Rethink relief to help you get back to living

Are you satisfied with your current chronic pain* treatment?

Talk to your doctor about BELBUCA® and rethink relief

What is BELBUCA®?

BELBUCA® (buprenorphine) contains an opioid (narcotic) medication that is used to help manage pain severe enough to require daily, around-the-clock treatment with an opioid. Opioids should only be used 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.

Why is BELBUCA® different?

BELBUCA® is different from other opiod medications. BELBUCA® contains buprenorphine, which is a long-acting opioid. This means BELBUCA can be taken every 12 hours, instead of the every 4 to 6 hours like immediate-release opioids.

BELBUCA® comes in the form of a small, thin square film. You don’t swallow BELBUCA®, instead, you put the film in your mouth and press it against the inside of your cheek. Within a few seconds, BELBUCA® adheres to the inside of your cheek. While BELBUCA® is dissolving (usually within 30 minutes), you can speak and swallow normally. The film technology helps the medicine in BELBUCA® get into your bloodstream more efficiently because, unlike a tablet, it doesn’t have to go through your digestive system first. This delivery allows for pain relief to be achieved with individual doses of less than 1 mg every 12 hours.

BELBUCA® is also different from other opioid medications because it contains buprenorphine, a Schedule III drug. Schedule III substances have less potential for abuse than Schedule II opioids.

"It's making a big difference for me and my family."

Beth, a real patient taking BELBUCA®

Discover how real patients like Beth have benefited from BELBUCA®

How BELBUCA® may help you

Your healthcare provider may have prescribed BELBUCA® for one or more of the following reasons:
  • Your short-acting opioid is no longer giving you consistent relief from your chronic pain*
  • The dosing of your previous pain medication was too frequent
  • To try to maintain chronic pain relief and minimize potential side effects

Speak with your doctor to assess how well your symptoms are improving with treatment.

BELBUCA® is not for use to treat pain on an as-needed basis or to treat pain that does not affect you daily.

Long-acting opioid pain medications can put you at risk for overdose and death. Even if you take BELBUCA® as prescribed, you could be at risk for opioid addiction, abuse, and misuse that can lead to death.

Do not use BELBUCA® if you have severe asthma, trouble breathing, or other lung problems, or if you have a bowel blockage or narrowing of the stomach or intestines.

Before starting treatment with BELBUCA®, speak with your healthcare provider about whether BELBUCA® is appropriate for you.

*Pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

BELBUCA® is a Schedule III medication

A drug's Schedule is determined by the US Drug Enforcement Administration (DEA). A drug is placed into 1 of 5 distinct categories, or Schedules, when it requires additional restrictions beyond a healthcare provider's prescription. Depending on the drug's acceptable medical use AND potential for abuse, it is placed into the appropriate Schedule.


Novel buccal film for simple delivery of medicine

The buccal film technology of BELBUCA® helps the medicine get into your bloodstream more directly.

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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