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pomalidomide

Imnovid (previously Pomalidomide Celgene) · ATC code L04AX06

Also known as: Pomalidomid · Brand names: Imnovid, Pomalidomid +pharma, Pomalidomid Devatis, Pomalidomid G.L., Pomalidomid Grindeks, Pomalidomid Sandoz, Pomalidomid Stada, Pomadel, Pomalem, Pomavid

Key facts
Active substance
pomalidomide
Drug class
Immunosuppressive drug
ATC code
L04AX06
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Imnovid 1 mg hard capsules / Imnovid 2 mg hard capsules / Imnovid 3 mg hard capsules
Marketing authorisation holder
Bristol-Myers Squibb Pharma EEIG
Information as of
2026-10-28

Key facts

Pomalidomide is an immunomodulatory agent structurally related to thalidomide. It is used in combination for previously treated multiple myeloma.

What it is used for

  • In combination with bortezomib and dexamethasone in adults with multiple myeloma who have received at least one prior regimen including lenalidomide.
  • In combination with dexamethasone in adults with relapsed and refractory multiple myeloma after at least two prior regimens including lenalidomide and bortezomib, with progression on the last therapy.

Dosing

  • Imnovid (hard capsules), with bortezomib and dexamethasone: 4 mg once daily on Days 1 to 14 of repeated 21-day cycles; bortezomib and dexamethasone per the scheme in the full text.
  • Imnovid, with dexamethasone: 4 mg once daily on Days 1 to 21 of each 28-day cycle; dexamethasone 40 mg on Days 1, 8, 15 and 22 (20 mg for patients > 75 years).
  • A new cycle requires neutrophils ≥ 1 x 10⁹/l and platelets ≥ 50 x 10⁹/l; for neutropenia or thrombocytopenia interrupt and resume one dose level lower; discontinue if adverse reactions occur after reduction to 1 mg.
  • Strong CYP1A2 inhibitors (e.g. ciprofloxacin, fluvoxamine): reduce the pomalidomide dose by 50%.
  • Renal or hepatic impairment: no starting-dose adjustment; on dialysis days take the dose after haemodialysis.

Contraindications

  • Pregnancy.
  • Women of childbearing potential unless all conditions of the pregnancy prevention programme are met; male patients unable to comply with required contraceptive measures.
  • Hypersensitivity to the active substance or to any of the excipients.

Important warnings

  • Teratogenicity: pomalidomide is related to thalidomide and a teratogenic effect is expected; the Pregnancy Prevention Programme must be followed.
  • Haematological toxicity (neutropenia, thrombocytopenia, anaemia): blood counts at baseline, weekly for the first 8 weeks, then monthly.
  • Venous and arterial thromboembolic events (e.g. deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke); anti-coagulation therapy is recommended unless contraindicated, especially with additional thrombotic risk factors.
  • Hepatitis B reactivation: establish HBV status before starting; monitor liver function regularly for the first 6 months.
  • Second primary malignancies, tumour lysis syndrome, severe skin reactions (SJS, TEN, DRESS), hypothyroidism.

Side effects

  • With bortezomib and dexamethasone: neutropenia (54.0%), thrombocytopenia (39.9%), anaemia (32.0%), peripheral sensory neuropathy (48.2%), fatigue (38.8%), diarrhoea (38.1%), constipation (38.1%); most common serious adverse reaction pneumonia (12.2%).
  • With dexamethasone: anaemia (45.7%), neutropenia (45.3%), thrombocytopenia (27%), fatigue (28.3%), pyrexia (21%), peripheral oedema (13%).

Interactions

  • Strong CYP1A2 inhibitors increase pomalidomide exposure; halve the dose.
  • Use erythropoietic agents and other agents increasing thromboembolic risk with caution. Effect on oral contraceptives not evaluated clinically.

Pregnancy and breastfeeding

  • Women: effective contraception for at least 4 weeks before, during and at least 4 weeks after treatment; medically supervised pregnancy tests at least every 4 weeks.
  • Men: condoms during treatment, dose interruptions and for 7 days after stopping if the partner is pregnant or of childbearing potential without contraception.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Austria

