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Vutrisiran Pregnancy and Breastfeeding Warnings

Brand names: Amvuttra

Medically reviewed by Drugs.com. Last updated on Feb 23, 2023.

Vutrisiran Pregnancy Warnings

Safety has not been established during pregnancy.
-According to some authorities: Use is not recommended.

US FDA pregnancy category: Not assigned

Comments:
-There is no data on use in pregnant women to know this drug's risks, including the risk of fetal harm or reproductive effects.
-Treatment with this drug may lead to a decrease in serum vitamin A levels. Vitamin A supplementation is advised for patients under treatment. Vitamin A is essential for normal embryofetal development; however, excessive levels of vitamin A are associated with adverse developmental effects.

Studies in pregnant rats showed that subcutaneous administration during organogenesis period resulted in embryofetal mortality at high doses and reduced fetal body weigh at mid and high doses, which were associated with maternal toxicity.
Subcutaneous administration in rabbits and in rats throughout pregnancy and lactation periods showed no adverse effects on embryofetal development or development effects on the offspring. 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

Vutrisiran Breastfeeding Warnings

Benefit should outweigh risk.

Excreted into human milk: Data not available
Excreted into animal milk: Data not available

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references

References for pregnancy information

  1. Product Information. Amvuttra (vutrisiran). Alnylam Pharmaceuticals. 2022;1.
  2. Product Information. Amvuttra (vutrisiran). Alnylam UK Ltd. 2022.

References for breastfeeding information

  1. Product Information. Amvuttra (vutrisiran). Alnylam Pharmaceuticals. 2022;1.
  2. Product Information. Amvuttra (vutrisiran). Alnylam UK Ltd. 2022.

Further information

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