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ORIGINAL RESEARCH article

Front. Public Health
Sec. Children and Health
Volume 12 - 2024 | doi: 10.3389/fpubh.2024.1389513
This article is part of the Research Topic The Impact of Exposure to Environmental Chemicals, Pharmaceuticals and Particles via Human Breast Milk: A Focus on Health Effects and Underlying Mechanisms View all articles

The Concentration of Maternal Sacubitril/Valsartan Transferred into Human Milk is Negligible

Provisionally accepted
Sirin Falconi Sirin Falconi 1Abiodun Okimi Abiodun Okimi 1Shaun Wesley Shaun Wesley 2,3Pooja Sethi Pooja Sethi 4Palika Datta Palika Datta 1Kaytlin Krutsch Kaytlin Krutsch 1*
  • 1 School of Medicine, Texas Tech University Health Science Center Amarillo, Amarillo, Texas, United States
  • 2 Obstetrics and Gynecology, School of Medicine, Texas Tech University Health Science Center Amarillo, Amarillo, Texas, United States
  • 3 University of Rochester, Rochester, New York, United States
  • 4 Cardiology, School of Medicine, Texas Tech University Health Sciences Center, Lubbock, Texas, United States

The final, formatted version of the article will be published soon.

    Background: Peripartum cardiomyopathy (PPCM) is a common cause of heart failure (HF) in the peripartum. Some medications are considered safe while breastfeeding. However, sacubitril/valsartan (Entresto), although efficacious, is not recommended in breastfeeding women for fear of adverse infant development and no published data stating otherwise.Objectives: Assess the transfer of sacubitril/valsartan into human milk and evaluate the infant's risk of drug exposure.The InfantRisk Human Milk Biorepository released samples and corresponding health information from 5 breastfeeding maternal-infant dyads exposed to sacubitril/valsartan. Sacubitril, valsartan, and LBQ657 (sacubitril active metabolite) concentrations were determined using liquid chromatography mass spectrometry (LC/MS/MS) from timed samples 0, 1, 2, 4, 6, 8, 10, and 12 hours following medication administration at steady state conditions.Results: Valsartan levels were below the detection limit of 0.19 ng/mL in all milk samples. Sacubitril was measurable in all milk samples of the five participants, peaking one hour after drug administration at a mean concentration of 1.52 ng/mL for a total infant dose of 0.00049 mg/kg/12 hours and relative infant dose (RID) calculated at 0.01%. The maximum concentration of its active metabolite LBQ657 in the milk samples was observed four hours after medication administration and declined over the remaining 12-hour dosing interval, for an average concentration of 9.5 ng/ml. The total infant dose was 0.00071 mg/kg/12 hours and RID was 0.22%. Two mothers reported continuing to breastfeed while taking sacubitril/valsartan; both mothers stated observing no negative effects in their breastfed infants.The transfer of sacubitril/valsartan into human milk is minimal. These concentrations are unlikely to pose a significant risk to breastfeeding infants with a combined calculated relative infant dose of <0.25%, far lower than the industry safety standards (RID <10%).

    Keywords: Heart Failure, Entresto, Lactation, Pharmacology, Peripartum cardiomyopathy (PPCM), Maternal health

    Received: 21 Feb 2024; Accepted: 22 Apr 2024.

    Copyright: © 2024 Falconi, Okimi, Wesley, Sethi, Datta and Krutsch. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Kaytlin Krutsch, School of Medicine, Texas Tech University Health Science Center Amarillo, Amarillo, 79106, Texas, United States

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