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Thalidomide Pregnancy and Breastfeeding Warnings

Thalidomide is also known as: Thalomid

Thalidomide Pregnancy Warnings

Animal studies have revealed evidence of fetotoxicity and increased abortion. Thalidomide can cause embryofetal harm when given to a pregnant female; it is a human teratogen. The use of thalidomide in humans has produced a high rate of severe and life-threatening birth defects such as phocomelia, amelia, hypoplasticity of the bones, absence of bones, external ear abnormalities (including anotia, micropinna, small or absent external auditory canals), facial palsy, eye abnormalities (anophthalmos, microphthalmos), and congenital heart defects. Alimentary tract, urinary tract, and genital malformation also observed and mortality at or shortly after birth reported in about 40% of infants. Even a single dose taken by a pregnant woman can cause birth defects. If used during pregnancy, or if patient becomes pregnant while using thalidomide, the patient should be apprised of the potential risk to a fetus. If pregnancy occurs during drug therapy, thalidomide must be discontinued immediately. The patient must be referred to an obstetrician/gynecologist who is experienced in reproductive toxicity for further evaluation and counseling. Any suspected fetal exposure must be reported to the FDA using the MedWatch program at 1-800-332-1088 and to the Celgene Corporation at 1-888-423-5436. When there is no alternative treatment, females of reproductive potential may be treated with the drug if precautions are taken to prevent pregnancy. Such patients must avoid pregnancy 4 weeks before therapy, while using thalidomide, during dose interruptions, and for at least 4 weeks after completing therapy. Even women with a history of infertility must follow this protocol, unless due to hysterectomy. Females of reproductive potential must commit to abstain from heterosexual sexual intercourse or to use 2 reliable methods of birth control (1 highly effective method of birth control such as IUD, tubal ligation, hormonal contraception or partner's vasectomy and 1 additional method of effective birth control such as male latex or synthetic condom, diaphragm, or cervical cap). Contraception must begin 4 weeks before starting thalidomide, during therapy, during dose interruptions, and continuing for 4 weeks after stopping thalidomide. Females of reproductive potential must have 2 negative pregnancy tests before starting therapy. The 1st test should be performed within 10 to 14 days and the 2nd test within 24 hours before prescribing thalidomide. Once therapy has begun and during dose interruptions, pregnancy testing should occur weekly during the first 4 weeks of use. Pregnancy testing should then be performed every 4 weeks in women with regular menstrual cycles and every 2 weeks in women with irregular menstrual cycles. Pregnancy testing and counseling should be performed if a menstrual cycle is missed or if any abnormality in menstrual bleeding occurs; thalidomide must be stopped during this evaluation. Because thalidomide is present in the semen of patients receiving the drug, males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while using thalidomide, during dose interruptions, and for up to 28 days after stopping thalidomide, even if they have had a successful vasectomy. Male patients using thalidomide must not donate sperm. Patients must sign an agreement form. Nonpregnant females of reproductive potential must comply with pregnancy testing and contraception requirements. Males must comply with contraception requirements. FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

FDA pregnancy category: X Use of thalidomide is contraindicated during pregnancy. Comments: Continuous abstinence or 2 reliable methods of contraception are required 4 weeks before starting thalidomide, during therapy, during dose interruptions, and continuing for 4 weeks after stopping thalidomide.

Thalidomide Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes The effects in the nursing infant are unknown.

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