Immunomodulatory Drug (IMiD) — Myeloma Pregnancy: Contraindicated in pregnancy - powerful human teratogen causing a high frequency (about 30%) of severe, life-threatening birth defects. Pregnancy Prevention Programme mandatory; effective contraception required at least 4 weeks before, throughout, and at least 4 weeks after treatment. Males must use condoms during treatment, during interruptions and for at least 7 days after stopping. Discontinue breast-feeding during treatment.

Thalidomide

Brand names: Thalidomide Celgene, Thalomid

Thalidomide is an oral immunomodulatory agent used, typically with dexamethasone, in the treatment of multiple myeloma.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 200 mg orally once daily

Route: Oral (swallow capsules whole; do not open or crush)

Frequency: Once daily at bedtime

Max: A maximum of 12 cycles of 6 weeks (42 days)

For multiple myeloma, in combination with melphalan and prednisone; thalidomide taken once daily at bedtime on Days 1 to 42 of each 42-day cycle (bedtime dosing improves tolerability of sedation). Starting dose depends on age and blood counts (Table 1): patients 75 years or younger with ANC at least 1,500/uL and platelets at least 100,000/uL start 200 mg daily; patients over 75 years start 100 mg daily. Dose delay, reduction or discontinuation per NCI CTC grade may be needed (neutropenia, thrombocytopenia, peripheral neuropathy, skin reactions, bradycardia, syncope, somnolence). Thromboprophylaxis (e.g. low molecular weight heparin or warfarin) for at least the first 5 months. Treatment must be initiated and monitored by physicians experienced with immunomodulatory/chemotherapeutic agents. Pregnancy Prevention Programme conditions mandatory for all male and female patients. Not formally studied in renal or hepatic impairment - no specific dose recommendation.

Dose adjustments

Renal

Not formally studied in renal impairment; no specific dose recommendation - monitor patients with severe organ impairment closely for adverse reactions.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to thalidomide or any excipient
Women who are pregnant
Women of childbearing potential unless all conditions of the Pregnancy Prevention Programme are met
Male patients unable to follow or comply with the required contraceptive measures

Side effects

Neutropenia, leukopenia, anaemia, lymphopenia, thrombocytopenia (very common)
Peripheral neuropathy and paraesthesia
Constipation
Somnolence, dizziness, tremor
Deep vein thrombosis and pulmonary embolism; peripheral oedema; bradycardia; severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS)

Interactions

CNS depressants (opioids, antihistamines, antipsychotics, anti-anxiety agents, alcohol) - additive sedative effect, avoid
Drugs that slow cardiac conduction (calcium channel blockers, beta blockers, digoxin, H2 blockers, lithium, tricyclics, neuromuscular blockers) - additive bradycardia, use with caution
Erythropoietin-stimulating agents and oestrogen-containing therapies (including hormonal contraceptives) - increased risk of thromboembolism

Clinical monograph

How it works

It has immunomodulatory, anti-angiogenic, and anti-inflammatory actions, modulating cytokine production and the tumour microenvironment to inhibit myeloma cell growth.

Prescribing in practice

It is a potent human teratogen, so pregnancy must be excluded and prevented through the mandatory Pregnancy Prevention Programme, with strict contraception requirements for those of childbearing potential and relevant precautions for male patients.
It markedly increases venous thromboembolism risk, particularly with dexamethasone, so thromboprophylaxis should be considered for all patients.
Peripheral neuropathy, sedation, and constipation are common; assess neurological symptoms regularly and counsel on falls and driving.

Monitoring

Monitor for peripheral neuropathy, thromboembolism, and full blood count, with pregnancy testing as required by the prevention programme.

Counselling the patient

This medicine causes severe birth defects; reliable contraception and adherence to the pregnancy prevention requirements are essential.
Report numbness, tingling, or weakness in the hands or feet promptly.
Do not share this medicine or donate blood while taking it, and report leg swelling, chest pain, or breathlessness urgently.

Evidence & guidelines

Thalidomide is licensed for multiple myeloma and its use is supported by established randomised trial evidence; MHRA mandates the Pregnancy Prevention Programme.

Reference: EMA Pregnancy Prevention Programme; BSH Myeloma Guidelines 2017; NICE TA228; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways