Limited Use Note(s)

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BUPRENORPHINE300mg/1.5mL Inj Sol- 1.5mL Pref Syr
Reason For Use CodeClinical Criteria
577For the management of moderate to severe opioid use disorder as a part of a complete treatment plan that includes counselling and psychosocial support in adult patients who meet the following criteria: - The patient has been induced and is stabilized on an equivalent of 8mg to 24mg per day of transmucosal buprenorphine for a minimum of seven days; AND - The patient is under the care of a health care provider with experience in the diagnosis and management of opioid use disorder; AND - Each dose is administered subcutaneously in the abdominal region by a certified healthcare provider who has received instruction and training. Recommended dose: 300mg/month for two months, followed by a maintenance dose of 100mg/month. Maintenance dose may be increased to 300mg/month only if patient does not demonstrate satisfactory clinical response. NOTE: In clinical trials, the 300mg/month maintenance dose did not provide additional efficacy as compared to the 100mg/month dose and was associated with a higher incidence of adverse events and study discontinuations. A minimum of 26 days is required between consecutive doses.
LU Authorization Period: 1 year