Pomalidomide STADA (Pomalidomide)

What Is Pomalidomide STADA and What Is It Used For?

Pomalidomide STADA is a generic medicine containing the active substance pomalidomide, a third-generation immunomodulatory drug (IMiD) derived from thalidomide. It is approved for adult patients with multiple myeloma, a cancer of the plasma cells in the bone marrow. The medicine works by directly killing myeloma cells, boosting the body’s immune response against the tumour, and cutting off the blood supply that feeds cancer growth. Pomalidomide STADA 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 myeloma, a single plasma-cell clone becomes cancerous and multiplies without control in the bone marrow, crowding out healthy blood cells and secreting an abnormal antibody called monoclonal protein, M-protein, or paraprotein. Over time, the accumulating cancer cells erode bone, impair kidney function, suppress immunity, and cause anaemia. According to the Global Cancer Observatory (GLOBOCAN 2022), multiple myeloma affects around 4 to 6 people per 100,000 each year worldwide, making it the second most common haematological cancer after non-Hodgkin lymphoma. Although myeloma remains incurable, survival has improved dramatically: median overall survival now exceeds 7 to 10 years in many cohorts, reflecting the arrival of several highly effective drug classes.

The modern treatment landscape for multiple myeloma is built around four backbone drug classes: proteasome inhibitors (bortezomib, carfilzomib, ixazomib), immunomodulatory drugs (thalidomide, lenalidomide, pomalidomide), monoclonal antibodies (daratumumab, isatuximab, elotuzumab), and – more recently – bispecific T-cell engagers and CAR-T cell therapies directed against BCMA and GPRC5D. Pomalidomide represents the third-generation IMiD, deliberately engineered to retain activity in myeloma cells that have become resistant to earlier IMiDs such as lenalidomide. Its increased potency and distinct substrate-degradation profile allow it to re-establish disease control in heavily pre-treated patients.

Pomalidomide STADA is a generic version of pomalidomide marketed by STADA Arzneimittel AG, a European pharmaceutical group specialising in generics, biosimilars, and consumer healthcare. Generic medicines contain the same active substance at the same strengths as the originator product and must demonstrate bioequivalence – meaning they deliver the active substance into the bloodstream at the same rate and extent as the reference medicine. After the patent of the originator Imnovid (Pomalyst in the US) expired, generic pomalidomide products entered the market to widen patient access and reduce the cost of treatment without compromising efficacy or safety. Like all authorised pomalidomide products, Pomalidomide STADA is manufactured under Good Manufacturing Practice (GMP) requirements and monitored through ongoing pharmacovigilance.

How Pomalidomide Works

Pomalidomide exerts its anti-myeloma activity through a series of interconnected molecular and cellular effects. Research published in journals such as Blood, Leukemia, and Science has shown that pomalidomide binds to cereblon (CRBN), a substrate-receptor subunit of the CRL4^CRBN E3 ubiquitin ligase complex. This binding reshapes the substrate specificity of the ligase so that it targets the transcription factors Ikaros (IKZF1) and Aiolos (IKZF3) for ubiquitination and proteasomal degradation. Because malignant plasma cells depend on these transcription factors for survival, their degradation triggers cell-cycle arrest and apoptosis – programmed cell death – within the tumour.

Three broad pharmacological effects follow from this molecular mechanism:

• 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 that is essential for the transcriptional programme of malignant plasma cells.
• Immune activation: Pomalidomide co-stimulates T-cells and natural killer (NK) cells, enhancing their cytotoxic activity against the tumour. It increases production of interleukin-2 (IL-2) and interferon-gamma (IFN-γ) while suppressing pro-inflammatory cytokines such as TNF-α in the tumour microenvironment. This immunomodulatory effect underpins the strong synergy between pomalidomide and monoclonal antibodies such as daratumumab and isatuximab.
• Anti-angiogenic activity: By inhibiting vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF) signalling, pomalidomide limits the formation of new blood vessels that would otherwise supply nutrients and oxygen to the expanding tumour. This ‘starving’ effect complements the direct and immune-mediated actions of the drug.

