Brixadi
Brixadi (buprenorphine) is an injection given under the skin by a healthcare professional for moderate to severe opioid use disorder. It's typically given along with counseling, as well as social and emotional support. Brixadi (buprenorphine) is conveniently given once per week or once per month, but it's only for people who've previously tolerated another form of buprenorphine (e.g., buprenorphine (Zubsolv) film or buprenorphine (Subutex)). Some side effects of Brixadi (buprenorphine) include injection site reactions (e.g., pain or swelling), headache, and constipation.
What is Brixadi (buprenorphine)?
What is Brixadi (buprenorphine) used for?
Moderate to severe opioid use disorder in adults who've already started treatment with a buprenorphine-containing medication.
How Brixadi (buprenorphine) works
Brixadi (buprenorphine) is a partial opioid agonist. It works by attaching to the same receptors in the brain as opioids, but less strongly. It helps ease cravings and lower the risk for withdrawal symptoms, but shouldn't cause the same "high" as opioids.
When Brixadi (buprenorphine) is injected into your body, it turns into a solid gel (called a depot) under the skin. This gel then slowly releases a steady amount of medication throughout the month.
Drug Facts
What are the risks and warnings for Brixadi (buprenorphine)?
Brixadi (buprenorphine) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Not for intravenous (IV) administration
Brixadi (buprenorphine) should only be given as an injection under the skin (subcutaneous). It should never be given into the veins (intravenous, or IV) because it can cause serious harm, including death.
Brixadi (buprenorphine) is part of the FDA's Risk Evaluation and Mitigation Strategy (REMS) program because of its risk of serious harm if given as an IV. Under the REMS program, your provider(s) will be trained on how to inject Brixadi (buprenorphine) properly.
Risk for addiction, misuse, and abuse
Take Brixadi (buprenorphine) only as directed by your provider. This medication is a controlled substance because it does have a risk for addiction and misuse.
Dangerously slow breathing (respiratory depression)
Risk factors: Taking medications that can cause slow breathing | Drinking alcohol | Medical conditions that cause breathing problems (e.g., COPD, asthma)
Brixadi (buprenorphine) can cause dangerously slow breathing, which can be life-threatening. This can happen at any time, even with recommended doses. Your risk is higher if you're taking medications that can slow breathing (e.g., benzodiazepines, opioids, sedatives), drinking alcohol, or have breathing problems (e.g., COPD, asthma). Your provider will likely prescribe you naloxone (Narcan) that you should carry with you at all times in case you experience breathing problems and need to reverse the effects of Brixadi (buprenorphine). If you or your loved one notice you have trouble breathing or have bluish-colored lips, fingers, or toes, give yourself naloxone (Narcan) if you have it and call 911 to get medical help right away.
Harm to newborns
Risk factors: Taking Brixadi (buprenorphine) during pregnancy
If you take Brixadi (buprenorphine) during pregnancy, you can pass the medication to your unborn baby. Long-term use during pregnancy can cause your unborn baby to become dependent on opioids and cause withdrawal symptoms at birth. Symptoms of withdrawal can include high-pitched crying, poor feeding and sucking behavior, and seizures. This condition can be life-threatening if not recognized and treated in time. Make sure to tell your provider if you've received Brixadi (buprenorphine) during pregnancy. Providers who are experts in this area will know how to treat your newborn and will make sure your baby gets the care they need once they're born.
Low adrenal hormone levels
Risk factors: Taking Brixadi (buprenorphine) for longer than 1 month
Though rare, taking opioids, like Brixadi (buprenorphine), can cause your adrenal hormone levels to drop. This is more likely to happen after taking opioids for longer than 1 month. Symptoms include nausea, vomiting, not feeling hungry, tiredness, dizziness, and weakness. Let your provider know right away if you experience these symptoms because you might need to stop Brixadi (buprenorphine) and be treated with corticosteroids.
Risk of withdrawal symptoms
Suddenly stopping Brixadi (buprenorphine) might lead to symptoms of opioid withdrawal. Don't suddenly stop taking Brixadi (buprenorphine) without first talking with your provider. If you want to stop this medication, your provider can help you do so safely by lowering your dose slowly over time.
