Fabrazyme Use In Pregnancy & Lactation

Pregnancy: Category B: There are no adequate and well-controlled studies of Fabrazyme use in pregnant women. Reproduction studies have been performed in rats at doses up to 30 times the human dose and have revealed no evidence of impaired fertility or negative effects on embryo fetal development due to Fabrazyme. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Women of childbearing potential should be encouraged to enroll in the Fabry patient registry (see Information for Patients under Precautions). The registry will monitor the effect of Fabrazyme on pregnant women and their offspring.
Labor and Delivery: There is no information on the effect of Fabrazyme during labor and delivery. Pregnant females are encouraged to enroll in the Fabry registry (see Information for Patients under Precautions).
Nursing Mothers: It is known whether Fabrazyme is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Fabrazyme is administered to a nursing woman.
Nursing mothers should be encouraged to enroll in the Fabry registry (see Information for Patients under Precautions.)
Responses in Women: Fabry disease is an X-linked genetic disorder. However, some heterozygous women will develop signs and symptoms of Fabry disease due to the variability of the X-chromosome inactivation within cells.
A total of 12 adult female patients with Fabry disease were enrolled in two separate randomized, double-blind, placebo-controlled clinical studies with Fabrazyme, and two female pediatric patients with Fabry disease, ages 11 years, were evaluated in an open-label, uncontrolled pediatric study (see Pediatric Use under Precautions). Although the safety and efficacy data available in female patients in these clinical studies are limited, there is no indication that female patients respond differently to Fabrazyme than do males.