Crizotinib Pregnancy and Breastfeeding Warnings

Crizotinib is also known as: Xalkori

Crizotinib Pregnancy Warnings

Animal studies have revealed evidence of embryofetotoxicity, but have failed to reveal evidence of teratogenicity. There are no adequate and well controlled data in human pregnancy. If crizotinib is used during pregnancy or if the patient becomes pregnant during treatment, the patient should be advised of the potential hazard to the developing fetus. No specific studies with crizotinib have been conducted in animals to evaluate the effect on fertility; however, crizotinib is considered to have the potential to impair reproductive function and fertility in humans based on findings from toxicity studies in the rat. Findings included testicular pachytene spermatocyte degeneration in male rats and single-cell necrosis of ovarian follicles in female rats. FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

FDA pregnancy category: D Use of crizotinib should be avoided. Comments: Women of childbearing potential and men who are receiving this drug should be advised to use appropriate contraceptive measures during crizotinib therapy and for at least 90 days after discontinuation of crizotinib.

Crizotinib Breastfeeding Warnings

A decision should be made whether to discontinue nursing or to discontinue crizotinib, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Unknown The effects in the nursing infant are unknown.

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