Clinical guidelines for use of depot buprenorphine (Buvidal® and Sublocade®) in the treatment of opioid dependence NSW Ministry of Health 100 Christie Street ST LEONARDS NSW 2065 Tel. (02) 9391 9000 Fax. (02) 9391 9101 TTY. (02) 9391 9900 www.health.nsw.gov.au Produced by: NSW Ministry of Health Lintzeris N, Dunlop A, Masters D (2019) Clinical guidelines for use of depot buprenorphine (Buvidal® and Sublocade®) in the treatment of opioid dependence. NSW Ministry of Health, Sydney Australia This work is copyright. It may be reproduced in whole or in part for study or training purposes subject to the inclusion of an acknowledgement of the source. It may not be reproduced for commercial usage or sale. Reproduction for purposes other than those indicated above requires written permission from the NSW Ministry of Health. © NSW Ministry of Health 2019 SHPN (CPH) 190431 ISBN 978-1-76081-226-3 Further copies of this document can be downloaded from the NSW Health website www.health.nsw.gov.au August 2019 ii NSW Health Use of depot BPN in the treatment of opioid dependence Authors Professor Nicholas Lintzeris (BMedSci MBBS PhD FAChAM) Director Drug and Alcohol Services, South East Sydney Local Health District Discipline Addiction Medicine, Faculty of Medicine and Health Sciences, University of Sydney NSW Drug and Alcohol Clinical Research and Improvement Network Professor Adrian Dunlop (MBBS, PhD, GdipEpiBiotat, FAChAM) Director Drug and Alcohol Clinical Services, Hunter New England Local Health District School of Medicine and Public Health, Faculty of Health, University of Newcastle Hunter Medical Research Institute NSW Drug and Alcohol Clinical Research and Improvement Network Debbie Masters (BHSHM, MBA(HlthMgmt)) Quality and Planning Manager, Drug and Alcohol Clinical Services, Hunter New England Local Health District NSW Health Use of depot BPN in the treatment of opioid dependence 1 Acknowledgements The authors acknowledge input from the NSW Ministry of Health and the contributions of the following groups who reviewed and commented on drafts of these guidelines • a Consultation Working Group comprising of Phillip Bannon, Principal Advisor, Centre for Aboriginal Health, NSW Ministry of Health Bruce Battye, Director Pharmaceutical Regulatory Unit, Legal and Regulatory Services, Ministry of Health Tanya Bosch, Senior Policy Officer, Clinical Policy Unit, Alcohol and Other Drugs, NSW Ministry of Health Dr Patricia Collie (FAChAM) Mid North Coast Local Health District Julie Fagan, Nurse Unit Manager, Drug and Alcohol Services, St George Hospital, South Eastern Sydney Local Health District Aleksandar Gavrilovic (B.Pharm) Principal Pharmaceutical Officer, Monitoring & Compliance, Pharmaceutical Regulatory Unit, Legal and Regulatory Services Branch Dr Anthony Gill (FAChAM), Chief Addiction Medicine Specialist, Alcohol and Other Drugs, Centre for Population Health Prof Paul Haber, Clinical Director, Drug Health Services, Sydney Local Health District Mary Ellen Harrod, NSW Users and AIDS Association Dr Phillipa Jenkins (PhD), Policy Officer, Alcohol and Other Drugs, Centre for Population Health, NSW Ministry of Health Annemarie Jones, Nurse Unit Manager, Kempsey Opioid Substitution Treatment Clinic, Mid North Coast Local Health District Debbie Kaplan, Manager, Clinical Policy, Alcohol and Other Drugs, Centre for Population Health, NSW Ministry of Health Dr Jill Roberts (MBBS Grad.Dip.A&D.St FAChAM. FFCFM(RCPA)) Clinical Director Drug and Alcohol, Justice Health and Forensic Mental Health Network Antoinette Sedwell, Agency for Clinical Innovation Sara Shaughnessy, Mid North Coast Local Health District Kristine Smith, District Coordinator Drug and Alcohol Program, Western NSW LHD Doug Smyth, Senior Policy Officer, Clinical Policy, Alcohol and Other Drugs, Centre for Population Health, NSW Ministry of Health Dr Milana Votrubec (MB BS MA MM ME USyd, FRACGP FFPMANZCA) Royal Australian College of General Practitioners Dr Hester Wilson, (BMed (Hons) Mas. Mental Health) Royal Australian College of General Practitioners • clinicians and consumers who have participated in clinical trials using depot buprenorphine products in Australia, highlighting the essential contribution of clinical research in translational activities. • an international panel of clinicians with expertise with depot buprenorphine treatment Dr Genie L. Bailey (MD) Diplomate, American Board of Addiction Medicine Clinical Assoc Prof of Psychiatry and Human Behavior Warren Alpert Medical School of Brown University Distinguished Life Fellow, American Psychiatry Assoc, Director of Research, Director of Medications for Addiction Division Stanley Street Treatment & Resources, Massachusetts Dr Oscar DAgnone, (MD, MRCPsych) Medical Director The OAD Clinic, London Dr Michael