Frequently asked questions about BELBUCA®

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  • How do I apply BELBUCA®?
    Before you begin, make sure the inside of your mouth is moist, using your tongue or by rinsing your mouth with water. Be sure your fingers are clean and dry. To apply BELBUCA®, just peel, place, and press. Simply peel and tear open the package to carefully remove the film. Place the film on your finger and press the yellow side against the inside of your cheek. It may take a few times to get accustomed to using BELBUCA®. Practice applying BELBUCA® with a placebo (inactive) film provided by your healthcare provider.
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  • Where is the right place to put BELBUCA® inside my cheek?
    BELBUCA® should be applied to the middle of the inside of your cheek. Do not place the film too high or too far back on your cheek. Avoid applying the film to areas of your mouth with any open sores or lesions.
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  • Can I eat, drink, or talk when the film is in my mouth?
    Do not eat or drink until the film has completely dissolved. After applying BELBUCA®, you can speak and swallow normally while the film is dissolving, usually within 30 minutes—just do not do anything that would move the film in your mouth.
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  • What does it feel like when the film starts to dissolve?
    While BELBUCA® is adhered to the inside of your cheek, you may taste a mild peppermint flavor. As it dissolves, it is normal for the texture of the film to change.
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  • How long does it take to dissolve?
    BELBUCA® works by sticking to the inside of your cheek and then dissolving completely—usually within 30 minutes. Leave BELBUCA® on the inside of your cheek until fully dissolved. Do not chew or swallow the film. If you do chew or swallow the film, it may not be as effective, and may cause choking, overdose, or death, so care must be taken.
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  • What side effects does BELBUCA® cause?
    Until your body adjusts to treatment, you may experience side effects like nausea, constipation, headache, vomiting, dizziness, or sleepiness. Your healthcare provider may adjust your dose to provide pain relief or to help minimize any side effects. Do not change your dose or stop taking BELBUCA® without talking to your healthcare provider.
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  • Is there a prescription copay program?
    In the 1st month, eligible patients pay as little as $0 up front and save up to $100 off their copay per prescription, for up to 3 prescriptions. In the 2nd month, patients pay as little as $25 up front and save up to $75 off their remaining copay per prescription, for up to 3 prescriptions. In the 3rd-12th months, patients pay as little as $25 up front and save up to $75 off their remaining copay per prescription, for only 1 prescription per month. Restrictions apply. Please see eligibility criteria on the back of the card.

    Visit our Savings page to download a copay card for your BELBUCA® prescription.

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Download the BELBUCA® Patient Brochure

BELBUCA patient brochure

Download the BELBUCA® Frequently Asked Questions

BELBUCA FAQs

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.

IMPORTANT SAFETY INFORMATION about BELBUCA®

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; AND NEONATAL OPIOID WITHDRAWAL SYNDROME; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Addiction, Abuse, and Misuse

BELBUCA® exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing BELBUCA® and monitor patients regularly for the development of these behaviors and conditions.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of BELBUCA®. Monitor for respiratory depression, especially during initiation of BELBUCA® or following a dose increase. Misuse or abuse of BELBUCA® by chewing, swallowing, snorting, or injecting buprenorphine extracted from the buccal film will result in the uncontrolled delivery of buprenorphine and pose a significant risk of overdose and death.

Accidental Exposure

Accidental exposure to even one dose of BELBUCA®, especially by children, can result in a fatal overdose of buprenorphine.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of BELBUCA® during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life threatening if not recognized and treated and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants

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.

Important Safety Information 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.

IMPORTANT SAFETY INFORMATION about BELBUCA®

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; AND NEONATAL OPIOID WITHDRAWAL SYNDROME; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Addiction, Abuse, and Misuse

BELBUCA® exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing BELBUCA® and monitor patients regularly for the development of these behaviors and conditions.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of BELBUCA®. Monitor for respiratory depression, especially during initiation of BELBUCA® or following a dose increase. Misuse or abuse of BELBUCA® by chewing, swallowing, snorting, or injecting buprenorphine extracted from the buccal film will result in the uncontrolled delivery of buprenorphine and pose a significant risk of overdose and death.

Accidental Exposure

Accidental exposure to even one dose of BELBUCA®, especially by children, can result in a fatal overdose of buprenorphine.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of BELBUCA® during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life threatening if not recognized and treated and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants

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
  • heart rhythm problems (long QT syndrome)
  • liver, kidney, thyroid problems
  • pancreas or gallbladder problems
  • problems urinating
  • 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

Marketed by: BioDelivery Sciences International, Inc., Raleigh, NC 27612,

www.bdsi.com or call 1-877-579-4578.Medication GuideFull Prescribing Information
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