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Injectable extended\u2010release naltrexone (XR\u2010NTX) may offer a safer alternative by avoiding first\u2010pass hepatic metabolism, but data on its safety and effectiveness in patients with advanced ALD are limited.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To describe the clinical experience with XR\u2010NTX in individuals with advanced ALD, evaluating its safety, tolerability and impact on liver function and alcohol use.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Retrospective case series of adults with ALD who received at least one dose of XR\u2010NTX 380\u2009mg IM at a tertiary care centre between 2023 and March 2025. Clinical data and laboratory tests were extracted from electronic health records over a minimum follow\u2010up of 12\u2009weeks. Safety was assessed based on adverse events and liver biochemistry. Alcohol use was evaluated using phosphatidylethanol (PEth) levels.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Fourteen individuals with ALD were included (2 had F3 and 9 cirrhosis Child A\u2013B). The median age was 51 [44\u201365] years, 64% were male, and median follow\u2010up was 127\u2009days. Four patients (29%) experienced mild adverse effects (injection site pain, nausea and vomiting, fatigue and sexual side effects); none had hepatotoxicity or hepatic decompensation. No significant changes in liver function tests or MELD\/Child\u2010Pugh scores were observed during the follow\u2010up period. Eight participants (57%) had a decrease in alcohol consumption, with a non\u2010significant decline in PEth levels.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>In this case series, XR\u2010NTX was well tolerated in patients with advanced ALD, without evidence of hepatotoxicity or liver decompensation.<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.70237","type":"journal-article","created":{"date-parts":[[2025,6,14]],"date-time":"2025-06-14T11:08:37Z","timestamp":1749899317000},"page":"692-698","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Safety and Tolerability of Injectable Extended\u2010Release Naltrexone for the Management of Alcohol Use Disorder in Advanced Alcohol\u2010Associated Liver Disease"],"prefix":"10.1111","volume":"62","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8540-4930","authenticated-orcid":false,"given":"Luis Antonio","family":"D\u00edaz","sequence":"first","affiliation":[{"name":"MASLD Research Center, Division of Gastroenterology and Hepatology University of California at San Diego  La Jolla California USA"},{"name":"Departamento de Gastroenterolog\u00eda Escuela de Medicina, Pontificia Universidad Cat\u00f3lica de Chile  Santiago Chile"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0784-3102","authenticated-orcid":false,"given":"Summer","family":"Collier","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology University of California at San Diego  La Jolla California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5125-8031","authenticated-orcid":false,"given":"Jeffrey","family":"Yin","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology University of California at San Diego  La Jolla California USA"},{"name":"Department of Pharmacy University of California at San Diego  La Jolla California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4845-9991","authenticated-orcid":false,"given":"Rohit","family":"Loomba","sequence":"additional","affiliation":[{"name":"MASLD Research Center, Division of Gastroenterology and Hepatology University of California at San Diego  La Jolla California USA"},{"name":"School of Public Health, University of California at San Diego  La Jolla California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,6,14]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(24)00933-4"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.3350\/cmh.2024.0835"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1093\/alcalc\/agac013"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/HC9.0000000000000145"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41572-022-00406-1"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41386-020-00950-y"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1511480"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2468\u20101253(24)00380\u20107"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1097\/HEP.0000000000000645"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1176\/ps.2010.61.4.392"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.31042"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/acer.13410"},{"issue":"12","key":"e_1_2_9_14_1","article-title":"A Retrospective Study of Hospital Recidivism Among Patients With Alcohol Use Disorders Treated With Intramuscular Naltrexone","volume":"11","author":"Espiridion E. 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