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Agalsidase beta Pregnancy and Breastfeeding Warnings

Agalsidase beta is also known as: Fabrazyme

Agalsidase beta Pregnancy Warnings

Women of childbearing potential should be encouraged to enroll in the Fabry registry. The registry will monitor the effects of the drug on pregnant women and their offspring. For more information, visit or call 1-800-745-4447 (USA).

Agalsidase beta has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of impaired fertility or fetal harm. There are no controlled data in human pregnancy. Agalsidase beta is only recommended for use during pregnancy when benefit outweighs risk.

Agalsidase beta Breastfeeding Warnings

There are no data on the excretion of agalsidase beta into human milk. The manufacturer recommends that caution be used when administering agalsidase beta to nursing women.

Nursing mothers should be encouraged to enroll in the Fabry registry. For more information, visit or call 1-800-745-4447 (USA).

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