BUPRENORPHINE INJ,SOLN,SA
Clinical Criteria Summary
Indications
- Treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of transmucosal buprenorphine product or who are already being treated with buprenorphine.
Dosage Forms & Dosing
- Weekly: 8mg, 16mg, 24mg, and 32mg doses.
- Monthly: 64mg, 96mg, and 128mg doses.
- Weekly and monthly dosage forms are NOT interchangeable.
Contraindications
- Hypersensitivity (e.g., anaphylactic shock) to buprenorphine or any other ingredients in the solution for injection.
Warnings & Precautions
- Risk of serious harm or death with intravenous administration; forms a liquid crystalline gel upon contact with bodily fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including life-threatening pulmonary emboli.
- May precipitate opioid withdrawal in patients physically dependent on full-agonist opioids.
- Administer a transmucosal test-dose (e.g., 4 milligram SL buprenorphine or buprenorphine/naloxone) before administering BRIXADI.
- Needle cap is synthetically derived from natural rubber latex, which may cause allergic reactions in latex-sensitive individuals.
- Consider co-prescribing naloxone for the emergency treatment of opioid overdose based on the patient’s risk factors for overdose.
Safety & Adverse Reactions
- Common treatment-emergent adverse events (TEAEs) include injection site reactions (mild to moderate severity), constipation, nausea, headache, and insomnia (>5%).
- Non-injection TEAEs occurring in >5% include headache (7.9%), nasopharyngitis (7.9%), nausea (7%), vomiting (5.3%), and urinary tract infection.
- TEAEs leading to discontinuation are rare (~2.2–2.5%).
Clinical Efficacy & Place in Therapy
- Provides similar clinical benefit to sublingual buprenorphine/naloxone for moderate-to-severe opioid use disorder.
- May have benefit in patients at higher risk (e.g., history of overdose) or at risk of non-adherence.
- Cost is similar to market competitor (SUBLOCADE).
- Stored at room temperature, offers multiple sites for subcutaneous injection, and provides more dose flexibility vs. market competitor.
REMS & Administration Requirements
- Only available via the BRIXADI REMS program; healthcare settings and pharmacies must be certified in this program.
- Must never be dispensed directly to a patient and must only be administered by a healthcare professional in a healthcare setting.