Topotecan Pregnancy and Breastfeeding Warnings

Topotecan is also known as: Hycamtin

Topotecan Pregnancy Warnings

Topotecan has been assigned to pregnancy category D by the FDA. Animal data have revealed evidence of maternal toxicity, embryolethality, reduced fetal body weight, fetal resorption, microphthalmia, and pre-implant loss. Topotecan may cause fetal harm when administered to a pregnant woman. There are no controlled data in human pregnancy. Women who are receiving topotecan should be advised to avoid pregnancy. If topotecan is used during pregnancy, or if the patient becomes pregnant while receiving the drug, she should be advised of the potential hazard to the fetus.

Animal data have revealed evidence of embryolethality, fetotoxicity, and teratogenicity when administered during organogenesis.

Topotecan Breastfeeding Warnings

There are no data on the excretion of topotecan into human milk. The manufacturer states that topotecan should be discontinued when women are receiving topotecan.

Topotecan is excreted in high concentrations into the milk of rats. Lactating female rats given 4.72 mg/m2 IV (about twice the clinical dose on a mg/m2 basis) excreted topotecan into milk at concentrations up to 48-fold higher than those in plasma.

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and 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.