink - shellac, titanium dioxide (E171), simeticone, propylene 
glycol (E1520) and ammonium hydroxide (E527). 

 



 

70 

What Imnovid looks like and contents of the pack  

Imnovid 1 mg hard capsules: Dark blue opaque cap and yellow opaque body, with “POML 1 mg” written 
on them. 

Imnovid 2 mg hard capsules: Dark blue opaque cap and orange opaque body, with “POML 2 mg” written 

on them. 

Imnovid 3 mg hard capsules: Dark blue opaque cap and green opaque body, with “POML 3 mg” written 

on them. 
Imnovid 4 mg hard capsules: Dark blue opaque cap and blue opaque body, with “POML 4 mg” written on 

them. 

 

Each pack contains 14 or 21 capsules. Not all pack sizes may be marketed. 

 

Marketing Authorisation Holder  
 

Celgene Europe B.V. 

Winthontlaan 6 N 

3526 KV Utrecht  

Netherlands 
 

Manufacturer 

 

Celgene Distribution B.V. 

Winthontlaan 6 N 
3526 KV Utrecht  

Netherlands 

 

This leaflet was last revised in 

 

Other sources of information 
 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments. 

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


 

71 

 

 

 

 

ANNEX IV 

CONCLUSIONS ON THE REQUEST FOR ONE-YEAR MARKETING PROTECTION 

PRESENTED BY THE EUROPEAN MEDICINES AGENCY 

 

  

  

 



 

72 

Conclusions presented by the European Medicines Agency on: 

• one-year marketing protection 

The CHMP reviewed the data submitted by the marketing authorisation holder, taking into account the 

provisions of Article 14(11) of Regulation (EC) No 726/2004, and considers that the new therapeutic 

indication brings significant clinical benefit in comparison with existing therapies as further explained 

in the European Public Assessment Report.  

 

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER 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
	CONCLUSIONS ON THE REQUEST FOR ONE-YEAR MARKETING PROTECTION PRESENTED BY THE EUROPEAN MEDICINES AGENCY