Imnovid (Pomalidomide)
Immunomodulatory Agent for Multiple Myeloma
Quick Facts About Imnovid
Key Takeaways About Imnovid (Pomalidomide)
- Specialist cancer medicine: Imnovid is only prescribed by haematologists experienced in treating multiple myeloma and is always used in combination with other medicines
- Strict pregnancy prevention: Pomalidomide is related to thalidomide and is expected to cause severe birth defects – a mandatory pregnancy prevention programme must be followed by all patients
- Regular blood monitoring required: Blood counts must be checked weekly for the first 8 weeks, then monthly, because pomalidomide can cause severe drops in white blood cells and platelets
- Increased blood clot risk: Patients taking pomalidomide have an elevated risk of venous thromboembolism (blood clots), and preventive anticoagulation therapy may be recommended
- Do not crush or open capsules: Capsules must be swallowed whole – if powder from a broken capsule contacts skin, wash the area immediately with soap and water
What Is Imnovid and What Is It Used For?
Imnovid contains the active substance pomalidomide, an immunomodulatory drug (IMiD) related to thalidomide. It is used to treat adult patients with multiple myeloma, a cancer of the plasma cells in the bone marrow. Imnovid works by directly killing cancer cells, boosting the immune system's ability to attack the tumour, and cutting off the blood supply that feeds cancer growth.
Multiple myeloma is a type of blood cancer that develops when a particular type of white blood cell – the plasma cell – becomes cancerous and multiplies uncontrollably in the bone marrow. Under normal circumstances, plasma cells produce antibodies that help the body fight infections. In multiple myeloma, the cancerous plasma cells produce abnormal antibodies (called M-protein or paraprotein) that serve no useful purpose. The excessive accumulation of these malignant cells in the bone marrow can lead to bone damage, kidney problems, weakened immunity, and anaemia.
Multiple myeloma generally cannot be cured, but treatments can significantly reduce signs and symptoms of the disease, slow its progression, and improve quality of life. When treatment produces a measurable reduction in the cancer, this is called a “response.” According to the International Myeloma Working Group (IMWG), treatment responses are classified from minimal response through to stringent complete response, depending on how much the cancer burden has decreased.
How Pomalidomide Works
Pomalidomide acts through several complementary mechanisms that together provide its anti-myeloma activity:
- Direct anti-tumour effect: Pomalidomide inhibits the growth of myeloma cells and induces apoptosis (programmed cell death) in cancer cells. At the molecular level, it binds to the protein cereblon (CRBN), a component of the CRL4CRBN E3 ubiquitin ligase complex. This binding leads to the ubiquitination and degradation of the transcription factors Ikaros (IKZF1) and Aiolos (IKZF3), which are essential for the survival of myeloma cells.
- Immune system stimulation: Pomalidomide enhances the activity of T-cells and natural killer (NK) cells, boosting the body's immune response against the cancer. This co-stimulatory effect on immune cells is a key distinguishing feature of the IMiD drug class.
- Anti-angiogenic effect: The drug inhibits the formation of new blood vessels (angiogenesis) that supply nutrients and oxygen to the growing tumour. By blocking the tumour's blood supply, pomalidomide helps starve the cancer cells.
Approved Indications
Imnovid is approved for use in two main treatment settings:
- In combination with bortezomib and dexamethasone (PVd): For patients who have received at least one prior therapy, including lenalidomide. In clinical trials, the addition of pomalidomide to bortezomib and dexamethasone extended the median time before the disease worsened to approximately 11 months, compared with 7 months for bortezomib and dexamethasone alone (the OPTIMISMM trial).
- In combination with dexamethasone (Pd): For patients whose myeloma has progressed despite at least two prior therapies, including both lenalidomide and bortezomib. In the pivotal MM-003 trial, pomalidomide plus dexamethasone extended the median progression-free survival to approximately 4 months, compared with 2 months for high-dose dexamethasone alone.
Pomalidomide was first approved by the European Medicines Agency (EMA) in 2013 and by the U.S. Food and Drug Administration (FDA) in the same year. It is classified as an orphan medicine in the European Union, reflecting that multiple myeloma is a relatively rare condition affecting approximately 4–6 per 100,000 people per year. The drug is now available in numerous generic formulations including Pomalidomide Viatris, Pomalidomide Grindeks, and Pomalidomide Sandoz.
What Should You Know Before Taking Imnovid?
