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Enzalutamide Pregnancy and Breastfeeding Warnings

Enzalutamide is also known as: Xtandi

Enzalutamide Pregnancy Warnings

Animal studies have shown reproductive toxicity. The drug can cause fetal harm when administered to a pregnant woman as use of an androgen receptor inhibitor could affect fetus development. There are no controlled data in human pregnancy. US 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.

Use in women who are or may become pregnant is contraindicated. US FDA pregnancy category: X Comments: Male patients should be encouraged to use adequate methods of contraception during and for at least 3 months after therapy if engaged in sexual activity with pregnant women and/or women of childbearing potential.

Enzalutamide Breastfeeding Warnings

This drug is not indicated for use in female patients. Excreted into human milk: Unknown Excreted into animal milk: Data not available The effects in the nursing infant are unknown.

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