What is a Brixadi Injection?
Brixadi is an extended-release injectable form of buprenorphine, a partial opioid agonist used to treat moderate to severe opioid use disorder (OUD). It is a component of a comprehensive treatment plan that includes counseling and psychosocial support. Unlike daily oral buprenorphine, Brixadi is administered by a healthcare provider on a weekly or monthly basis, maintaining consistent medication levels in the body.
Approved by the FDA in May 2023, Brixadi offers flexible dosing for both new patients (after an initial transmucosal dose) and those transitioning from other buprenorphine products. This long-acting injectable (LAI) format aims to enhance treatment adherence by removing the need for daily medication, allowing individuals to concentrate on the behavioral and supportive aspects of recovery.
How the Brixadi Injection Works
Brixadi works through its active ingredient, buprenorphine, a partial opioid agonist.
- Partial Opioid Agonist: Buprenorphine partially activates the same opioid receptors in the brain as full opioids, effectively reducing cravings and withdrawal symptoms without inducing the same intense high.
- Blocking Effect: By binding to these receptors, buprenorphine also blocks other opioids from attaching, diminishing their effects.
- FluidCrystal® Technology: Injected subcutaneously, Brixadi utilizes FluidCrystal®, a lipid-based technology that forms a biodegradable gel deposit. This gel releases buprenorphine gradually and steadily over a week or a month, providing stable medication levels and avoiding the fluctuations seen with daily oral doses.
The Brixadi REMS Program: A Critical Safety Measure
Due to severe risks from potential intravenous self-administration, Brixadi is only available through a restricted program called the Brixadi Risk Evaluation and Mitigation Strategy (REMS). This program ensures that only a certified healthcare provider administers the medication in a healthcare setting. Injecting Brixadi into a vein can cause a dangerous liquid crystalline gel to form in the bloodstream, potentially leading to fatal blockages. The REMS program prevents this by requiring administration by trained medical professionals.
Dosing and Administration
Brixadi comes in various strengths and both weekly and monthly formulations. For patients not on buprenorphine, a test dose of transmucosal buprenorphine is given first, followed by weekly injections if tolerated. Patients stable on transmucosal buprenorphine can switch directly to weekly or monthly Brixadi. Injections are given under the skin in the buttock, thigh, abdomen, or upper arm. Weekly injection sites should be rotated. Weekly doses can be given within 2 days of the schedule, and monthly doses within 1 week. More details can be found on {Link: Drugs.com https://www.drugs.com/pro/brixadi-injection.html}.
Brixadi vs. Sublocade: A Comparison Table
Brixadi and Sublocade are both long-acting injectable buprenorphine treatments for OUD with distinctions.
| Feature | Brixadi (Buprenorphine Injection) | Sublocade (Buprenorphine Injection) |
|---|---|---|
| Dosing Frequency | Weekly and monthly options. | Monthly only. |
| Dosing Flexibility | Multiple dose strengths for both weekly and monthly. | Two fixed dosages. |
| Injection Sites | Buttock, thigh, abdomen, or upper arm. | Abdominal region only. |
| Initiation for New Patients | Weekly version possible after a test dose of transmucosal buprenorphine. | Requires at least 7 days on stable transmucosal buprenorphine. |
| Market Availability | FDA approved in May 2023. | FDA approved since 2017. |
Potential Side Effects and Safety Warnings
Brixadi can cause side effects, with injection site reactions being common.
Common Side Effects (≥5% of patients):
- Injection site pain, redness, or itching
- Headache
- Nausea and constipation
- Insomnia
- Urinary tract infection
Serious Warnings and Risks:
- Respiratory Depression: Buprenorphine can cause severe breathing problems, particularly when combined with substances like alcohol or benzodiazepines. Patients should have access to naloxone.
- Neonatal Opioid Withdrawal Syndrome (NOWS): Use during pregnancy can result in NOWS in the newborn.
- Liver Problems: Liver function should be monitored throughout treatment.
- Dependence and Abuse: Brixadi is a controlled substance and carries risks of dependence and abuse. Patients require monitoring for these behaviors.
- Opioid Withdrawal: Stopping treatment abruptly can cause withdrawal. Buprenorphine can remain detectable for months after discontinuation.
Conclusion
Brixadi injection is a beneficial addition to medication-assisted treatment for opioid use disorder. Offering flexible weekly or monthly dosing administered by a healthcare provider, it can improve treatment adherence and provide steady buprenorphine levels to manage cravings and prevent relapse. As a controlled substance, Brixadi has significant safety risks, notably the danger of intravenous injection, and is available through a restricted program to ensure proper administration. Brixadi is most effective when part of a comprehensive treatment plan including counseling and psychosocial support. For more information, visit the official {Link: Brixadi website https://www.brixadi.com/}.
