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Brixadi (buprenorphine) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat adults with moderate to severe opioid use disorder.

How Brixadi Works and How It’s Taken

Brixadi contains buprenorphine. Buprenorphine partly activates a type of opioid receptor called the mu-opioid receptor. It also blocks another type called the kappa-opioid receptor.

In a clinical study, weekly Brixadi reduced the drug-liking effects of hydromorphone, an opioid, in people with moderate to severe opioid use disorder.

Doctors prescribe Brixadi when adults with moderate to severe opioid use disorder have taken a single dose of buprenorphine through the mouth or are already being treated with buprenorphine. Brixadi should be used as part of a complete treatment plan that includes counseling and psychosocial support.

Brixadi is given as an injection just under the skin by a healthcare provider. It may be given once a week or once a month. The injection may be given in the buttock, thigh, abdomen, or upper arm.

If you are not already taking buprenorphine, the upper arm should only be used for weekly Brixadi after you have received four consecutive doses.

Typical Dosing for Opioid Use Disorder

For people who are not currently taking buprenorphine, treatment starts with a 4-milligram dose of buprenorphine given through the mouth. This test dose helps make sure buprenorphine is tolerated without causing sudden opioid withdrawal.

If the test dose is tolerated, the first weekly Brixadi dose is 16 milligrams. An additional 8-milligram dose is given within three days. This brings the recommended dose for the first week to 24 milligrams.

If needed, another 8-milligram weekly dose may be given during the first week, at least 24 hours after the previous injection. The maximum weekly dose is 32 milligrams.

After the first week, the weekly dose is based on the total dose established during week 1. Your healthcare provider may adjust the dose based on how well the medicine is working and how well you tolerate it.

People who are already taking buprenorphine through the mouth may be switched directly to weekly or monthly Brixadi. The dose depends on the person’s current buprenorphine dose.

This information is based on prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.

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Brixadi Side Effects

In a clinical study of Brixadi, the most common side effects each occurred in about 5 percent to 21 percent of people. These included:

  • Injection site pain
  • Headache
  • Constipation
  • Nausea
  • Injection site erythema (redness)
  • Injection site pruritus (itching)
  • Insomnia (trouble sleeping)
  • Urinary tract infection

Serious Side Effects and Warnings

Brixadi can cause serious side effects that may require immediate medical attention. These include:

  • Intravenous administration — Brixadi can cause serious harm or death if injected into a vein. Intravenous use can cause blood vessel blockage, tissue damage, blood clots, or a life-threatening lung clot called a pulmonary embolism.
  • Respiratory and central nervous system depression — This can cause life-threatening breathing problems, including dangerously slow or shallow breathing, and may cause extreme sleepiness, confusion, or coma.
  • Hypersensitivity (severe allergic reactions) — Reactions can include anaphylaxis, a life-threatening allergic reaction that can cause swelling, trouble breathing, or shock.
  • Adrenal insufficiency (low adrenal hormone levels) — Symptoms can include severe tiredness, weakness, nausea, dizziness, or low blood pressure.
  • Liver injury — This can include hepatitis and jaundice, or liver inflammation that can cause yellowing of the skin or eyes, dark urine, or abdominal pain.
  • Opioid withdrawal — Withdrawal symptoms can happen if Brixadi triggers withdrawal or if treatment is stopped suddenly.
  • Serotonin syndrome — This rare but serious reaction can happen when opioids are taken with certain medicines that affect serotonin.
  • Orthostatic hypotension (low blood pressure when standing) — This can cause dizziness or fainting.
  • QTc prolongation (changes in the heart’s electrical activity) — This can raise the risk if you have certain heart or electrolyte problems.
  • Severe injection site complications — These can include a lump, abscess, ulcer, or tissue death called necrosis that may need medical treatment.
  • Hypoglycemia (low blood sugar) — This means blood sugar levels can become too low.
  • Opioid-induced esophageal dysfunction — This can cause swallowing problems due to opioid effects on the esophagus.
  • Elevation of cerebrospinal fluid pressure — This may increase pressure around the brain. People with a head injury, brain problem, or another condition that raises pressure in the brain may need extra caution.
  • Elevation of intracholedochal pressure — Increased pressure in the bile ducts may be a concern for people with gallbladder or bile duct problems.
  • Harder-to-diagnose stomach problems — Brixadi can cause changes that make stomach problems harder to diagnose.

Get medical help right away if you think you are having a serious reaction.

