Elaprase Use In Pregnancy & Lactation

Pregnancy: Risk Summary: There are no adequate and well controlled studies with ELAPRASE. use in pregnant women. Available data from a small number of postmarketing cases with ELAPRASE use in pregnancy are insufficient to inform drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In an animal reproduction study, no evidence of adverse effects on pre- and postnatal development was observed with twice weekly intravenous administration of idursulfase to pregnant rats from gestation day 6 through lactation day 19 at about 4 times the recommended human weekly dose of 0.5 mg/kg based on body surface area (see Data as follows).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data: Animal Data: In a pre- and post-natal development study, idursulfase was administered to pregnant rats twice weekly, intravenously, from gestation day 6 through lactation day 19. No significant adverse effects on pre- and post-natal development of the offspring were observed at twice weekly intravenous doses up to 12.5 mg/kg (about 4 times the recommended human weekly dose of 0.5 mg/kg based on body surface area).
Lactation: Risk Summary: There are no data on the presence of idursulfase in human milk, the effects on the breastfed infant, or the effects on milk production. Idursulfase was excreted in breast milk of lactating rats (see Data as follows). When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ELAPRASE and any potential adverse effects on the breastfed child from ELAPRASE or from the underlying maternal condition.
Data: Idursulfase ELAPRASE was excreted in breast milk of lactating rats at a concentration higher (4 to 5-fold) than the maximum blood concentration, when administered as a single intravenous dose up to 2.5 mg/kg. The concentration of drug in animal milk does not necessarily predict the concentration of drug in human milk.