Brixadi

Pronunciation: brix-a-dee
Generic name: buprenorphine
Dosage form: extended-release injection for subcutaneous use

Medically reviewed by Carmen Pope, BPharm. Last updated on Aug 16, 2024.

What is Brixadi?

Brixadi is an extended-release injection of buprenorphine given by a healthcare provider that may be used to treat moderate to severe opioid use disorder (OUD) (also known as opioid addiction).

• Brixadi injection can be used for people who are addicted to either prescription or illegal opioids.
• It may be used to treat opioid-dependent patients who are already being treated with buprenorphine or who have started treatment with a single dose of sublingual/buccal buprenorphine.
  • A test dose establishes that buprenorphine is tolerated without causing opioid withdrawal before a long-acting Brixadi injection is given.
• Brixadi is used as part of a complete treatment plan that includes counseling and psychosocial support.

Brixadi (buprenorphine) works by attaching to opioid receptors in the brain, preventing the intense cravings and withdrawal symptoms associated with opioid addiction. Unlike full opioid agonists, Brixadi doesn't produce the same euphoric effects, making it a safer treatment option.

Brixadi gained FDA approval on May 23, 2023. Brixadi is only approved for OUD, it is not approved for pain relief.

Is Brixadi a controlled substance?

Yes, Brixadi (buprenorphine) is a Schedule 3 under the Controlled Substances Act (CSA). This means that it has more abuse potential than Schedule 4 and Schedule 5 medicines, and abuse may lead to moderate or low physical dependence.

Brixadi REMS

Because of the serious risk of potential harm or death from self-injecting Brixadi into a vein (intravenously), it is only available through a restricted program called the Brixadi REMS Program.

• Brixadi is not available in retail pharmacies.
• Your Brixadi injection will only be given to you by a healthcare provider.

Related/similar drugs

naltrexone, buprenorphine, Suboxone, Subutex, Vivitrol, Sublocade, Probuphine

Brixadi side effects

The most common side effects of Brixadi include:

• injection site pain, redness, or itching
• headache
• constipation
• trouble sleeping (insomnia)
• nausea
• urinary tract infections.

Serious side effects and warnings

Brixadi carries a Boxed warning for the risk of serious harm or death with intravenous administration. This is why Brixadi is only available through a Brixadi REMS-certified healthcare provider.

Brixadi contains buprenorphine which is an opioid that can cause serious and life-threatening breathing problems, especially if you take or use certain other medicines or drugs, such as opioids, benzodiazepines,
alcohol, street drugs, or other central nervous system depressants. Get emergency help right away if you:

• feel faint
• have blurred vision
• feel dizzy
• have slurred speech
• are confused
• are breathing slower than normal
• feel sleepy or uncoordinated
• cannot think well or clearly.

If you are prescribed Brixadi, talk to your healthcare provider about naloxone. Naloxone is a medicine that is available to patients for the emergency treatment of an opioid overdose. If naloxone is given, you must call 911 or get emergency medical help right away to treat an overdose or accidental use of an opioid.

In an emergency, have family members tell the emergency department staff that you are physically dependent on an opioid and are being treated with Brixadi.

Brixadi can be detected in drug tests for several months after treatment stops.

Other serious side effects of Brixadi include the following.

• Sleepiness, dizziness, and problems with coordination
• Physical dependence or abuse
• Liver problems. Call your healthcare provider right away if you notice any of these symptoms:
  • your skin or the white part of your eyes turns yellow (jaundice)
  • dark or “tea-colored” urine
  • light-colored stools (bowel movements)
  • loss of appetite
  • pain, aching, or tenderness on the right side of your stomach area
  • nausea.

Your healthcare provider should do tests to check your liver before and during treatment with Brixadi.

• Allergic reactions. Get emergency medical help if you have signs of an allergic reaction to Brixadi. Symptoms may include hives, itching; severe dizziness; wheezing, difficulty breathing; and swelling of your face, lips, tongue, or throat.
• Opioid withdrawal. Call your healthcare provider right away if you get any of these symptoms:
  • shaking
  • goosebumps
  • sweating more than normal
  • diarrhea
  • feeling hot or cold more than normal
  • vomiting
  • runny nose
  • muscle aches
  • watery eyes.

These symptoms may start weeks to months after your last dose of Brixadi. Tell your healthcare provider if you develop any of these symptoms.

• Decrease in blood pressure. You may feel dizzy if you get up too fast from sitting or lying down. The most common side effects of Brixadi include:
  • injection site pain
  • injection site redness
  • headache
  • injection site itching
  • constipation
  • trouble sleeping (insomnia)
  • nausea
  • urinary tract infection

Call your doctor at once if you have:

• weak or shallow breathing, breathing that stops during sleep;
• severe drowsiness or dizziness, loss of coordination;
• pain, redness, itching, or skin changes where the injection was given;
• a light-headed feeling, like you might pass out;
• opioid withdrawal symptoms--shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, vomiting;
• liver problems--loss of appetite, upper stomach pain, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• low cortisol levels-- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults.

Brixadi may affect fertility in males and females. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects of Brixadi. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088

Before taking this medicine

You should not use this medicine if you are allergic to buprenorphine, Brixadi, or any of the other ingredients in the injection. Click here for a full list of Brixadi ingredients.

To make sure Brixadi is safe for you, tell your healthcare provider about all your medical conditions, including if you have:

• trouble breathing or lung problems
• an enlarged prostate (men)
• a head injury or brain problem
• a curve in your spine that affects your breathing
• Addison’s disease
• problems urinating
• liver, kidney, or gallbladder problems
• a history of alcoholism
• mental health problems
• adrenal gland or thyroid gland problems
• a latex allergy. The Brixadi needle cap contains latex.

