Erleada Use In Pregnancy & Lactation

Pregnancy: Apalutamide (Erleada) is contraindicated in women who are or may become pregnant. Based on its mechanism of action, Apalutamide (Erleada) may cause fetal harm when administered during pregnancy. There are no data available with the use of Apalutamide (Erleada) during pregnancy.
Animal reproductive and development studies have not been conducted with Apalutamide (Erleada).
Contraception: Apalutamide (Erleada) may be harmful to a developing fetus. Patients having sex with female partners of reproductive potential should use a condom along with another highly effective contraceptive method during treatment and for 3 months after the last dose of Apalutamide (Erleada) (see Pregnancy as previously mentioned).
Breast-feeding: There are no data on the presence of apalutamide or its metabolites in human milk, the effect on the breastfed infant, or the effect on milk production.
Fertility: Based on animal studies, Apalutamide (Erleada) may impair fertility in males of reproductive potential (see Pharmacology: Toxicology: Non-Clinical information under Actions).