Pomalidomid Devatis (Pomalidomide)
Generic Immunomodulatory Drug (IMiD) for Multiple Myeloma
Quick Facts About Pomalidomid Devatis
Key Takeaways About Pomalidomid Devatis
- Generic pomalidomide: Pomalidomid Devatis is a generic formulation of pomalidomide, bioequivalent to the originator medicine Imnovid and approved for the same indications in adults with relapsed or refractory multiple myeloma
- Mandatory pregnancy prevention programme: Because pomalidomide is structurally related to thalidomide and causes severe birth defects, both women and men must comply with a strict risk-management programme including contraception, pregnancy testing, and blood-donation restrictions
- Weekly blood monitoring at the start: Complete blood counts must be checked weekly for the first 8 weeks and at least monthly thereafter, because pomalidomide commonly causes severe neutropenia, thrombocytopenia, and anaemia
- Elevated blood-clot risk: Venous and arterial thromboembolism occur more frequently during treatment, so thromboprophylaxis with aspirin or low-molecular-weight heparin is routinely prescribed for at least the first 4 to 6 months
- Swallow capsules whole: Capsules must never be crushed, opened, or chewed – if powder from a damaged capsule contacts skin, wash the area immediately with soap and water, and pregnant women must not handle the capsules
What Is Pomalidomid Devatis and What Is It Used For?
Pomalidomid Devatis is a generic medicine containing the active substance pomalidomide, an immunomodulatory drug (IMiD) related to thalidomide. It is used to treat adults with multiple myeloma, a blood cancer of the plasma cells. The medicine works by directly killing cancer cells, enhancing the body's immune response, and cutting off the blood supply that feeds tumour growth. Pomalidomid Devatis is always prescribed together with dexamethasone, and in some regimens also with bortezomib.
Multiple myeloma is a malignancy of the plasma cells – a type of white blood cell that normally produces antibodies to fight infection. In multiple myeloma, a single clone of plasma cells becomes cancerous and multiplies uncontrollably in the bone marrow, crowding out healthy blood cells and producing abnormal antibodies known as M-protein or paraprotein. The accumulating cancer cells damage bone, impair kidney function, suppress the immune system, and cause anaemia. According to the Global Cancer Observatory (GLOBOCAN), multiple myeloma affects approximately 4 to 6 people per 100,000 each year and remains an incurable but increasingly manageable disease.
Treatment aims to reduce the cancer burden, control symptoms, and extend survival. Since the introduction of novel agents in the early 2000s – including proteasome inhibitors (bortezomib), immunomodulatory drugs (thalidomide, lenalidomide, pomalidomide), and more recently monoclonal antibodies (daratumumab, elotuzumab) and CAR-T cell therapies – median overall survival has improved markedly. Pomalidomide represents the third-generation IMiD with potent activity in patients whose disease has progressed on lenalidomide.
Pomalidomid Devatis is a generic version of pomalidomide. Generic medicines contain the same active substance at the same strength as the original medicine and must demonstrate bioequivalence – meaning they deliver the active substance into the bloodstream at the same rate and extent. Once the patent on the originator (Imnovid, marketed internationally as Pomalyst) expired, generic versions such as Pomalidomid Devatis entered European markets to improve patient access and reduce treatment costs without compromising efficacy or safety. The 1 mg strength is the lowest capsule strength in the pomalidomide range and is typically used at the start of treatment, for dose reductions, or for patients with significant renal or hepatic impairment.
How Pomalidomide Works
Pomalidomide exerts its anti-myeloma activity through several interlinked mechanisms. Research published in journals such as Blood and Leukemia has shown that pomalidomide binds to cereblon (CRBN), a substrate-receptor subunit of the CRL4CRBN E3 ubiquitin ligase complex. This binding changes the substrate specificity of the ligase so that it targets the transcription factors Ikaros (IKZF1) and Aiolos (IKZF3) for ubiquitination and proteasomal degradation. Because myeloma cells depend on these transcription factors for survival, their degradation triggers cell-cycle arrest and apoptosis.
