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Pregnancy: Pregnancy Category C.
Teratogenicity studies have not been conducted with ELAPRASE. A pre- and postnatal development study in rats showed no evidence of adverse effects on pre- and postnatal development at intravenous doses up to 12.5 mg/kg, administered twice weekly (about 4 times the recommended human weekly dose of 0.5 mg/kg based on body surface area). There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers: ELAPRASE was excreted in breast milk of lactating rats at a concentration higher (4 to 5-fold) than that of the plasma. It is not known whether ElAPRASE is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ELAPRASE is administered to a nursing woman.
