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buprenorphine (implant)

Generic Name: buprenorphine (implant) (BUE pre NOR feen)
Brand Name: Probuphine

What is buprenorphine?

Buprenorphine is an opioid medication. An opioid is sometimes called a narcotic.

Buprenorphine implant (placed under the skin) is used to treat narcotic addiction in certain people whose addiction has already been treated and controlled with other forms of this medicine (such as Subutex or Suboxone). Buprenorphine implants are for adults and teenagers who are at least 16 years old.

Buprenorphine implants are available only from a certified pharmacy under a special program. You must be registered in the program and understand the risks and benefits of using this medicine. Buprenorphine implants are not for use as a pain medication.

Buprenorphine implants may also be used for purposes not listed in this medication guide.

What is the most important information I should know about buprenorphine?

Inserting and removing buprenorphine implants can cause serious or life-threatening complications.

Talk with your doctor about the risks and benefits of using this medicine. Read all patient information, medication guides, and instruction sheets provided to you.

What should I discuss with my healthcare provider before using buprenorphine?

You should not use the implants if you are allergic to buprenorphine.

You should not use buprenorphine implants unless you are opioid-tolerant. Ask your doctor if you are not sure.

To make sure buprenorphine is safe for you, tell your doctor if you have ever had:

  • any type of breathing problem or lung disease;

  • liver disease;

  • problems with your gallbladder or thyroid;

  • an enlarged prostate, urination problems;

  • Addison's disease (an adrenal gland disorder);

  • abnormal curvature of the spine that affects breathing;

  • skin problems such as unusual scars or growths;

  • a head injury, brain tumor, or spinal cord problems;

  • alcoholism;

  • an infection that was resistant to antibiotics; or

  • if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

If you use buprenorphine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Buprenorphine can pass into breast milk and may cause drowsiness or breathing problems in a nursing baby. Tell your doctor if you are breast-feeding a baby.

Buprenorphine implants not approved for use by anyone younger than 16 years old.

How is buprenorphine implant given?

A buprenorphine implant is a 1-inch rod that is inserted through a needle (under local anesthesia) into the skin of your upper arm, just inside and above the elbow. You will receive a total of 4 implants.

After the implants are inserted, your arm will be covered with 2 bandages. Remove the top bandage after 24 hours, but leave the smaller bandage on for 3 to 5 days. Keep the area clean and dry. Apply an ice pack to the area every 2 hours during the first day, leaving the ice pack on for 40 minutes at a time.

For at least 1 week after insertion, check the incision area for warmth, redness, swelling, or other signs of infection.

You should be able to feel the implants under your skin. Tell your doctor if you cannot feel the implants at any time while it is in place.

Call your doctor at once if you notice any of the following symptoms after the the implants are inserted:

  • an implant sticks out of your skin;

  • an implant comes out by itself;

  • you have pain, itching, redness, swelling, bleeding or severe irritation;

  • you have numbness or weakness in your arm; or

  • you feel short of breath.

The implants may be harder to find if it is inserted too deeply, if you press on your arm trying to reposition the implants, or if you gain a lot of weight. Your doctor may perform medical tests or refer you to a surgeon if you can no longer feel the implants in your arm.

Buprenorphine implants can remain in place for up to 6 months and must be surgically removed. Do not attempt to remove the implants yourself.

Buprenorphine, the medicine contained in the implant, is a habit-forming drug of abuse. If an implant comes out of your arm, keep it in a place where others cannot get to it. As soon as possible, return the implant to your doctor. MISUSE OF A BUPRENORPHINE IMPLANT CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the implant improperly or without a prescription. Selling or giving away a buprenorphine implant is against the law.

Buprenorphine is only part of a complete treatment program that may also include counseling and other types of addiction support. Tell your doctor if you feel that the buprenorphine implants are not helping to improve your symptoms of addiction.