Three broad pharmacological effects follow from this molecular action:
- Direct tumour-cell killing: Pomalidomide inhibits myeloma-cell proliferation and induces apoptosis, including in cells that have become resistant to lenalidomide. Loss of Aiolos also suppresses interferon regulatory factor 4 (IRF4), a master regulator of myeloma-cell survival.
- Immune-system activation: Pomalidomide co-stimulates T-cells and natural killer (NK) cells, enhancing their cytotoxic activity against tumour cells. It also increases production of interleukin-2 (IL-2) and interferon-gamma (IFN-γ), while suppressing pro-inflammatory cytokines such as TNF-α produced by the tumour microenvironment.
- Anti-angiogenic activity: By inhibiting vascular endothelial growth factor (VEGF) signalling, pomalidomide reduces the formation of new blood vessels that supply nutrients and oxygen to the growing tumour.
Approved Indications
Pomalidomid Devatis is approved by the European Medicines Agency (EMA) and equivalent national authorities for two main treatment settings in adults with multiple myeloma:
- In combination with bortezomib and dexamethasone (PVd regimen): For adults with multiple myeloma who have received at least one prior therapy, including lenalidomide. Approval was based on the phase 3 OPTIMISMM trial, which demonstrated that adding pomalidomide to bortezomib-dexamethasone extended median progression-free survival to 11.2 months compared with 7.1 months for bortezomib-dexamethasone alone.
- In combination with dexamethasone alone (Pd regimen): For adults with multiple myeloma who have received at least two prior therapies, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy. This indication was based on the pivotal MM-003 trial (NIMBUS), which showed a near-doubling of median progression-free survival (4.0 vs 1.9 months) and improved overall survival compared with high-dose dexamethasone alone.
Pomalidomide (originator brand Imnovid in the European Union, Pomalyst in the United States) was first approved by the FDA in February 2013 and by the EMA in August 2013. The medicine holds orphan drug designation in the EU, reflecting that multiple myeloma is relatively rare. Pomalidomid Devatis and other generic pomalidomide products became available following patent expiry, expanding patient access to this important treatment option.
What Should You Know Before Taking Pomalidomid Devatis?
Before starting Pomalidomid Devatis you must understand the strict pregnancy-prevention requirements, undergo baseline blood tests and screening for infections such as hepatitis B, and inform your doctor about all medical conditions and medicines you take. Pomalidomide is contraindicated in pregnancy and in patients who cannot comply with the pregnancy-prevention programme.
Pomalidomid Devatis is a specialist medicine that should only be prescribed by a physician experienced in treating multiple myeloma. Before your first prescription your doctor will review your medical history, carry out a physical examination, order baseline blood tests (full blood count, renal and liver function, calcium, and glucose), and enrol you in the mandatory pregnancy-prevention programme. Vaccination status and active infections – including viral hepatitis and tuberculosis – must also be assessed.
Contraindications
You must not take Pomalidomid Devatis if any of the following apply to you:
- Pregnancy: If you are pregnant, think you may be pregnant, or are planning to become pregnant. Pomalidomide is related to thalidomide and is expected to cause serious birth defects, including limb malformations, cardiac abnormalities, and ear defects.
- Women of childbearing potential who do not use effective contraception: Unless all conditions of the Pregnancy Prevention Programme are met, including documented counselling, two reliable contraceptive methods, and regular pregnancy testing.
- Men who do not use condoms when sexually active with a woman who is pregnant or of childbearing potential: Pomalidomide passes into semen and could harm an unborn child.
- Hypersensitivity: If you are allergic to pomalidomide or to any of the excipients listed in the composition section below.
Warnings and Precautions
Tell your doctor, pharmacist, or nurse before taking Pomalidomid Devatis if any of the following apply to you:
- History of blood clots or cardiovascular disease: Pomalidomide increases the risk of venous thromboembolism (deep-vein thrombosis and pulmonary embolism) and arterial events (myocardial infarction and stroke). Your doctor will usually prescribe thromboprophylaxis – most commonly low-dose aspirin 75–100 mg daily, or low-molecular-weight heparin or warfarin in higher-risk patients.
