Safety and Tolerability of Injectable Extended‐Release Naltrexone for the Management of Alcohol Use Disorder in Advanced Alcohol‐Associated Liver Disease
No Thumbnail Available
Date
2025
Journal Title
Journal ISSN
Volume Title
Publisher
John Wiley & Sons Ltd.
Abstract
Background: Pharmacologic treatment of alcohol use disorder (AUD) in patients with advanced alcohol-associated liver dis-ease (ALD) remains underutilised due to concerns regarding hepatotoxicity. Injectable extended-release naltrexone (XR-NTX)may offer a safer alternative by avoiding first-pass hepatic metabolism, but data on its safety and effectiveness in patients withadvanced ALD are limited.Aim: To describe the clinical experience with XR-NTX in individuals with advanced ALD, evaluating its safety, tolerability andimpact on liver function and alcohol use.Methods: Retrospective case series of adults with ALD who received at least one dose of XR-NTX 380 mg IM at a tertiary carecentre between 2023 and March 2025. Clinical data and laboratory tests were extracted from electronic health records over aminimum follow-up of 12 weeks. Safety was assessed based on adverse events and liver biochemistry. Alcohol use was evaluatedusing phosphatidylethanol (PEth) levels.Results: Fourteen individuals with ALD were included (2 had F3 and 9 cirrhosis Child A–B). The median age was 51 [44–65]years, 64% were male, and median follow-up was 127 days. Four patients (29%) experienced mild adverse effects (injection sitepain, nausea and vomiting, fatigue and sexual side effects); none had hepatotoxicity or hepatic decompensation. No significantchanges in liver function tests or MELD/Child-Pugh scores were observed during the follow-up period. Eight participants (57%)had a decrease in alcohol consumption, with a non-significant decline in PEth levels.
Description
Keywords
Addiction treatment, Alcohol use disorder, Alcoholic cirrhosis, Alcohol-related liver disease, Cirrhosis, Hepatotoxicity, Naltrexone, Phosphatidylethanol, Vivitrol