Before starting Imnovid, you must understand the strict pregnancy prevention requirements, undergo baseline blood tests, and inform your doctor about all medical conditions and medications. Pomalidomide is contraindicated in pregnancy and in patients who cannot comply with the pregnancy prevention programme.
Contraindications
You must not take Imnovid 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. Both women and men taking this medicine must follow strict pregnancy prevention measures.
- Inability to comply with pregnancy prevention: If you are a woman of childbearing potential and cannot or will not follow the required contraceptive measures. Your doctor will document at each prescription that all necessary measures are being taken.
- Allergy: If you are allergic to pomalidomide or any of the other ingredients in the capsules (listed in the composition section below). Consult your doctor if you suspect you may be allergic.
Warnings and Precautions
Talk to your doctor, pharmacist, or nurse before taking Imnovid if any of the following apply to you:
- History of blood clots: Pomalidomide increases the risk of venous and arterial thromboembolism (blood clots in your veins and arteries). Your doctor may recommend additional treatment with anticoagulants such as warfarin or low-molecular-weight heparin, or may reduce your pomalidomide dose to minimise this risk.
- Previous allergic reactions to related drugs: If you have ever had an allergic reaction (rash, itching, swelling, dizziness, or difficulty breathing) when taking thalidomide or lenalidomide, inform your doctor before starting pomalidomide.
- Cardiovascular risk factors: If you have had a heart attack, have heart failure, difficulty breathing, or if you smoke, have high blood pressure, or high cholesterol levels, as these conditions combined with pomalidomide may further increase your thrombotic risk.
- High tumour burden: If you have a large total amount of tumour throughout your body, including in the bone marrow. This can lead to tumour lysis syndrome (TLS), a condition where rapid breakdown of cancer cells causes dangerous levels of chemicals in the blood, potentially leading to kidney failure and abnormal heart rhythms.
- Neuropathy: If you have or have had nerve damage (peripheral neuropathy) causing tingling, numbness, or pain in your hands or feet.
- Hepatitis B: If you have or have ever had hepatitis B infection. Treatment with pomalidomide may reactivate the hepatitis B virus in patients who carry it, resulting in a recurrence of the infection. Your doctor should test you for hepatitis B before starting treatment.
- Severe skin reactions: If you have ever experienced drug reaction with eosinophilia and systemic symptoms (DRESS), toxic epidermal necrolysis (TEN), or Stevens-Johnson syndrome (SJS). These are rare but potentially life-threatening skin conditions that require immediate medical attention.
Blurred vision, loss of vision or double vision, difficulty speaking, weakness in an arm or leg, a change in how you walk, balance problems, persistent numbness, decreased sensation, memory loss, or confusion. These may be symptoms of progressive multifocal leukoencephalopathy (PML), a serious and potentially fatal brain condition that has been reported in patients treated with pomalidomide.
Pregnancy, Contraception, and Breastfeeding
Due to pomalidomide's structural relationship to thalidomide, strict pregnancy prevention measures are mandatory for all patients. Pomalidomide is expected to cause severe foetal harm.
Women
- Do not take Imnovid if you are pregnant, think you may be pregnant, or are planning to become pregnant
- If you are of childbearing potential, you must use two effective methods of contraception for at least 4 weeks before treatment, throughout the entire treatment period, and for at least 4 weeks after stopping treatment
- Your doctor will arrange pregnancy tests before treatment starts, at least every 4 weeks during treatment, and at least 4 weeks after treatment ends
- If you become pregnant despite using contraception, stop treatment immediately and inform your doctor without delay
Men
- Pomalidomide passes into human semen
- If your partner is pregnant or could become pregnant, you must use condoms throughout treatment and for 7 days after the last dose
- If your partner becomes pregnant while you are taking Imnovid, inform your doctor immediately – it is recommended that your partner also contacts her doctor
- Do not donate semen or sperm during treatment and for 7 days after stopping
Breastfeeding
It is not known whether pomalidomide passes into breast milk. Tell your doctor if you are breastfeeding or planning to breastfeed. Your doctor will advise whether to stop breastfeeding or to discontinue the medicine, considering the benefit of breastfeeding for the child and the benefit of therapy for you.
Blood Monitoring and Donation
Regular blood tests are essential during treatment with pomalidomide because the drug can significantly reduce the number of blood cells that fight infections (white blood cells) and the cells that help stop bleeding (platelets). Your doctor will request blood tests:
- Before treatment begins
- Every week for the first 8 weeks of treatment
- At least once a month thereafter, for as long as you take Imnovid
Based on these results, your doctor may change the dose of Imnovid or pause treatment temporarily. You must not donate blood during treatment and for 7 days after stopping.