- Previous reactions to related drugs: If you have ever developed a rash, swelling, dizziness, or breathing problems after taking thalidomide or lenalidomide, inform your doctor – cross-reactivity is possible.
- Cardiovascular risk factors: A history of heart attack, heart failure, significant arrhythmias, uncontrolled hypertension, hyperlipidaemia, or active smoking all increase the risk of thrombotic events during treatment.
- High tumour burden: Patients with very high tumour burden are at risk of tumour lysis syndrome (TLS), an acute metabolic disturbance caused by the rapid breakdown of cancer cells that can lead to kidney failure and dangerous heart-rhythm abnormalities.
- Peripheral neuropathy: Pre-existing nerve damage causing numbness, tingling, or pain in the hands and feet may worsen during treatment. Report any new or worsening symptoms promptly.
- Hepatitis B or C: Pomalidomide can reactivate hepatitis B virus infection, sometimes with fatal consequences. Your doctor will test for HBV and HCV before treatment and may prescribe antiviral prophylaxis if needed.
- Severe skin reactions: If you have ever experienced Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS), pomalidomide is generally contraindicated because of the risk of recurrence.
- Second primary malignancies: IMiDs have been associated with an increased risk of new cancers, including acute myeloid leukaemia, myelodysplastic syndrome, and solid tumours, particularly when combined with melphalan. Your doctor will monitor for new malignancies throughout treatment.
New or progressive blurred vision, loss of vision, difficulty speaking, weakness or numbness in one side of the body, problems with balance or walking, memory loss, or confusion. These may be symptoms of progressive multifocal leukoencephalopathy (PML), a rare but potentially fatal brain infection caused by the JC virus that has been reported in patients treated with pomalidomide.
Pregnancy, Contraception, and Breastfeeding
Because pomalidomide is a teratogen – a drug capable of causing severe birth defects – a Pregnancy Prevention Programme is mandatory for every patient, regardless of gender. Your doctor will explain the programme in detail and require written acknowledgement before each prescription.
Women of Childbearing Potential
- Do not take Pomalidomid Devatis if you are pregnant, think you may be pregnant, or intend to conceive
- Use two effective methods of contraception – one highly effective method (e.g. intrauterine device, contraceptive implant, or medroxyprogesterone acetate injection) plus one additional barrier method (e.g. latex condom, diaphragm with spermicide) – for at least 4 weeks before starting, throughout treatment, and for 4 weeks after stopping
- Undergo supervised pregnancy testing (at least as sensitive as 25 mIU/mL) before starting, every 4 weeks during treatment, and 4 weeks after treatment ends
- If you become pregnant despite these measures, stop the medicine immediately, inform your prescribing doctor without delay, and consider referral to a specialist in teratology
Men
- Pomalidomide is present in semen, so you must use a latex or synthetic condom during any sexual contact with a pregnant woman or a woman of childbearing potential, throughout treatment and for 7 days after the last dose
- If your partner becomes pregnant, inform your doctor immediately and advise your partner to contact her own healthcare provider
- Do not donate semen or sperm during treatment and for 7 days after stopping
Breastfeeding
It is not known whether pomalidomide passes into human breast milk, but because of its potential to cause serious harm in a breastfed infant, breastfeeding is not recommended during treatment with Pomalidomid Devatis. Discuss the risks and benefits with your doctor.
Blood Monitoring and Donation Restrictions
Pomalidomide commonly suppresses bone marrow function, so close monitoring is essential. Your doctor will order a full blood count:
- Before starting treatment
- Weekly for the first 8 weeks of treatment
- At least monthly thereafter, for as long as treatment continues
Based on these results, your doctor may reduce the dose, interrupt treatment, or add growth-factor support such as granulocyte colony-stimulating factor (G-CSF). You must not donate blood during treatment with Pomalidomid Devatis or for 7 days after the last dose, and you should return all unused capsules to the pharmacy after treatment ends.
