Nexviazyme Use In Pregnancy & Lactation

Pregnancy: There are no available data on the use of Nexviazyme in pregnant women. Animal studies do not indicate direct harmful effects with respect to reproductive toxicity. Indirect foetal effects in mice were considered related to an anaphylactic response to avalglucosidase alfa (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for humans is unknown. No conclusions can be drawn regarding whether or not Nexviazyme is safe for use during pregnancy. Nexviazyme should be used during pregnancy only if the potential benefits to the mother outweigh the potential risks, including those to the foetus.
Breast-feeding: There are no available data on the presence of Nexviazyme in human milk or the effects of Nexviazyme on milk production or the breast-fed infant. No conclusions can be drawn regarding whether or not Nexviazyme is safe for use during breast-feeding. Nexviazyme should be used during breast-feeding only if the potential benefits to the mother outweigh the potential risks, including those to the breast-fed child (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Fertility: There are no clinical data on the effects of Nexviazyme on human fertility. Animal studies in mice showed no impairment of male or female fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).