Summary of Use during Lactation

Sacubitril is available in the United States only in combination with valsartan. Milk levels after the lowest dose of the combination are very low. If sacubitril milk levels of the highest dosage (4 times greater) are proportional to maternal dosage, they would still be quite low. Valsartan was undetectable at this dosage, so the combination product appears unlikely to affect the nursing infant.

Drug Levels

Maternal Levels. Five mothers taking sacubitril 24 mg and valsartan 26 mg (Entresto) twice daily collected milk samples at 0, 1, 2, 4, 6, 8, 10, and 12 hours after taking a dose at steady state. The peak sacubitril milk concentration of 12.2 mcg/L occurred at 1 hour after the dose. Its average concentration was 0.497 mcg/L. The peak LBQ657 milk concentration of 1.52 mcg/L occurred at 4 hours after the dose. Its average concentration was 9.5 mcg/L. Calculated infant dosages of sacubitril and its metabolite were 0.98 mcg/kg and 1.42 mcg/kg daily, which translate into 0.01% and 0.22%, respectively.[1]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Two women taking sacubitril 24 mg and valsartan 26 mg (Entresto) did not observe any symptoms in their breastfed infants. Their extent of breastfeeding was not reported.[1]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Benazepril, Enalapril, Quinapril

References

1.

Falconi S, Okimi A, Wesley S, et al. The concentration of maternal sacubitril/valsartan transferred into human milk is negligible. Front Public Health 2024;12:1389513 [PMC free article: PMC11150817] [PubMed: 38841677]

Substance Name

Sacubitril

CAS Registry Number

149709-62-6

Drug Class

Breast Feeding

Lactation

Milk, Human

Angiotensin-Converting Enzyme Inhibitors

Antihypertensive Agents

ACE Inhibitors

ACEIs