Children and Adolescents
Pomalidomid Devatis is not recommended in children and adolescents under 18 years of age. Multiple myeloma is extremely rare in this age group, and the safety and efficacy of pomalidomide have not been established in paediatric patients.
Driving and Operating Machinery
Pomalidomide can cause fatigue, dizziness, confusion, reduced alertness, and blurred vision. If any of these effects occur, do not drive or use tools or machinery until the symptoms have resolved. Because dexamethasone is always administered with pomalidomide, mood changes and sleep disturbance may also impair concentration.
How Does Pomalidomid Devatis Interact with Other Drugs?
Pomalidomide is metabolised by the liver enzymes CYP1A2 and CYP3A4, so drugs that inhibit or induce these enzymes can change pomalidomide blood levels. Strong CYP1A2 inhibitors such as fluvoxamine and ciprofloxacin, and strong CYP3A4 inhibitors such as ketoconazole, should generally be avoided. Always inform your doctor about every medicine, supplement, and herbal product you take.
Pomalidomide is primarily metabolised by cytochrome P450 enzymes CYP1A2 and CYP3A4, with smaller contributions from CYP2C19 and CYP2D6. Pomalidomide is also a substrate of the efflux transporter P-glycoprotein (P-gp). Co-administered drugs that inhibit these enzymes or transporters can raise pomalidomide exposure and the risk of toxicity, while inducers can lower pomalidomide exposure and reduce efficacy. Because pomalidomide is always combined with dexamethasone – and often bortezomib – interactions with those agents also need to be considered.
Major Interactions
| Drug | Category | Effect | Recommendation |
|---|---|---|---|
| Fluvoxamine | Antidepressant (strong CYP1A2 inhibitor) | Almost doubles pomalidomide exposure (AUC); significantly raises risk of neutropenia and infection | Avoid combination. Switch to an antidepressant that does not inhibit CYP1A2 (e.g. sertraline, escitalopram) |
| Ciprofloxacin | Fluoroquinolone antibiotic (CYP1A2 inhibitor) | Moderate increase in pomalidomide plasma levels | If combination is necessary, reduce pomalidomide dose and monitor closely for toxicity |
| Enoxacin | Fluoroquinolone antibiotic (strong CYP1A2 inhibitor) | Substantial increase in pomalidomide exposure | Avoid combination. Select an alternative antibiotic |
| Ketoconazole / Itraconazole | Azole antifungals (strong CYP3A4 inhibitors) | Increase pomalidomide levels, raising the risk of serious side effects | Avoid concomitant use. Prefer fluconazole at moderate doses if antifungal prophylaxis is required |
| Clarithromycin | Macrolide antibiotic (strong CYP3A4 inhibitor) | Can significantly increase pomalidomide exposure | Use an alternative antibiotic (e.g. azithromycin) whenever possible |
Moderate Interactions
| Drug | Category | Effect | Recommendation |
|---|---|---|---|
| Erythromycin | Macrolide antibiotic | Moderate CYP3A4 inhibitor that may raise pomalidomide levels | Monitor for increased adverse effects; consider dose adjustment |
| Rifampicin | Antibiotic (strong CYP3A4/CYP1A2 inducer) | Substantially decreases pomalidomide exposure, potentially reducing efficacy | Avoid if possible; consult haematologist if combination is unavoidable |
| Carbamazepine / Phenytoin | Antiepileptic (CYP3A4 inducer) | May reduce pomalidomide blood levels and efficacy | Monitor response; consider levetiracetam or lamotrigine as alternatives |
| Warfarin / DOACs | Oral anticoagulants | Anticoagulation is often indicated for thromboprophylaxis; complex balance of bleeding and clotting risks | Monitor INR or anti-Xa levels closely; co-ordinate with haematologist |
| St John's Wort (Hypericum perforatum) | Herbal supplement (CYP3A4/P-gp inducer) | May reduce pomalidomide levels and compromise treatment response | Avoid completely during treatment |
| Smoking (tobacco) | CYP1A2 inducer | Tobacco smoke induces CYP1A2 and may reduce pomalidomide blood levels | Inform your doctor of smoking status and any changes during treatment; smoking cessation is strongly encouraged |
Always tell your doctor, pharmacist, or nurse about all medicines and supplements you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal preparations. Ask before starting anything new – even simple cold remedies can contain ingredients that interact with pomalidomide or with dexamethasone.