Wear a medical alert tag or carry an ID card stating that you are physically dependent on an opioid. Any medical care provider who treats you should know that you have buprenorphine implants inserted. Be sure your family and caregivers know what information to give to emergency medical workers.

If you need surgery or pain management, tell your caregivers ahead of time that you have buprenorphine implants in your arm.

What happens if I miss a dose?

Because this medicine is implanted under your skin, low-level doses of buprenorphine will be continuously delivered into your body for up to 6 months.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of buprenorphine can be fatal.

Overdose symptoms may include severe drowsiness, pinpoint pupils, weak or shallow breathing, or loss of consciousness.

What should I avoid while using buprenorphine?

Avoid drinking alcohol. Dangerous side effects could occur.

Buprenorphine may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Buprenorphine side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Inserting or removing the implants can cause serious or life-threatening complications, including damage to nerves or blood vessels. Ask your doctor about these risks.

Call your doctor at once if you have:

  • confusion, agitation, or other changes in your mental status;

  • extreme drowsiness, trouble concentrating;

  • a light-headed feeling, like you might pass out;

  • weak or shallow breathing;

  • blurred vision, slurred speech;

  • problems with balance, walking, reflexes, or coordination;

  • stiff muscles, or a feeling of being too hot; or

  • low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common side effects may include:

  • pain, itching, or redness where the implants were inserted;

  • headache, depressed mood;

  • nausea, vomiting, constipation;

  • back pain;

  • tooth pain; or

  • sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects (complete list)

Buprenorphine dosing information

Usual Adult Dose for Opiate Dependence:

Treatment should be initiated when objective and clear signs of moderate opioid withdrawal appear AND not less than 4 hours after the patient has last used heroin or other short-acting opioids OR not less than 24 hours after last use of methadone or other long-acting opioids:

INDUCTION:
Day 1: 8 mg sublingually once a day (may give in 2 to 4 mg increments, if preferred)
Day 2: 16 mg sublingually once a day

MAINTENANCE:
-Adjust in 2 to 4 mg increments/decrements to a level that holds patient in treatment and suppresses opioid withdrawal signs and symptoms
-Target dose: 16 mg sublingually once a day; range 4 to 24 mg/day
-Maximum dose: 24 mg/day; higher doses have not shown a clinical advantage

Comments:
-This drug should be used as part of a complete treatment plan to include counseling and psychosocial support.
-Buprenorphine (without naloxone) is the preferred drug for induction; buprenorphine/naloxone is the preferred drug for maintenance therapy.
-It is important to achieve adequate treatment doses as rapidly as possible as gradual induction over several days has led to higher dropout rates.
-There is no maximum recommended duration for maintenance therapy as patients may require indefinite treatment; when the decision is made to discontinue, doses should be tapered.

Subdermal IMPLANT: For use in opioid-tolerant patients who meet ALL of the following criteria:
-Achieved and sustained prolonged clinical stability on transmucosal buprenorphine as evidenced by a stable dose for 3 months or longer without any need for supplemental dosing or dose adjustments.
-Currently receiving maintenance buprenorphine (with or without naloxone) doses of 8 mg/day or less, or equivalent transmucosal product (e.g. Bunavail[R] buprenorphine 4.2 mg/naloxone 0.7 mg per day or less; or Zubsolv[R] buprenorphine 5.7 mg/naloxone 1.4 mg per day or less)
-Patients should not be tapered to a lower dose for the sole purpose of transitioning to the implant.

Insert 1 dose subdermally in the inner side of the upper arm
-Remove at the end of the sixth month

Comments:
-Implant insertions and removals should be performed by certified healthcare providers.
-Each dose consists of 4 implants; each implant contains buprenorphine 74.2 mg
-After 1 insertion in each arm, most patients should be transitioned back to transmucosal products for continued treatment as there is no experience with inserting additional implants into other sites in the arm or into a previously-used site.

