Thalidomide Capsules

  • Medicine- Thalix
  • API- Thalidomide
  • Packaging- Capsules
  • Strength- 50 mg, 100 mg, 150 mg & 200 mg
  • Manufactured by- Fresenius Kabi India Pvt Ltd
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  • Thalidomide Capsule combined with dexamethasone is approved for the treatment of newly diagnosed multiple myeloma (MM).
  • Thalidomide Capsule is approved for the treatment of moderate to severe erythema nodosum leprosum (ENL) cutaneous symptoms.
  • In the presence of moderate to severe neuritis, Thalidomide Capsule is not suggested as monotherapy for such ENL treatment.
  • Thalidomide Capsule is also used as a preventative and suppressive therapy for the cutaneous signs of ENL recurrence.

Dosage and Side Effects

In multiple myeloma treatment, the suggested thalidomide dosage, along with dexamethasone, is 200 mg taken orally once daily in 28-day cycles. It’s recommended to take it at bedtime, with water, and at least an hour after dinner. The dexamethasone dose is 40 mg per day orally on days 1 to 4, 9 to 12, and 17 to 20, repeating every 28 days.

For erythema nodosum leprosum, the thalidomide dose for a skin episode ranges from 100 to 300 mg per day, taken once daily at bedtime, with water, at least an hour after eating. Start at the lower end of the dose range for patients under 50 kg.

Consider higher doses, possibly up to 400 mg/day, for severe cutaneous erythema nodosum leprosum reactions or for those who have previously required higher doses. Administer once daily at bedtime or in divided doses, with water, an hour after meals.

Commonly observed side effects of Thalidomide Capsules may include:

For multiple myeloma: fatigue, hypocalcemia, edema, sensory neuropathy, constipation, shortness of breath, muscle weakness, leukopenia, neutropenia, skin rash or peeling, confusion, loss of appetite, nausea, anxiety, weakness, tremor, fever, weight loss or gain, motor neuropathy, blood clotting issues, dizziness, and dry skin.

For erythema nodosum leprosum: drowsiness, rash, and headaches.

Warning and Precautions

  • Consider giving corticosteroids alongside Thalidomide in patients with moderate to severe nerve inflammation caused by serious Erythema Nodosum Leprosum reactions. Corticosteroid use can be tapered and stopped when the nerve inflammation improves.

  • Thalidomide often leads to drowsiness. Patients should be aware of possible difficulties in mental and physical abilities needed for tasks like driving or using machinery. Adjustments in doses might be necessary.

  • Thalidomide use may cause dizziness and a drop in blood pressure when standing up. Patients should sit upright for a few minutes before getting up from lying down.

  • Patients should be examined monthly for the first three months of Thalidomide therapy to detect early signs of nerve issues like numbness or pain in the hands and feet. Regular evaluations should follow during treatment for signs of nerve problems.

  • Reduced white blood cell counts, including low neutrophil levels, have been observed with Thalidomide use. Treatment should start with a certain level of neutrophils and ongoing monitoring is crucial, particularly in patients at higher risk, like those with HIV.

  • Thrombocytopenia (Grade 3 or 4) may occur with Thalidomide use. Regular blood tests, including platelet counts, are necessary. Adjustments or interruptions in the dose may be needed. Watch for signs of bleeding.

  • Bradycardia, a slow heart rate, may occur with Thalidomide use. Patients should be monitored for fainting and a slow heart rate. Adjustments or interruptions in treatment may be necessary. Use caution with drugs that reduce heart rate in patients taking Thalidomide.

  • Hypersensitivity reactions like angioedema and anaphylaxis may occur. Signs may include rashes, possibly with a fast heart rate, fever, and low blood pressure. Severe reactions may need to pause therapy. If the reaction occurs again after restarting, Thalidomide should be stopped permanently.

  • Thalidomide is a potent cause of severe birth defects, even after just one dose. Women of reproductive age should avoid pregnancy before, during, and after Thalidomide therapy.

  • Patients should not donate blood while on Thalidomide and for four weeks after stopping it to avoid exposing a pregnant woman’s fetus to Thalidomide.


Can Thalidomide affect a person’s ability to perform tasks?

Yes, Thalidomide may cause drowsiness and dizziness. Patients should be cautious when performing tasks that require mental alertness, such as driving or operating machinery.

Are there any specific monitoring requirements while taking Thalidomide?

Patients are often monitored for signs of nerve issues, such as numbness or pain in the hands and feet, and regular blood tests are performed to check blood cell counts.

Can Thalidomide cause heart-related issues?

Yes, Thalidomide may lead to bradycardia (slow heart rate). Patients should be monitored for signs of slow heart rate or fainting.