Liver damage
Risk factors: History of liver damage | Hepatitis B or C infection | Taking other medications that can cause liver damage | Injection drug use
There have been reports of liver damage in people who take Brixadi (buprenorphine). This medication isn't recommended for you if you already have liver problems. Your provider might ask that you get blood tests before and during Brixadi (buprenorphine) treatment to make sure your liver is healthy. Let your provider know if you experience symptoms of liver problems such as feeling tired, nausea, dark urine, pale stool, and yellowing of the whites of the eyes and skin.
Risks with treatment for pain
If you need to take pain medications for whatever reason, make sure to let your provider know that you're already taking Brixadi (buprenorphine). Since Brixadi (buprenorphine) is an opioid, it's best to start with non-opioid pain medications first. This is because opioid medications might not work as well for you and treatment can put you at risk for opioid toxicity and side effects, such as trouble breathing. If you need opioid therapy, you'll only be able to receive care under a provider's supervision.
Not for use in people who haven't taken opioids before
There have been reports of deaths of people who haven't taken opioids before and received 2 mg of buprenorphine. Brixadi (buprenorphine) is only for people who are currently taking opioids.
Life-threatening heart rhythm problems (QT prolongation)
Risk factors: Heartbeat or heart rhythm problems | Taking medications that affect your heartbeat or heart rhythm | Electrolytes (body salts) not in balance
Buprenorphine can cause QT prolongation, a potentially life-threatening heart rhythm problem. Your risk for these problems is higher if you already have heart problems or are taking other medications that cause QT prolongation that can change your heartbeat and heart rhythm, such as amiodarone (Pacerone), beta-blockers, and moxifloxacin (Avelox). Make sure to tell your provider about all the medications you're taking and also check with them before you start any new medications. If you feel symptoms of heart problems, such as pounding chest, trouble breathing, feeling faint or lightheaded, or chest pain while taking Brixadi (buprenorphine), call 911 right away.
What are the side effects of Brixadi (buprenorphine)?
Common Side Effects
- Injection site reactions, including pain, itching, and swelling (up to 21%)
- Headache (8%)
- Constipation (8%)
- Nausea (7%)
- Difficulty sleeping (6%)
- Urinary tract infection (5%)
Other Side Effects
- Upper respiratory tract infection
- Vomiting
- Diarrhea
- Joint pain
- Anxiety
Serious Side Effects
- Opioid withdrawal: suicidal thoughts, anxiety, restlessness, runny nose, yawning, sweating, chills, wide pupils, irritability
- Dangerously slow breathing: trouble breathing; bluish-colored lips, fingers, or toes
- Serious allergic reactions: rash, hives, shortness of breath, low blood pressure, fast heartbeat, dizziness, flushing (feeling warm all of a sudden), fatigue
- Heart rhythm problems: chest pounding, fluttering in the chest, difficulty breathing, chest pain, feeling faint or lightheaded
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
- Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
- Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
- Urinary tract infection (UTI)—burning when passing urine, passing frequent small amounts of urine, bloody or cloudy urine, pain in the lower back or sides
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Constipation
- Headache
- Nausea
- Pain, redness, or irritation at injection site
- Trouble sleeping
Pros and cons of Brixadi (buprenorphine)
Pros
Works well to treat moderate to severe opioid use disorder
Given once per week or once per month
Only trained healthcare providers who are registered with the REMS program can give you Brixadi (buprenorphine), to make sure this medication is as safe for you as possible
Cons
Injection only
Needs to go to the provider's office regularly to receive injection
Has a lot of potential risks and side effects, such as breathing problems and sleepiness
Pharmacist tips for Brixadi (buprenorphine)
Make sure to mark your appointments on your calendar for when you need to see your provider and receive your Brixadi (buprenorphine) doses. These appointments are important to discuss how treatment is going for you and make sure you don't miss any doses.
If you miss a dose of Brixadi (buprenorphine), contact your provider's office as soon as possible. There's a risk that missed doses can lead you to experience symptoms of opioid withdrawal, including muscle pain, stomach cramps, and diarrhea.
You might notice a lump at the injection site after receiving Brixadi (buprenorphine). This is the solid gel that'll slowly release the medication over time. As the medication is released, the lump will get smaller. Don't rub the lump.
