Skip to Content
New To Chronic Myeloid Leukemia? Get Information Today >>

Lepirudin Pregnancy and Breastfeeding Warnings

Lepirudin is also known as: Refludan

Lepirudin Pregnancy Warnings

Lepirudin has been assigned to FDA pregnancy category B by the FDA. Animal data failed to reveal evidence of teratogenicity or fetotoxicity after doses 1.2 and 2.4 times the maximum recommended daily human dosage (controlled for body size). Limited data revealed evidence of increased maternal mortality with these doses. There are no adequate or controlled data from human pregnancy. Lepirudin should be given during pregnancy only when need has been clearly established.

See references

Lepirudin Breastfeeding Warnings

There are no data on the excretion of lepirudin into human milk. The manufacturer recommends that due to the potential for serious adverse events in nursing infants, a decision should be made whether to discontinue nursing or lepirudin therapy, taking into account the importance of the drug to the woman.

See references

References for pregnancy information

  1. "Product Information. Refludan (lepirudin)." Hoechst Marion-Roussel Inc, Kansas City, MO.

References for breastfeeding information

  1. "Product Information. Refludan (lepirudin)." Hoechst Marion-Roussel Inc, Kansas City, MO.

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.