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.
Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.