Probuphine Implant

GENERIC NAME(S): Buprenorphine Hcl

OTHER NAME(S): Probuphine Implant

WARNINGS:

The insertion and removal of the buprenorphine implants may cause serious (rarely fatal) problems. Tell your doctor right away if the implant moves to another location, sticks out of your skin, or comes out by itself. If the implant comes out by itself, put the implant in a plastic bag and bring it to your doctor. Do not let others touch the implant and keep it away from others, especially children. Cover the area where the implant came out with a clean bandage.

You may also be at risk for nerve damage, infections at the insertion or removal site, or blockage of a blood vessel by the implant. Tell your doctor right away if you notice any of the following symptoms: numbness or weakness in your arm, severe pain/redness/swelling/bleeding at the insertion/removal site, or shortness of breath.

For patients to receive this medication, all doctors and patients must agree to, understand, and carefully follow the requirements of the Probuphine REMS Program. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor for your country's regulations.

Who should not take Probuphine Implant?

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Uses

Uses

Buprenorphine is used to treat opioid (narcotic) dependence/addiction. 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 drug abuse (such as compliance monitoring, counseling, behavioral contract, lifestyle changes).

How to use Probuphine Implant

Read the Medication Guide provided by your doctor before you get this medication and each time you get it. If you have any questions, ask your doctor.

Your doctor will place 4 medicated implants under the skin of your upper arm. Each implant releases buprenorphine into your blood slowly and continuously over 6 months. After 6 months, your doctor will remove the implants. Your doctor may insert new implants in your other arm if you need to continue treatment. Follow your doctor's instructions for proper care of the place where the implants were inserted or removed. Consult your doctor for details.

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 reactions, your doctor may direct you to take another medication. 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.

Do not remove the buprenorphine implants by yourself. This may cause severe withdrawal symptoms (see Side Effects section). Consult your doctor or pharmacist for more details.

Tell your doctor right away if you have any withdrawal reactions.

Side Effects

Side Effects

See also Warning section.

Drowsiness, dizziness, lightheadedness, constipation, or headache may occur. Itching, pain, or redness at the insertion/removal site may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

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

Remember that your doctor has prescribed this medication because he or she 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, injected, or mixed with other depressants (such as alcohol, benzodiazepines including diazepam, other opioids).

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

Precautions

Precautions

Before using buprenorphine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, 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), skin problems (such as scleroderma, skin infections, excessive scarring).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. Alcohol also increases your risk for breathing problems.

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.

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 benefits and risks. Tell your doctor if you are pregnant or if you 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 this medication 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, abnormal/constant crying, 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 breast-feeding.

Interactions

Interactions

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

Many drugs besides buprenorphine may affect the heart rhythm (QT prolongation), such as amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, sotalol, among others.

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 affect breathing or cause drowsiness. Tell your doctor or pharmacist if you are taking other products such as alcohol, marijuana, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and other narcotic pain relievers (such as codeine, hydrocodone).

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.

Deaths have occurred when buprenorphine has been misused by injecting it ("shooting up"), especially when used in combination with benzodiazepines (such as diazepam) or other depressants such as alcohol or additional opioids.

Overdose

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow breathing, slow heartbeat, loss of consciousness.

Notes

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

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

Lab and/or medical tests (such as liver function tests, skin exams) should be done before you receive this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

Not applicable.

Storage

Not applicable. This medication is given in a doctor's office and will not be stored at home.Information last revised July 2017. Copyright(c) 2017 First Databank, Inc.

Images

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.