Usual Adult Dose for Pain:

Initial dose: 0.3 mg deep IM or slow IV (over at least 2 minutes); may repeat this dose once after 30 to 60 minutes if needed; then, 0.3 mg IV/IM every 6 hours as needed
-A single 0.6 mg IM dose may be given to patients who are not in a high risk category (see Warnings)
Maximum single dose: 0.3 mg (IV) or 0.6 mg (IM)

Comments:
-Use extra caution with IV administration, especially the first dose.
-Monitor closely for respiratory depression, especially within the first 24 to 72 hours.
-Use the lowest effective dose for the shortest duration consistent with the individual patient's treatment goals.

Use: For the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.

Usual Adult Dose for Chronic Pain:

Buccal Film:
Opioid-Naive and Opioid Non-Tolerant:
As Initial Opioid Analgesic: 75 mcg buccally once a day, or if tolerated every 12 hours for at least 4 days; then increase to 150 mcg every 12 hours
-Titrate individually in increments of 150 mcg every 12 hours no more frequently than every 4 days to a dose that provides adequate analgesia and minimizes adverse reactions; doses of 600 mcg, 750 mcg, and 900 mcg should only be used following titration from lower doses
Maximum dose: 900 mcg every 12 hours

Conversion from Other Opioids to Buccal Film: To reduce the risk of opioid withdrawal, taper patients to no more than 30 mg/day oral morphine mg equivalents (MME) before beginning therapy
Discontinue all around-the-clock opioid drugs when initiating buccal film
For opioid dose of less than 30 mg/day MME prior to taper:
-Initial dose: 75 mcg buccally once a day, or every 12 hours
For opioid dose between 30 and 89 mg/day MME prior to taper:
-Initial dose: 150 mcg buccally every 12 hours
For opioid dose between 90 and 160 mg/day MME prior to taper:
-Initial dose: 300 mcg buccally every 12 hours
For opioid doses greater than 160 mg/day MME: Consider alternate analgesics as buccal film may not provide adequate analgesia
Conversion from Methadone: The ratio between methadone as a function of previous dose exposure varies widely; methadone has a long half-life and accumulates in the plasma; close monitoring is of particular importance.

Transdermal System:
Opioid-Naive and Opioid Non-Tolerant:
As Initial Opioid Analgesic: Initiate with 5 mcg/hr patch transdermally; change every 7 days
-Titrate individually titrate to a dose that provides adequate analgesia and minimizes adverse reactions; minimal titration interval is 72 hours
Maximum dose: 20 mcg/hr

Conversion from Other Opioids to Transdermal System:
Discontinue all other around-the-clock opioid drugs when initiating therapy
-For prior opioid dose of less than 30 mg/day oral morphine mg equivalents (MME): Initiate with 5 mcg/hr applied transdermally at next dosing interval
-For prior opioid dose between 30 and 80 mg/day MME: Taper around-the-clock opioids for up to 7 days to no more than 30 mg/day MME; then, initiate with 10 mcg/hr transdermally at next dosing interval; may use short-acting analgesics as needed until analgesic efficacy is attained
-For prior opioid dose greater than 80 mg/day MME: Consider an alternate analgesic as transdermal therapy may not provide adequate analgesia
Conversion from Methadone: The ratio between methadone as a function of previous dose exposure varies widely; methadone has a long half-life and accumulates in the plasma; close monitoring is of particular importance.

Comments:
-The buccal film and transdermal system should be prescribed by healthcare providers knowledgeable in the use of potent opioids for chronic pain; these products are not for use as as-needed analgesics.
-Monitor patients closely for respiratory depression, especially within 24 to 72 hours after initiating therapy and with dose increases.
-If pain level increases after dose stabilization, attempt to identify source of increased pain before increasing dose; rescue medication with an immediate-release analgesic may be needed.
-Because of the risks of opioid addiction, abuse, and misuse, this drug should be reserved for patients for whom alternative treatment options have not or are not expected to be tolerated; or have not or are not expected to provide adequate analgesia.
-Upon discontinuation, use a gradual downward titration; for patients on transdermal system, may need to switch to an immediate-release opioid.

