Uses

Indicated in combination with dexamethasone for treatment of newly diagnosed multiple myeloma, and as acute and maintenance therapy for the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL).

Do not use if

Absolutely contraindicated in pregnancy due to severe teratogenicity causing birth defects or embryo-fetal death. Contraindicated in patients with known hypersensitivity to thalidomide or its components.

Side effects

Major adverse effects include severe teratogenicity causing birth defects, venous and arterial thromboembolism, peripheral neuropathy, drowsiness, and constipation. Increased risk of mortality has been reported in some patient populations.

Warnings

Carries a boxed warning for embryo-fetal toxicity and venous thromboembolism. Must only be prescribed under a strict risk management program (REMS in the US). Male patients must also use contraception. Regular neurological monitoring is required.

How it works

Thalidomide exerts immunomodulatory, anti-inflammatory, and antiangiogenic effects mediated through its target protein cereblon, a component of a cullin ring E3 ubiquitin ligase complex. The exact mechanism of action is not fully elucidated.

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C. Protect from light. Must not be repackaged.