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Buprenorphine extended-release injection is only available through a special distribution program called 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.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with buprenorphine extended-release injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.
WHY is this medicine prescribed?
Buprenorphine extended-release injection is used to treat opioid dependence (addiction to opioid drugs, including heroin and narcotic painkillers) in people who have received buccal or sublingual buprenorphine for at least 7 days. Buprenorphine extended-release 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.
HOW should this medicine be used?
Buprenorphine extended-release (long-acting) injection comes as a solution (liquid) to be injected subcutaneously (just under the skin) by a health care provider into the stomach area. It is usually given once monthly with at least 26 days in between doses. Each buprenorphine injection slowly releases the drug into your body over a month.
After you receive a dose of buprenorphine extended-release 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 or waistband 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 extended-release injection.
If buprenorphine extended-release 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.
Are there OTHER USES for this medicine?
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,
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 extended-release injection dose, you should call your doctor to receive the dose as soon as possible. Your next dose should be given at least 26 days later.
What SIDE EFFECTS can this medicine cause?
Buprenorphine extended-release injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms call your doctor immediately or get emergency medical treatment:
Buprenorphine extended-release 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 at1-800-222-1222. 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.
Symptoms of overdose may include the following:
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 extended-release injection.
Buprenorphine extended-release injection is a controlled substance. Be sure to schedule appointments with your doctor on a regular basis to receive your injections. Ask your pharmacist if you have any questions.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: January 15, 2019.
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