Women of childbearing potential/Contraception in females: Women of childbearing potential should use highly effective contraception methods (e.g. double-barrier contraception) during treatment and for at least 3 weeks after completing therapy (see Interactions).
Pregnancy: There are no data from the use of abemaciclib in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Verzenio is not recommended during pregnancy and in women of child-bearing potential not using contraception.
Breast-feeding: It is unknown whether abemaciclib is excreted in human milk. A risk to newborns/infants cannot be excluded. Patients receiving abemaciclib should not breast-feed.
Fertility: The effect of abemaciclib on fertility in humans is unknown. In animal studies, no effects on female reproductive organs were observed. However, cytotoxic effects to the male reproductive tract in rats and dogs indicate that abemaciclib may impair fertility in males (see Pharmacology: Toxicology: Preclinical safety data under Actions).