Class Name(s):

• 28:08.12 Opioid Partial Agonists

Pronunciation:

• (byoo pre nor' feen)

Brand Name(s):

• Brixadi^®
• Sublocade^®

IMPORTANT WARNING:

Because of the risks with this medication, buprenorphine injection is only available through a special distribution program called the Brixadi^® and Sublocade^® REMS. Your doctor and your pharmacy must be enrolled in this program before you can receive buprenorphine injection. Ask your doctor for more information about this program and how you will receive your medication.

Keep all appointments with your doctor and the laboratory.

You will be given the Medication Guide when you begin treatment with buprenorphine extended-release injection and each time you receive a dose. Read the information carefully and ask your doctor or pharmacist if you have any questions.

WHY is this medicine prescribed?

Buprenorphine injection is used to treat certain people who are addicted to opioid (narcotic) drugs. Buprenorphine injection is in a class of medications called opiate partial agonists. It works to prevent withdrawal symptoms when someone stops taking opioid drugs.

HOW should this medicine be used?

Buprenorphine injection comes as an extended-release (long-acting) solution (liquid) to be injected subcutaneously (just under the skin) by a health care provider into the stomach area, thigh, buttock, or upper arm. Inject once a week or once a month. Each type of buprenorphine injection slowly releases the drug into your body over a week or a month.

After you receive a dose of buprenorphine injection, you may notice a lump at the injection site for several weeks. It should decrease in size over time. Do not rub or massage the injection site. Be sure that your belt, waistband, or sleeve does not put pressure on the place where the medication was injected.

Your doctor may increase or decrease your dose depending on how well the medication works for you, and any side effects you experience.

Talk to your doctor or pharmacist about access to rescue medicines, naloxone or nalmefene, while using buprenorphine injection. Rescue medications can reverse the life-threatening effects of an opioid overdose and are available from a community-based program, over the counter, or with a prescription. Make sure that you and your family members and people usually around you know how to recognize an overdose, how to use naloxone or nalmefene, and what to do until emergency medical help arrives. Your doctor or pharmacist will show you and others how to use it. If symptoms of an overdose occur, they should give the first dose of naloxone, call 911 immediately, and stay with you and watch you closely until emergency medical help arrives. If your symptoms return, the person should give you another dose of the rescue medication. Additional doses may be given every 2 to 3 minutes, if symptoms return before medical help arrives.

Are there OTHER USES for this medication?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before receiving buprenorphine injection,

• tell your doctor and pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• you should know that some medications should not be taken with buprenorphine. Make sure you have discussed any medications you are currently taking or plan to take before starting buprenorphine with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking buprenorphine, please get the advice of your doctor or pharmacist.
• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid, linezolid, methylene blue, phenelzine, selegiline, or tranylcypromine.
• the following nonprescription or herbal products may interact with buprenorphine injection: St. John's wort and tryptophan. Be sure to let your doctor and pharmacist know that you are taking these medications before you start receiving buprenorphine injection. Do not start these medications while receiving buprenorphine injection without discussing it with your healthcare provider.
• tell your doctor if you or a family member drinks or has ever drunk large amounts of alcohol or have or have ever had prolonged QT syndrome (condition that increases the risk of developing an irregular heartbeat that may cause loss of consciousness or sudden death). Also, tell your doctor if you have or have ever had heart failure; a slow or irregular heartbeat; chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways); other lung diseases; a head injury; a brain tumor; any condition that increases the amount of pressure in your brain; adrenal problems such as Addison's disease (condition in which the adrenal gland produces less hormone than normal); benign prostatic hypertrophy (BPH, enlargement of the prostate gland); difficulty urinating; depression or other mental illness; a curve in the spine that makes it hard to breathe; liver disease, including hepatitis B or C; or thyroid or gallbladder disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while receiving buprenorphine call your doctor immediately. You should not breastfeed while receiving buprenorphine injection.
• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of using buprenorphine extended-release injection.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving buprenorphine injection.
• you should know that buprenorphine injection may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• you should not drink alcohol or use street drugs during your treatment. Drinking alcohol, taking prescription or nonprescription medications that contain alcohol, or using street drugs during your treatment with buprenorphine injection increases the risk that you will experience serious and life-threatening breathing problems.
• you should know that buprenorphine injection may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• you should know that buprenorphine injection may cause constipation. Talk to your doctor about changing your diet or using other medications to prevent or treat constipation while you are using buprenorphine injection.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss a scheduled buprenorphine injection dose, you should call your doctor to receive the dose as soon as possible.

What SIDE EFFECTS can this medicine cause?

Buprenorphine injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea, vomiting
• headache
• fatigue
• difficulty falling asleep or staying asleep
• pain, itching, swelling, discomfort, redness, bruising, or bumps in the injection site
• painful or difficult urination
• decreased sexual desire, inability to get or keep an erection

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately or get emergency medical treatment:

• slowed, shallow, or difficulty breathing
• extreme drowsiness, shortness of breath.
• agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, slurred speech, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea
• nausea, vomiting, loss of appetite, weakness, or dizziness
• rash; hives; itching; difficulty breathing or swallowing; lightheadedness; feeling faint; or swelling of your face, throat, tongue, lips, or eyes
• restlessness, teary eyes, sweating, chills, widening of the pupils (black circles in the middle of the eyes), irritability, anxiety, backache, weakness, stomach cramps, difficulty falling asleep or staying asleep, nausea, loss of appetite, vomiting, diarrhea, fast breathing, or fast heartbeat
• blurred vision
• chest pain, changes in heartbeat
• yellowing of the skin or eyes, dark-colored urine, light-colored stools, loss of appetite, nausea, or pain in the upper right part of the stomach
• unusual snoring or long pauses during breaths during sleep

Buprenorphine injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

Call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• narrowing or widening of the pupils (black circles in the center of the eye)
• slowed, shallow, or difficulty breathing
• extreme sleepiness or drowsiness
• unable to respond or wake up
• coma (loss of consciousness for a period of time)
• slow heartbeat

What OTHER INFORMATION should I know?

Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are using buprenorphine injection.

In the case of an emergency, a family member or caregiver should tell the emergency medical staff that you are physically dependent on an opioid and are receiving treatment with buprenorphine injection.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™ Copyright, 2026. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: April 15, 2026.