What Is the Correct Dosage of Pomalidomid Devatis?
The recommended starting dose of pomalidomide is 4 mg once daily, taken on specified days of each treatment cycle. The 1 mg strength of Pomalidomid Devatis is used at the start of treatment alongside higher-strength capsules, for dose reductions, or for patients with significant kidney or liver impairment. The medicine is always given in combination with dexamethasone, and in some regimens also with bortezomib. Cycles last 21 or 28 days depending on the regimen.
Take Pomalidomid Devatis exactly as your doctor has told you. Treatment is delivered in repeating cycles, with the specific schedule determined by which combination regimen you are receiving. Your prescribing haematologist will adjust the starting dose if you have moderate or severe kidney or liver impairment, are elderly, or are taking an interacting medicine. The 1 mg strength allows fine-tuning of the dose from the standard 4 mg to 3 mg, 2 mg, or 1 mg in response to side effects.
Pomalidomid Devatis with Bortezomib and Dexamethasone (PVd Regimen)
Each treatment cycle lasts 21 days (3 weeks).
Cycles 1 to 8
- Pomalidomide 4 mg: Once daily orally on Days 1–14 of each 21-day cycle
- Bortezomib: 1.3 mg/m² body surface area subcutaneously on Days 1, 4, 8, and 11
- Dexamethasone 20 mg: Orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 (10 mg if over 75 years or with performance status limitations)
Cycles 9 and Beyond
- Pomalidomide 4 mg: Once daily orally on Days 1–14 of each 21-day cycle
- Bortezomib: 1.3 mg/m² subcutaneously on Days 1 and 8 only
- Dexamethasone 20 mg: Orally on Days 1, 2, 8, and 9 (10 mg if over 75 years)
Pomalidomid Devatis with Dexamethasone Alone (Pd Regimen)
Each treatment cycle lasts 28 days (4 weeks).
28-Day Cycle
- Pomalidomide 4 mg: Once daily orally on Days 1–21 (3 weeks on, 1 week off)
- Dexamethasone 40 mg: Orally on Days 1, 8, 15, and 22 of each 28-day cycle (20 mg if over 75 years)
After each cycle, a new cycle begins immediately, unless your doctor decides to pause treatment because of side effects. Treatment continues until disease progression or unacceptable toxicity.
Dose Adjustments
Your doctor may reduce the pomalidomide dose from 4 mg to 3 mg, 2 mg, or 1 mg – or temporarily pause treatment – based on:
- Results of your blood tests, particularly if neutrophil count falls below 0.5 x 109/L or platelet count below 25 x 109/L
- New or worsening non-haematological toxicity (rash, neuropathy, oedema, thrombosis)
- Concomitant use of moderate or strong CYP1A2 or CYP3A4 inhibitors
- Kidney or liver impairment – dose adjustments are specified in the product information for moderate-to-severe renal impairment and hepatic impairment
If you are on dialysis, take your dose of Pomalidomid Devatis after the dialysis session on treatment days. Missing doses or breaking capsules can compromise efficacy and safety. The 1 mg strength is particularly useful for patients tolerating only a reduced dose due to toxicity or impaired organ function.
How to Take Pomalidomid Devatis
- Swallow the capsules whole with a glass of water. Do not crush, chew, open, or break them
- You may take the capsules with or without food
- Take your dose at approximately the same time each day
- When removing a capsule from the blister, press on only one end so the capsule pushes through the foil. Avoid pressing on the middle of the capsule
- If the capsule breaks and powder contacts your skin, wash the area immediately and thoroughly with soap and water. If powder enters the eyes, nose, or mouth, rinse with plenty of water
- Healthcare professionals, carers, and family members should wear disposable gloves when handling capsules or blisters, dispose of the gloves in a sealable plastic bag, and wash their hands with soap and water afterwards
- Women who are pregnant or think they may be pregnant must not handle the blister or capsule
Missed Dose
If you forget to take your dose of Pomalidomid Devatis and less than 12 hours have passed since the usual time, take it as soon as you remember. If more than 12 hours have passed, skip the missed dose and take your next capsule at the normal time the following day. Never take two capsules at once to make up for a missed dose.
