Vutrisiran Pregnancy and Breastfeeding Warnings

Brand names: Amvuttra

Vutrisiran Pregnancy Warnings

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

AU TGA pregnancy category: D

US FDA pregnancy category: Not assigned

Risk summary: There is no data on use in pregnant women to know this drug's risks, including the risk of fetal harm or reproductive effects.

Comments:
-Treatment with this drug reduces serum vitamin A levels and supplementation is advised. Both high and low levels of vitamin A may be associated with increased risk of fetal malformation.
-According to some authorities, pregnancy should be excluded before treatment initiation and women of childbearing potential should use effective contraception.
-If a woman intends to become pregnant, treatment and vitamin A supplementation should be discontinued. Serum vitamin A levels should be monitored and have returned to normal before pregnancy is attempted. Serum vitamin A levels may remain low for more than 12 months after the last dose of treatment .
-IF used during pregnancy, vitamin A and thyroid stimulating hormone levels should be obtained early in pregnancy and close monitoring of the fetus should be carried out, especially during the first trimester.

Animal 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.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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

Safety has not been established; benefits should outweigh risk.

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

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.
--- According to some authorities, a decision should be made to discontinue breastfeeding or discontinue the drug, considering the importance of the drug to the mother.

See references

Further information

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

Medical Disclaimer