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Pregnancy: There is limited data from the use of alglucosidase alfa in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical Safety Data under Actions). Myozyme should not be used during pregnancy unless the clinical condition of the woman requires treatment with alglucosidase alfa
Breast-feeding: Limited data suggest that alglucosidase alfa is excreted in breast milk in very low concentrations. No clinical effect is expected in a breastfed infant due to low breast milk transfer and poor bioavailability. Breastfeeding during treatment with Myozyme may therefore be considered. As a precautionary measure, breastfeeding interruption for the first 24 hours after treatment may be considered.
Fertility: There is too limited clinical data on the effects of alglucosidase alfa on fertility to evaluate its impact. Preclinical data did not reveal any significant adverse findings (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).