Overdose
If you accidentally take too many capsules of Pomalidomid Devatis, contact your doctor, pharmacist, or nearest emergency department immediately and take the medicine packaging with you for identification. There is no specific antidote; management is supportive, and your blood counts and organ function will need close observation.
Pomalidomid Devatis is a long-term therapy. Your haematologist will continue treatment as long as you are benefiting from it and side effects are manageable. Regular blood tests, imaging, and serum protein electrophoresis help assess how well the cancer is responding. At the end of treatment, return all unused capsules to the pharmacy.
What Are the Side Effects of Pomalidomid Devatis?
Like all medicines, Pomalidomid Devatis can cause side effects, though not everyone experiences them. The most frequent are infections (pneumonia, upper respiratory infections), low blood-cell counts (anaemia, neutropenia, thrombocytopenia), fatigue, shortness of breath, bone pain, peripheral neuropathy, and gastrointestinal upset. Some side effects can be serious and require urgent medical assessment.
Fever, chills, cough, mouth ulcers, or other signs of infection (possible neutropenic sepsis); unexplained bleeding or bruising, nosebleeds, or bloody stools (thrombocytopenia); rapid breathing, rapid pulse, confusion, or unconsciousness (sepsis); chest pain, leg pain or swelling (blood clots); severe breathlessness (pulmonary embolism); swelling of the face, lips, tongue, or throat (angioedema); or widespread rash with fever and mouth sores (Stevens-Johnson syndrome or DRESS).
Very Common
May affect more than 1 in 10 people
- Pneumonia and other lower respiratory infections
- Upper respiratory tract infections (colds, sinusitis, pharyngitis)
- Neutropenia (low neutrophil count) and febrile neutropenia
- Thrombocytopenia (low platelets)
- Anaemia with fatigue and pallor
- Shortness of breath (dyspnoea)
- Cough and bronchitis
- Decreased appetite and weight loss
- Low potassium (hypokalaemia) with weakness and muscle cramps
- Constipation, diarrhoea, nausea, or vomiting
- Abdominal pain
- Fatigue, asthenia, and lethargy
- Peripheral oedema (swelling of the ankles and legs)
- Insomnia and disturbed sleep
- Dizziness and tremor
- Muscle spasm, bone pain, and back pain
- Peripheral sensory neuropathy (tingling, numbness, burning)
- Skin rash and itching
- Urinary tract infection
- Pyrexia (fever)
Common
May affect up to 1 in 10 people
- Falls, especially in older patients
- Intracranial haemorrhage (bleeding in or around the brain)
- Peripheral sensorimotor neuropathy (weakness and sensory loss)
- Paraesthesia (pins and needles) and dysaesthesia
- Vertigo and balance disturbance
- Confusion, anxiety, or depression
- Syncope (fainting) and loss of consciousness
- Cataracts (clouding of the lens of the eye)
- Deep-vein thrombosis and pulmonary embolism
- Myocardial infarction and atrial fibrillation
- Hypertension or hypotension
- Pancytopenia (all three cell lines low) and lymphopenia
- Abnormal electrolytes: low magnesium, phosphate, or sodium; high calcium, potassium, or uric acid
- Tumour lysis syndrome
- Oral mucositis, dry mouth, taste disturbance
- Abdominal distension and gastrointestinal bleeding
- Urticaria (hives), herpes zoster (shingles), and fungal skin infections
- Chest pain, chest infection, wheezing
- Kidney impairment and urinary retention
- Abnormal liver function tests (raised ALT/AST)
- Pelvic pain
Uncommon
May affect up to 1 in 100 people
- Ischaemic stroke or transient ischaemic attack (TIA)
- Hepatitis (liver inflammation) with jaundice and dark urine
- Cholestasis and liver failure
- Hypothyroidism with fatigue, weight gain, and bradycardia
- Squamous cell carcinoma and basal cell carcinoma of the skin
- Second primary haematological malignancies (AML, MDS)
- Severe bradycardia or heart failure
- Septic shock
Rare / Frequency Not Known
Frequency cannot be estimated from available data
- Hepatitis B reactivation – may cause jaundice, dark urine, right-upper-quadrant pain, fever, nausea
- Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and DRESS syndrome – widespread rash with high fever
- Progressive multifocal leukoencephalopathy (PML) – serious brain infection
- Solid-organ transplant rejection (in patients with prior transplantation)
- Anaphylaxis and angioedema
If you notice any side effects, including those not listed above, talk to your doctor, pharmacist, or nurse. In the European Union, side effects can also be reported to national regulatory authorities via the EudraVigilance system or national pharmacovigilance portals. Your reports help protect other patients.
