Kisqali Use In Pregnancy & Lactation

Women of childbearing potential/Contraception: Pregnancy status should be verified prior to starting treatment with Kisqali.
Women of childbearing potential who are receiving Kisqali should use effective contraception (e.g. double-barrier contraception) during therapy and for at least 21 days after stopping treatment with Kisqali.
Pregnancy: There are no adequate and well-controlled studies in pregnant women. Based on findings in animals, ribociclib can cause foetal harm when administered to a pregnant woman (see Pharmacology: Toxicology: Preclinical safety data under Actions). Kisqali is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding: It is not known if ribociclib is present in human milk. There are no data on the effects of ribociclib on the breast-fed infant or the effects of ribociclib on milk production. Ribociclib and its metabolites readily passed into the milk of lactating rats. Patients receiving Kisqali should not breast-feed for at least 21 days after the last dose.
Fertility: There are no clinical data available regarding effects of ribociclib on fertility. Based on animal studies, ribociclib may impair fertility in males of reproductive potential (see Pharmacology: Toxicology: Preclinical safety data under Actions).