For patients with OUD, taking medication daily may come with challenges1-4
Patients may start their recovery journey with daily medication, but could face obstacles.5-9
Remembering or choosing to take doses
Feeling dependent on a substance
Taking it as directed
Diversion, theft, or loss
Secure storage/safe disposal
Concerns about dental issues
Research shows that even brief interruptions in buprenorphine treatment can lead to relapse.4
- Nonadherent patients were 10x more likely to relapse4
- Nonadherent patients overdosed almost 3x as often as adherent patients11
Even patients who are not struggling with OUD may have a hard time taking their daily medications properly. They often forget to take their medication or take it at the wrong times. For someone who is struggling with OUD, this can be a greater challenge and present more opportunities for misuse.”
Healthcare provider is a paid consultant of Braeburn Inc.
OUD, opioid use disorder.
References: 1. Johnson B, Monwell B, Capusan AJ. Long-acting injectable depot buprenorphine from a harm reduction perspective in patients with ongoing substance use and multiple psychiatric comorbidities: a qualitative interview study. Harm Reduct J. 2024;21(1):68. 2. Johnson B, Flensburg OL, Capusan AJ. Patient perspectives on depot buprenorphine treatment for opioid addiction - a qualitative interview study. Subst Abuse Treat Prev Policy. 2022;17(1):40. 3. Martin E, Maher H, McKeon G, Patterson S, Blake J, Chen KY. Long-acting injectable buprenorphine for opioid use disorder: a systematic review of impact of use on social determinants of health. J Subst Abuse Treat. 2022;139:108776. 4. Tkacz J, Severt J, Cacciola J, Ruetsch C. Compliance with buprenorphine medication-assisted treatment and relapse to opioid use. Am J Addict. 2012;21(1):55-62. 5. Godersky ME, Saxon AJ, Merrill JO, Samet JH, Simoni JM, Tsui JI. Provider and patient perspectives on barriers to buprenorphine adherence and the acceptability of video directly observed therapy to enhance adherence. Addict Sci Clin Pract. 2019;14(1):11. 6. Volkow ND, Frieden TR, Hyde PS, Cha SS. Medication-assisted therapies—tackling the opioid-overdose epidemic. N Engl J Med. 2014;370(22):2063-2066. 7. Kumar R, Viswanath O, Saadabadi A. Buprenorphine. In: StatPearls. StatPearls Publishing; 2024. 8. Heidbreder C, Fudala PJ, Greenwald MK. History of the discovery, development, and FDA-approval of buprenorphine medications for the treatment of opioid use disorder. Drug Alcohol Depend Rep. 2023;6:100133. 9. US Food & Drug Administration. FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain. Published January 12, 2022. Updated January 21, 2022. Accessed July 29, 2025. https:// www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-dental-problems-buprenorphine-medicines-dissolved-mouth-treat-opioid-use-disorder 10. Morgan JR, Schackman BR, Leff JA, Linas BP, Walley AY. Injectable naltrexone, oral naltrexone, and buprenorphine utilization and discontinuation among individuals treated for opioid use disorder in a United States commercially insured population. J Subst Abuse Treat. 2018;85:90-96. 11. Gibbons JB, McCullough JS, Zivin K, Brown ZY, Norton EC. Association between buprenorphine treatment gaps, opioid overdose, and health care spending in US Medicare beneficiaries with opioid use disorder. JAMA Psychiatry. 2022;79(12):1173-1179.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION; BRIXADI RISK EVALUATION AND MITIGATION STRATEGY
- Serious harm or death could result if administered intravenously. BRIXADI forms a liquid crystalline gel 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, BRIXADI is only available through a restricted program called the BRIXADI REMS. Healthcare settings and pharmacies that order and dispense BRIXADI must be certified in this program and comply with the REMS requirements.
BRIXADI (buprenorphine) extended-release injection (weekly, 50 mg/mL buprenorphine) and BRIXADI (monthly, 356 mg/mL buprenorphine) are different formulations. Doses of BRIXADI (weekly) cannot be combined to yield an equivalent monthly dose.
BRIXADI is contraindicated in patients with hypersensitivity (e.g. anaphylactic shock) to buprenorphine or any other ingredients in the solution for injection.
WARNINGS AND PRECAUTIONS
Addiction, Abuse, and Misuse: BRIXADI contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioids. Buprenorphine is sought by people with opioid use disorder and is subject to criminal diversion. Monitor all patients for progression of opioid dependence and addictive behaviors.
Respiratory and CNS Depression: Buprenorphine has been associated with life-threatening respiratory depression and death. Use BRIXADI with caution in patients with compromised respiratory function. Due to its extended-release characteristics, if BRIXADI is discontinued as a result of compromised respiratory function, monitor patients for ongoing buprenorphine effects for approximately 1 month for BRIXADI (weekly) and for approximately 4 months for BRIXADI (monthly). Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose.
Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose: Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver. Because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose, strongly consider prescribing naloxone for the emergency treatment of opioid overdose, both when initiating and renewing treatment with BRIXADI. If naloxone is prescribed, educate patients and caregivers on how to treat with naloxone, and emphasize the importance of calling 911 or getting emergency medical help, even if naloxone is administered.