How Should You Store Pomalidomid Devatis?
Store Pomalidomid Devatis in the original packaging at room temperature and keep it out of the sight and reach of children. Do not use after the expiry date printed on the blister and carton. Return any unused capsules to the pharmacy after treatment ends – never dispose of them in household waste.
Safe storage is especially important for pomalidomide because of its serious potential harms if accidentally taken by children or women who are pregnant. Keep the medicine in the original carton so you can see the expiry date and batch number.
- Keep this medicine out of the sight and reach of children at all times
- Store in the original packaging below 30 °C (no refrigeration is required)
- Do not use this medicine after the expiry date printed on the blister and carton after “EXP.” The expiry date refers to the last day of the stated month
- Do not use the medicine if the blister appears damaged or shows signs of tampering
- Do not throw medicines down the drain or in household waste – return all unused capsules to your pharmacy after treatment ends. This helps protect the environment and prevents accidental exposure to other people
What Does Pomalidomid Devatis Contain?
The active substance in Pomalidomid Devatis is pomalidomide. Each hard capsule contains 1 mg of pomalidomide. Inactive ingredients (excipients) typically include mannitol, pre-gelatinised starch, and sodium stearyl fumarate, with gelatin, titanium dioxide, and colouring agents in the capsule shell. Pomalidomid Devatis contains less than 1 mmol sodium (23 mg) per capsule, so it is essentially sodium-free.
Active Substance
Each hard capsule of Pomalidomid Devatis contains 1 mg of pomalidomide. Pomalidomide is the third-generation immunomodulatory drug (IMiD) in the thalidomide family, with higher potency than lenalidomide and a distinct activity profile in myeloma cells resistant to earlier IMiDs. The 1 mg strength is typically used as part of combination therapy together with higher-strength capsules during dose reductions or when the starting dose needs to be adjusted for organ impairment or toxicity.
Inactive Ingredients (Excipients)
The capsule contents typically include:
- Mannitol (E421) – a diluent that helps form the capsule powder
- Pre-gelatinised starch – a binder that stabilises the formulation
- Sodium stearyl fumarate – a lubricant that aids capsule filling
The hard capsule shell is made of gelatin and contains titanium dioxide (E171) as a whitening agent, together with colourants that differ by strength (iron oxides and other approved pharmaceutical colourants). The printing ink typically contains shellac, titanium dioxide, simethicone, propylene glycol (E1520), and ammonium hydroxide (E527).
If you have an intolerance to any of these excipients – for example, a known gelatin allergy – tell your doctor before starting treatment. Pomalidomid Devatis contains less than 1 mmol of sodium per capsule and is therefore considered essentially sodium-free, which is relevant for patients on a sodium-restricted diet.
