|FDA Approved For:
|THALOMID® (thalidomide) is indicated erythema nodosum leprosum (ENL). THALOMID® (thalidomide) is not indicated severe neuritis. THALOMID® (thalidomide) is also indicated manifestations of ENL recurrence.
|Safety and effectiveness in pediatric patients below the age of 12 years have not been established.
|Long-term carcinogenicity tests have not been conducted using thalidomide.
|Thalidomide gave no evidence of mutagenic effects when assayed in in vitro bacterial (Salmonella typhimurium and Escherichia coli; Ames mutagenicity test), in vitro mammalian (AS52 Chinese hamster ovary cells; AS52/XPRT mammalian cell forward gene mutation assay) and in vivo mammalian (CD-1 mice; in vivo micronucleus test) test systems.
|Manufacturer and/or Distributor:
The most serious toxicity associated with thalidomide is its documented human teratogenicity. (See BOXED WARNINGS and CONTRAINDICATIONS.) The risk of severe birth defects, primarily phocomelia or death to the fetus, is extremely high during the critical period of pregnancy. The critical period is estimated, depending on the source of information, to range from 35 to 50 days after the last menstrual period. The risk of other potentially severe birth defects outside this critical period is unknown, but may be significant. Based on present knowledge, thalidomide must not be used at any time during pregnancy. Because thalidomide is present in the semen of patients receiving the drug, males receiving thalidomide must always use a latex condom during any sexual contact with women of childbearing potential. Thalidomide is associated with drowsiness/somnolence, peripheral neuropathy, dizziness/orthostatic hypotension, neutropenia, and HIV viral load increase. (See WARNINGS.) Hypersensitivity to THALOMID® (thalidomide) and bradycardia in patients treated with thalidomide have been reported. (See PRECAUTIONS.) Somnolence, dizziness, and rash are the most commonly observed adverse events associated with the use of thalidomide. Thalidomide has been studied in controlled and uncontrolled clinical trials in patients with ENL and in people who are HIV-seropositive. In addition, thalidomide has been administered investigationally for more than 20 years in numerous indications. Adverse event profiles from these uses are summarized in the sections that follow. (See FDA Label for Additional Adverse Events and tables.)