Approved Indications

Pomalidomide STADA is approved by the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA, via the originator Pomalyst labelling), and equivalent national regulatory authorities for adults with multiple myeloma. Approved combination regimens include:

• In combination with bortezomib and dexamethasone (PVd regimen): For adults with multiple myeloma who have received at least one prior therapy including lenalidomide. This approval is based on the phase 3 OPTIMISMM trial (Richardson et al., Lancet Oncology 2019), 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 – a clinically meaningful improvement that translates into several additional months without disease progression.
• 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 whose disease has progressed on or within 60 days of completing the last therapy. This indication is supported by the pivotal MM-003 (NIMBUS) trial (San Miguel et al., Lancet Oncology 2013), which showed an approximate doubling of median progression-free survival (4.0 vs 1.9 months) and improved overall survival compared with high-dose dexamethasone alone.

Beyond these licensed indications, pomalidomide is used in other evidence-based combinations supported by later clinical trials and updated NCCN and ESMO guidelines – including triplet regimens with daratumumab plus dexamethasone (DPd, APOLLO trial) and with isatuximab plus dexamethasone (IsaPd, ICARIA-MM trial). The specific combination selected by your haematologist depends on prior treatments, depth and duration of response to those therapies, coexisting medical conditions, and access to newer agents such as monoclonal antibodies and CAR-T cell therapy.

What Should You Know Before Taking Pomalidomide STADA?

Before starting Pomalidomide STADA you must understand the strict pregnancy-prevention requirements, undergo baseline blood tests and screening for infections such as hepatitis B, and tell your doctor about every medical condition and medicine you take. Pomalidomide is contraindicated in pregnancy and in patients who cannot comply with the Pregnancy Prevention Programme.

Pomalidomide STADA is a specialist-only medicine that should be prescribed by a physician with experience in treating multiple myeloma – typically a haematologist or haemato-oncologist working in a centre that dispenses oral anti-cancer medicines under a structured risk-management programme. Before your first prescription your doctor will review your medical history, perform a physical examination, order baseline blood tests (full blood count, creatinine and glomerular filtration rate, liver enzymes and bilirubin, calcium, electrolytes, and glucose), and enrol you in the mandatory Pregnancy Prevention Programme. Your vaccination status and any active infections – including viral hepatitis B, hepatitis C, HIV, and latent tuberculosis – must also be assessed, because the immunosuppressive effect of treatment can reactivate or worsen these conditions.

Contraindications

You must not take Pomalidomide STADA 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 severe birth defects, including limb malformations, cardiac abnormalities, craniofacial defects, and ear abnormalities.
• Women of childbearing potential who do not meet the Pregnancy Prevention Programme conditions: Such as documented counselling, two reliable contraceptive methods, and regular supervised 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 Pomalidomide STADA 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 normally prescribe thromboprophylaxis – usually 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 rash, swelling, dizziness, or breathing problems after taking thalidomide or lenalidomide, inform your doctor – cross-reactivity between IMiDs is possible.
• Cardiovascular risk factors: A history of heart attack, heart failure, significant arrhythmias, uncontrolled hypertension, dyslipidaemia, or active smoking all increase the risk of thrombotic complications 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, severe electrolyte imbalance, and life-threatening heart-rhythm abnormalities.
• Peripheral neuropathy: Pre-existing nerve damage causing numbness, tingling, or pain in the hands and feet may worsen during treatment, especially when combined with bortezomib. Report any new or worsening symptoms promptly so that dose adjustments can be considered.
• Hepatitis B or C infection: 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 (typically with entecavir or tenofovir) when appropriate.
• 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 alkylating agents such as melphalan. Your doctor will monitor for new malignancies throughout treatment and long-term follow-up.
• Kidney or liver impairment: Pomalidomide is excreted mainly by the kidneys and metabolised by the liver. Patients with significant renal or hepatic dysfunction may need dose reductions or more frequent monitoring to avoid accumulation and toxicity.

