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Sevelamer Pregnancy and Breastfeeding Warnings

Sevelamer is also known as: Renagel, Renvela

Sevelamer Pregnancy Warnings

Sevelamer has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of embryotoxicity and fetolethality. There are no controlled data in human pregnancy. Sevelamer is only recommended for use during pregnancy when benefit outweighs risk.

Sevelamer slightly increased prenatal mortality in rabbits receiving 10 times the recommended human dose (1g/kg/day, based on mg/kg), due to an increased incidence of early resorptions. In rats receiving doses 15 and 45 times the recommended human dose (1.5 and 4.5 g/kg/day, based on mg/kg), sevelamer caused reduced or irregular ossification of fetal bones, probably due to a reduced absorption of fat-soluble vitamin D.

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Sevelamer Breastfeeding Warnings

There are no data on the excretion of sevelamer into human milk. The effects in the nursing infant are unknown.

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References for pregnancy information

  1. "Product Information. Renagel (sevelamer)." Genzyme Corporation, Cambridge, MA.

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