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Overview: Brixadi is a long-acting injection used to treat opioid use disorder. It partially activating the same receptors in your body as opioids. Common side effects include pain, redness, and itching at the injection site, constipation, nausea, insomnia, and urinary tract infection.

Uses

What is Brixadi used for?

Brixadi is commonly used for opioid use disorder disorder to help people reduce or stop their use of opioids. After injection,  a depot forms under your skin that slowly releases the medicine over the entire week or month.

Brixadi may also be used for other conditions as determined by your health care provider.

How does Brixadi work (mechanism of action)?

Brixadi attaches to opioid receptors in the brain. This makes opioids less likely to attach, blocking their rewarding effects.

How is Brixadi supplied (dosage forms)?

Brixadi is available as a subcutaneous (under the skin) injection that is given by a health care provider.

How should I store Brixadi?

Brixadi injection is given by a health care provider in a hospital or clinic. You will not store it at home.

Side Effects

What are the most common side effects of Brixadi?

The most common side effects of Brixadi are listed below. These side effects may vary depending on the Brixadi product you are using. Tell your health care provider if you have any of these side effects that bother you.

  • Nausea
  • Constipation
  • Urinary tract infection
  • Headache
  • Itching, redness, or pain at the injection site
  • Trouble sleeping (insomnia)

There may be other side effects of Brixadi that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Brixadi?

While less common, the most serious side effects of Brixadi are described below, along with what to do if they happen.

Severe Allergic Reactions. Brixadi may cause allergic reactions, which can be serious. Stop using Brixadi and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Breathing Problems. Brixadi may cause slow or shallow breathing, especially if you have breathing problems from another condition or take other medicines that can slow your breathing. Tell your health care provider right away if you develop severe sleepiness or trouble breathing, especially when you start Brixadi or when your dose is increased. Get emergency help if you have any of the following symptoms.

  • Changes in the color of your skin, including bluish color to your lips and fingernails
  • Confusion
  • Shortness of breath
  • Feeling dizzy, lightheaded, or fainting
  • Changes in your heart rate or rhythm, such as a fast, slow, pounding or skipping heartbeat
  • Slow or shallow breathing
  • Excessive sleepiness or trouble staying awake 

Low Blood Pressure (Hypotension). Brixadi may cause low blood pressure, including a sudden drop in blood pressure when standing up from a seated or lying position (orthostatic hypotension). To help prevent this, be careful not to get up too quickly. If you feel faint or dizzy, sit or lie down until the dizziness stops, then take your time getting up again. Tell your health care provider right away if you have any of the following symptoms of low blood pressure.

  • Dizziness, feeling lightheaded, or fainting
  • Confusion
  • Feeling weak or tired

Risk of Misuse and Addiction. Misusing Brixadi can lead to serious side effects like coma or death. Misuse means using a medicine in a way other than how it was prescribed. Use Brixadi exactly as prescribed. Tell your health care provider if you feel that Brixadi is not working. Call your health care provider right away or go to the nearest emergency room if you have any of the following serious symptoms.

  • Sudden confusion or feeling disoriented
  • Feeling paranoid
  • Suicidal thoughts or actions
  • Seizures
  • Trouble breathing

Liver Damage. Liver damage, also called hepatotoxicity, can happen when using Brixadi, especially if you have or are at risk for liver disease. Keep all appointments with your health care provider to check your blood work before and during treatment. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Central Nervous System (CNS) Depression. Brixadi may slow down your central nervous system (CNS), which controls many vital functions throughout the body. Call your health care provider right away if you have any of the following symptoms of CNS depression.

  • Confusion
  • Excessive sleepiness or trouble staying awake
  • Memory problems
  • Slow or shallow breathing
  • Slowed response or reaction time
  • Slurred speech

Warnings & Precautions

Who should not use Brixadi?

Allergies to Ingredients. People who are allergic to any of the following should not use Brixadi.

  • Buprenorphine
  • Brixadi
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Brixadi.

What should I know about Brixadi before using it?

People using Brixadi should have naloxone available in case of an emergency. Brixadi is a type of opioid and may cause a bad reaction where your breathing slows or potentially stops. Naloxone is a medicine used to reverse the effects of opioids. Your health care provider can tell you how to use and where to get naloxone. You should teach your family, friends, and caregivers when and how to use naloxone in case of an overdose. If naloxone is used, be sure to call 911. 

Brixadi turns into a gel form called a depot after it is injected. You may not be able to feel the depot under your skin. Do not try to remove the depot.

Brixadi can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how Brixadi affects you.

