Xtandi Use In Pregnancy & Lactation

Women of childbearing potential: There are no human data on the use of Xtandi in pregnancy and this medicinal product is not for use in women of childbearing potential. This medicine may cause harm to the unborn child or potential loss of pregnancy if taken by women who are pregnant (see Contraindications, Pharmacology: Toxicology: Preclinical safety data under Actions, and Special precautions for disposal and other handling under Cautions for Usage).
Contraception in males and females: It is not known whether enzalutamide or its metabolites are present in semen. A condom is required during and for 3 months after treatment with enzalutamide if the patient is engaged in sexual activity with a pregnant woman. If the patient engages in sexual intercourse with a woman of childbearing potential, a condom and another form of birth control must be used during and for 3 months after treatment. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Pregnancy: Enzalutamide is not for use in women. Enzalutamide is contraindicated in women who are or may become pregnant (see Contraindications, Pharmacology: Toxicology: Preclinical safety data under Actions, and Special precautions for disposal and other handling under Cautions for Usage).
Breast-feeding: Enzalutamide is not for use in women. It is not known if enzalutamide is present in human milk. Enzalutamide and/or its metabolites are secreted in rat milk (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Fertility: Animal studies showed that enzalutamide affected the reproductive system in male rats and dogs (see Pharmacology: Toxicology: Preclinical safety data under Actions).