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Sacubitril / valsartan Pregnancy and Breastfeeding Warnings

Sacubitril / valsartan is also known as: Entresto

Medically reviewed by Last updated on Nov 20, 2019.

Sacubitril / valsartan Pregnancy Warnings

Animal studies have revealed evidence of embryofetal lethality. In humans, use of drugs that act on the renin angiotensin system (RAS) during the second and third trimesters increases fetal and neonatal morbidity and death. 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.

This drug should not be used during pregnancy unless there are no alternatives and the benefit outweighs the risk.

US FDA pregnancy category: Not Assigned

See references

Sacubitril / valsartan Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Unknown (sacubitril); Unknown (valsartan)
Excreted into animal milk: Yes (sacubitril); Yes (valsartan)

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Entresto (sacubitril-valsartan)." Novartis Pharmaceuticals, East Hanover, NJ.

References for breastfeeding information

  1. "Product Information. Entresto (sacubitril-valsartan)." Novartis Pharmaceuticals, East Hanover, NJ.

Further information

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