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How To Save on Brixadi

Braeburn, the manufacturer of Brixadi, offers the Brixadi Copay Savings Program. Eligible people with commercial insurance may pay as little as $0 per injection.

The program also offers an online enrollment option. To learn more, visit the Brixadi Copay Savings Program or call 833-274-9234.

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What To Know Before Taking Brixadi

Before starting Brixadi, your doctor will check your liver function with blood tests.

Tell your doctor if you have any allergies to buprenorphine or any ingredients in Brixadi, or if you have a latex allergy. The Brixadi needle cap contains material made from natural rubber latex.

Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.

Do not drive, operate heavy machinery, or do other dangerous activities until you know how Brixadi affects you. Brixadi may make you sleepy, dizzy, or lightheaded and may slow your reaction time. These effects may be more likely during the first few days after an injection or when your dose changes.

Do not drink alcohol or use medicines that contain alcohol during treatment with Brixadi. Combining Brixadi with alcohol can cause loss of consciousness or even death.

Do not receive Brixadi if you are allergic to buprenorphine or any of the ingredients in Brixadi.

If you miss a dose, see your doctor to get your injection as soon as possible. A weekly dose may be given up to two days before or after the scheduled time. A monthly dose may be given up to one week before or after the scheduled time.

Brixadi may also affect fertility in males and females. Talk with your doctor if this is a concern.

Tell your doctor if you are pregnant or plan to become pregnant. If you receive Brixadi during pregnancy, your baby may have opioid withdrawal symptoms after birth. These symptoms can be life-threatening if they are not recognized and treated.

Tell your doctor if you are breastfeeding. Brixadi can pass into breast milk and may harm your baby. Talk with your doctor about the best way to feed your baby during treatment.

If you breastfeed, watch your baby for increased sleepiness or breathing problems.

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Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Brixadi for opioid use disorder?

In a 24-week study of 428 people with moderate to severe opioid use disorder, 16.9 percent of people taking Brixadi met the study’s responder goal. This compared with 14.0 percent of people taking buprenorphine/naloxone under the tongue.

Brixadi also had better overall results based on the percentage of opioid-negative assessments during the study. However, there was little to no difference between the groups among people who had opioid-negative assessments 80 percent or more of the time.

In a separate study, weekly Brixadi at 24 milligrams or 32 milligrams blocked the average drug-liking effects of hydromorphone, an opioid. This blockade was seen after the first Brixadi injection and continued through the first two weekly dosing periods.

How long does Brixadi take to work for opioid use disorder?

In an opioid blockade study, weekly Brixadi at 24 milligrams or 32 milligrams blocked the average drug-liking effects of hydromorphone beginning after the first injection. The blockade continued through the first two weekly dosing periods.

After a Brixadi injection, buprenorphine levels in the blood reach their median peak at about 24 hours with weekly Brixadi and about six to 10 hours with monthly Brixadi. The amount of buprenorphine in the body reaches a steady level by the fourth weekly or monthly dose.

Does Brixadi interact with other medicines?

Yes. Brixadi can interact with some medicines and substances. These interactions may increase side effects or change how well Brixadi works.

Important interactions include:

  • Benzodiazepines and other medicines that slow the brain and breathing — These include sleeping medicines, sedatives, muscle relaxants, antipsychotic medicines, gabapentin, pregabalin, other opioids, and alcohol. Using these with Brixadi can increase the risk of severe sleepiness, breathing problems, coma, overdose, and death.
  • Medicines that affect how buprenorphine is broken down in the body — Some medicines can raise buprenorphine levels, while others can lower them. Examples include certain antifungal medicines, antibiotics, anti-seizure medicines, and HIV medicines.
  • Medicines that affect serotonin — These include some antidepressants and migraine medicines. Using these with Brixadi may increase the risk of serotonin syndrome, a potentially life-threatening condition.
  • Monoamine oxidase inhibitors (MAOIs) — Brixadi is not recommended while taking these medicines or within 14 days after stopping them.
  • Muscle relaxants — These may increase the risk of breathing problems.
  • Diuretics (water pills) — Opioids may make these medicines less effective.
  • Anticholinergic medicines — These may increase the risk of trouble urinating or severe constipation.

Before starting Brixadi, tell your healthcare provider about all prescription medicines, over-the-counter medicines, vitamins, and herbal supplements you take. Your healthcare provider may need to monitor you more closely or adjust your treatment.

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