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. Your doctor may order certain tests before and during your treatment to check your body's response to buprenorphine extended-release injection.
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. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.
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 by producing similar effects to these drugs.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
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. It is usually given once a week or once a month. Each 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, but 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. Be sure to tell your doctor how you are feeling during your treatment with buprenorphine injection.
If buprenorphine injection is to be discontinued, your doctor will probably decrease your dose gradually. You may experience withdrawal symptoms including 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. These withdrawal symptoms may occur 1 month or longer after your last buprenorphine extended-release injection dose.
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.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid (Marplan ® ), linezolid (Zyvox ® ), methylene blue, phenelzine (Nardil ® ), selegiline (Emsam ®
- , Zelapar ® ), or tranylcypromine (Parnate ® ).
- 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 low levels of potassium or magnesium in the blood; 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 or plan to become pregnant. If you receive buprenorphine injection regularly during your pregnancy, your baby could experience life-threatening withdrawal symptoms after birth. Tell your baby's doctor right away if your baby experiences any of the following symptoms: irritability, hyperactivity, abnormal sleep, high-pitched cry, uncontrollable shaking of a part of the body, vomiting, diarrhea, or failure to gain weight.
- tell your doctor if you are breastfeeding. Tell your baby's doctor right away if your baby is sleepier than usual or has trouble breathing while you are receiving this medication.
- 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.
- 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 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.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving buprenorphine injection.
- 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.
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 should I do in case of overdose?
Call the poison control helpline at 1-800-222-1222
. Information is also available online at https://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.
Talk to your doctor about a rescue medication called naloxone for you to use (e.g., home, office). Naloxone is used to reverse the life-threatening effects of an overdose. It works by blocking the effects of opiates. It relieves dangerous symptoms caused by high levels of opiates in the blood. Your doctor may also prescribe you naloxone if you live with small children or with someone who has abused street or prescription drugs. Ask your doctor about other ways that you can obtain naloxone (directly from a pharmacy or as part of a community based program). Make sure that you and your family members, caregivers, or the people who spend time with you know how to recognize an overdose, how to use naloxone, and what to do until emergency medical help arrives. Your doctor or pharmacist will show you and your family members how to use the medication. Ask your pharmacist for the instructions or visit the manufacturer's website to get the instructions. If symptoms of an overdose occur, a friend or family member should give the first dose of naloxone, call 911 immediately, and stay with you and watch you closely until emergency medical help arrives. Your symptoms may return within a few minutes after you receive naloxone. If your symptoms return, the person should give you another dose of naloxone. Additional doses may be given every 2 to 3 minutes, if symptoms return before medical help arrives.
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 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
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
- 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
- inability to get or keep an erection
- irregular menstruation
- decreased sexual desire
- rash; hives; itching; difficulty breathing or swallowing; lightheadedness; feeling faint; or swelling of your face, throat, tongue, lips, or eyes
- slurred speech
- blurred vision
- 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
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 ( https://www.fda.gov/Safety/MedWatch ) or by phone (
1-800-332-1088).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.
Buprenorphine injection is a controlled substance. Schedule appointments with your doctor on a regular basis to receive your injections. Ask your pharmacist if you have any questions.
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.