Temsirolimus Pregnancy and Breastfeeding Warnings

Temsirolimus is also known as: Torisel

Temsirolimus Pregnancy Warnings

Temsirolimus has been assigned to pregnancy category D by the FDA. Animal studies have revealed that temsirolimus administered daily as an oral formulation caused embryo-fetal and intrauterine toxicities at human subtherapeutic exposures. There are no controlled data in human pregnancy. Temsirolimus should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

Women of childbearing potential should be advised to avoid becoming pregnant throughout treatment and for three months after temsirolimus therapy has stopped. Temsirolimus can cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Female animal studies have reported an increased incidence of pre- and post-implantation losses at oral doses greater than or equal to 4.2 mg/m2/day resulting in decreased numbers of live fetuses. Men should be counseled regarding the effects of temsirolimus on the fetus and sperm prior to starting treatment. Men with partners of childbearing potential should use reliable contraception throughout treatment and are recommended to continue this for three months after the last dose of temsirolimus. Male animal studies have reported the following fertility effects: decreased number of pregnancies, decreased sperm concentration and motility, decreased reproductive organ weights, and testicular tubular degeneration. These effects were observed at oral temsirolimus doses greater than or equal to 3 mg/m2/day. Fertility was absent at 30 mg/m2/day.

Temsirolimus Breastfeeding Warnings

There are no data on the excretion of temsirolimus into human milk. Because many drugs are excreted into human milk and because of the potential for tumorigenicity shown for sirolimus (the active metabolite of temsirolimus) in animal studies, the manufacturer recommends that a decision be made whether to discontinue nursing or to discontinue sirolimus, taking into account the importance of the drug to the mother.

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