Thalidomide

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DRUG STATUS

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Government Approvals

US(FDA), UK(BNF)

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WHO Essential Medicine

YES

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Known Teratogen

Definite

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Pharmaceutical Class

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Controlled Drug Substance

NO

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Drug Ingredient

Thalidomide

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Summary

  • Thalidomide is used to treat multiple myeloma, a type of cancer, and erythema nodosum leprosum (ENL), which involves painful nodules and inflammation on the skin. It also manages certain complications of leprosy.

  • Thalidomide works by strengthening the immune system to fight cancer cells and reducing inflammation. It does this by blocking natural substances in the body that cause swelling.

  • For multiple myeloma, the recommended dose is 200 mg once daily, taken at bedtime. For ENL, doses range from 100-300 mg daily, adjusted based on symptom severity and weight. Thalidomide is taken orally with water.

  • Common side effects of Thalidomide include drowsiness, dizziness, constipation, and neuropathy (nerve damage). Serious risks include severe birth defects, blood clots, and permanent nerve damage.

  • Thalidomide is contraindicated in pregnant women due to its severe teratogenic effects, which can cause birth defects. It should also be avoided by patients with severe neuropathy, hypersensitivity to the drug, or those at high risk for blood clots.

Indications and Purpose

What is Thalidomide used for?

Thalidomide is used with dexamethasone for newly diagnosed multiple myeloma. It also treats and prevents the skin symptoms of ENL, such as painful nodules and inflammation, and manages certain complications of leprosy.

How does Thalidomide work?

Thalidomide modulates the immune system by inhibiting the production of inflammatory cytokines, reducing inflammation. It also enhances the immune system’s ability to target cancer cells, aiding in the treatment of multiple myeloma.

Is Thalidomide effective?

Clinical trials have demonstrated Thalidomide’s effectiveness in reducing cancer progression in multiple myeloma and controlling skin symptoms in ENL. Its combination with dexamethasone has shown a significant improvement in patient outcomes compared to dexamethasone alone.

How does one know if Thalidomide is working?

For multiple myeloma, effectiveness is evaluated by monitoring blood counts, bone marrow tests, and symptoms like fatigue. For ENL, a reduction in nodules and inflammation indicates progress. Regular doctor visits ensure proper monitoring.

Directions for Use

What is the usual dose of Thalidomide?

For multiple myeloma, the recommended dose is 200 mg once daily, taken at bedtime. For ENL, doses range from 100–300 mg daily, adjusted based on symptom severity and weight. Dosing for other conditions is determined individually by a healthcare provider.

How do I take Thalidomide?

Thalidomide capsules should be taken orally with water, preferably at bedtime or at least 1 hour after the evening meal. Patients taking it for ENL may need to divide the dose throughout the day. Avoid opening or handling broken capsules, as they can be harmful if absorbed through the skin.

For how long do I take Thalidomide?

Treatment duration depends on the condition being treated. For multiple myeloma or ENL, therapy may continue as long as there is a clinical benefit or until side effects require discontinuation. Tapering is often needed to prevent withdrawal effects.

How long does it take for Thalidomide to start working?

Thalidomide’s effects on multiple myeloma and ENL may be observed within weeks. Symptom improvement depends on the severity of the condition, with significant results often seen after 1–2 months of consistent use.

How should I store Thalidomide?

Store Thalidomide capsules at room temperature, away from moisture and heat. Keep them in their original packaging and out of reach of children. Do not use expired medication.

Warnings and Precautions

Who should avoid taking Thalidomide?

Thalidomide is contraindicated in pregnant women due to its severe teratogenic effects. It should also be avoided by patients with severe neuropathy, hypersensitivity to the drug, or those at high risk for blood clots unless precautions are taken.

Can I take Thalidomide with other prescription drugs?

Thalidomide can interact with drugs that cause drowsiness (e.g., opioids, antihistamines) or increase blood clot risks (e.g., erythropoietic agents). Inform your doctor about all medications you’re taking to avoid harmful interactions.

Can I take Thalidomide with vitamins or supplements?

Some supplements, like St. John’s Wort, can interact with Thalidomide and reduce its effectiveness. Always consult your doctor before taking vitamins, supplements, or herbal products while on this medication.

Can Thalidomide be taken safely while pregnant?

No. Thalidomide causes severe birth defects, even with a single dose during pregnancy. Women of childbearing potential must use two forms of contraception and undergo regular pregnancy tests while taking this medication.

Can Thalidomide be taken safely while breastfeeding?

Thalidomide is not recommended while breastfeeding, as it may pass into breast milk and harm the baby. Women on Thalidomide should avoid breastfeeding during treatment.

Is Thalidomide safe for the elderly?

Elderly patients may require dose adjustments and close monitoring due to an increased risk of side effects, including neuropathy and blood clots. Doctors typically assess individual health factors before prescribing.

Is it safe to exercise while taking Thalidomide?

Light to moderate exercise is generally safe but avoid intense physical activity if you experience side effects like dizziness, fatigue, or neuropathy. Always consult your doctor before starting a new exercise routine.

Is it safe to drink alcohol while taking Thalidomide?

Alcohol can worsen Thalidomide’s side effects, such as drowsiness and dizziness. It is best to avoid or limit alcohol while on this medication.