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Pregnancy: There is very limited data on pregnancies exposed to Replagal. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy or embryonic/fetal development when exposed during organogenesis (see Pharmacology: Toxicology: Preclinical safety data under Actions). Caution should be exercised when prescribing to pregnant women.
Breast-feeding: It is not known whether Replagal is excreted in human milk. Caution should be exercised when prescribing to breast-feeding women.
Fertility: No effects on male fertility were seen in reproductive studies in male rats.