Use: For the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.

Usual Pediatric Dose for Pain:

2 to 12 years:
Initial dose: 2 to 6 mcg/kg IM or slow IV every 4 to 6 hours
-Some patients may not need to be remedicated for 6 to 8 hours; fixed interval or round the clock dosing should not be used until the proper inter-dose interval has been established

Over 12 years:
Initial dose: 0.3 mg deep IM or slow IV (over at least 2 minutes); may repeat this dose once after 30 to 60 minutes if needed; then, 0.3 mg IV/IM every 6 hours as needed
Maximum single dose: 0.3 mg

Comments:
-Use extra caution with IV administration, especially the first dose.
-Monitor closely for respiratory depression, especially within the first 24 to 72 hours.
-Use the lowest effective dose for the shortest duration consistent with the individual patient's treatment goals.

Use: For the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.

Usual Pediatric Dose for Opiate Dependence:

Treatment should be initiated when objective and clear signs of moderate opioid withdrawal appear AND not less than 4 hours after the patient has last used heroin or other short-acting opioids OR not less than 24 hours after last use of methadone or other long-acting opioids:

16 years or older:

INDUCTION:
Day 1: 8 mg sublingually once a day (may give in 2 to 4 mg increments, if preferred)
Day 2: 16 mg sublingually once a day

MAINTENANCE:
-Adjust in 2 to 4 mg increments/decrements to a level that holds patient in treatment and suppresses opioid withdrawal signs and symptoms
-Target dose: 16 mg sublingually once a day; range 4 to 24 mg/day
-Maximum dose: 24 mg/day; higher doses have not shown a clinical advantage

Comments:
-This drug should be used as part of a complete treatment plan to include counseling and psychosocial support.
-Buprenorphine (without naloxone) is the preferred drug for induction; buprenorphine/naloxone is the preferred drug for maintenance therapy.
-It is important to achieve adequate treatment doses as rapidly as possible as gradual induction over several days has led to higher dropout rates.
-There is no maximum recommended duration for maintenance therapy as patients may require indefinite treatment; when the decision is made to discontinue, doses should be tapered.

Subdermal IMPLANT: For use in opioid-tolerant patients who meet ALL of the following criteria:
-Achieved and sustained prolonged clinical stability on transmucosal buprenorphine as evidenced by a stable dose for 3 months or longer without any need for supplemental dosing or dose adjustments.
-Currently receiving maintenance buprenorphine (with or without naloxone) doses of 8 mg/day or less, or equivalent transmucosal product (e.g. Bunavail[R] buprenorphine 4.2 mg/naloxone 0.7 mg per day or less; or Zubsolv[R] buprenorphine 5.7 mg/naloxone 1.4 mg per day or less)
-Patients should not be tapered to a lower dose for the sole purpose of transitioning to the implant.

Insert 1 dose subdermally in the inner side of the upper arm
-Remove at the end of the sixth month

Comments:
-Implant insertions and removals should be performed by certified healthcare providers.
-Each dose consists of 4 implants; each implant contains buprenorphine 74.2 mg
-After 1 insertion in each arm, most patients should be transitioned back to transmucosal products for continued treatment as there is no experience with inserting additional implants into other sites in the arm or into a previously-used site.

What other drugs will affect buprenorphine?

Using other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death while buprenorphine implants are in your body. Ask your doctor before taking a sleeping pill, opioid pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Many drugs can interact with buprenorphine, and some drugs should not be used while you have the implants in your body. Tell your doctor about all your current medicines and any you start or stop using, especially:

  • an antibiotic, antifungal, or antiviral medicine;

  • any type of antidepressant, sedative, or tranquilizer;

  • heart or blood pressure medication;

  • seizure medication; or

  • tuberculosis medicine.

This list is not complete and many other drugs can interact with buprenorphine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about buprenorphine implants.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.01.

Date modified: November 15, 2017
Last reviewed: September 11, 2017

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