For healthcare professionals managing Opioid Use Disorder (OUD), understanding all available treatment modalities is crucial.

Brixadi HCP: A Comprehensive Overview for Healthcare Professionals

For healthcare professionals managing Opioid Use Disorder (OUD), understanding all available treatment modalities is crucial. Brixadi (buprenorphine extended-release) injection for subcutaneous use represents an important option within the comprehensive treatment landscape for OUD. This guide provides an overview of Brixadi, focusing on key information relevant to healthcare providers to ensure informed decision-making and optimal patient care.

Understanding Brixadi (Buprenorphine Extended-Release)

Brixadi is an extended-release formulation of buprenorphine delivered as a subcutaneous injection. Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. Its unique pharmacological profile makes it suitable for medication-assisted treatment (MAT) of OUD, helping to reduce opioid cravings and withdrawal symptoms without producing the full euphoric effects of a full opioid agonist.

Mechanism of Action

As a partial mu-opioid agonist, buprenorphine provides sufficient opioid effects to prevent withdrawal and cravings, but its effects plateau at higher doses (ceiling effect), reducing the risk of respiratory depression compared to full opioid agonists. As a kappa-opioid antagonist, it may also contribute to its antidepressant and anti-addiction properties. The extended-release formulation of Brixadi allows for once-weekly or once-monthly administration, offering sustained therapeutic levels of buprenorphine.

Indications and Patient Selection

Brixadi is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already receiving treatment with a transmucosal buprenorphine product. It is an integral part of a complete treatment program that includes counseling and psychosocial support.

Patient selection is critical. Brixadi is not intended for use in opioid-naive patients. Patients must be stable on a transmucosal buprenorphine product for at least seven days before transitioning to Brixadi to ensure tolerability and to avoid precipitating withdrawal symptoms.

Dosing and Administration for HCPs

Brixadi is administered by a healthcare professional as a subcutaneous injection in the abdomen, buttock, thigh, or upper arm. It must not be administered intravenously, intra-arterially, or intramuscularly. The availability of both once-weekly and once-monthly dosing options allows for flexibility in treatment plans, catering to individual patient needs and adherence considerations.

Initial Dosing

For patients stable on transmucosal buprenorphine, the transition to Brixadi involves converting the daily transmucosal dose to an equivalent weekly or monthly subcutaneous dose. Brixadi is available in various strengths for both weekly (e.g., 8 mg, 16 mg, 24 mg, 32 mg) and monthly (e.g., 64 mg, 96 mg, 128 mg) administrations. Healthcare providers must follow the prescribed dosing schedule and ensure proper conversion to prevent under- or over-dosing.

Administration Technique

Strict adherence to aseptic technique is required during administration. The injection site should be alternated to minimize local skin reactions. Detailed instructions for preparation and administration are provided in the prescribing information, which healthcare professionals should review thoroughly prior to use. Due to the viscosity of the solution, a specific injection technique is required to ensure proper delivery.

Important Safety Information and REMS Program

Brixadi carries several important safety considerations that healthcare professionals must be aware of and communicate to patients. The medication is part of a Risk Evaluation and Mitigation Strategy (REMS) program to ensure its safe use.

Risk Evaluation and Mitigation Strategy (REMS)

Brixadi is subject to a REMS program due to the risk of serious harm or death that could result from accidental intravenous administration. This program mandates that Brixadi is only available through a restricted distribution program, requiring certified pharmacies and healthcare settings to dispense and administer the product. Prescribers must be certified and patients must be enrolled in the program.

Key Safety Considerations

• Respiratory Depression: Serious, life-threatening respiratory depression may occur, especially in non-tolerant individuals or when combined with other central nervous system depressants.


• Accidental Injection: Inadvertent intravenous administration can lead to life-threatening emboli. Brixadi must be administered only via the subcutaneous route.


• Hepatic Events: Cases of hepatic injury have been observed with buprenorphine products. Liver function should be monitored before and during treatment.


• Precipitation of Opioid Withdrawal: Patients must be in a state of opioid withdrawal or have been initiated on transmucosal buprenorphine to avoid precipitating acute withdrawal.


• CNS Depression: Concomitant use with benzodiazepines or other CNS depressants can increase the risk of profound sedation, respiratory depression, coma, and death.


• Neonatal Opioid Withdrawal Syndrome: Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome.


• Local Injection Site Reactions: Common reactions include pain, erythema, pruritus, and nodules at the injection site.

Clinical Efficacy and Role in OUD Treatment

Clinical studies have demonstrated the efficacy of Brixadi in maintaining abstinence from illicit opioids, reducing opioid cravings, and improving treatment retention in patients with OUD. Its extended-release profile supports adherence and can reduce the burden of daily medication management for patients, potentially leading to better outcomes within a comprehensive treatment framework. By providing sustained buprenorphine levels, Brixadi helps patients focus on recovery without the daily reminder of medication dosing.

As healthcare professionals, careful patient assessment, ongoing monitoring, and adherence to prescribing information are paramount when utilizing Brixadi as part of an individualized OUD treatment plan. Its role as a long-acting buprenorphine option further enhances the toolkit available for combating the opioid crisis.