Children and Adolescents
Imnovid is not recommended for use in children and adolescents under 18 years of age. There are no data on the safety or effectiveness of pomalidomide in the paediatric population.
Driving and Operating Machinery
Some people may experience fatigue, dizziness, weakness, confusion, or drowsiness while taking Imnovid. If you experience any of these effects, do not drive or operate tools or machinery until the symptoms resolve. Consult your doctor if these effects persist or worsen.
How Does Imnovid Interact with Other Drugs?
Imnovid can interact with certain antifungal medications, antibiotics, and antidepressants. Since pomalidomide is metabolised by the liver enzymes CYP1A2 and CYP3A4, drugs that inhibit these enzymes can increase pomalidomide blood levels, potentially increasing the risk of side effects. Always inform your doctor about all medicines you are taking.
Pomalidomide is primarily metabolised by cytochrome P450 enzymes CYP1A2 and CYP3A4 in the liver. Substances that inhibit or induce these enzymes can alter pomalidomide blood levels and potentially affect both efficacy and safety. Additionally, pomalidomide is always administered in combination with other medicines (dexamethasone, with or without bortezomib), so interactions with these co-administered drugs must also be considered.
Major Interactions
| Drug | Category | Effect | Recommendation |
|---|---|---|---|
| Ketoconazole | Antifungal (CYP3A4 inhibitor) | Increases pomalidomide blood levels, raising the risk of side effects | Avoid combination or use with close monitoring; dose reduction may be needed |
| Fluvoxamine | Antidepressant (CYP1A2 inhibitor) | Significantly increases pomalidomide exposure by inhibiting its primary metabolic pathway | Avoid combination; consider alternative antidepressants |
| Ciprofloxacin | Antibiotic (CYP1A2 inhibitor) | Moderate CYP1A2 inhibitor that increases pomalidomide levels | Use with caution; monitor for increased side effects |
| Enoxacin | Antibiotic (CYP1A2 inhibitor) | Strong CYP1A2 inhibitor that can substantially increase pomalidomide exposure | Avoid combination; choose an alternative antibiotic |
Moderate Interactions
| Drug | Category | Effect | Recommendation |
|---|---|---|---|
| Erythromycin | Macrolide antibiotic | Moderate CYP3A4 inhibitor that may increase pomalidomide levels | Monitor for increased side effects; consider dose adjustment |
| Rifampicin | Antibiotic (CYP3A4 inducer) | Strong CYP3A4 inducer that may decrease pomalidomide effectiveness | Avoid combination if possible; pomalidomide dose may need adjustment |
| Carbamazepine / Phenytoin | Antiepileptic (CYP3A4 inducer) | May reduce pomalidomide blood levels, potentially reducing efficacy | Monitor treatment response; consider alternative anticonvulsants |
| Warfarin | Anticoagulant | Combined thrombotic and bleeding risk management complexity | Monitor INR closely; anticoagulation often needed for VTE prevention |
| Smoking (tobacco) | CYP1A2 inducer | Smoking induces CYP1A2 and may decrease pomalidomide blood levels | Inform your doctor if you smoke or stop smoking during treatment |
Always inform your doctor, pharmacist, or nurse about all medicines you are taking, have recently taken, or might take, including over-the-counter products, herbal supplements, and vitamins. This is essential because Imnovid can affect how other medicines work, and other medicines can affect how Imnovid works.
What Is the Correct Dosage of Imnovid?
The recommended dose of Imnovid is 4 mg once daily, taken on specified days as part of a treatment cycle. Imnovid is always used in combination with other medicines – either bortezomib plus dexamethasone (21-day cycles) or dexamethasone alone (28-day cycles). Only a haematologist experienced in treating multiple myeloma should prescribe this medicine.
Always take Imnovid exactly as your doctor has told you. Treatment is given in repeated cycles, and the specific regimen depends on which combination therapy you are receiving.