Frost (MD, FACP, FASAM) President/Medical Director, The Frost Medical Group Dr Michelle R. Lofwall, (MD, DFASAM) University of Kentucky College of Medicine, Departments of Behavioral Science and Psychiatry, Center on Drug and Alcohol Research Dr Edward V Nunes (MD) New York State Psychiatric Institute, Columbia University Medical Center Dr Kaarlo Simojoki, (MD PhD) Medical Director A-Clinic Ltd, Finland, Addiction Medicine Professor of Practise, University of Helsinki, Finland Representatives from Camurus (manufacturers of Buvidal®) and Indivior (manufacturers of Sublocade®) have had the opportunity to provide comment on the draft guidelines, however all decisions have been made by the authors and endorsed by the consultation working group. 2 NSW Health Use of depot BPN in the treatment of opioid dependence Disclaimer This document is a general guide to appropriate practice, to be followed subject to the clinician’s judgement and patient’s preference in each individual case. The guidelines are designed to provide information to assist decision-making and is based on the best available evidence at the time of development of this publication. South Eastern Sydney and Hunter New England Local Health Districts have been reimbursed for conducting clinical trials sponsored by Camurus. Nicholas Lintzeris has served on an advisory board for Indivior and Mundipharma. Acronyms AE Adverse Events COWS Clinical Opiate Withdrawal Scale CS Consensus Statement DDIs Drug Drug Interactions Depot BPN Depot Buprenorphine FC FluidCrystal® IUGR Intrauterine Growth Restriction LAI BPN Long Acting Injection Buprenorphine LFT Liver Function Test MAOIs Monoamine Oxidase Inhibitors MATOD Medication-Assisted Treatment of Opioid Dependence NAS Neonatal Abstinence Syndrome NOWS Neonatal Opioid Withdrawal Syndrome NTX Naltrexone OAT Opioid Agonist Treatment OUD Opioid Use Disorder SC Subcutaneous SL BPN Sublingual Buprenorphine SL BPN NX Sublingual Buprenorphine / Naloxone TGA Therapeutic Goods Administration NSW Health Use of depot BPN in the treatment of opioid dependence 3 Contents Acronyms .......................................................................................................................................3 Background to guideline for depot BPN for the treatment opioid dependence .............. 9 1. Introduction to opioid agonist treatment (OAT) with depot BPN medications ......10 a. Overview of treatment model of care .................................................................................................10 b. Evidence of efficacy of depot BPN in the treatment of opioid dependence ....................... 11 2. Clinical pharmacology ........................................................................................................... 12 a. Formulations ................................................................................................................................................. 12 i. Buvidal® formulations ......................................................................................................................... 12 ii. Sublocade® formulations .................................................................................................................. 12 b. Overview of pharmacokinetic properties .......................................................................................... 12 i. Absorption and onset of effects .................................................................................................... 14 ii. Metabolism ............................................................................................................................................. 14 iii. Elimination and duration of effects.................................................................................................... 14 iv. Withdrawal, cravings, opioid blockade ....................................................................................... 15 c. Side effects and safety issues ................................................................................................................ 15 i. Adverse events ..................................................................................................................................... 15 ii. Contraindications................................................................................................................................. 15 d. Special Warnings ......................................................................................................................................... 16 i. Risk of serious harm or death with intravenous administration ........................................ 16 ii. Risk of respiratory and central nervous system (CNS) depression ................................. 16 iii.