Tell your healthcare provider if you are pregnant or planning to become pregnant or if you are breastfeeding.

Pregnancy

If you receive Brixadi while pregnant, your baby may have symptoms of opioid withdrawal at birth that could be life-threatening if not recognized and treated. Talk to your healthcare provider if you are pregnant or become pregnant.

Breastfeeding

Brixadi can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with Brixadi. Monitor your baby for increased drowsiness and
breathing problems if you breastfeed during treatment with Brixadi.

How will I receive Brixadi?

Brixadi is a subcutaneous injection that is injected under the skin by your healthcare provider.

• Your healthcare provider will administer Brixadi once a week or once a month.
  • The Brixadi weekly and Brixadi monthly injections are different formulations.
• You should not give yourself this medicine.
• Brixadi will be injected slowly just under the skin (subcutaneous) of your buttock, thigh, stomach (abdomen), or upper arm.
• Injection sites for weekly Brixadi should be alternated/rotated for each injection.

If you are not currently receiving buprenorphine treatment, your healthcare provider will give you a test dose of buprenorphine first to see if you can tolerate it, and then switch you over to Brixadi.

When you are new to buprenorphine treatment, the upper arm should only be used after 4 doses of Brixadi.

• This medicine is injected as a liquid which then forms a gel once it is under the skin. The gel form (depot) is not always felt under the skin.
• Do not try to remove the depot.

Brixadi dosing information

People who have started addiction treatment with an oral form of buprenorphine (such as Suboxone) can be changed to an equivalent dose of Brixadi Weekly or Brixadi Monthly.

• Brixadi (weekly) should be administered in 7-day intervals.
• Brixadi (monthly) should be administered in 28-day intervals.
• Doses of Brixadi (weekly) cannot be combined to yield a monthly dose.

Patients Not Currently Receiving Buprenorphine Treatment

The recommended weekly dose in patients not currently receiving buprenorphine treatment is 24 mg of Brixadi (weekly) titrated up over the first week of treatment as follows:

• To avoid precipitating an opioid withdrawal syndrome, administer a test dose of transmucosal buprenorphine 4 mg when objective signs of mild to moderate withdrawal appear.
• If the dose of transmucosal buprenorphine is tolerated without precipitated withdrawal, administer the first dose of Brixadi (weekly), 16 mg.
• Administer an additional dose of 8 mg Brixadi (weekly) within 3 days of the first dose to achieve the recommended 24 mg Brixadi (weekly) dose.
• See the Brixadi Package Insert for detailed information about Brixadi dosing.

Comments:

If needed, during this first week of treatment, administer an additional 8 mg dose of Brixadi (weekly), waiting at least 24 hours after the previous injection, for a total weekly dose of 32 mg Brixadi (weekly).

Administer subsequent Brixadi (weekly) injections based on the total weekly dose that was established during Week One. Dosage adjustments can be made at weekly appointments with the maximum weekly dose being 32 mg.

A patient who misses a dose of a weekly injection should receive the next dose as soon as possible. Brixadi (weekly) should be administered in 7-day intervals.

Patients Switching from Transmucosal Buprenorphine-containing Products to Brixadi

Patients currently being treated with a transmucosal buprenorphine-containing product may be switched directly to either Brixadi (weekly) or Brixadi (monthly).

• See the Brixadi Package Insert for detailed information about Brixadi dosing.

What happens if I miss a dose?

To avoid missed doses, the weekly dose may be administered up to 2 days before or after the weekly time point, and the monthly dose may be administered up to 1 week before or after the monthly time point. If a dose is missed, the next dose should be administered as soon as practically possible.

What should I avoid while receiving Brixadi?

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drink alcohol. Dangerous side effects or death could occur.

What other drugs will affect Brixadi?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective. Tell your doctor if you also use an antibiotic, antidepressant, antifungal medication, seizure medication, or medicine to treat HIV or hepatitis C, muscle relaxants or monoamine oxidase (MAO) inhibitors.

Do not take Brixadi with certain medicines. Taking Brixadi with other opioid medicines, benzodiazepines,
alcohol, other central nervous system depressants (including street drugs) can cause severe drowsiness,
decreased awareness, breathing problems, coma, and death.

This list is not complete. Many drugs may affect Brixadi including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Storage

Your healthcare provider will store Brixadi at room temperature at 20°C to 25°C (68°F to 77° F); with excursions permitted at 15°C to 30° C (59°F to 86°F).

Ingredients

Active ingredient: buprenorphine (weekly: 8, 16, 24, 32 mg; monthly; 64, 96, 128 mg)

Inactive ingredients

• Brixadi (weekly) anhydrous ethanol and soybean phosphatidylcholine/glycerol dioleate.
• Brisadi (monthly) N-methyl pyrrolidine and soybean phosphatidylcholine/glycerol dioleate.

Natural rubber latex: The Brixadi needle cap is synthetically derived from natural rubber latex which may cause allergic reactions in latex-sensitive individuals.

Brixadi (weekly) injections are available in 8 mg/0.16 mL, 16 mg/0.32 mL, 24 mg/0.48 mL, 32 mg/0.64 mL.

Brixadi (monthly) injections are available in 64 mg/0.18 mL, 96 mg/0.27 mL, and 128 mg/0.36 mL.

Who makes Brixadi?

Pharmaceutics International, Inc. makes Brixadi for distribution by Braeburn, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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