Thalidomide

FDA label

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Renal Undefined

Hepatic Undefined

MM: dexamethasone 40 mg PO days 1–4, 9–12, 17–20 of each 28-day cycle

Instructions

• Take with water, preferably at bedtime and ≥1 hr after the evening meal
• ENL taper: 50 mg decrements q2–4wk once reaction subsides; if on maintenance, attempt taper q3–6mo
• THALOMID REMS required: 2 negative pregnancy tests before start, then weekly x1 month, then monthly (q2wk if irregular cycles); 2 reliable contraception methods from 4 wk before through 4 wk after therapy; males use latex/synthetic condom and must not donate sperm; no blood donation during and 4 wk after
• Interrupt for constipation, somnolence, or peripheral neuropathy; consider reduced dose on resumption
• Permanently discontinue for angioedema, anaphylaxis, Grade 4 rash, skin exfoliation, or bullae

Available strengths

• cap 50, 100, 150, 200 mg

Contraindications

• Pregnancy — powerful human teratogen; ~40% infant mortality at or shortly after birth; discontinue immediately if pregnancy occurs

Cautions

• Venous and arterial thromboembolism (DVT/PE; ischemic heart disease incl. MI; stroke) — consider thromboprophylaxis
• Increased mortality when PD-1/PD-L1 blocker (pembrolizumab) added to thalidomide analogue + dexamethasone in MM
• Drowsiness/somnolence — avoid hazardous tasks; additive with other sedating drugs
• Peripheral neuropathy — common, may be irreversible; discontinue if symptoms occur
• Dizziness and orthostatic hypotension — sit upright before standing
• Neutropenia and thrombocytopenia — may need dose interruption/reduction
• Increased HIV viral load — measure during treatment
• Bradycardia — possible syncope; may need dose reduction/discontinuation
• Severe cutaneous reactions — discontinue for severe reactions
• Seizures — monitor patients with seizure history/risk factors
• Tumor lysis syndrome — monitor high tumor burden

Adverse reactions

• MM (≥20%): fatigue, hypocalcemia, edema, constipation, sensory neuropathy, dyspnea, muscle weakness, leukopenia/neutropenia, rash/desquamation, confusion, anorexia, nausea, anxiety/agitation, tremor, fever, weight change, thrombosis/embolism, motor neuropathy, dizziness, dry skin
• ENL (≥10%): somnolence, rash, headache
• DVT 13% and PE 7% (Grade 3/4) with dex in Study 2

Pregnancy Contraindicated — human teratogen; severe birth defects (amelia, phocomelia) or fetal death even after a single dose; REMS + pregnancy exposure registry

Lactation Advise women not to breastfeed during treatment