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 Instructions for use and 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 contraindicated for use in pregnant women because the drug can cause fetal harm and potential loss of pregnancy. Enzalutamide is not indicated for use in females. There are no human data on the use of enzalutamide in pregnant women. In animal reproduction studies, oral administration of enzalutamide in pregnant mice during organogenesis caused adverse developmental effects at doses lower than the maximum recommended human dose (see Contraindications, PHARMACOLOGY: Toxicology: Preclinical safety data under Actions and Instructions for use and handling under Cautions for Usage).
Breast-feeding: Enzalutamide is not indicated for use in females. There is no information available on the presence of enzalutamide in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. Enzalutamide and/or its metabolites were present in milk of lactating rats (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).