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Immunomodulatory Drug (IMiD) — Myeloma Pregnancy: ABSOLUTE CONTRAINDICATION — one of the most dangerous teratogens known; strict Pregnancy Prevention Programme mandatory

Thalidomide

Brand names: Thalidomide Celgene, Thalomid

Adult dose

Dose: 100–200 mg once daily at bedtime (myeloma); 50–100 mg in elderly or frail
Route: Oral
Frequency: Once daily at bedtime
Max: 400 mg/day
Used in multiple myeloma — MPT (melphalan + prednisolone + thalidomide) regimen in transplant-ineligible patients. Largely superseded by lenalidomide and bortezomib-based regimens in newly diagnosed MM. Retained for relapsed/refractory myeloma and in resource-limited settings.

Paediatric dose

Dose: Seek specialist opinion mg/kg
Route: Oral
Frequency: Once daily at bedtime
Max: Not established in children
Not recommended in children — specialist use only with oversight from paediatric oncology

Dose adjustments

Renal

No dose adjustment required

Hepatic

No dose adjustment required; use with caution in hepatic impairment

Paediatric weight-based calculator

Not recommended in children — specialist use only with oversight from paediatric oncology

Clinical pearls

  • ABSOLUTE CONTRAINDICATION in pregnancy — historical teratogen responsible for 10,000+ birth defects (phocomelia) in the 1950s–60s; strictly controlled via Pregnancy Prevention Programme (PPP)
  • Pregnancy Prevention Programme (EMA): monthly pregnancy test for women of childbearing potential; two effective contraception methods; prescriber, pharmacy, and patient registration mandatory
  • VTE prophylaxis mandatory — aspirin, LMWH, or warfarin depending on individual risk (IMiD + dexamethasone = high VTE risk)
  • Peripheral neuropathy is cumulative and can be irreversible — monitor with validated scale; reduce dose at grade 2
  • Largely replaced by lenalidomide (fewer side effects, oral convenience, similar mechanism) — thalidomide still used where lenalidomide unavailable or for specific regimens
  • Never crush, break, or open capsules — risk of skin absorption and teratogen exposure

Contraindications

  • Pregnancy — ABSOLUTE CONTRAINDICATION (phocomelia, limb defects)
  • Women of childbearing potential not using two forms of contraception
  • Inability to comply with REMS/risk minimisation programme

Side effects

  • Peripheral neuropathy (dose-limiting — irreversible with prolonged use)
  • Drowsiness/sedation
  • Constipation
  • Thromboembolism (DVT/PE — requires VTE prophylaxis)
  • Teratogenicity
  • Bradycardia
  • Hypothyroidism

Interactions

  • Warfarin — increased INR (monitor closely)
  • CNS depressants — additive sedation
  • Erythropoietic agents — increased thrombosis risk

Monitoring

  • Neurological assessment (monthly)
  • FBC
  • VTE symptoms
  • Pregnancy test (monthly — women of childbearing potential)
  • Thyroid function

Reference: BNFc; BNF 90; EMA Pregnancy Prevention Programme; BSH Myeloma Guidelines 2017; NICE TA228. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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