Zykadia Use In Pregnancy & Lactation

Women of childbearing potential: Women of childbearing potential should be advised to use a highly effective method of contraception while taking Zykadia and for up to 3 months after discontinuing treatment (see Interactions).
Pregnancy: There are no or limited amount of data from the use of ceritinib in pregnant women.
Animal studies are insufficient with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Zykadia should not be used during pregnancy unless the clinical condition of the woman requires treatment with ceritinib.
Breast-feeding: It is unknown whether ceritinib/metabolites are excreted in human milk. A risk to the newborn/infant cannot be excluded.
A decision must be made whether to discontinue breast-feeding or discontinue/abstain from Zykadia therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Fertility: The potential for Zykadia to cause infertility in male and female patients is unknown (see Pharmacology: Toxicology: Preclinical safety data under Actions).