buprenorphine ER 128 mg/0.36 mL solution,ext.rel.subcutaneous syringe

Generic name:
Buprenorphine extended-release - subcutaneous injection

Pronunciation
(BUE-pre-NOR-feen)

Brand name(s)
Brixadi , Sublocade

This medication must be given only by injection under the skin. This form of buprenorphine changes from a liquid to a more solid form upon contact with body fluids, so giving it by injection into a vein or muscle may cause serious harm or death. Blockage, dangerous blood clots, or local injury can happen if this medication is not used properly.

Ask your doctor or pharmacist if you should have naloxone available to treat opioid overdose. Teach your family or household members about the signs of an opioid overdose and how to treat it.

Buprenorphine is used to treat opioid use disorder. This long-acting form of buprenorphine should be used only after treatment with a transmucosal form of buprenorphine (one that is used under the tongue or inside the cheek). Buprenorphine belongs to a class of drugs known as mixed opioid agonist-antagonists. It helps prevent withdrawal symptoms caused by stopping other opioids. It is used as part of a complete treatment program for opioid use disorder (such as compliance monitoring, counseling, behavioral contract, lifestyle changes).

Read the Medication Guide provided by your pharmacist before you start using buprenorphine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection under the skin as directed by your doctor. Depending on your brand, it is usually given once weekly or once monthly by a health care professional. After injection, this medication changes from a liquid to a more solid form (depot). You may see or feel a small bump under your skin at the injection site. The bump will get smaller over time. Do not try to remove the depot. Do not rub or massage the injection site. Try not to let belts or clothing waistbands rub against the injection site.

The dosage is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder. If you miss a dose, contact your doctor or pharmacist right away.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as restlessness, watering eyes, runny nose, nausea, sweating, muscle aches). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used buprenorphine for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

Nausea, vomiting, drowsiness, dizziness, constipation, or headache may occur. Pain, itching, or redness at the injection site may also occur. If any of these effects last or get worse, tell your doctor or pharmacist right away.

To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Severe (possibly fatal) breathing problems can occur if this medication is abused or used with other depressants (such as alcohol, benzodiazepines including diazepam, other opioids).

Tell your doctor right away if you have any serious side effects, including:

• pus/blister/ulcer at injection site
• interrupted breathing during sleep (sleep apnea)
• mental/mood changes (such as agitation, confusion, hallucinations)
• stomach/abdominal pain
• signs of your adrenal glands not working well (such as unusual tiredness, weight loss)

Get medical help right away if you have any very serious side effects, including:

• fainting
• fast/irregular heartbeat
• severe dizziness
• slow/shallow breathing
• unusual drowsiness/difficulty waking up

Although this medication is used to prevent withdrawal reactions, it may rarely cause opioid withdrawal symptoms, including diarrhea, severe mental/mood changes (such as anxiety, irritability, trouble sleeping), muscle stiffness or shakiness. This is more likely when you first start treatment or if you have been using long-acting opioids such as methadone. If such symptoms occur, tell your doctor or pharmacist right away.

This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, such as:

• nausea/vomiting that doesn't stop
• loss of appetite
• severe stomach/abdominal pain
• yellowing eyes/skin
• dark urine

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as latex found in the needle cap of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• brain disorders (such as head injury, tumor, seizures)
• breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD)
• liver disease
• mental/mood disorders (such as confusion, depression)
• stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus)
• difficulty urinating (such as due to enlarged prostate)

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Alcohol also increases your risk for breathing problems. Talk to your doctor if you are using marijuana (cannabis).

Buprenorphine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using buprenorphine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions:

• certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG)
• family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death)

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using buprenorphine safely.

Tell all of your doctors that you use this medication and have regularly used opioids, especially in cases of emergency treatment.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, slow/shallow breathing, and QT prolongation (see above).

Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, use the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, crying that is unusual or does not stop, vomiting, or diarrhea.

This drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor right away if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• certain pain medications (mixed opioid agonist-antagonists such as butorphanol, nalbuphine, pentazocine)
• naltrexone
• samidorphan

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is used with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, give them naloxone if available, then call 911. If the person is awake and has no symptoms, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: slow breathing, slow heartbeat, loss of consciousness.

Do not share this medication with others. Sharing it is against the law.

Lab and/or medical tests (such as liver function) should be done while you are using this medication. Keep all medical and lab appointments.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital or clinic or doctor's office and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.