Concomitant Use of Benzodiazepines or other CNS Depressants: Concomitant use of buprenorphine and benzodiazepines or other CNS depressants increase the risk of adverse reactions including respiratory depression, overdose and death. Ensure that other healthcare providers prescribing benzodiazepines or other CNS depressants are aware of the patient’s buprenorphine treatment and coordinate care to minimize the risk associated with concomitant use. Inform patients and caregivers that potentially fatal additive effects may occur if BRIXADI is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider.
Neonatal Opioid Withdrawal Syndrome, Pregnancy, and Lactation: Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy. NOWS may be life-threatening if not recognized and treated in the neonate. Healthcare providers should observe newborns for signs of NOWS and manage accordingly. Advise pregnant women receiving opioid addiction treatment with BRIXADI of the risk of neonatal opioid withdrawal syndrome. Warn patients that buprenorphine passes into breast milk. Advise the nursing mother taking buprenorphine to monitor the infant for increased drowsiness and breathing difficulties.
Adrenal Insufficiency: If adrenal insufficiency is diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.
Risk of Opioid Withdrawal with Abrupt Discontinuation: Patients who elect to discontinue BRIXADI treatment should be monitored for withdrawal signs and symptoms with consideration given to the product’s extended-release characteristics.
Risk of Hepatitis, Hepatic Events, and Use in Patients with Impaired Hepatic Function: Liver function tests should be performed on all patients prior to initiation, during treatment, and if a hepatic event is suspected. Because buprenorphine levels cannot be rapidly decreased, patients with pre‐existing moderate to severe hepatic impairment are not candidates for treatment with BRIXADI. Patients who develop moderate to severe hepatic impairment while being treated with BRIXADI should be monitored for signs and symptoms of toxicity or overdose of buprenorphine and may require a dose adjustment.
Hypersensitivity Reactions: Cases of bronchospasm, angioneurotic edema, and anaphylactic shock have been reported in patients receiving buprenorphine-containing products. The most common signs and symptoms include rashes, hives, and pruritus. The BRIXADI needle cap is synthetically derived from natural rubber latex which may cause allergic reactions in latex-sensitive individuals.
Precipitation of Opioid Withdrawal in Patients Dependent on Full Opioid Agonists: BRIXADI injection may precipitate opioid withdrawal signs and symptoms in individuals physically dependent on full opioid agonists such as heroin, morphine, or methadone before the effects of the full opioid agonist have subsided. In patients who are new entrants to treatment, to avoid precipitating an opioid withdrawal syndrome, administer a 4 mg test dose of transmucosal buprenorphine when objective signs of mild to moderate withdrawal appear and monitor for precipitated withdrawal before injecting BRIXADI.
Risks Associated with Treatment of Emergent Acute Pain: While on BRIXADI, situations may arise where patients need acute pain management, or may require anesthesia. Treat patients receiving BRIXADI with non-opioid analgesic whenever possible. Patients requiring opioid therapy for analgesia may be treated with a high-affinity full opioid analgesic under the supervision of a healthcare provider, with particular attention to respiratory function. Higher doses may be required for analgesic effect. Therefore, a higher potential for toxicity exists with opioid administration. Advise patients of the importance of instructing their family members, in the event of emergency, to inform the treating healthcare provider or emergency room staff that the patient is being treated with BRIXADI.
Use in Opioid Naïve Patients: There have been reported deaths of opioid naïve individuals who received a 2 mg dose of buprenorphine as a sublingual tablet. BRIXADI is not appropriate for use in opioid naïve patients.
Patients at Risk for Arrhythmia: Thorough QT studies with buprenorphine products have demonstrated QT prolongation ≤ 15 msec. This QTc prolongation effect does not appear to be mediated by hERG channels. Based on these two findings, buprenorphine is unlikely to be pro-arrhythmic when used alone in patients without risk factors. The risk of combining buprenorphine with other QT- prolonging agents is not known.
Impairment of Ability to Drive and Operate Machinery: BRIXADI may impair the mental or physical abilities required for the performance of potentially dangerous tasks such as driving a car or operating machinery. Caution patients about driving or operating hazardous machinery until they are reasonably certain that BRIXADI does not adversely affect their ability to engage in such activities.
Orthostatic Hypotension: Buprenorphine may produce orthostatic hypotension in ambulatory patients.
Elevation of Cerebrospinal Fluid Pressure: Buprenorphine may elevate cerebrospinal fluid pressure and should be used with caution in patients with head injury, intracranial lesions, and other circumstances when cerebrospinal pressure may be increased.
Elevation of Intracholedochal Pressure: Buprenorphine has been shown to increase intracholedochal pressure, as do other opioids, and thus should be administered with caution to patients with dysfunction of the biliary tract.
Effects in Acute Abdominal Conditions: Buprenorphine may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
Unintentional Pediatric Exposure: Buprenorphine can cause severe, possibly fatal, respiratory depression in children who are accidentally exposed to it.
ADVERSE REACTIONS
Adverse reactions commonly associated with BRIXADI administration (in ≥5% of patients) were injection site pain, headache, constipation, nausea, injection site erythema, injection site pruritus, insomnia, and urinary tract infection.
To report SUSPECTED ADVERSE REACTIONS, contact Braeburn at 1-833-274-9234 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
INDICATIONS AND USAGE
BRIXADI is indicated for the 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.
BRIXADI should be used as a part of a complete treatment plan that includes counseling and psychosocial support.
Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING, and MEDICATION GUIDE.