Thalidomide

Cytostatic · Immunomodulator, anti-inflammatory

Indications

In combination with melphalan and prednisolone in the first-line treatment for untreated multiple myeloma in patients aged 65 years or above or those not eligible for high-dose chemotherapy. Leukaemia. Erythema nodosum leprosum.

Dosage

Adults: Over 18 yr, 200 mg every day for 6 wk cycle. Max: 12 cycles. See literature. Erythema nodosum leprosum, acute cutaneous: Initially 100-300 mg once daily at bedtime, continue until signs/symptoms subside (usually approx. 2 wks), then taper off in 50 mg decrements every 2-4 wks. For severe cases with moderate to severe neuritis, corticosteroids may be initiated with thalidomide (taper off and discontinue corticosteroids when neuritis improves). See literature. Children: Not recommended.

Adverse Effects

Somnolence, headache, rash, impotency, dizziness, diarrhoea, leukopenia, anaemia, peripheral neuropathy, tremor, dizziness, syncope, paraesthesia, dysaesthesia, abnormal coordination, cardiac failure, bradycardia, pulmonary embolism, interstitial lung disease, skin reaction, oedema, fever, asthenia, fatigue, confusion, depression, blood dyscrasias. Reports of hepatic disorders.

Risk Factor (Pregnancy/Lactation)

Pregnancy: Contraindicated in pregnancy. Lactation: Contraindicated or not recommended. Precautions: Liver impairment, neurological disorders, constipation, CHF, hypertension, use caution in patient with history of seizures, performing task with required alertness. Risk factors for or history of thromboembolism. Administer thromboprophylaxis for at least the first 5 months of treatment; discontinue if thromboembolic event occurs until stabilised on anticoagulation therapy. Monitor for thromboembolic events, severe infections, peripheral neuropathy, rash/skin reactions, bradycardia, syncope, somnolence, neutropenia and thrombocytopenia; delay or reduce dose or discontinue treatment if necessary, Advise patients to report signs or symptoms of bleeding. Monitor LFTs. Test for HBV before starting and refer to specialist if seropositive. Monitor for viral reactivation incl HBV and varicella…

Interactions

Sedatives, CNS depressants, alcohol, drugs associated with bradycardia (e.g., p-blockers or anticholinesterase agents), drugs associated with peripheral neuropathy (e.g., vincristine, bortezomib), combined oral contraceptives (see precautions), HRT, erythropoietic agents, warfarin.

Advice to Patient

Take atleast 1 hour after the evening meal. Contact prescriber if there is severe nausea or vomiting, diarrhoea, constipation, oral thrush, chest pain, palpitations, swelling of extremities, back pain, neck pain, muscle pain, skin rash, increased nervousness, anxiety, insomnia, skin eruptions, muscle stiffness, numbness/pain/tingling in feet and hands. Use two methods of contraception starting 4 weeks before therapy and continue for upto 4 weeks after therapy as directed by prescriber. Avoid alcohol and blood donation during therapy. Male patients should avoid donating sperms during therapy. Change position slowly. Regular mouth care is required to prevent oral thrush. HIV-positive patients must get viral-load test done after first and third months of therapy and then every 3 months.

Pharmacokinetics

Absorption: Slow, good. Metabolism: Minimal (unchanged drug is the predominant circulating component). Half-life elimination: 5.5 to 7.3 hours. Time to peak, plasma: Approx. 2 to 5 hours. Excretion: Urine, feces.

Compiled by Healify Pharmacy from published drug references. How we compile it →

Always consult a pharmacist or doctor.