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Use in Pregnancy: Pregnancy Category B: There are no adequate and well-controlled studies of Fabrazyme use in pregnant women. Reproduction studies performed in rats at doses up to 30 times the human dose 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. The registry will monitor the effect of Fabrazyme on pregnant women and their offspring. For more information, visit www.fabryregistry.com (see PATIENT COUNSELING INFORMATION).
Use in Lactation: It is not 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 PRECAUTIONS and PATIENT COUNSELING INFORMATION).
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