Aldurazyme Use In Pregnancy & Lactation

Pregnancy: Pregnancy Exposure Registry: An MPS I Registry has been established. pregnant women with MPS I and healthcare providers are encouraged to contact the pregnancy sub-registry by visiting www.registrynxt.com or email at: Med.SAMS@sanofi.com
Risk Summary: Available data from the MPS I Registry pregnancy sub-registry, published case reports and the global pharmacovigilance database with ALDURAZYME use in more than 30 pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. The continuation of treatment for MPS I during pregnancy should be individualized to the pregnant woman. Untreated MPS I may result in adverse pregnancy and infant outcomes (see Clinical Considerations as follows). 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 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.
Clinical Considerations: Disease-associated maternal and/or 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: Available information from one mother: infant pair are insufficient to evaluate the presence or absence of laronidase in human milk. No adverse effects have been reported in breastfed infants in post-marketing cases of ALDURAZYME 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 and healthcare providers are encouraged to contact the MPS I Registry by visiting www.registrynxt.com or email at: Med.SAMS@sanofi.com.