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Pegfilgrastim Pregnancy and Breastfeeding Warnings

Pegfilgrastim is also known as: Neulasta

Pegfilgrastim Pregnancy Warnings

Pegfilgrastim has been assigned to pregnancy category C by the FDA. Studies in pregnant rabbits have shown adverse effects with doses of 50 mcg/kg/dose, an amount approximately 4-fold higher than the recommended human dose. Doses of 200 to 250 mcg/kg/dose of filgrastim resulted in an increased incidence of abortions. Subcutaneous injections of pegfilgrastim of up to 1000 mcg/kg/dose administered every other day during the period of organogenesis in rats were not associated with an embryotoxic or fetotoxic outcome. There are no controlled data in human pregnancy. Pegfilgrastim is only recommended for use during pregnancy when benefit outweighs risk.

Pegfilgrastim Breastfeeding Warnings

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

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