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.

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.

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