Brixadi (buprenorphine) is a weekly or monthly injection used to treat moderate to severe opioid use disorder (OUD) which is also known as opioid dependence.  Brixadi can be used for opioid-dependent patients who are already being treated with buprenorphine or who have initiated treatment with a test dose of transmucosal buprenorphine to establish that buprenorphine is tolerated without causing opioid withdrawal.

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 may prefer to have weekly, or monthly medication rather than taking a daily medication. This medicine should be used as part of a complete treatment plan that includes counseling and psychosocial support. 

Brixadi is not used to treat pain; other forms of buprenorphine injection (Buprenex Injection) are used to treat moderate to severe pain.

Brixadi became an FDA-approved medicine on May 23, 2023.

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.

There is a serious risk of potential harm or death from self-injecting this medicine into a vein (intravenously). When you have your injection it will be administered to you by a healthcare provider.

The active ingredient in this medicine is 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.

Talk to your healthcare provider about naloxone. Naloxone is a medicine used 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.

This medicine can cause serious and life-threatening breathing problems. You should 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, or cannot think well or clearly.

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

In an emergency, make sure the emergency department staff are told that you are physically dependent on an opioid and are being treated with Brixadi.

You may have detectable levels of this medicine in your body for several months after stopping treatment.

Brixadi is a subcutaneous injection that is injected under the skin by your healthcare provider once a week or once a month. You should not give yourself this medicine.

This medicine will be injected just under the skin (subcutaneous) of your buttock, thigh, stomach (abdomen), or upper arm.

Injection sites for Brixadi (weekly) 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 are able to 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 (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.

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).
For information on dosing see product information.

What strengths is Brixadi available as?

Brixadi Weekly

• 8mg
• 16mg
• 24 mg
• 32mg

Brixadi Monthly

• 64mg
• 96mg
• 128mg

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

To make sure Brixadi is safe for you, tell your doctor if you have ever had:

• breathing problem, sleep apnea;
• a head injury or brain tumor;
• alcoholism, mental illness;
• an enlarged prostate and urination problems;
• liver or kidney disease;
• a heart rhythm disorder (especially if you take medication to treat it);
• long QT syndrome (in you or a family member);
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);
• curvature of the spine that affects breathing;
• Addison's disease (adrenal gland disorder); or
• problems with your gallbladder or thyroid.
• a latex allergy, as the needle cap contains latex

For patients not currently receiving buprenorphine treatment, begin with a test dose of 4 mg transmucosal buprenorphine to establish that buprenorphine is tolerated without precipitated withdrawal,

Pregnancy

Tell your doctor if you are pregnant or planning a pregnancy. If you receive Brixadi while pregnant, when born, your baby may have symptoms of opioid withdrawal that could be life-threatening if not recognized and treated

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 this medicine Monitor your baby for increased drowsiness and breathing problems if you breastfeed during treatment with this medicine.

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.

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.

Brixadi may cause serious side effects

Get emergency medical help if you have signs of an allergic reaction to Brixadi : hives, itching; severe dizziness; wheezing, difficulty breathing; swelling of your face, lips, tongue, or throat.

Taking this medicine with opioid medicine, benzodiazepines, alcohol, or other central nervous system depressants can slow or stop your breathing, and death may occur.

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.

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

Common Brixadi side effects may include:

• feeling tired;
• nausea, vomiting, constipation;
• itching, redness, pain, or a lump where the medicine was injected;
• headache; or
• abnormal liver function tests.
• trouble sleeping (insomnia)
• urinary tract infection

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.

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.