Generic
Thalidomide
1 brands available in the market
At a glance
Thalidomide is an immunomodulatory drug used for multiple myeloma and erythema nodosum leprosum (type 2 lepra reaction). It modulates the immune system and exhibits antiangiogenic activity.
Description
Thalidomide is a synthetic glutamic acid derivative immunomodulator with anti-inflammatory, antiangiogenetic, sedative, and hypnotic activity. It reduces TNF-α production, modulates immune cell activity, and inhibits angiogenesis to slow tumor growth.
Indications
- Multiple myeloma
- Erythema nodosum leprosum (type 2 lepra reaction)
Therapeutic class
Immunomodulatory Drugs
Pharmacological class
Immunomodulatory Agent
Pharmacology
Thalidomide reduces TNF-α production, modulates immune cell activity, inhibits angiogenesis, and slows tumor growth. It alters cytokine secretion and reduces VEGF, impairing tumor blood supply.
Mechanism of action
Modulates the immune system and inhibits angiogenesis to slow tumor growth.
Dosage
Adult Dose (Oral):
- Multiple myeloma: Start 200 mg/day; increase by 100 mg weekly (based on tolerability); max 800 mg/day
- ENL (type 2 lepra reaction): 100-300 mg/day at bedtime; reduce by 50 mg every 2-4 weeks after satisfactory response; <50 kg: start 100 mg/day; max 400 mg/day
Administration
- Take on an empty stomach
- Do not chew, crush, or break tablets
- Take at the same time each day (at bedtime)
Missed dose
If you miss a dose, take it as soon as you remember; if almost time for the next dose, skip it; do not double the dose.
Side effects
Common Side Effects:
- Headache, sleepiness
- Nausea, rash
- Weakness, dizziness
- Edema, loss of appetite
- Decreased white blood cells, decreased calcium
- Weight gain, fatigue, muscle weakness
- Neuropathy, constipation, tremor
Serious:
- Venous thromboembolism (blood clots)
- Neutropenia, thrombocytopenia
- Tumor lysis syndrome
Precautions & warnings
- Highly unsafe in pregnancy (causes severe fetal malformations)
- Use effective contraception (4 weeks before, during, and 4 weeks after treatment)
- Do not donate blood (during treatment and 1 week after stopping)
- May affect driving ability (somnolence, dizziness)
- Monitor for signs of blood clots
Contraindications
- Hypersensitivity
- Pregnancy and lactation
Drug interactions
- Barbiturates, alcohol, chlorpromazine, reserpine: Enhanced sedative activity
- Avoid drugs that can cause peripheral neuropathy
- Darbepoetin-alfa, doxorubicin: Increased thromboembolic event risk
- Peginterferon alfa: Increased bone marrow suppression risk (potentially fatal)
Food interactions
Alcohol is unsafe with Thalidomide (excessive drowsiness).
Use in pregnancy
Use in Pregnancy: Highly unsafe (Category X); significant fetal harm; do not use; consult your doctor.
Pregnancy Category: X — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Probably unsafe; limited data suggests drug may pass into breast milk and harm the baby; consult your doctor.
Pediatric use
Safety and efficacy not established in children
Geriatric use
Caution required in elderly patients
Renal / hepatic impairment
Renal Impairment: Safe in kidney disease; dose adjustment may not be needed; consult your doctor.
Hepatic Impairment: Safe in liver disease; dose adjustment may not be needed; consult your doctor.
Overdose effects
Overdose may cause excessive sedation, somnolence; provide symptomatic treatment.
Storage conditions
Store in a cool and dry place, protected from light; keep out of reach of children.
Chemical structure
Thalidomide