Capsule Appearance and Pack Sizes
| Strength | Dosage Form | Typical Pack Sizes |
|---|---|---|
| 1 mg | Hard capsule | 14 or 21 capsules per carton |
Not all pack sizes may be marketed in every country, and the exact appearance of the capsules may vary between countries. Other strengths of pomalidomide (2 mg, 3 mg, 4 mg) are available from other manufacturers and are used together with the 1 mg capsules to build a patient's prescribed daily dose. Consult the patient information leaflet supplied with your pack for details specific to your formulation, including the marketing authorisation holder.
Frequently Asked Questions About Pomalidomid Devatis
Pomalidomid Devatis is a generic pomalidomide medicine used to treat adults with multiple myeloma, a cancer of the plasma cells in the bone marrow. It is always prescribed in combination with other medicines: either with bortezomib and dexamethasone for patients who have received at least one prior therapy including lenalidomide, or with dexamethasone alone for patients who have received at least two prior therapies including both lenalidomide and bortezomib. Pomalidomide belongs to the immunomodulatory drug (IMiD) class and works by attacking cancer cells directly, stimulating the immune system, and inhibiting tumour blood-vessel formation.
Pomalidomid Devatis is a generic version of the originator medicine Imnovid (known in the United States as Pomalyst). Both contain the same active substance – pomalidomide – and have the same indications, contraindications, and warnings. Generic medicines are authorised only after demonstrating bioequivalence, meaning they deliver the same amount of active substance to the bloodstream as the reference product. Clinically, Pomalidomid Devatis can be used interchangeably with Imnovid under medical supervision, and the 1 mg capsule strength is bioequivalent to the 1 mg originator capsule.
Pomalidomide is structurally related to thalidomide, the drug responsible for devastating birth defects in the late 1950s and early 1960s. Pomalidomide is expected to cause similar foetal harm, including limb malformations, cardiac abnormalities, and other serious birth defects. For this reason, every patient prescribed Pomalidomid Devatis must take part in the Pregnancy Prevention Programme. Women of childbearing potential use two effective contraceptives and undergo regular pregnancy testing; men use condoms during any sexual contact where pregnancy is possible. Both sexes must avoid donating blood, semen, or sperm during treatment and for 7 days afterwards.
Treatment continues in repeated cycles – 21-day cycles for the PVd regimen and 28-day cycles for the Pd regimen – for as long as the cancer is responding and side effects are manageable. There is no fixed duration. Your haematologist will review response every 1–2 cycles using blood tests, serum protein electrophoresis, and when needed imaging and bone-marrow biopsy. Treatment is stopped if the disease progresses, if severe side effects occur that cannot be managed with dose reduction, or if you and your doctor decide that the balance of benefits and risks has changed.
No. You must not donate blood during treatment with Pomalidomid Devatis or for 7 days after the last dose, because any recipient could be harmed by pomalidomide in the donated blood – including a pregnant woman and her unborn child. Men must also not donate semen or sperm during treatment and for 7 days afterwards. Return all unused capsules to the pharmacy when treatment ends rather than keeping them at home.
If you realise you have missed a dose and less than 12 hours have passed since your usual dosing time, take the missed dose as soon as possible. If more than 12 hours have passed, skip the missed dose entirely and take your next capsule at the normal time the following day. Never take two capsules at once to compensate for a missed dose. If you accidentally take more capsules than prescribed, contact your doctor immediately or go to the nearest hospital with the packaging so the team can identify the medicine.
Pomalidomide significantly increases the risk of blood clots, so most patients are prescribed thromboprophylaxis for at least the first 4 to 6 months of treatment. Low-dose aspirin (75–100 mg daily) is used for patients at standard risk, while low-molecular-weight heparin or full-dose warfarin is preferred for patients with additional risk factors such as previous thrombosis, obesity, immobility, or concomitant dexamethasone use. Your haematologist will choose the most appropriate option based on your personal risk profile.
References and Sources
- European Medicines Agency (EMA). Imnovid (pomalidomide) – Summary of Product Characteristics and European Public Assessment Report. Last updated 2025. Available at: EMA – Imnovid.
- U.S. Food and Drug Administration (FDA). Pomalyst (pomalidomide) – Prescribing Information. Revised 2024.
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