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Lenalidomide Pregnancy and Breastfeeding Warnings

Lenalidomide is also known as: Revlimid

Lenalidomide Pregnancy Warnings

When there is no alternative, females of childbearing potential may be treated with lenalidomide provided adequate precautions are taken to avoid pregnancy. Females must commit either to abstain continuously from heterosexual sexual intercourse 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 four weeks prior to initiating treatment with lenalidomide, during therapy with lenalidomide, during therapy delay, and continuing for four weeks following discontinuation of lenalidomide therapy. If hormonal or IUD contraception is medically contraindicated, two other effective or highly effective methods may be used. Females of childbearing potential being treated with lenalidomide should have pregnancy testing (sensitivity of at least 50 MIU/mL). The first test should be performed within ten to fourteen days and the second test within 24 hours prior to beginning lenalidomide therapy and then weekly during the first month of lenalidomide, then monthly thereafter in women with regular menstrual cycles or every two 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, lenalidomide must be immediately discontinued. Under these conditions, the patient should be referred to an obstetrician / gynecologist experienced in reproductive toxicity for further evaluation and counseling.

Lenalidomide has been assigned to pregnancy category X by the FDA. Animal studies have revealed evidence of embryocidal effects. The structural similarity of lenalidomide to thalidomide (a known human teratogen) suggests a potential risk to the developing fetus. There are no controlled data in human pregnancy. Lenalidomide is considered contraindicated during pregnancy.

Lenalidomide Breastfeeding Warnings

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

There are no data on the excretion of lenalidomide into human milk. Because many drugs are excreted in human milk and because of the potential for adverse reactions in nursing infants from lenalidomide, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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