Informational only — Not medical advice. Always consult a licensed healthcare provider.

Community data Updated 2 months ago

Indications

Midothal, combined with dexamethasone, is used to treat patients newly diagnosed with multiple myeloma (MM). Midothal is also used to treat the skin symptoms of moderate to severe erythema nodosum leprosum (ENL) flare-ups, and to help prevent and control these skin symptoms from recurring as a maintenance therapy.

⚠️ Always consult a registered physician before taking any medicine.

Pharmacology

Cellular effects of thalidomide occur through its binding target cereblon, a component of a cullin ring E3 ubiquitin ligase enzyme complex. The medicine has immunomodulatory, anti-inflammatory and antiangiogenic properties. In vitro studies and clinical trials suggest that its immune effects may stem from suppressing excess production of tumor necrosis factor-alpha (TNF-a) and reducing certain cell surface adhesion molecules that leukocytes use to migrate. Other anti-inflammatory and immunomodulatory actions may include reduced macrophage involvement in prostaglandin synthesis, along with changes in interleukin-10 and interleukin-12 production by peripheral blood mononuclear cells. In patients with multiple myeloma, treatment with thalidomide is accompanied by a rise in circulating natural killer cells and higher plasma levels of interleukin-2 and interferon-gamma. Among the cellular processes involved in angiogenesis, thalidomide is thought to inhibit the proliferation of endothelial cells.

Pregnancy & Breastfeeding

Pregnancy: Thalidomide can cause harm to the embryo and fetus when it is given to a pregnant woman. This is based on how the medicine works and on both human and animal data. It is contraindicated during pregnancy. If it is used during pregnancy, or if the patient becomes pregnant while taking it, she should be told about the possible risk to the fetus. If pregnancy does occur during treatment, the medicine should be stopped immediately.

Lactation: Nothing is known about whether thalidomide passes into human milk, what it does to a breastfed child, or whether it affects milk production. Many drugs do pass into breast milk, and thalidomide could cause adverse reactions in a breastfed child. For this reason, women should be advised not to breastfeed during treatment with thalidomide.

Females and Males of Reproductive Potential, Pregnancy Testing: Females of reproductive potential must have 2 negative pregnancy tests before starting thalidomide. The first test should be done within 10 to 14 days, and the second within 24 hours before thalidomide is prescribed. Once treatment has started, and also during any dose interruptions, pregnancy testing should be done weekly for the first 4 weeks. After that, it should be repeated every 4 weeks in women with regular menstrual cycles. If the cycles are irregular, testing should be done every 2 weeks.

Contraception: Females of reproductive potential must commit either to avoiding heterosexual sexual intercourse completely and continuously, or to using 2 reliable methods of birth control at the same time. Contraception must start 4 weeks before treatment with thalidomide begins. It must continue during therapy and during dose interruptions, and for 4 weeks after thalidomide is stopped.

Males: Thalidomide is present in the semen of men who take it. So a man must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while he is taking thalidomide, during dose interruptions, and for up to 28 days after stopping it.

⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.

Dosage Reference

⚠️ Reference ranges from official sources only. Consult your doctor for personalized dosing.

Adults: Multiple Myeloma: The recommended dosing of thalidomide in combination with dexamethasone is 200 mg once daily, taken orally with water in 28-day treatment cycles, preferably at bedtime and at least 1 hour after the evening meal. Erythema Nodosum Leprosum: The recommended dosing of thalidomide for an episode of cutaneous ENL is 100 to 300 mg per day, taken orally once daily with water, preferably at bedtime and at least 1 hour after the evening meal. Patients weighing less than 50 kilograms should begin dosing at the low end of this range. A higher dosage range should be considered for patients with a severe cutaneous ENL reaction, or for those who have previously needed higher doses to control the reaction (possibly up to 400 mg per day), taken once daily at bedtime or in divided doses with water, at least 1 hour after meals. Using corticosteroids alongside thalidomide should be considered for patients with moderate to severe neuritis linked to a severe ENL reaction. Steroid use can be tapered and stopped once the neuritis has improved. The higher dosage of thalidomide should be continued until signs and symptoms of the active reaction have subsided, usually for at least 2 weeks. Patients can then be tapered off the medication in 50 mg decrements every 2 to 4 weeks.

Side Effects & Interactions