Brixadi can cause physical dependence, which means your body relies on the medicine. If you stop Brixadi suddenly, it could lead to withdrawal symptoms, which may require you to go to the hospital. Physical dependence is not necessarily a sign that you have developed a substance use disorder. Do not stop using Brixadi without talking with your health care provider. Your health care provider can tell you how to stop Brixadi to reduce the risk of withdrawal reactions. Call your health care provider right away or go to the nearest emergency room if you have any of the following serious symptoms.

  • Sweating
  • Shaking more than normal 
  • Feeling more hot or cold than normal
  • Runny nose
  • Watery eyes
  • Goosebumps
  • Vomiting or diarrhea
  • Muscle aches

You should tell all of your health care providers that you are using Brixadi. Also tell your family, friends, or caregivers to let all of your health care providers know that you are using Brixadi in an emergency. Brixadi can cause life-threatening problems when used with certain medicines or anesthesia.

Brixadi works best when combined with counseling, behavioral therapy, and support. Brixadi can be used for as long as you feel it is helping for opioid use disorder. Keep all counseling appointments your health care provider recommends. If you want to stop using Brixadi, call your health care provider. 

People who are 65 or older can be at greater risk for some side effects from Brixadi. Talk to your health care provider about your risks if you are in this age group.

Using Brixadi for a long time may affect your ability to become pregnant or get a partner pregnant. Talk with your health care provider if you have any concerns.

What should I tell my health care provider before using Brixadi?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Brixadi is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have or have had any of the following.

Other Medicines and Supplements. Brixadi may interact with other medicines and supplements. Before using Brixadi, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Brixadi may cause harm to an unborn baby. If you use Brixadi during pregnancy, your baby may have withdrawal symptoms that can be life-threatening if not treated. Tell your health care provider if you are or plan to become pregnant, or if you used Brixadi while pregnant. Your health care provider will advise you if you should use Brixadi while you are pregnant or trying to get pregnant.

Breastfeeding. Brixadi passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will advise you if you should use Brixadi while breastfeeding.

For more information about Brixadi, you can visit the drugmaker’s website at www.brixadi.com or call them at 833-274-9234.

Interactions

Does Brixadi interact with foods or drinks?

There are no known interactions between Brixadi and foods or nonalcoholic drinks.

Do not use Brixadi with alcohol or with over-the-counter medicines that contain alcohol. Using Brixadi with alcohol may cause breathing problems that may be life-threatening.

Does Brixadi interact with other medicines (drug interactions)?

  • A benzodiazepine, such as clonazepam (Klonopin), diazepam (Valium and others), or lorazepam (Ativan and others), which is a medicine used for anxiety, muscle spasms, or seizures
  • An opioid, such as oxycodone, morphine, codeine, fentanyl, or butorphanol, which is a medicine used for certain types of pain
  • A monoamine oxidase inhibitor (MAOI) within the past two weeks, which is a medicine usually used for depression or Parkinson’s disease
  • A muscle relaxant, such as carisoprodol (Soma), cyclobenzaprine, metaxalone, or tizanidine (Zanaflex)
  • A diuretic, also called a water pill, which is a medicine used to reduce edema (fluid retention) and blood pressure
  • An anticholinergic medicine, which includes antihistamines and medicines commonly used for overactive bladder, Parkinson’s disease, or stomach problems
  • Erythromycin (Ery-Tab and others), which is a medicine used for bacterial infections
  • A medicine for HIV or AIDS
  • Ketoconazole, which is a medicine used for fungal infections
  • Carbamazepine (Carbatrol, Tegretol, and others) or phenytoin (Dilantin, Phenytek, and others), which is a medicine commonly used to treat seizures 
  • Rifampin, which is a medicine commonly used to treat an infection called tuberculosis
  • A selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI), which is a medicine commonly used for anxiety and depression
  • A tricyclic antidepressant, such as amitriptyline, nortriptyline, or protriptyline, even if it is not used for depression
  • A triptan, such as eletriptan (Relpax), sumatriptan (Imitrex and others), and others, which is a medicine commonly used to treat migraines
  • Digoxin (Lanoxin), which is a medicine used to treat irregular heartbeat and some types of heart failure
  • Any other medicine that causes dizziness and sleepiness, such as prescription pain medicines, sleep medicines, or medicines for anxiety

Many other medicines may alter the blood levels of Brixadi. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Brixadi. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Brixadi?

If you or someone else has used too much Brixadi, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222. 

It is also important to have naloxone on hand in case of an opioid overdose. Be sure that you and your family, caregivers, and friends know how to recognize an opioid overdose and how to use naloxone. See the Warnings & Precautions section for more details.

What should I do if I miss a dose of Brixadi?

If you miss a dose of Brixadi, contact your health care provider as soon as possible to receive your next dose.