Galsulfase Pregnancy and Breastfeeding Warnings

Galsulfase is also known as: Naglazyme

Galsulfase Pregnancy Warnings

Pregnancy women treated with galsulfase should be encouraged to enroll in the MPS VI Clinical Surveillance Program at 1-800-983-4587 (USA).

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

Galsulfase Breastfeeding Warnings

There are no data on the excretion of galsulfase into human milk. Because many drugs are excreted in human milk, the manufacturer recommends that caution be used when administering galsulfase to nursing women.

Nursing women treated with galsulfase should be encouraged to enroll in the MPS VI Clinical Surveillance Program at 1-800-983-4587 (USA).

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