Generic Name: Buprenorphine Extended-Release Injection (byoo pre NOR feen)
Brand Name: Sublocade
- This medicine 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 medicine has an opioid drug in it. The use of opioid drugs along with a benzodiazepine drug or other drugs that may make you drowsy or slow your actions has led to very bad side effects. Side effects that have happened include slowed or trouble breathing and deaths. Benzodiazepine drugs include drugs like alprazolam, diazepam, and lorazepam. Benzodiazepine drugs are used to treat many health problems like anxiety, trouble sleeping, or seizures. Talk with the doctor.
- Many drugs interact with buprenorphine extended-release injection 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 medicine 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.
- This medicine 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.
- You may only get buprenorphine extended-release injection through a special program. Talk with your doctor.
- Using this medicine for a long time during pregnancy may lead to withdrawal in the newborn baby. This can be life-threatening. Talk with the doctor.
Uses of Buprenorphine Extended-Release Injection:
- It is used to treat pain drug (opioid) addiction.
- This medicine is only for use by people who have been taking pain drugs (opioids) and are used to their effects. Talk with the doctor.
What do I need to tell my doctor BEFORE I take Buprenorphine Extended-Release Injection?
- If you have an allergy to buprenorphine or any other part of buprenorphine extended-release injection.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- 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 used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking this medicine within 14 days of those drugs can cause very bad high blood pressure.
- If you are taking any of these drugs: Linezolid or methylene blue.
This is not a list of all drugs or health problems that interact with buprenorphine extended-release injection.
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 medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take Buprenorphine Extended-Release Injection?
- Tell all of your health care providers that you take buprenorphine extended-release injection. 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 medicine 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.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- This medicine may cause withdrawal symptoms if you are dependent or addicted to narcotics. Talk with your doctor.
- Very bad and sometimes deadly liver problems have happened with buprenorphine extended-release injection. 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 like this medicine may lead to lower sex hormone levels. This may lead to signs like change in sex ability in men, no menstrual period in women, lowered interest in sex, or fertility problems. Call your doctor if you have any of these signs.
- This medicine 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 buprenorphine extended-release injection.
- If you are 65 or older, use this medicine with care. You could have more side effects.
- Follow up with the doctor as you have been told.
- Be sure you know how to treat pain while you take buprenorphine extended-release injection. Do not take opioid pain drugs unless your doctor tells you to. Pain drugs may not work as well while you take this medicine. 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 buprenorphine extended-release injection. If you have questions, talk with your doctor.
- If you need to stop treatment with this medicine, 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 buprenorphine extended-release injection comes out by itself, keep it away from children. Accidental exposure may cause death. If someone else, especially a child, is exposed to this medicine by accident, get medical help right away.
- Do not try to take buprenorphine extended-release injection out by yourself. This could lead to infection and withdrawal. Talk with your doctor.
- Try not to touch the area where this medicine is put in very often. Touching it often may raise the chance of infection.
- This medicine is not approved for use in children. Talk with the doctor.
- This medicine 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 buprenorphine extended-release injection, call your doctor right away.
- Tell your doctor if you are breast-feeding or plan to breast-feed. This medicine passes into breast milk and may harm your baby.
How is this medicine (Buprenorphine Extended-Release Injection) best taken?
Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Do not take buprenorphine extended-release injection 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.
- It is given as a shot into the fatty part of the skin.
- Your doctor will give this medicine.
- Do not use pressure (waist band or belt) on the part where the shot is given.
What do I do if I miss a dose?
- Call your doctor to find out what to do.
See also: Dosage Information (in more detail)
What are some side effects that I need to call my doctor about right away?
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.
- Trouble breathing, slow breathing, or shallow breathing.
- Very bad dizziness or passing out.
- Too much sweat.
- Fast or slow heartbeat.
- A heartbeat that does not feel normal.
- Feeling confused.
- Very hard stools (constipation).
- Feeling very tired or weak.
- Feeling nervous and excitable.
- Fever or chills.
- Sore throat.
- Change in balance.
- Mood changes.
- Very bad belly pain.
- Extra muscle action or slow movement.
- Slurred speech.
- 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.
- Trouble passing urine.
- Hallucinations (seeing or hearing things that are not there).
- Muscle or joint pain.
- Memory problems or loss.
- Very bad headache.
- Feeling very sleepy.
- A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take buprenorphine extended-release injection with drugs for depression, migraines, or 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; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
- Taking an opioid drug like this medicine 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.
- Irritation where buprenorphine extended-release injection is given.
- Swelling, warmth, or redness where this medicine was given.
What are some other side effects of Buprenorphine Extended-Release Injection?
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:
- Hard stools (constipation).
- Feeling sleepy.
- Upset stomach or throwing up.
- Belly pain.
- Feeling tired or weak.
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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
See also: Side effects (in more detail)
If OVERDOSE is suspected:
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.
How do I store and/or throw out Buprenorphine Extended-Release Injection?
- If you need to store buprenorphine extended-release injection 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.
Consumer Information Use and Disclaimer
- 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.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about buprenorphine extended-release injection, 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.
Disclaimer: 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 buprenorphine extended-release injection. 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 buprenorphine extended-release injection.
Review Date: February 7, 2018
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