Imnovid with Bortezomib and Dexamethasone (PVd Regimen)
Each treatment cycle lasts 21 days (3 weeks). The recommended starting doses are:
Cycles 1 to 8
- Pomalidomide 4 mg: Once daily on Days 1–14 of each 21-day cycle
- Bortezomib: 1.3 mg/m² body surface area, given on Days 1, 4, 8, and 11
- Dexamethasone 20 mg: On Days 1, 2, 4, 5, 8, 9, 11, and 12 (reduced to 10 mg if over 75 years)
Cycles 9 and Beyond
- Pomalidomide 4 mg: Once daily on Days 1–14 of each 21-day cycle
- Bortezomib: 1.3 mg/m² body surface area, given on Days 1 and 8 only
- Dexamethasone 20 mg: On Days 1, 2, 8, and 9 (reduced to 10 mg if over 75 years)
After completing each 21-day cycle, a new cycle begins immediately. Treatment continues as long as you are benefiting from it and the side effects are manageable.
Imnovid with Dexamethasone Alone (Pd Regimen)
Each treatment cycle lasts 28 days (4 weeks). The recommended starting doses are:
28-Day Cycle
- Pomalidomide 4 mg: Once daily on Days 1–21 of each 28-day cycle (3 weeks on, 1 week off)
- Dexamethasone 40 mg: On Days 1, 8, 15, and 22 of each cycle (reduced to 20 mg if over 75 years)
After completing each 28-day cycle, a new cycle begins immediately. Treatment continues until disease progression or unacceptable toxicity.
Dose Adjustments
Your doctor may need to reduce the dose of pomalidomide, bortezomib, or dexamethasone, or temporarily stop treatment, based on:
- Results of your blood tests (especially if white blood cells or platelets fall too low)
- Your general health and overall condition
- Other medicines you are taking (particularly CYP1A2 or CYP3A4 inhibitors such as ciprofloxacin, enoxacin, and fluvoxamine)
- Side effects you experience during treatment, especially rash, neuropathy, or swelling
If you have liver or kidney problems, your doctor will monitor your condition very carefully and may adjust the dose accordingly. Patients receiving dialysis should take their dose after dialysis on treatment days.
How to Take Imnovid
- Do not crush, open, or chew the capsules. Swallow them whole, preferably with water
- You may take the capsules with or without food
- Take your capsules at approximately the same time each day
- When removing a capsule from the blister pack, press on one end only so it pushes through the foil. Do not press on the middle of the capsule as this may cause it to break
- If powder from a broken capsule contacts your skin, wash the area immediately and thoroughly with soap and water
- Healthcare professionals, carers, and family members should use disposable gloves when handling the blister or capsule, then carefully remove the gloves, place them in a sealable plastic bag, and wash hands thoroughly with soap and water
- Women who are pregnant or suspect they may be pregnant must not handle the blister or capsule
Missed Dose
If you forget to take Imnovid at your usual time, do not take the missed dose. Simply take the next capsule at the normal time the following day. Never take a double dose to make up for a forgotten dose.
Overdose
If you take more Imnovid than prescribed, contact your doctor or go to the nearest hospital immediately. Bring the medicine packaging with you so that healthcare professionals can identify what you have taken.
Continue taking Imnovid in treatment cycles for as long as your doctor tells you. This is a long-term treatment, and your doctor will regularly assess your response using blood tests, imaging, and potentially bone marrow examinations to determine whether to continue therapy. At the end of treatment, return all unused capsules to your pharmacy.
What Are the Side Effects of Imnovid?
Like all medicines, Imnovid can cause side effects, though not everyone experiences them. The most common side effects include infections (pneumonia, upper respiratory infections), low blood cell counts (anaemia, neutropenia, thrombocytopenia), fatigue, shortness of breath, bone pain, nausea, diarrhoea, and peripheral neuropathy. Some side effects can be serious and require immediate medical attention.
Fever, chills, sore throat, cough, mouth ulcers, or other signs of infection (due to low white blood cells); bleeding or bruising without injury, including nosebleeds and gastrointestinal bleeding (due to low platelets); rapid breathing, rapid pulse, fever combined with little or no urine output, nausea, vomiting, confusion, or unconsciousness (signs of sepsis or septic shock); chest pain or leg pain and swelling, especially in the lower legs or calves (blood clots); shortness of breath (serious lung infection, heart failure, or blood clot in the lungs); swelling of the face, lips, tongue, or throat causing difficulty breathing (angioedema or anaphylaxis).
