Skip to Content

Palifermin Pregnancy and Breastfeeding Warnings

Palifermin is also known as: Kepivance

Palifermin Pregnancy Warnings

Clinical studies have revealed increased post-implantation loss and decreased fetal body weight with intravenous administration of doses 2.5 times greater than human doses on days 6 to 18 of gestation in pregnant rabbits. These doses also showed signs of maternal toxicity consisting of clinical signs and reductions in body weight gain/food consumption. Intravenous doses greater than 8 times human doses administered to pregnant rats from days 6 to 17 or 19 of gestation revealed an increased post-implantation loss, decreased fetal body weight and/or increased skeletal variations. These doses were also associated with maternal toxicity (clinical signs and body weight effects).

Palifermin is has been assigned to pregnancy category C by the FDA. Animal data have revealed embryotoxicity with doses 2.5 to 8 times the human dose. There are no controlled data in human pregnancy. Palifermin is only recommended for use during pregnancy when benefit outweighs risk.

See references

Palifermin Breastfeeding Warnings

There are no data on the excretion of palifermin into human milk. The manufacturer recommends that caution be used when administering palifermin to nursing women.

See references

References for pregnancy information

  1. "Product Information. Kepivance (palifermin)." Shire US Inc, Florence, KY.

References for breastfeeding information

  1. "Product Information. Kepivance (palifermin)." Shire US Inc, Florence, KY.

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.