Risk Of Serious Harm Or Death With Intravenous Administration; Sublocade Risk Evaluation And Mitigation Strategy

• Serious harm or death could result if administered intravenously. Buprenorphine Extended Release Subcutaneous Injection forms a crystalline gel or solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo‐embolic events, including life-threatening pulmonary emboli, if administered intravenously.
• Because of the risk of serious harm or death that could result from intravenous self-administration, SUBLOCADE and BRIXADI are only available through  restricted programs called the SUBLOCADE REMS Program or the BRIXADI REMS Program. Healthcare settings and pharmacies that order and dispense these agents must be certified in the program and comply with the REMS requirements.