Very Common
May affect more than 1 in 10 people
- Shortness of breath (dyspnoea)
- Lung infections (pneumonia and bronchitis)
- Upper respiratory tract infections (nose, sinuses, throat)
- Influenza-like symptoms
- Anaemia (low red blood cells) causing tiredness and weakness
- Low potassium levels (hypokalaemia) – weakness, muscle cramps, palpitations
- High blood sugar levels
- Rapid and irregular heartbeat (atrial fibrillation)
- Decreased appetite
- Constipation, diarrhoea, or nausea
- Vomiting and abdominal pain
- Fatigue and lack of energy
- Sleep disturbances (insomnia)
- Dizziness and tremor
- Muscle cramp or muscle weakness
- Bone pain and back pain
- Peripheral sensory neuropathy (numbness, tingling, or burning in hands or feet)
- Swelling in the body, including arms and legs
- Skin rash
- Urinary tract infection
Common
May affect up to 1 in 10 people
- Falls
- Intracranial haemorrhage (bleeding in the head)
- Peripheral sensorimotor neuropathy (reduced movement or sensation in limbs)
- Paraesthesia (numbness, itching, and pin-and-needle sensations)
- Vertigo (spinning sensation)
- Oedema (fluid-related swelling)
- Urticaria (hives) and itching
- Shingles (herpes zoster)
- Heart attack (myocardial infarction)
- Chest pain and chest infection
- High blood pressure
- Pancytopenia (simultaneous decrease in red cells, white cells, and platelets)
- Lymphopenia (low lymphocyte count)
- Low magnesium, phosphate, or sodium levels in the blood
- High calcium, potassium, or uric acid levels in the blood
- Low blood pressure (may cause dizziness or fainting)
- Sore or dry mouth, taste changes
- Abdominal distension
- Confusion and depression
- Loss of consciousness, fainting
- Cataracts (clouding of the eye lens)
- Kidney damage
- Inability to urinate
- Abnormal liver tests
- Pelvic pain and weight loss
Uncommon
May affect up to 1 in 100 people
- Stroke
- Hepatitis (liver inflammation) – may cause itching, jaundice, pale stools, dark urine, abdominal pain
- Tumour lysis syndrome – breakdown of cancer cells releasing toxic substances into the blood, potentially causing kidney problems
- Hypothyroidism (underactive thyroid) – fatigue, listlessness, muscle weakness, slow heart rate, weight gain
- Squamous cell carcinoma and basal cell carcinoma of the skin
Rare / Frequency Not Known
Frequency cannot be estimated from available data
- Hepatitis B reactivation – may cause yellowing of skin and eyes, dark urine, right-sided abdominal pain, fever, nausea
- DRESS syndrome (drug reaction with eosinophilia and systemic symptoms), toxic epidermal necrolysis (TEN), or Stevens-Johnson syndrome (SJS) – widespread rash, high fever, enlarged lymph nodes
- Progressive multifocal leukoencephalopathy (PML) – a serious brain condition
- Solid organ transplant rejection (e.g. heart, liver)
If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed above. By reporting side effects, you can help provide more information on the safety of this medicine.
How Should You Store Imnovid?
Store Imnovid out of the sight and reach of children. No special temperature or storage conditions are required. Do not use the medicine after the expiry date printed on the blister and carton. Return any unused capsules to the pharmacy after treatment ends.
Keep this medicine out of the sight and reach of children at all times. This is especially important because of the potential for serious harm if the medicine is accidentally ingested by children or pregnant women.
- Do not use this medicine after the expiry date stated on the blister and carton after “EXP.” The expiry date refers to the last day of the stated month.
- No special storage conditions are required – store at room temperature.
- Do not use this medicine if the packaging appears damaged or shows signs of tampering.
- Do not throw medicines down the drain or in household waste. Unused medicine must be returned to the pharmacy after treatment ends. These measures help protect the environment and prevent accidental exposure.
What Does Imnovid Contain?
The active substance in Imnovid is pomalidomide. The capsules are available in four strengths: 1 mg, 2 mg, 3 mg, and 4 mg. Each capsule also contains inactive ingredients including mannitol, pre-gelatinised starch, and sodium stearyl fumarate. This medicine contains less than 1 mmol sodium (23 mg) per capsule, meaning it is essentially sodium-free.
Active Substance
Each capsule contains either 1 mg, 2 mg, 3 mg, or 4 mg of pomalidomide as the active substance.
Inactive Ingredients (Excipients)
The other ingredients are mannitol (E421), pre-gelatinised starch, and sodium stearyl fumarate. The capsule shell contains gelatin, titanium dioxide (E171), and various colouring agents that differ by strength. Printing ink contains shellac, titanium dioxide, simethicone, propylene glycol (E1520), and ammonium hydroxide (E527).