Brixadi (buprenorphine) levels can be detected in your blood and urine for a long time after you've stopped taking it. If you're required to undergo a drug test, make sure to notify the drug-test center that you previously received Brixadi (buprenorphine).
Make sure to tell your provider about all of the medications you're taking before starting Brixadi (buprenorphine). Don't start any new medications while you're in the middle of Brixadi (buprenorphine) treatment without talking to your provider first. Taking Brixadi (buprenorphine) together with benzodiazepines, opioids, sedatives, or alcohol can worsen the side effects of Brixadi (buprenorphine) (e.g., slow breathing rate, severe sleepiness), which can be life-threatening.
Let your provider know if you're taking any mood medications, such as fluoxetine (Prozac) or citalopram (Celexa). Taking with mood medications that raise serotonin levels can raise your risk of a rare, but serious, side effect called serotonin syndrome. Symptoms of serotonin syndrome include sweating, fast heart rate, and trouble sleeping.
Don't stop taking Brixadi (buprenorphine) without talking to your provider first because they'll need to lower your dose slowly before stopping it completely so you don't get any withdrawal symptoms (e.g., suicidal thoughts, anxiety, restlessness, runny nose, yawning, sweating, chills, wide pupils, irritability). Since Brixadi (buprenorphine) is long-acting, withdrawal symptoms can be seen 2 to 5 months after the last injection.
Brixadi (buprenorphine) can make you sleepy and dizzy, which can affect your ability to focus, think, or react. Don't drive or do anything requiring your full attention, especially during the first few days following treatment or a change in your dose, until you know how this medication affects you.
Let your provider know right away if you have a head injury while receiving treatment with Brixadi (buprenorphine). Because taking buprenorphine might raise the pressure of fluids inside your brain, there's a risk that head trauma can be particularly dangerous.
Frequently asked questions about Brixadi (buprenorphine)
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Brixadi (buprenorphine) dosage forms
Typical dosing for Brixadi (buprenorphine)
If you've never taken buprenorphine before, your provider will give you buprenorphine 4 mg, either under the tongue or absorbed through the cheek (e.g., buprenorphine (Zubsolv) film or buprenorphine (Subutex)), as a test dose.
People not currently taking buprenorphine: When you first start treatment, your provider will determine your dose of Brixadi (buprenorphine) by giving you small doses of Brixadi (buprenorphine) over the course of a week to see how you respond. The typical maintenance dose of Brixadi (buprenorphine) ranges from 24 mg to 32 mg injected under the skin once a week.
People switching from transmucosal buprenorphine to Brixadi (buprenorphine): Your provider will determine your dose of Brixadi (buprenorphine) based on how much transmucosal buprenorphine you've been taking. The typical dose of Brixadi (buprenorphine) ranges from 8 mg to 32 mg injected under the skin once a week, to 64 mg to 128 mg injected once a month.
Brixadi (buprenorphine) contraindications
Allergy to any buprenorphine product
People who haven't taken opioids before
What are alternatives to Brixadi (buprenorphine)?
Moderate to severe opioid use disorder in adults who've already started treatment with a buprenorphine-containing medication.
Moderate-to-severe opioid use disorder in adults who've already started treatment with a buprenorphine-containing medication
What is the latest news about Brixadi (buprenorphine)?
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References
Best studies we foundAl-Khatib, S. M., e tal. (2003). What clinicians should know about the QT interval. Journal of the American Medical Association.
Braeburn, Inc. (2023). Brixadi- buprenorphine injection [package insert]. DailyMed.
Braeburn, Inc. (n.d.). Welcome to the Brixadi REMS (risk evaluation and mitigation strategy).
Centers for Disease Control and Prevention. (2022). About opioid use during pregnancy.
Lutfy, K., et al.. (2004). Buprenorphine: A unique drug with complex pharmacology. Current Neuropharmacology.
National Institute of Diabetes and Digestive and Kidney Diseases. (2018). Adrenal insufficiency & Addison’s disease.
National Institute of Diabetes and Digestive and Kidney Diseases. (2018). Symptoms & causes of adrenal insufficiency & Addison's disease.
Shah, M., et al. (2023). Opioid withdrawal. StatPearls.
Substance Abuse and Mental Health Services Administration. (2023). Drug testing resources.
U.S. Food and Drug Administration. (2023). Risk evaluation and mitigation strategies | REMS.
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