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Sargramostim Pregnancy and Breastfeeding Warnings

Sargramostim is also known as: Leukine

Sargramostim Pregnancy Warnings

Sargramostim has been assigned to FDA pregnancy category C by the FDA. Animal reproduction studies have not been conducted. There are no controlled data in human pregnancy. Sargramostim is only recommended for use during pregnancy when benefit outweighs risk.

Sargramostim Breastfeeding Warnings

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

Endogenous GM-CSF has been detected in human milk; however, no effect on neutrophil chemotaxis in the infant was shown. Whether recombinant GM-CSF (sargramostim) is present in human milk, and its clinical effects, are not presently known.

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