Aldurazyme Use In Pregnancy & Lactation

Pregnancy: Pregnancy Exposure Registry: An MPS I Registry has been established and pregnant women with MPS I should be encouraged to enroll in the pregnancy sub-registry. For more information, visit www.registrynxt.com or email at: Med.SAMS@sanofi.com
Risk Summary: Available data from published case reports and postmarketing experience with ALDURAZYME use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. No evidence of fetal harm has been observed in rats when laronidase was administered during organogenesis at doses up to 6.2 times the recommended human dose (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 defects, 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.
Clinical Considerations: Disease-associated maternal and embryo/fetal risk: Pregnancy can exacerbate preexisting clinical manifestations of MPS and lead to adverse pregnancy outcomes for both mother and fetus.
Data: Animal Data: When laronidase was administered to pregnant female rats during organogenesis (gestation days [GD] 7-17) at doses of 0, 0.036, 0.36 or 3.6 mg/kg/day intravenously (equivalent to 7.3, 73.1, 730.8 units/kg/day) decreased maternal body weight gains and food consumption were observed with no corresponding effects on reproductive and litter parameters including number and distribution of corpora lutea, implantations and early and late resorptions at doses up to 3.6 mg/kg/day (6.2 times the recommended human dose of 0.58 mg/kg on a mg/kg basis). Laronidase has not been evaluated for effects on embryo-fetal development in any other species.
Lactation: Risk Summary: There are no available data on the presence of laronidase in human milk or the effects on milk production. No adverse effects have been reported in breastfed infants in a few post-marketing cases of laronidase use in lactating women. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ALDURAZYME and any potential adverse effects on the breastfed child from ALDURAZYME or from the underlying maternal condition.
Lactating women with MPS I are encouraged to enroll in the MPS I Registry. For more information, visit www.registrynxt.com or email at: Med.SAMS@sanofi.com