Pregnancy, Contraception, and Breastfeeding

Because pomalidomide is a potent teratogen – a drug capable of causing severe birth defects – a Pregnancy Prevention Programme is mandatory for every patient regardless of sex. Your doctor will explain the programme in detail and require written acknowledgement before each prescription, and pharmacists will dispense pomalidomide only after confirming compliance with the programme.

Women of Childbearing Potential

• Do not take Pomalidomide STADA 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 or diaphragm with spermicide) – for at least 4 weeks before starting, throughout treatment, and for 4 weeks after the last dose
• Undergo supervised pregnancy testing (with a sensitivity of at least 25 mIU/mL) before starting, every 4 weeks during treatment, and 4 weeks after treatment ends
• If pregnancy occurs despite these measures, stop the medicine immediately, inform your prescribing doctor without delay, and consider referral to a specialist in teratology or obstetrics for counselling

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 – even if you have had a vasectomy
• 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 or 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 Pomalidomide STADA or for a sufficient period after stopping. Discuss the risks and benefits with your doctor before making any decisions about feeding your baby.

Blood Monitoring and Donation Restrictions

Pomalidomide commonly suppresses bone-marrow function, so close monitoring is essential to catch problems before they cause symptoms. Your doctor will order a full blood count at the following intervals:

• Before starting treatment
• Weekly for the first 8 weeks of treatment
• At least monthly thereafter, for as long as treatment continues

Depending on the results, your doctor may reduce the dose, pause treatment temporarily, or add growth-factor support such as granulocyte colony-stimulating factor (G-CSF) to help restore white-blood-cell counts. You must not donate blood during treatment with Pomalidomide STADA or for 7 days after the final dose, and any unused capsules should be returned to the pharmacy at the end of treatment.

Children and Adolescents

Pomalidomide STADA is not recommended in children and adolescents under 18 years of age. Multiple myeloma is exceptionally rare in this age group, and the safety and efficacy of pomalidomide have not been established in paediatric patients.

Elderly Patients

Pomalidomide can be used safely in older adults, and many patients with multiple myeloma are over the age of 75 when their disease relapses. However, elderly patients are more prone to certain adverse effects – particularly infections, cytopenias, thrombosis, and cardiac events – and may require closer monitoring. The dexamethasone partner is usually reduced to 20 mg weekly (from 40 mg) in patients over 75 or those with performance-status limitations; the pomalidomide starting dose itself is usually unchanged, but responsiveness to subsequent dose modifications may differ with age and frailty.

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, insomnia, and irritability may also affect concentration – particularly in the first few cycles of treatment when dexamethasone exposure is highest.

How Does Pomalidomide STADA 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 tell your doctor, pharmacist, or nurse about every medicine, supplement, and herbal product you take.

Pomalidomide is primarily metabolised by the 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 potentially reduce efficacy. Because pomalidomide is always combined with dexamethasone – and often bortezomib or a monoclonal antibody – interactions with those agents also need to be considered.

Major Interactions

Moderate Interactions

What Is the Correct Dosage of Pomalidomide STADA?

The recommended starting dose of pomalidomide is 4 mg once daily, taken on specified days of each treatment cycle in combination with dexamethasone and – in some regimens – bortezomib. The 1 mg strength of Pomalidomide STADA is mainly used for dose reductions or in patients with severe organ impairment. Cycles last 21 or 28 days depending on the regimen. Only a haematologist experienced in multiple myeloma should prescribe Pomalidomide STADA.

Take Pomalidomide STADA exactly as your doctor has told you. Treatment is delivered in repeating cycles, and the specific schedule depends on 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 capsule strength is particularly useful when dose reductions are required for toxicity.

Pomalidomide STADA with Bortezomib and Dexamethasone (PVd Regimen)

Each treatment cycle lasts 21 days (3 weeks).

Pomalidomide STADA with Dexamethasone Alone (Pd Regimen)

Each treatment cycle lasts 28 days (4 weeks).

