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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 (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 side effects

The most common side effects of Brixadi include:

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:

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.

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

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

Call your doctor at once if you have:

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:

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.

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.

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.

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:

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).

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.

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

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

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.

Popular FAQ

What is the difference between Sublocade and Brixadi?

Sublocade and Brixadi are both subcutaneous long-acting buprenorphine injections that may be used for the maintenance treatment of opioid misuse disorder in adults. Sublocade was approved on November 30, 2017, and Brixadi was approved on May 23, 2023. Sublocade is administered once a month, with a minimum of 26 days between doses. If extended travel is deemed necessary, a single 300mg injection may be given to cover 2 months. Brixadi is given once a week or once a month. Continue reading

How long does opioid withdrawal last?

How long opioid withdrawal lasts depends on the opioid you have been taking and whether it is a short-acting or long acting opioid.

If you have been using a short-acting opioid, acute opioid withdrawal lasts 4 to 10 days, with withdrawal symptoms starting 8 to 24 hours after last use.

If you have been using a long-acting opioid, acute opioid withdrawal lasts 10 to 20 days, with withdrawal symptoms starting 12 to 48 hours after last use. Continue reading

How long does buprenorphine stay in your system?

After one sublingual (under the tongue) or buccal (in the cheek) dose, buprenorphine stays in your system for about 5 to 8 days if you are healthy or 7 to 12 days if you have liver disease. Continue reading

What are the different brands of buprenorphine?

It is available in a number of dosage forms under the brand names Sublocade, Brixadi, Probuphine (discontinued), Belbuca, Butrans, Buprenex, and Subutex (discontinued). Continue reading

What are the different types of buprenorphine/naloxone?

Buprenorphine and naloxone is a combination medicine used for the maintenance treatment of opioid dependence in adults. It is available in sublingual film and sublingual tablet dosage forms under the brand names Suboxone, Zubsolv, Bunavail (discontinued), and Cassipa (discontinued). Continue reading

How long do you take buprenorphine for?

There is no one-size-fits-all treatment duration for patients taking buprenorphine. There are many factors involved in determining the length of treatment when administering buprenorphine. Continue reading

Is Buprenex the same as buprenorphine?

Yes, Buprenex is the brand name for an injectable form of buprenorphine. Buprenex (generic name: buprenorphine) is a potent opioid (narcotic) medication used to manage pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Continue reading

Further information

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