Advanced Breast Cancer: Learn about treatment options.

Dabrafenib Pregnancy and Breastfeeding Warnings

Dabrafenib is also known as: Tafinlar

Dabrafenib Pregnancy Warnings

Dabrafenib was teratogenic and embryotoxic in rats at exposures 3 times the human clinical exposure at the recommended dose. There are no controlled data in human pregnancy. Effects on spermatogenesis have been observed in animals. Male patients should be advised of the potential risk for impaired spermatogenesis, and to seek counseling on fertility and family planning options prior to starting treatment. 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 Dabrafenib can cause fetal harm. Use dabrafenib only if clearly needed and benefit outweighs potential risk. Comments: Female patients of reproductive potential should use a highly effective non-hormonal method of contraception during treatment and for at least 2 weeks after treatment with dabrafenib or 4 months after combination treatment with trametinib. Dabrafenib can render hormonal contraceptives ineffective.

Dabrafenib Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue dabrafenib, 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.

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 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.

Hide
(web1)