Xalkori Use In Pregnancy & Lactation

Fertility: Based on non-clinical safety findings, male and female fertility may be compromised by treatment with crizotinib (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).
Pregnancy: Crizotinib may cause fetal harm when administered to a pregnant woman. Crizotinib was not shown to be teratogenic in pregnant rats or rabbits. Reduced fetal body weights were considered adverse effects in the rat and rabbit at 200 and 60 mg/kg/day, respectively (approximately equivalent to human clinical exposure based on AUC).
There are no adequate and well-controlled studies in pregnant women using crizotinib. Women of child-bearing potential should be advised to avoid becoming pregnant while receiving crizotinib. Women of child-bearing potential who are receiving this drug, or partners of women of child-bearing potential receiving this drug, should use adequate contraceptive methods during therapy and for at least 90 days after completing therapy.
Female patients taking crizotinib during pregnancy or who become pregnant while taking crizotinib should be apprised of the potential hazard to a fetus. Male patients taking crizotinib should also be apprised of the potential hazard to a fetus if their partner is or should become pregnant.
Lactation: It is not known whether crizotinib and its metabolites are excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from exposure to crizotinib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.