Sacubitril / valsartan Pregnancy and Breastfeeding Warnings
Sacubitril / valsartan is also known as: Entresto
Medically reviewed by Drugs.com. 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
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.
References for pregnancy information
- "Product Information. Entresto (sacubitril-valsartan)." Novartis Pharmaceuticals, East Hanover, NJ.
References for breastfeeding information
- "Product Information. Entresto (sacubitril-valsartan)." Novartis Pharmaceuticals, East Hanover, NJ.
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Further information
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