Thalidomide has been reported to enhance the sedative activity of barbiturates, alcohol, chlorpromazine, and reserpine.
Peripheral Neuropathy: Medications known to be associated with peripheral neuropathy should be used with caution in patients receiving thalidomide.
There have been three cases of overdose reported, all attempted suicides. There have been no reported fatalities in doses of up to 14.4 grams, and all patients recovered without reported sequelae.
CONTRAINDICATIONS (See BOXED WARNINGS)
Pregnancy: Category X
Due to its known human teratogenicity, even following a single dose, thalidomide is contraindicated in pregnant women and women capable of becoming pregnant. (See BOXED WARNINGS.) When there is no alternative treatment, women of childbearing potential may be treated with thalidomide provided adequate precautions are taken to avoid pregnancy. Women must commit either to abstain continuously from heterosexual sexual contact or to use two methods of reliable birth control, including at least one highly effective method (e.g., IUD, hormonal contraception, tubal ligation, or partner’s vasectomy) and one additional effective method (e.g., latex condom, diaphragm, or cervical cap), beginning 4 weeks prior to initiating treatment with thalidomide, during therapy with thalidomide, and continuing for 4 weeks following discontinuation of thalidomide therapy. If hormonal or IUD contraception is medically contraindicated (see also PRECAUTIONS: Drug Interactions), two other effective or highly effective methods may be used.
Women of childbearing potential being treated with thalidomide should have a pregnancy test (sensitivity of at least 50 mIU/mL). The test should be performed within the 24 hours prior to beginning thalidomide therapy and then weekly during the first 4 weeks of thalidomide therapy, then at 4 week intervals in women with regular menstrual cycles or every 2 weeks in women with irregular menstrual cycles. Pregnancy testing and counseling should be performed if a patient misses her period or if there is any abnormality in menstrual bleeding. If pregnancy occurs during thalidomide treatment, thalidomide must be discontinued immediately. Under these conditions, the patient should be referred to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling.
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. The risk to the fetus from the semen of male patients taking thalidomide is unknown.
THALOMID® (thalidomide) is contraindicated in patients who have demonstrated hypersensitivity to the drug and its components.
DRUG ABUSE AND DEPENDENCE
Physical and psychological dependence has not been reported in patients taking thalidomide. However, as with other tranquilizers/hypnotics, thalidomide too has been reported to create in patients habituation to its soporific effects.
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- Unpublished data, on file at Celgene.
S.T.E.P.S. ® is a registered trademark of Celgene Corporation.
U.S. Pat. Nos. 6,045,501 & 6,315,720.
THALPI.011 02/07 CG
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