Brixadi (buprenorphine)

Brixadi generic

Brixadi is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs.

A different injectable form of buprenorphine (the active drug in Brixadi) is available in a generic form. A buprenorphine oral tablet that dissolves under your tongue is also available in a generic form. If you’re interested in using a generic form of buprenorphine, talk with your doctor.

Common questions about Brixadi

Here are answers to some frequently asked questions about Brixadi.

Is Brixadi similar to Sublocade?

Yes, in several ways. Brixadi and Sublocade are prescribed to treat opioid use disorder (OUD) in adults. Each drug contains an extended-release* form of buprenorphine given as a subcutaneous injection.

Doses of both Brixadi and Sublocade may be given once per month. However, Brixadi can also be given once per week. To learn more about Brixadi’s dosage, see the “Brixadi dosage” section below. For details about Sublocade’s dosage, see this article.

If you have other questions about how Brixadi and Sublocade are alike and different, talk with your doctor or pharmacist.

* “Extended release” means the drug is long-acting and slowly releases into your body over a long period of time.

How does Brixadi work?

Brixadi is prescribed to treat OUD. With OUD, a person is unable to stop taking opioids even though doing so may be causing harm.

Brixadi belongs to a class of drugs called partial opioid agonists. It works by attaching to opioid receptors (binding sites) in the body. However, Brixadi doesn’t activate these receptors as strongly as other opioids. In this way, Brixadi helps reduce opioid cravings without causing the euphoric feeling that other opioids can cause.

Brixadi can also help prevent withdrawal symptoms that may happen after stopping other opioids. Withdrawal symptoms are side effects that can occur when you stop taking a drug your body has become dependent on. With dependence, your body needs a drug to function as usual.

To learn more about how Brixadi works, talk with your doctor or pharmacist.

Does Brixadi cause long-term side effects?

Yes, it’s possible. Specifically, long-term use of Brixadi may lead to adrenal insufficiency. With this condition, the adrenal glands don’t make enough of a hormone called cortisol. This condition may cause symptoms such as fatigue, loss of appetite, and muscle weakness.

Liver problems, such as liver failure, are also a possible side effect of Brixadi. In rare cases, this side effect can be long term.

Keep in mind that suddenly stopping Brixadi treatment after long-term use may also cause withdrawal symptoms. These are side effects that can occur when you stop taking a drug your body has become dependent on. With dependence, your body needs a drug to function as usual. To learn more, see the “Brixadi withdrawal and dependence” section below.

If you have questions about Brixadi and long-term side effects, talk with your doctor or pharmacist.

Brixadi cost

As with all medications, the cost of Brixadi can vary. The actual price you’ll pay depends on your insurance plan, your location, and where you receive Brixadi injections.

Financial and insurance assistance: If you need financial support to pay for Brixadi or help to understand your insurance coverage, help is available.

To learn more about saving money on prescriptions, check out this article.

Generic version: Brixadi is not available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

Brixadi dosage

The Brixadi dosage your doctor prescribes will depend on the severity of your condition or any side effects you may have. It also depends on whether you’re already taking buprenorphine oral tablets that dissolve under your tongue.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Brixadi comes as a solution in a single-use syringe. It’s given as a subcutaneous injection by a healthcare professional.* They’ll inject the drug under the skin of your arm, abdomen, buttock, or thigh.

Brixadi is available in several strengths that vary depending on how often the injection is given.

Brixadi weekly injections are available in four strengths:

• 8 milligrams (mg) in 0.16 milliliters (mL) of solution
• 16 mg/0.32 mL
• 24 mg/0.48 mL
• 32 mg/0.64 mL

Brixadi monthly injections are available in three strengths:

• 64 mg/0.18 mL
• 96 mg/0.27 mL
• 128 mg/0.36 mL

* Brixadi has a boxed warning for the risk of serious harm with injection into a vein. This is a serious warning from the FDA. To learn more, see the “Brixadi precautions” section below.

Dosage for opioid use disorder

For opioid use disorder (OUD), Brixadi may be given weekly (once every 7 days) or monthly (once every 28 days). Your dosage will depend on whether you’re already taking buprenorphine oral tablets that dissolve under your tongue.

