Peginesatide has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity and embryofetal lethality at doses and/or exposures that resulted in polycythemia. There are no adequate and well controlled studies in pregnant women. The manufacturer recommends that peginesatide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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It is not known whether peginesatide is excreted in human milk. Because many drugs are excreted into human milk, caution should be exercised when peginesatide is administered to a nursing woman.

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