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Enzalutamide Pregnancy and Breastfeeding Warnings

Enzalutamide is also known as: Xtandi

Enzalutamide Pregnancy Warnings

There are no controlled data in human pregnancy. Atrophy of the prostate and seminal vesicles was observed in rats, and hypospermatogenesis and atrophy of the prostate and epididymides were observed in dogs. 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 Not indicated for use in female patients, and is contraindicated in women who are or may become pregnant. Females should use adequate methods of contraception to avoid becoming pregnant. Males should use a condom and another effective form of birth control during and for 3 months after treatment.

Enzalutamide Breastfeeding Warnings

A decision should be made to discontinue breast-feeding or discontinue the drug, 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. Enzalutamide is not indicated for use in women.

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