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Pomalidomide

AEMPS

Immunomodulatory drug (IMiD)

ATC code: L04AX06

Brand names: Pomalidomida Sandoz, Pomalidomida Accord, Imnovid, Pomalyst

Updated · Methodology

Indications

B

Multiple myeloma

Third line

Relapsed or refractory multiple myeloma in adults previously treated with at least two lines including lenalidomide and bortezomib, with progression on the last line. Per IMWG 2024 and SEHH 2023 – third-line and beyond, combined with dexamethasone plus one of: daratumumab, isatuximab, elotuzumab, bortezomib, cyclophosphamide. Dose: 4 mg orally once daily on days 1–21 of a 28-day cycle. Adjust for neutropenia and thrombocytopenia.

Sources

  1. AEMPS: Ficha técnica de Pomalidomida (2024)
  2. Lancet Oncol: 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. (2013)
  3. Lancet Oncol: Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial. (2019)

ICD-10: C90.0 · ICD-11: 2A83.1

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Pomalidomide binds cereblon – a component of the E3 ubiquitin ligase – redirecting it to degrade the transcription factors IKZF1 and IKZF3 in myeloma plasma cells. This blocks tumor proliferation, increases T- and NK-cell activity against myeloma, and inhibits angiogenesis. Third IMiD after thalidomide and lenalidomide, active in patients refractory to both.

Safety

Boxed warning

FDA Black Box: severe birth defects due to teratogenicity (pomalidomide is a thalidomide analog). Use only under the Pregnancy Prevention Programme with mandatory dual contraception in women and male partners.

Contraindications

  • Pregnancy
  • Women and men of reproductive age not enrolled in the Pregnancy Prevention Programme
  • Hypersensitivity
  • Breastfeeding

Serious adverse effects

  • Severe febrile neutropenia and sepsis
  • Venous and arterial thromboembolism
  • Progressive multifocal leukoencephalopathy
  • Acute liver failure
  • Severe cutaneous reactions (Stevens-Johnson, toxic epidermal necrolysis, DRESS)
  • Hepatitis B reactivation

Common adverse effects

  • Neutropenia, thrombocytopenia, anemia
  • Fatigue
  • Constipation and diarrhea
  • Nausea
  • Rash
  • Peripheral neuropathy
  • Respiratory infections

Pregnancy: can you take Pomalidomide?

Categorically contraindicated. Severe teratogenicity (see Black Box). Contraception starting 4 weeks before, during therapy, and for 4 weeks after stopping in women; barrier contraception during therapy and 7 days after in men.

Breastfeeding: can you take Pomalidomide?

Contraindicated. Likely milk transfer.

Calculate RIDFull profile on NIH LactMed ↗

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Monitoring

CBC weekly for 8 weeks, then monthly. Pregnancy test in women of reproductive age before each cycle and every 4 weeks for 4 weeks after stopping. Thromboprophylaxis in all patients (LMWH or aspirin) – VTE risk.
Label mentions7 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • MajorCiprofloxacin
    «Drugs That Affect Pomalidomide Plasma Concentrations: In healthy subjects, coadministration of fluvoxamine, a strong CYP1A2 inhibitor, increased Cmax and AUC of pomalidomide by 24% and 125%…»

    FDA, section 7 · Open on DailyMed

  • MajorFluvoxamine
    «Pomalidomida se metaboliza parcialmente por CYP1A2 y CYP3A4/5. También es un sustrato de la glicoproteína P. La administración concomitante de pomalidomida con ketoconazol, inhibidor potente del…»

    AEMPS, section 4.5 · Open on CIMA

  • MajorFluvoxamine
    «Drugs That Affect Pomalidomide Plasma Concentrations: In healthy subjects, coadministration of fluvoxamine, a strong CYP1A2 inhibitor, increased Cmax and AUC of pomalidomide by 24% and 125%…»

    FDA, section 7 · Open on DailyMed

  • Majorinhibidores del CYP1A2class named in the label
    «Pomalidomida se metaboliza parcialmente por CYP1A2 y CYP3A4/5. También es un sustrato de la glicoproteína P. La administración concomitante de pomalidomida con ketoconazol, inhibidor potente del…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateanticonceptivos hormonalesclass named in the label
    «Anticoncepción: Debido al riesgo aumentado de tromboembolismo venoso en pacientes con mieloma múltiple que toman pomalidomida y dexametasona, no se recomienda el uso concomitante de anticonceptivos…»

    AEMPS, section 4.4 · Open on CIMA

  • ModerateCYP1A2 inhibitorsclass named in the label
    «DRUG INTERACTIONS: Strong CYP1A2 Inhibitors: Avoid concomitant use of strong CYP1A2 inhibitors. If concomitant use of a strong CYP1A2 inhibitor is unavoidable, reduce pomalidomide capsules dose to 2…»

    FDA, section 7 · Open on DailyMed

  • ModerateWarfarin
    «Dexametasona: Se desconoce el efecto de dexametasona sobre la warfarina. Se aconseja realizar una monitorización rigurosa de la concentración de warfarina durante el tratamiento.»

    AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Pomalidomide used for?

Pomalidomide is evaluated for the following indications with varying evidence strength: Multiple myeloma (evidence tier B). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Pomalidomide?

Common side effects of Pomalidomide (≥ 1 in 100): Neutropenia, thrombocytopenia, anemia, Fatigue, Constipation and diarrhea, Nausea, Rash, Peripheral neuropathy. See the Safety section for uncommon and serious reactions.

Is Pomalidomide safe during pregnancy?

Categorically contraindicated. Severe teratogenicity (see Black Box). Contraception starting 4 weeks before, during therapy, and for 4 weeks after stopping in women; barrier contraception during therapy and 7 days after in men.

Is Pomalidomide compatible with breastfeeding?

Contraindicated. Likely milk transfer.

Who should not take Pomalidomide?

Pomalidomide is contraindicated in: Pregnancy; Women and men of reproductive age not enrolled in the Pregnancy Prevention Programme; Hypersensitivity; Breastfeeding. Full list in the Safety section.

Does Pomalidomide carry an FDA boxed warning?

FDA Black Box: severe birth defects due to teratogenicity (pomalidomide is a thalidomide analog). Use only under the Pregnancy Prevention Programme with mandatory dual contraception in women and male partners.

Official sources

Direct links to regulator labels. Open in a new tab.

Other drugs in this group

Sirolimus, Tacrolimus, Ustekinumab, Adalimumab, Dimethyl Fumarate, Lenalidomide, Azathioprine, Ciclosporin