Use in Pregnancy: Category B.
A developmental toxicity study has been performed in rats at doses up to 6.2 times the human dose and has revealed no evidence of impaired fertility or harm to the fetus due to ALDURAZYME. However, there are no adequate and well-controlled studies of ALDURAZYME in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Pregnant women with MPS I should be encouraged to enroll in the MPS I Registry (see PATIENT COUNSELING INFORMATION).
Use in Lactation: It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ALDURAZYME is administered to a nursing woman.
Nursing mothers with MPS I should be encouraged to enroll in the MPS I Registry (see PATIENT COUNSELING INFORMATION).