Vimizim Pregnancy Warnings
Animal studies have failed to reveal evidence of embryofetal toxicity. A dose-dependent increase in stillbirths was observed with daily administration in rats during organogenesis through lactation at doses 5 times the human steady-state AUC. An increase in pup mortality was observed at doses producing maternal toxicity. There are no controlled data in human pregnancy.
Pregnancy can adversely affect the health of patients with mucopolysaccharidosis type IVA (MPS IVA) and lead to adverse pregnancy outcomes.
AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
AU TGA pregnancy category: B3
US FDA pregnancy category: C
Comments: A Morquio A Registry collects data on pregnant women with MPS IVA treated with this drug. For additional information and enrollment: [email protected]
See references
Vimizim Breastfeeding Warnings
Caution is recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Yes
Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for the drug.
-Potential side effects in the breastfed child due to the drug or the mother's underlying condition should be considered.
A Morquio A Registry collects data on breastfeeding women with mucopolysaccharidosis type IVA treated with this drug. For additional information and enrollment: [email protected]
See references
