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Elosulfase alfa Pregnancy and Breastfeeding Warnings

Elosulfase alfa is also known as: Vimizim

Elosulfase alfa Pregnancy Warnings

Animal studies have failed to reveal evidence of embryofetal 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.

A Morquio A Registry collects data on pregnant women with MPS IVA treated with this drug. For additional information and enrollment: MARS@bmrn.com

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.

US FDA pregnancy category: C

See references

Elosulfase alfa 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: MARS@bmrn.com

See references

References for pregnancy information

  1. "Product Information. Vimizim (elosulfase alfa)." BioMarin Pharmaceutical Inc, Novato, CA.

References for breastfeeding information

  1. "Product Information. Vimizim (elosulfase alfa)." BioMarin Pharmaceutical Inc, Novato, CA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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