Sorafenib Pregnancy and Breastfeeding Warnings

Sorafenib is also known as: Nexavar

Sorafenib Pregnancy Warnings

Sorafenib has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of embryotoxicity, fetolethality, and teratogenicity. There are no controlled data in human pregnancy. The manufacturer states that based on the proposed mechanism of multikinase inhibition and multiple adverse effects seen in animals at exposure levels significantly below the clinical dose, sorafenib should be assumed to cause fetal harm when administered to a pregnant women. Sorafenib should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

Sorafenib Breastfeeding Warnings

There are no data on the excretion of sorafenib into human milk. Because many drugs are excreted into human milk and because the effects of sorafenib on infants have not been studied, the manufacturer has stated that women should be advised against breast-feeding while receiving sorafenib.

Animal studied have reported that the drug has been secreted into the milk of lactating animals.

See Also...

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 drug information 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 drug combination in no way should be construed to indicate that the drug of drug 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 in 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.

Advertisement
Close

Recommended

(web4)