Brixadi, Butrans

Buprenorphine Extended-Release Injection

(byoo pre NOR feen)

Sublocade

This drug may cause very bad and sometimes deadly breathing problems. Call your doctor right away if you have slow, shallow, or trouble breathing. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. This drug has an opioid drug in it. Severe side effects have happened when opioid drugs were used with benzodiazepines or other drugs that may make you drowsy or slow your actions. This includes slow or troubled breathing and death. Benzodiazepines include drugs like alprazolam, diazepam, and lorazepam. Benzodiazepines may be used to treat many health problems like anxiety, trouble sleeping, or seizures. If you have questions, talk with your doctor. Many drugs interact with this drug and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use this drug with all of your drugs. Do not take with alcohol or products that have alcohol. Unsafe and sometimes deadly effects may happen. Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up. Using this drug for a long time during pregnancy may lead to withdrawal in the newborn baby. This can be life-threatening. Talk with the doctor. This drug is given into the fatty part of the skin only. If given other ways (into a vein or muscle), this can be deadly. If you have questions, talk with the doctor.

It is used to treat pain drug (opioid) addiction. This drug is only for use by people who have been taking pain drugs (opioids) and are used to their effects. Talk with the doctor.

If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had. If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing. If you have liver disease. If you or a family member have a long QT on ECG. If you are taking any of these drugs: Butorphanol, nalbuphine, or pentazocine. If you are using another drug that has the same drug in it. If you are taking any of these drugs: Certain drugs to treat a heartbeat that is not normal like amiodarone, disopyramide, dofetilide, procainamide, quinidine, or sotalol. If you are taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure. If you have taken certain drugs for depression or Parkinson's disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen. If you are taking any of these drugs: Linezolid or methylene blue. If you are breast-feeding. Do not breast-feed while you take this drug. This is not a list of all drugs or health problems that interact with this drug. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists. Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you. To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs. Very bad and sometimes deadly liver problems have happened with this drug. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes. Long-term use of an opioid drug may lead to lower sex hormone levels. Call your doctor if you have a lowered interest in sex, fertility problems, no menstrual period (women), or change in sex ability (men). This drug may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to your doctor to see if you have a greater chance of seizures while taking this drug. Taking an opioid drug like this drug may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak. If you are 65 or older, use this drug with care. You could have more side effects. This drug may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this drug, call your doctor right away. This drug is not approved for use in children. Talk with the doctor. Follow up with the doctor as you have been told. Be sure you know how to treat pain while you take this drug. Do not take opioid pain drugs unless your doctor tells you to. Pain drugs may not work as well while you take this drug. Do not take more pain drugs to try to get them to work. If you have an emergency, tell your health care provider that you take this drug. If you have questions, talk with your doctor. If you need to stop treatment with this drug, you will need to watch for signs of withdrawal. Tell your doctor if you have any bad effects. If you have questions, talk with your doctor. If this drug comes out by itself, keep it away from children. Accidental exposure may cause death. If someone else, especially a child, is exposed to this drug by accident, get medical help right away. Do not try to take this drug out by yourself. This could lead to infection and withdrawal. Talk with your doctor. Try not to touch the area where this drug is put in very often. Touching it often may raise the chance of infection.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Sweating a lot. Fast, slow, or abnormal heartbeat. Feeling nervous and excitable. Fever, chills, or sore throat. Change in balance. Mood changes. Severe constipation or stomach pain. These may be signs of a severe bowel problem. Extra muscle action or slow movement. Swelling in the arms or legs. Change in eyesight. A burning, numbness, or tingling feeling that is not normal. Trouble speaking. Chest pain or pressure or passing out. Noisy breathing. Breathing problems during sleep (sleep apnea). Trouble passing urine. Hallucinations (seeing or hearing things that are not there). Muscle or joint pain. Memory problems or loss. Seizures. Shakiness. Slurred speech, stumbling, or feeling confused, very sleepy or dizzy, or drunk. Not able to focus. A severe and sometimes deadly problem called serotonin syndrome may happen if you take this drug with certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or severe headache. Implant and long-acting injection: Irritation where this drug is given. Swelling, warmth, or redness where this drug was given.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: Constipation, diarrhea, stomach pain, upset stomach, or throwing up. Feeling dizzy, sleepy, tired, or weak. Headache. Trouble sleeping. Back pain. Dry mouth. Signs of a common cold. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely. Do not take this drug with other strong pain drugs or if you are using a pain patch without talking to your doctor first. If you drink grapefruit juice or eat grapefruit often, talk with your doctor. Have blood work checked as you have been told by the doctor. Talk with the doctor. This drug may cause withdrawal symptoms if you are dependent or addicted to narcotics. Talk with your doctor. It is given as a shot into the fatty part of the skin. Do not use pressure (waist band or belt) on the part where the shot is given.

Call your doctor to find out what to do.

If you need to store this drug at home, talk with your doctor, nurse, or pharmacist about how to store it. Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

If your symptoms or health problems do not get better or if they become worse, call your doctor. Do not share your drugs with others and do not take anyone else's drugs. This drug comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this drug is refilled. If you have any questions about this drug, please talk with the doctor, pharmacist, or other health care provider. If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.