Thalidon
Generic Name
Thalidomide
Manufacturer
Beacon Pharmaceuticals Ltd.
Country
Bangladesh
Loading images...
Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| thalidon 25 mg tablet | ৳ 5.02 | ৳ 50.20 |
Description
Overview of the medicine
Thalidomide is an immunomodulatory agent with anti-inflammatory, anti-angiogenic, and anti-neoplastic properties. It is approved for the treatment of moderate to severe erythema nodosum leprosum (ENL) and, in combination with dexamethasone, for newly diagnosed multiple myeloma. Due to its severe teratogenicity, it is available only through restricted distribution programs.
Uses & Indications
Dosage
Adults
For ENL: Initially 100-300 mg orally daily; maintenance 100-200 mg daily. Max 400 mg/day. For Multiple Myeloma: 200 mg orally once daily, in combination with dexamethasone.
Elderly
Use with caution; dose reduction may be necessary due to increased susceptibility to adverse effects.
Renal_impairment
Use with caution. Dose adjustment may be required in severe renal impairment.
How to Take
Oral administration. Take with water, preferably at bedtime and at least 1 hour after the evening meal to mitigate somnolence.
Mechanism of Action
Thalidomide's mechanism is complex and includes immunomodulatory, anti-inflammatory, and anti-angiogenic effects. It inhibits TNF-alpha production, modulates cytokine synthesis, decreases phagocytosis of neutrophils, and inhibits angiogenesis by downregulating VEGF and bFGF. In multiple myeloma, it induces apoptosis of myeloma cells, inhibits adhesion to bone marrow stromal cells, and modulates the bone marrow microenvironment.
Pharmacokinetics
Onset
Clinical improvement for ENL typically observed within days to weeks. For multiple myeloma, onset varies.
Excretion
Mainly excreted in urine as metabolites; a small amount of unchanged drug is excreted.
Half life
Approximately 5-7 hours.
Absorption
Slow and variable oral absorption, Tmax 2-6 hours. Food may delay but not significantly affect bioavailability.
Metabolism
Primarily non-enzymatic hydrolysis in plasma, forming multiple metabolites. Minimal hepatic metabolism.
Side Effects
Contraindications
- Pregnancy (absolute contraindication)
- Known hypersensitivity to thalidomide or any excipients
- Severe neutropenia (<0.75 x 10^9/L)
- Severe thrombocytopenia (<50 x 10^9/L)
Drug Interactions
Dexamethasone
Increased risk of venous thromboembolism (VTE).
CNS Depressants
Increased sedation and somnolence when co-administered with other CNS depressants (e.g., opioids, benzodiazepines, alcohol, hypnotics).
Erythropoietic agents
Possible increased risk of VTE.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Limited information is available on thalidomide overdose. Symptoms may include drowsiness, dizziness, orthostatic hypotension, and bradycardia. There is no specific antidote. Management should be supportive, focusing on maintaining vital signs and symptomatic treatment.
Pregnancy & Lactation
Thalidomide is an absolute contraindication in pregnancy due to severe teratogenicity, causing life-threatening birth defects. Females of reproductive potential must use two reliable methods of contraception starting at least 4 weeks before treatment and continuing for at least 4 weeks after stopping. Breastfeeding is not recommended.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months
Availability
Hospital pharmacies, specialized outpatient pharmacies
Approval Status
Approved by FDA (e.g., for ENL and Multiple Myeloma)
Patent Status
Expired (original compound)
Clinical Trials
Thalidomide has undergone extensive clinical trials for its approved indications, leading to its re-introduction under strict risk management programs. Ongoing trials investigate its use in other cancers and inflammatory conditions, often in combination therapies.
Lab Monitoring
- Complete Blood Count (CBC) with differential (monitor for neutropenia and thrombocytopenia)
- Liver Function Tests (LFTs)
- Thyroid Function Tests (TFTs)
- Regular pregnancy testing for females of reproductive potential (before, during, and after treatment)
Doctor Notes
- Strict adherence to the REMS program (e.g., S.T.E.P.S.) is mandatory.
- Ensure two forms of reliable contraception for females of reproductive potential.
- Monitor for signs and symptoms of peripheral neuropathy and VTE. Consider VTE prophylaxis.
- Baseline and regular monitoring of CBC, LFTs, and TFTs is crucial.
Patient Guidelines
- Understand and adhere to the REMS program requirements, including strict contraception if you are a female of reproductive potential.
- Report any numbness, tingling, or pain in hands/feet immediately.
- Report any signs of blood clots (e.g., chest pain, shortness of breath, leg swelling).
- Avoid alcohol and other CNS depressants due to increased sedation.
- Do not donate blood or sperm during treatment and for a specified period after cessation.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is close to the time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not double the dose.
Driving Precautions
Thalidomide can cause significant somnolence, dizziness, and confusion. Patients should be advised not to drive or operate heavy machinery if they experience these side effects.
Lifestyle Advice
- Maintain adequate hydration to reduce the risk of constipation.
- Avoid driving or operating heavy machinery if experiencing drowsiness or dizziness.
- Engage in light physical activity if possible, but consult your doctor regarding exercise if you have peripheral neuropathy.
Alternative Medicines in Bangladesh
Similar medicines available in the market
Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.