Rethink relief to help you get back to living

Starting treatment with BELBUCA®

If your healthcare provider prescribes BELBUCA®, you will be assessed throughout your treatment. Your healthcare provider will determine whether BELBUCA® is the right treatment for you based on the following:

  • Your medical history and condition
  • Personal habits
  • Psychological factors
  • Risk for opioid addiction, abuse, or misuse.

Frequent communication with your healthcare provider is important to make sure you are getting consistent pain relief and managing any side effects.

Start a conversation with your healthcare provider by asking the right questions. Use this Doctor Discussion Guide so you are prepared on your next visit.

How does BELBUCA® work?

BELBUCA® is a small, thin film you press against the inside of your cheek. Once BELBUCA® adheres to the inside of your cheek, the medication in the film begins to travel through the lining of your cheek and into your bloodstream. The film technology helps the medicine in BELBUCA® get into your bloodstream more directly because, unlike a tablet, it doesn’t have to go through your digestive system first.

While the BELBUCA® film is dissolving, you can speak and swallow normally. Do not eat or drink until the film is completely dissolved (usually within 30 minutes).

What to expect with BELBUCA®

When you start BELBUCA®, you may experience an adjustment period. Remember to:

  1. Give your body time to adjust.

    You may experience a change in symptoms while your body adjusts to BELBUCA®. Your healthcare provider can adjust your dose to provide adequate pain relief and to help minimize any side effects.

  2. Record your symptoms daily.

    Keep a list of symptoms you experience to help your healthcare provider address any side effects. Record exactly what you’re feeling and when.

  3. Report any changes to your healthcare provider.

    Tell your healthcare provider if you experience any change in symptoms, and immediately report any side effects to your provider. Never attempt to manage or deal with side effects on your own.

7 dosing options

Find YOUR optimal dose


BELBUCA® is designed to provide the optimal dose for your condition. The optimal dose is the dose that provides YOU with the best balance of pain relief and tolerability, and that you are willing to stay on long term.

  • 7 dosing options will help you and your healthcare provider find the dose that works best for you
  • You may be started on a low dose that may need to change over time
  • Titration helps you get the right amount of medicine to achieve chronic pain relief

Finding YOUR optimal dose may take a few visits to your healthcare provider, so be patient and let your provider know if you are not yet on YOUR optimal dose.

Potential side effects

The possible side effects of BELBUCA® include nausea, constipation, headache, vomiting, dizziness, and sleepiness. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency help if you have any of the following symptoms:

  • Trouble breathing
  • Shortness of breath
  • Fast heartbeat
  • Chest pain
  • Swelling in your face, tongue, or throat
  • Extreme drowsiness
  • Light-headedness when changing positions
  • Feeling faint
  • Agitation
  • High body temperature
  • Trouble walking
  • Stiff muscles
  • Mental changes such as confusion

Medication Guide

BELBUCA (bel-BUE-kuh) (buprenorphine buccal film), CIII

BELBUCA is:

  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.

WARNING: ADDICTION, ABUSE AND MISUSE: RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES AND OTHERS CNS DEPRESSANTS

See full prescribing information for complete boxed warning.

  • BELBUCA exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing, and monitor regularly for these behaviors and conditions.
  • To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products.
  • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initation or following a dose increase. Instruct patients on proper administration of BELBUCA to reduce the risk.
  • Accidental exposure to BELBUCA, especially in children, can result in fatal overdose of buprenorphine.
  • Prolonged use of BELBUCA during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
  • Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.

Medication Guide

BELBUCA (bel-BUE-kuh) (buprenorphine buccal film), CIII

BELBUCA is:

  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.
  • A long-acting opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.
  • Not for use to treat pain that is not around-the-clock.

Important information about BELBUCA:

  • Get emergency help right away if you take too much BELBUCA (overdose). When you first start taking BELBUCA, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
  • Taking BELBUCA with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
  • Never give anyone else your BELBUCA. They could die from taking it. Store BELBUCA away from children and in a safe place to prevent stealing or abuse. Selling or giving away BELBUCA is against the law.

WARNING: ADDICTION, ABUSE AND MISUSE: RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES AND OTHERS CNS DEPRESSANTS

See full prescribing information for complete boxed warning.

  • BELBUCA exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing, and monitor regularly for these behaviors and conditions.
  • To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products.
  • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initation or following a dose increase. Instruct patients on proper administration of BELBUCA to reduce the risk.
  • Accidental exposure to BELBUCA, especially in children, can result in fatal overdose of buprenorphine.
  • Prolonged use of BELBUCA during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
  • Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.

Do not use BELBUCA if you have:

  • severe asthma, trouble breathing, or other lung problems.
  • a bowel blockage or have narrowing of the stomach or intestines.

Before applying BELBUCA, tell your healthcare provider if you have a history of:

  • head injury, seizures
  • liver, kidney, thyroid problems
  • problems urinating
  • heart rhythm problems (long QT syndrome)
  • pancreas or gallbladder problems
  • abuse of street or prescription drugs, alcohol addiction, or mental health problems.

Tell your healthcare provider if you are:

  • pregnant or planning to become pregnant. Prolonged use of BELBUCA during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • breastfeeding. Not recommended during treatment with BELBUCA. It may harm your baby.
  • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking BELBUCA with certain other medicines can cause serious side effects and could lead to death.

While using BELBUCA:

  • Do not change your dose. Apply BELBUCA exactly as prescribed by your healthcare provider. Use the lowest effective dose possible for the shortest time needed.
  • See the detailed Instructions for Use for information about how to apply BELBUCA.
  • Do not apply BELBUCA if the package seal is broken or the film is cut, damaged, or changed in any way.
  • After the film has adhered to your cheek, avoid eating or drinking until the film has completely dissolved, usually within 30 minutes.
  • Avoid touching or moving the buccal film with your tongue or fingers.
  • Do not chew, swallow, snort or inject BELBUCA. This will result in uncontrolled delivery of buprenorphine and may cause you to overdose and die.
  • Call your healthcare provider if the dose you are using does not control your pain.
  • Do not stop using BELBUCA without talking to your healthcare provider.
  • After you stop using BELBUCA, remove any unused film from the foil pack and flush down the toilet. Throw the empty foil packaging in the trash.

While using BELBUCA DO NOT:

  • Drive or operate heavy machinery, until you know how BELBUCA affects you. BELBUCA can make you sleepy, dizzy, or lightheaded.
  • Drink alcohol or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with BELBUCA may cause you to overdose and die.

The possible side effects of BELBUCA are:

  • nausea, constipation, headache, vomiting, dizziness, and sleepiness. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help if you have:

  • trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

These are not all the possible side effects of BELBUCA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov

Manufactured for: BioDelivery Sciences International, Inc., Raleigh, NC 27612, www.BELBUCA.com or call 1-877-579-4578.

Medication GuideFull Prescribing Information
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