Capsule Appearance and Pack Sizes
| Strength | Capsule Appearance | Marking |
|---|---|---|
| 1 mg | Opaque, dark blue cap and yellow body | POML 1 mg |
| 2 mg | Opaque, dark blue cap and orange body | POML 2 mg |
| 3 mg | Opaque, dark blue cap and green body | POML 3 mg |
| 4 mg | Opaque, dark blue cap and blue body | POML 4 mg |
Each carton contains 14 or 21 capsules. Not all pack sizes may be marketed in every country. The marketing authorisation holder is Bristol-Myers Squibb Pharma EEIG, Dublin, Ireland.
Frequently Asked Questions About Imnovid
Imnovid (pomalidomide) is used to treat adults with multiple myeloma, a cancer of the bone marrow. It is always prescribed in combination with other medicines: either with bortezomib and dexamethasone for patients who have had at least one prior treatment including lenalidomide, or with dexamethasone alone for patients who have had at least two prior treatments 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.
The most common side effects (affecting more than 1 in 10 patients) include fatigue, anaemia, neutropenia (low white blood cells), pneumonia, upper respiratory tract infections, shortness of breath, constipation, diarrhoea, nausea, vomiting, bone pain, back pain, peripheral neuropathy (tingling or numbness in hands and feet), muscle cramps, insomnia, dizziness, skin rash, and swelling. Blood counts must be regularly monitored throughout treatment because pomalidomide frequently causes significant reductions in blood cells.
Pomalidomide is structurally related to thalidomide, a drug historically known for causing severe birth defects when taken during pregnancy. Because of this relationship, pomalidomide is expected to cause foetal harm. A mandatory pregnancy prevention programme requires women of childbearing potential to use two effective contraception methods for at least 4 weeks before, during, and 4 weeks after treatment, with regular pregnancy testing. Men must use condoms during treatment and for 7 days after the last dose. Neither men nor women should donate blood during treatment or for 7 days afterwards.
Treatment with Imnovid continues in repeated cycles for as long as you are benefiting from it and the side effects remain manageable. The PVd regimen uses 21-day cycles, while the Pd regimen uses 28-day cycles. There is no fixed treatment duration. Your haematologist will regularly reassess your condition using blood tests, imaging, and potentially bone marrow biopsies to determine whether treatment should continue, be adjusted, or be stopped. In clinical trials, the median duration of treatment varied from several months to over a year.
No, you must not donate blood during treatment with Imnovid and for 7 days after stopping treatment. This precaution exists to prevent the possibility of pomalidomide being given to a pregnant woman through a blood transfusion, which could cause serious harm to an unborn child. For the same reason, men must not donate semen or sperm during treatment and for 7 days after stopping. All unused capsules should be returned to the pharmacy for safe disposal after treatment ends.
If you forget to take your dose of Imnovid at the usual time, do not take the missed dose. Instead, take the next capsule at the normal scheduled time the following day. Do not take two capsules to compensate for the missed dose. If you accidentally take more than your prescribed dose, contact your doctor immediately or go to the nearest hospital, and bring the medicine packaging with you for identification.
References and Sources
- European Medicines Agency (EMA). Imnovid (pomalidomide) – Summary of Product Characteristics. Last updated 2025. Available at: EMA – Imnovid.
- U.S. Food and Drug Administration (FDA). Pomalyst (pomalidomide) – Prescribing Information. Revised 2024.
- Miguel JS, Weisel K, Moreau P, et al. Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial. The Lancet Oncology. 2013;14(11):1055–1066. doi:10.1016/S1470-2045(13)70380-2.
- Richardson PG, Oriol A, Beksac M, et al. Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial. The Lancet Oncology. 2019;20(6):781–794. doi:10.1016/S1470-2045(19)30152-4.
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Multiple Myeloma. Version 2.2025.
- Dimopoulos MA, Moreau P, Terpos E, et al. Multiple myeloma: EHA-ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology. 2021;32(3):309–322. doi:10.1016/j.annonc.2020.11.014.
- World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd list, 2023.
- British National Formulary (BNF). Pomalidomide. National Institute for Health and Care Excellence (NICE). Accessed December 2025.
Medical Editorial Team
This article has been written and medically reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians in haematology, oncology, and clinical pharmacology. Our editorial process follows the principles of evidence-based medicine, with all clinical claims supported by peer-reviewed research and international guidelines.
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