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Alglucosidase alfa Pregnancy and Breastfeeding Warnings

Alglucosidase alfa is also known as: Lumizyme, Myozyme

Overview

If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Alglucosidase Alfa while you are pregnant. It is not known if Alglucosidase Alfa is found in breast milk. If you are or will be breast-feeding while you use Alglucosidase Alfa, check with your doctor. Discuss any possible risks to your baby.

Alglucosidase alfa Pregnancy Warnings

Pregnant women are encouraged to participate in the Pompe registry program at 1-800-745-4447, extension 15500 or at http://www.lsdregistry.net/pomperegistry.

Alglucosidase alfa has been assigned to pregnancy category B by the FDA. A short-term animal study has revealed no evidence of impaired fertility or harm to the fetus. Long-term studies in animals to evaluate carcinogenic potential or studies to evaluate mutagenic potential have not been performed. There are no controlled data in human pregnancy. Alglucosidase alfa should be given during pregnancy when need has been clearly established.

Alglucosidase alfa Breastfeeding Warnings

Nursing women are encouraged to participate in the Pompe registry program at 1-800-745-4447, extension 15500 or at http://www.lsdregistry.net/pomperegistry.

There are no data on the excretion of alglucosidase alfa into human milk. Because many drugs are excreted in human milk, caution is recommended if alglucosidase alfa is administered to a nursing woman.

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