  • Pomalidomid +pharma+pharma Arzneimittel Gmbh · 1 register entry
  • Pomalidomid DevatisDevatis Gmbh · 1 register entry
  • Pomalidomid G.L.G.L. Pharma Gmbh · 1 register entry
  • Pomalidomid GrindeksGrindeks · 1 register entry
  • Pomalidomid SandozSandoz Gmbh · 1 register entry
  • Pomalidomid StadaStada Arzneimittel Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • PomadelTad Pharma Gmbh · 1 register entry
  • Pomalidomid123 Acurae Pharma Gmbh, Grindeks, Devatis Gmbh, Stragen Pharma Gmbh, Hexal Ag, Olpha As, Stadapharm Gmbh, Abdi Farma Gmbh, Aliud Pharma Gmbh · 9 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • ImnovidBRISTOL-MYERS SQUIBB İLAÇLARI INC. İSTANBUL ŞUBESİ · 4 register entries
  • PomalemDEVA HOLDİNG A.Ş. · 4 register entries
  • PomavidABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 4 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 27 more European countries
Belgium
Pomalidomide Eg, Pomalidomide Eugia, Pomalidomide Grindeks
Bulgaria
Помалидомид Devatis, Помалидомид Булгермед, Помалидомид Гриндекс, Помалидомид Рнт
Cyprus
Pomalidomide, Sivolix
Czechia
Pomalidomid Sanexcel, Pomalidomide Abdi, Pomalidomide Grindeks, Pomalidomide Olpha, Pomalidomide Sandoz
Denmark
Pomalidomid Devatis, Pomalidomid Grindeks, Pomalidomide "bioglan", Pomalidomide Bioglan, Pomalidomide Glenmark, Pomalidomide Newbury, Pomalidomide Sandoz, Pomalidomide Stada
Estonia
Pomalidomide Grindeks, Pomalidomide Olpha, Pomalidomide Sandoz, Pomalidomide Stada
Finland
Pomalidomid Avansor, Pomalidomid Devatis, Pomalidomide Bioglan, Pomalidomide Glenmark, Pomalidomide Grindeks, Pomalidomide Olpha, Pomalidomide Sandoz, Pomalidomide Stada
France
Pomalidomide Eg, Pomalidomide Eugia, Pomalidomide Grindeks, Pomalidomide Lupin, Pomalidomide Medisol, Pomalidomide Olpha, Pomalidomide Reig Jofre, Pomalidomide Sandoz, Pomalidomide Stragen
Greece
Polidma, Pomalidomide Anabiosis, Pomalidomide Ariti, Pomalidomide Faran, Pomalidomide Grindeks, Pomalidomide Rafarm, Pomalidomide Sandoz, Pomalidomide Stada, Pomalidomide/Abbio, Sivolix
Hungary
Pomalidomid Onkogen, Pomalidomide Grindeks, Pomalidomide Sandoz, Pomalidomide Stada
Iceland
Imnovid, Pomalidomide Accord, Pomalidomide Krka, Pomalidomide Sandoz, Pomalidomide Stada, Pomalidomide Teva, Pomalidomide Viatris, Pomalidomide Wh, Pomalidomide Zentiva
Ireland
Pomalidomide Clonmel, Pomalidomide Grindeks, Pomalidomide Rowex
Italy
Pomalidomide Abdi, Pomalidomide Aurobindo, Pomalidomide Eg, Pomalidomide Ever Pharma, Pomalidomide G.L. Pharma, Pomalidomide Glenmark, Pomalidomide Grindeks, Pomalidomide Olpha, Pomalidomide Reig Jofre, Pomalidomide Sandoz
Latvia
Pomalidomide Grindeks, Pomalidomide Olpha, Pomalidomide Sandoz, Pomalidomide Stada
Liechtenstein
Imnovid, Pomalidomide Accord, Pomalidomide Teva, Pomalidomide Viatris, Pomalidomide Zentiva
Lithuania
Pomalidomide Grindeks, Pomalidomide Olpha, Pomalidomide Sandoz, Pomalidomide Stada
Luxembourg
Pomalidomide Eg, Pomalidomide Eugia
Malta
Pomalidomide
Netherlands
Polidma, Pomalidomide Adalvo, Pomalidomide Cf, Pomalidomide Devatis, Pomalidomide Eugia, Pomalidomide G.L., Pomalidomide Genthon, Pomalidomide Glenmark, Pomalidomide Grindeks, Pomalidomide Lotus, Pomalidomide Newbury, Pomalidomide Reig Jofre, Pomalidomide Sandoz, Pomalidomide Stada Arzneimittel Ag, Pomalidomide Synthon, Sivolix
Norway
Imnovid, Pomalidomid Devatis, Pomalidomide Accord, Pomalidomide Glenmark, Pomalidomide Grindeks, Pomalidomide Krka, Pomalidomide Newbury, Pomalidomide Sandoz, Pomalidomide Stada, Pomalidomide Teva, Pomalidomide Viatris, Pomalidomide Zentiva
Poland
Pomalidomid Reig Jofre, Pomalidomid Sanexcel, Pomalidomide Eugia, Pomalidomide Glenmark, Pomalidomide Grindeks, Pomalidomide Olpha, Pomalidomide Pph, Pomalidomide Reig Jofre Sp. Z O.O., Pomalidomide Sandoz, Pomalidomide Stada
Portugal
Pomalidomida Aurobindo, Pomalidomida Bluepharma, Pomalidomida Erawya, Pomalidomida Eugia, Pomalidomida Farmoz, Pomalidomida Generis, Pomalidomida Grindeks, Pomalidomida Rafarm, Pomalidomida Stada, Pomalidomida Tecnigen
Romania
Pomalidomida Sandoz, Pomalidomida Sanexcel, Pomalidomide Grindeks, Pomalidomidă Dr. Reddy’s, Pomalidomidă Grindeks, Pomalidomidă Stada
Slovakia
Pomalidomid Grindeks, Pomalidomid Stada, Pomalidomide Olpha, Pomalidomide Sandoz
Slovenia
Pomadel, Pomalidomid Grindeks, Pomalidomid Hcs, Pomalidomid Sandoz, Pomalidomid Stada, Pomalidomide Sandoz
Spain
Pomalidomida Abdi, Pomalidomida Erawya, Pomalidomida Eugia, Pomalidomida Grindeks, Pomalidomida Olpha, Pomalidomida Sala, Pomalidomida Sandoz, Pomalidomida Stada, Pomalidomida Stragen, Pomalidomida Tecnigen, Pomalidomide Sandoz
Sweden
Davunfite, Pomalidomid Avansor, Pomalidomid Devatis, Pomalidomide Anabiosis, Pomalidomide Bioglan, Pomalidomide Glenmark, Pomalidomide Grindeks, Pomalidomide Newbury, Pomalidomide Sandoz, Pomalidomide Stada Stada, Sulabcote

EMA – Article 57 product data (EU/EEA), 2026-10-29

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Sources

  1. European Medicines Agency. Imnovid (previously Pomalidomide Celgene) – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/imnovid-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC L04AX.

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.