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Sacubitril / valsartan Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Apr 3, 2023.

Sacubitril / valsartan is also known as: Entresto

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 induce fetotoxicity (including decreased renal function, oligohydramnios, skull ossification retardation), and increases neonatal complications (renal failure, hypotension, hyperkalemia) 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 is not recommended during pregnancy and some authorities consider it contraindicated during the second and third trimesters.

US FDA pregnancy category: Not Assigned

Risk Summary:
-Exposure to this drug during the second and third trimester is known to induce human fetotoxicity.

-When pregnancy is diagnosed, therapy with this drug should be stopped immediately and an alternative treatment should be started.
-If there is no therapeutic alternative and this drug is considered lifesaving to the mother, advise her of the potential risk to the fetus and closely observe the neonate renal function.

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. 2015.

References for breastfeeding information

  1. Product Information. Entresto (sacubitril-valsartan). Novartis Pharmaceuticals. 2015.

Further information

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