Contraception in males and females: It is not known whether apalutamide or its metabolites are present in semen. ERLEADA may be harmful to a developing foetus. For patients having sex with female partners of reproductive potential, a condom should be used along with another highly effective contraceptive method during treatment and for 3 months after the last dose of ERLEADA.
Pregnancy: ERLEADA is contraindicated in women who are or may become pregnant (see Contraindications). Based on its mechanism of action, ERLEADA may cause foetal harm when administered during pregnancy. There are no data available from the use of ERLEADA in pregnant women. Animal reproductive studies have not been conducted with ERLEADA.
Breast-feeding: It is unknown whether apalutamide/metabolites are excreted in human milk. A risk to the suckling child cannot be excluded. ERLEADA should not be used during breast-feeding.
Fertility: Based on animal studies, ERLEADA may decrease fertility in males of reproductive potential (see Pharmacology: Toxicology under Actions).