Not already taking oral buprenorphine

If you’re not already taking oral buprenorphine, your healthcare professional will likely start by giving you at least one dose of oral buprenorphine. They’ll do this to make sure you don’t have withdrawal symptoms from stopping opioids.*

After that, your healthcare professional will likely start weekly injections of Brixadi. You’ll receive one 16-mg injection of Brixadi on the first day. Up to 3 days later, you’ll receive one injection of 8 mg. After that, you’ll receive 24 mg of Brixadi once per week.

Your healthcare professional may increase your dosage to 32 mg of Brixadi once per week. This will depend on how effective the drug is for you and the severity of any side effects you may have.

* Withdrawal symptoms are side effects that can occur when you stop taking a drug your body has become dependent on. With dependence, your body needs a drug to function as usual.

Already taking oral buprenorphine

If you’re already taking oral buprenorphine, your healthcare professional may switch you to weekly or monthly injections of Brixadi. Your Brixadi dosage will depend on your current oral buprenorphine dosage, as shown in the table below.

About taking Brixadi

Below you’ll find information about key dosage issues.

• When to take: You’ll receive one injection of Brixadi each week or month.Receiving the medication around the same time of week or month helps keep a steady level of the drug in your body. This helps Brixadi work effectively.
• If you miss a dose: If you miss an appointment to receive your Brixadi injection, call your healthcare professional. They’ll help you reschedule your appointment as soon as possible.
• Length of use: Brixadi may be used as a long-term treatment. If you and your doctor determine that Brixadi is safe and effective for you, you’ll likely receive it long term.

Brixadi side effects

Brixadi can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Brixadi. These lists do not include all possible side effects.

For more information about the possible side effects of Brixadi, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you’d like to notify the FDA about a side effect you’ve had with Brixadi, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of Brixadi. To learn about other mild side effects, talk with your doctor or pharmacist, or view Brixadi’s prescribing information.

Mild side effects of Brixadi can include:

• constipation
• headache
• insomnia
• joint pain
• nausea
• injection site reactions, such as itching, pain, or skin discoloration
• urinary tract infection (UTI)
• mild allergic reaction*

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

* For more information about allergic reaction and Brixadi, see “Allergic reaction” below.

Serious side effects

Serious side effects from Brixadi aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• Respiratory depression. Symptoms can include:
  • shallow, slow, or weak breathing
  • confusion
  • fatigue
• Central nervous system (CNS) depression. Symptoms can include:
  • loss of coordination
  • sleepiness
  • dizziness
• Liver problems, such as hepatitis. Symptoms can include:
  • jaundice
  • dark urine
  • upper right abdominal pain
  • nausea and vomiting
• Adrenal insufficiency. Symptoms can include:
  • fatigue
  • loss of appetite
  • muscle weakness
  • abdominal pain
• Orthostatic hypotension. Symptoms can include:
  • feeling lightheaded
  • dizziness
  • blurry vision
• Opioid withdrawal, if you’re taking opioids and receive Brixadi. Symptoms can include:
  • diarrhea
  • vomiting
  • muscle aches
  • sweating more than usual
• Risk of serious harm with injection into a vein.*
• Severe allergic reaction.†

* Brixadi has a boxed warning for this side effect. This is a serious warning from the FDA. To learn more, see the “Brixadi precautions” section below.
† For details about allergic reaction and Brixadi, see “Allergic reaction” below.

ALLERGIC REACTION

As with most drugs, some people can have an allergic reaction after taking Brixadi. This was reported in clinical trials of other forms of buprenorphine, but it’s not clear if it happened in Brixadi studies. It has also been reported since the drug was approved.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have an allergic reaction to Brixadi, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency

Brixadi uses

The Food and Drug Administration (FDA) approves prescription drugs such as Brixadi to treat certain conditions.

Brixadi for opioid use disorder

Brixadi is FDA-approved to treat moderate to severe opioid use disorder (OUD) in adults.

With OUD, a person is unable to stop taking opioids even though doing so may be causing harm. Opioids are a group of drugs prescribed to relieve pain. Examples include hydrocodone (Hysingla ER) and morphine (Mitigo, MS Contin).

For this purpose, Brixadi is prescribed after you’ve taken at least one dose of buprenorphine oral tablets that dissolve under your tongue. Doctors typically prescribe Brixadi in combination with counseling and other mental health support.

