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Vosoritide Pregnancy and Breastfeeding Warnings

Medically reviewed by Drugs.com. Last updated on Mar 30, 2022.

Vosoritide is also known as: Voxzogo

Vosoritide Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: There are no available data on the use of this drug during pregnancy to evaluate the drug-associated risk of birth defects, miscarriage, or adverse maternal or fetal outcomes.

Animal studies have failed to reveal evidence of embryofetal toxicity or congenital malformations. Rats and rabbits received this drug subcutaneously at doses equivalent to 14-times and 200-times, respectively, the exposure at the maximum recommended human dose; no effects on embryofetal development were observed. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Vosoritide Breastfeeding Warnings

Benefit should outweigh risk.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-There is no information regarding the presence of this drug in human milk, and the effects on the breastfed infant. However, since it is excreted in animal milk, it is likely that the drug will be present in human milk. -The health benefits of breastfeeding should be considered along with the mother's clinical need for treatment and any potential adverse effects on the breastfed child from this drug or from the underlying maternal condition.

See references

See also

References for pregnancy information

  1. "Product Information. Voxzogo (vosoritide)." BioMarin Pharmaceutical Inc (2022):

References for breastfeeding information

  1. "Product Information. Voxzogo (vosoritide)." BioMarin Pharmaceutical Inc (2022):

Further information

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

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