After each cycle a new cycle begins immediately, unless your doctor decides to pause treatment because of side effects or intercurrent illness. Treatment continues until disease progression or unacceptable toxicity. Response is assessed every 1–2 cycles using serum and urine protein electrophoresis, serum free light-chain assays, and – when appropriate – imaging (whole-body low-dose CT, MRI, or PET-CT) and bone-marrow biopsy.

Dose Adjustments

Your doctor may reduce the pomalidomide dose from 4 mg to 3 mg, 2 mg, or 1 mg – or pause treatment temporarily – based on:

• Results of your blood tests, particularly if neutrophil count drops below 0.5 × 10⁹/L or platelet count below 25 × 10⁹/L
• New or worsening non-haematological toxicity (rash, neuropathy, oedema, thrombosis)
• Concomitant use of moderate or strong CYP1A2 or CYP3A4 inhibitors (such as ciprofloxacin)
• Kidney or liver impairment – specific dose adjustments are detailed in the product information for moderate-to-severe renal or hepatic impairment

If you are on haemodialysis, take your dose of Pomalidomide STADA after the dialysis session on treatment days, because a small amount of pomalidomide is removed by dialysis. Missing doses or breaking capsules can compromise both efficacy and safety. The 1 mg strength of Pomalidomide STADA is the lowest dose used in dose-reduction steps and is often dispensed alongside higher strengths so that titration can be performed within the same manufacturer’s product range.

Dosage in Specific Patient Groups

How to Take Pomalidomide STADA

• 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 to maintain stable blood levels
• 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, which could damage it
• If a 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 the 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 at all

Missed Dose

If you forget to take your dose of Pomalidomide STADA and less than 12 hours have passed since your 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 Pomalidomide STADA, contact your doctor, pharmacist, or the nearest emergency department immediately and take the medicine packaging with you for identification. There is no specific antidote; management is supportive, with close observation of blood counts, organ function, and clinical status. Haemodialysis removes only a small fraction of pomalidomide and is generally not used for overdose management.

What Are the Side Effects of Pomalidomide STADA?

Like all medicines, Pomalidomide STADA 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.

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; in the United States, reports can be submitted to the FDA MedWatch programme. Your reports help protect other patients by contributing to ongoing post-authorisation safety monitoring.

How Should You Store Pomalidomide STADA?

Store Pomalidomide STADA in the original packaging at room temperature (below 30 °C) 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 at the end of treatment – never throw them away in household waste.

Safe storage is especially important for pomalidomide because of the serious harms that could occur if children or women who are pregnant were accidentally exposed to the medicine. Keep Pomalidomide STADA in its original carton so that the expiry date and batch number remain visible, and handle the blisters carefully to avoid damaging the capsules.

• 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 at the end of treatment – this helps protect the environment and prevents accidental exposure to other people

What Does Pomalidomide STADA Contain?

The active substance in Pomalidomide STADA is pomalidomide. Each hard capsule contains 1 mg of pomalidomide (with 2, 3, and 4 mg strengths also marketed in many countries). Inactive ingredients (excipients) typically include mannitol, pre-gelatinised starch, and sodium stearyl fumarate, with gelatin, titanium dioxide, and colouring agents in the capsule shell. Pomalidomide STADA contains less than 1 mmol sodium (23 mg) per capsule, so it is essentially sodium-free.

Active Substance

Each hard capsule contains pomalidomide as its active substance. The 1 mg strength is the lowest dose used in dose-reduction steps and is frequently dispensed alongside higher strengths so that titration can be performed within the same manufacturer’s product range. 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 that have become resistant to earlier IMiDs.

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 on the capsule usually 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. Pomalidomide STADA 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

Not all pack sizes or strengths may be marketed in every country, and the exact appearance of the capsules may vary between countries. Consult the patient information leaflet supplied with your pack for details specific to your formulation, including the marketing authorisation holder and any country-specific excipients.

Frequently Asked Questions About Pomalidomide STADA

References and Sources

Medical Editorial Team