Your doctor may also advise you to have naloxone (Narcan, Kloxxado, others) available during Brixadi treatment. This drug can help treat an opioid overdose that may occur if you take other opioids with Brixadi. Naloxone may be available without a prescription at your local pharmacy. To learn more about this, talk with your doctor or pharmacist.

Brixadi and children

Brixadi is not FDA-approved for use in children. It’s unknown whether the drug is safe or effective for children.

Brixadi interactions

Brixadi can interact with several other medications. However, the drug isn’t known to interact with supplements or foods.

Before taking Brixadi, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you take. Sharing this information can help you avoid potential interactions.

Medication interactions

Below is a list of medications that can interact with Brixadi. This list does not contain all drugs that may interact with Brixadi. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Alcohol interaction

It’s not safe to consume alcohol during Brixadi treatment.

This is because drinking alcohol with Brixadi may increase the risk of certain side effects with Brixadi. These include central nervous system (CNS) depression and respiratory depression. With CNS depression, your brain activity slows. With respiratory depression, your breathing is shallow, slow, or weak. These side effects may cause symptoms such as confusion, sleepiness, dizziness, and shortness of breath. In extreme cases, CNS and respiratory depression can lead to coma or death.

Due to these risks, if you drink alcohol, the manufacturer of Brixadi recommends not consuming it during treatment with this drug.

If you have questions about the safety of alcohol and Brixadi, talk with your doctor or pharmacist.

Similar drugs

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Brixadi, talk with your doctor. They can tell you about other medications that may work well for you.

The following drugs are similar to Brixadi:

• other injectable drugs, such as:
  • buprenorphine (Sublocade)
  • naltrexone (Vivitrol)
• oral drugs, such as:
  • buprenorphine oral tablets that dissolve under your tongue
  • buprenorphine/naloxone (Suboxone, Zubsolv)
  • methadone (Methadose)

Things to consider when taking Brixadi

If you can become pregnant, consider the following information about pregnancy and breastfeeding.

Brixadi and pregnancy

There are risks to receiving Brixadi injections during pregnancy. This includes the risk of opioid withdrawal in an infant after birth. With this condition, the infant may have uncomfortable side effects after they stop receiving a drug their body has gotten used to. However, there are also risks with having untreated opioid use disorder (OUD) while pregnant. (Brixadi is prescribed to treat OUD.)

If you’re planning a pregnancy or can become pregnant, talk with your doctor about potential treatments for OUD during pregnancy. Together, you can consider the risks and benefits of your treatment options and decide whether you should receive Brixadi injections during pregnancy.

Brixadi and breastfeeding

It’s not known whether Brixadi should be used while breastfeeding. The drug passes into breast milk, which may cause drowsiness and breathing problems in a child who’s breastfed. If you’re breastfeeding or planning to do so, talk with your doctor before starting treatment with this medication.

Brixadi precautions

This drug comes with several precautions.

FDA warning: Risk of serious harm with injection into a vein

This drug has a boxed warning. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Risk of serious harm with injection into a vein. Brixadi is given as a subcutaneous injection by a healthcare professional. It’s not given as an intravenous (IV) injection into a vein.

This is because Brixadi forms a solid mass after it’s injected. Injecting the drug into a vein may cause the mass to block the blood supply to your body. This can lead to serious conditions, such as tissue damage around the injection site and blood clots. In some cases, the effects of having a reduced blood supply can be fatal.

Due to this risk, Brixadi is injected only by a healthcare professional certified by the Brixadi risk evaluation and mitigation strategy (REMS) program. This program helps ensure that Brixadi is injected safely. To learn more about this risk and the Brixadi REMS program, talk with your doctor. You can also visit the Brixadi REMS website or call 833-274-9234.

Other precautions

Before taking Brixadi, discuss your health history with your doctor. Brixadi may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

• alcohol use disorder
• breathing problems, such as sleep apnea
• brain or head injury
• gallbladder problems
• Addison’s disease
• a curve in your spine, such as scoliosis or kyphosis, which affects breathing
• mental health condition, such as depression
• liver problems, such as liver failure
• factors that increase the risk of long QT syndrome, such as heart failure or low blood levels of potassium
• previous allergic reaction to latex, Brixadi, or a similar drug
• pregnancy
• breastfeeding

Note: For more information about the potential adverse effects of Brixadi, see the “Brixadi side effects” section above.