Thalidomide

The label describes thalidomide, together with dexamethasone, for adults with newly diagnosed multiple myeloma, a cancer of plasma cells in the bone marrow.

It is also described for the acute treatment of skin symptoms of moderate to severe erythema nodosum leprosum (ENL), and for maintenance to help prevent these skin symptoms from returning. It is not meant to be used alone when ENL involves moderate to severe nerve inflammation.

• Newly diagnosed multiple myeloma, with dexamethasone
• Acute skin symptoms of moderate to severe ENL
• Maintenance to prevent ENL skin symptoms from returning

The label says the exact way thalidomide works is not fully understood. It acts on a protein called cereblon inside cells.

It is described as having immune-modulating, anti-inflammatory and blood-vessel-limiting properties, possibly linked to lowering excess TNF-alpha.

This page covers the US label for thalidomide capsules taken by mouth, with the dosing the label gives for adults.

This is label-level information, not personal advice. Indian pack labels may differ, and your prescriber's instruction always comes first.

For adults with multiple myeloma, the label describes 200 mg once daily in 28-day cycles, taken by mouth with water, preferably at bedtime and at least 1 hour after the evening meal. Dexamethasone is given on set days of each cycle.

For an episode of skin ENL, the label describes 100 to 300 mg once daily, and up to 400 mg a day for severe skin reactions. People under 50 kg start at the low end.

The label says treatment may be prescribed only under a restricted program, with pregnancy testing for females who could become pregnant.

• Take at bedtime with water
• Leave at least 1 hour after the evening meal
• Dose depends on the condition being treated
• Prescribed only under a restricted safety program

The boxed warning says thalidomide can cause severe birth defects or loss of the baby, even after a single capsule. It must never be used by females who are pregnant or could become pregnant while taking it, and two reliable methods of contraception are required.

It also raises the risk of deep vein blood clots and lung clots in people with multiple myeloma who take it with dexamethasone.

It is contraindicated in pregnancy and in people with proven allergy to it.

• Never use in pregnancy; severe birth defects
• Two reliable contraception methods are required
• Higher risk of blood clots
• Can cause drowsiness and dizziness
• Available only through a restricted program

• Opioids, antihistamines, antipsychotics, anti-anxiety medicines
• Alcohol and other sedatives
• Medicines that slow the heart
• Estrogen-containing therapies and erythropoietin
• The label advises caution with medicines that cause sedation, slow the heart or damage nerves.
• Opioids, antihistamines, antipsychotics, anti-anxiety medicines and alcohol may add to drowsiness and should be avoided.
• Medicines that slow the heart, such as beta blockers and digoxin, and erythropoietin or estrogen-containing therapies may increase risk.

No match in this label text. Ask your pharmacist about any medicine you take.

The label gives a storage range of 20 to 25 degrees C.

The label also says to protect it from light.

Follow the storage line on your own pack, and keep medicines out of the reach of children.

In the Drugs Rules schedules we checked, thalidomide is listed under Schedule H (serial and rule: Schedule H, serial 492 (rules 65 and 97)). Schedule H medicines are sold only on a registered doctor's prescription.

Thalidomide is on the National List of Essential Medicines 2022. Listed forms include: Capsule 100 mg (page 82).

NPPA lists ceiling prices for scheduled thalidomide formulations. The table shows the rows we found. Check NPPA directly for the current list.

The Jan Aushadhi (PMBJP) list we checked has 3 product rows that mention thalidomide. We did not capture prices for them.

NPPA ceiling prices set the most a seller can charge per unit for the listed formulations, before local taxes. They are ceilings, not the price you will always pay.

Jan Aushadhi lists thalidomide products including Thalidomide Capsules 100mg 100mg; Thalidomide Capsules 200mg 200mg; Thalidomide Capsules 50mg 50mg. We have not shown a price for them. Check the pack and the seller for the actual price.