Starting Belbuca®
(buprenorphine buccal film) for chronic pain*

Starting Belbuca®
(buprenorphine buccal film) for chronic pain*

Before you start


There are a few things your healthcare provider will consider to be sure that BELBUCA is the right treatment for your chronic pain, including your:

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

If you are prescribed BELBUCA, you may be evaluated throughout your treatment. Your healthcare provider may change your treatment based on your needs.

Getting Started

When starting BELBUCA, it is important to know that, as with other opioids, your starting dose may not be the final dose you need to optimally manage your chronic pain. BELBUCA has 7 dosing options to help you and your doctor find the dose that works best for you.

Listen, Track, and Talk

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 when you start BELBUCA. You might need time to reach your optimal dose to make sure you get adequate chronic pain relief to help minimize side effects.

2. Track your progress.

Keep a record of your pain, symptoms, and any side effects. Record exactly what you’re feeling to make the discussion with your doctor easier.

3. Report any changes.

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

Recording your experience with BELBUCA will help you and your doctor understand if you are getting the consistent relief you need.


Track Your Progress

Find your optimal dose

Your optimal dose provides the chronic pain relief you need while minimizing side effects.

BELBUCA has 7 dosing options to help you and your doctor find the dose that works best for you

optimal dose graphic

In clinical trials, 84% of patients found their optimal dose to be between 450 mcg and 900 mcg twice daily

84% of patients infographic

In clinical trials, once a patient reached their optimal dose, 86% were able to stay on that dose without making any changes for the duration of the 48-week study (almost a year).

Did you know?

There is no one-size-fits-all approach for getting to the right, or optimal, dose. How long it takes, and what doses are required, will depend on your response to BELBUCA and your doctor's instructions.

Easy as 1–2–3


BELBUCA is a small, thin square film. It works by sticking to the inside of your cheek and dissolving completely. This allows the medicine, buprenorphine, to get into your body more efficiently than when swallowed.

BELBUCA has a mild peppermint taste.

Peel the foil to open the Belbuca packaging

1 Peel

  • Make sure your fingers are clean and dry. Peel open the foil package by folding on the dotted line and tearing down at the perforation, or by carefully cutting the package with scissors. Remove the buccal film from the package.
place the film on your fingers

2 Place

  • Wet the inside of your cheek with your tongue or with water
  • Remove the BELBUCA film from the foil package and place it on your dry finger, with the yellow side facing up
Press the yellow side of buccal film against the inside of cheek

3 Press

  • Press the yellow side against the inside of your cheek and hold it in place for 5 seconds
  • Leave BELBUCA on the inside of your cheek until fully dissolved, usually within 30 minutes

Watch an application video

Read the Full Video Transcript +

Hide Video Transcript -

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.
Now that you and your healthcare provider have decided to use BELBUCA, this video will show you how to correctly apply your pain relief therapy. Just peel, place, and press. Please watch the entire video, where each step will be fully explained. BELBUCA is a buccal film that works by sticking to the inside of your cheek, then completely dissolving, usually within 30 minutes after you apply it. Before applying BELBUCA, make sure the inside of your cheek is moist, using your tongue or by rinsing your mouth with water. Before you begin handling BELBUCA, make sure your fingers are clean and dry.
Check the foil package to make sure it is sealed. Do not use if package seal is broken, the film is cut, damaged, or changed in any way. Hold the foil package at both top corners with the instructions facing you, right side up. Then, holding firmly, fold, but do not tear along the dotted line at the top of the foil package. Keeping the edge folded down, tear down at the notch along the dotted line on the right side, where you see the scissor symbol. Be sure to tear the package all the way to the bottom. You may use scissors to cut the package along the dotted line. Just be careful not to cut the film inside.
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, and do not 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.
Carefully pull the film from the package. You may have to peel back the package to fully expose the film. Check to make sure the film is not cut or damaged. Now, place the film on your fingertip, making sure that the yellow side is facing up toward you. The yellow side is the side that touches the inside of your cheek. You may need to use 2 fingers to hold the film securely. As you get ready, make sure the inside of your cheek is moist and that there are no open sores or lesions where you apply the film. Now you’re ready to press the film into the inside of your cheek.
Use your fingertip to press the yellow side of the film against the middle inside of your moistened cheek and hold for 5 seconds. To position the film correctly, it may help to press another finger to the outside of your cheek so that 2 fingers are holding the film in place. Do not place the film too high or too far back in your cheek. After 5 seconds, remove your finger. The film will stick to the inside of your cheek.
Now, allow the film to dissolve completely. It dissolves usually within 30 minutes, and you may notice it has a mild peppermint flavor. During this time, do not eat or drink or touch the film in any way with your tongue or your finger. Please do not chew or swallow the film. If you do chew or swallow the film, it may not be as effective. This may cause choking, so care must be taken. You can speak and swallow normally while the film is dissolving. Just do not do anything that would move the film in your mouth. Make sure you apply BELBUCA at the same time or times each day.
Remember, to apply BELBUCA, follow these simple steps. Peel open the foil package, place the film on your finger, and press the film against the inside of your moistened cheek. It should dissolve in about 30 minutes.

Tips for applying Belbuca

  • Apply at the same time each day, following your healthcare provider’s instructions
  • Never use BELBUCA if the pouch seal is broken or the film is damaged in any way
  • You may need to use 2 fingers to hold the film securely
  • It may help to press another finger on the outside of your cheek to position the film correctly
  • Do not apply the film to any area of your mouth where there are open cuts or sores
  • Do not place the film too high or too far back on the inside of your cheek
  • Do not chew or swallow the film; this may decrease the film’s effectiveness and could cause choking or accidental overdose
  • It is normal for the texture of the film to change as it dissolves
  • Do not eat or drink anything until the film has completely dissolved, usually within 30 minutes

APPROVED USE

*BELBUCA® (buprenorphine buccal film) 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; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES AND OTHER CNS DEPRESSANTS

See full prescribing information for complete boxed warning.

APPROVED USE

*BELBUCA® (buprenorphine buccal film) 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. Selling or giving away BELBUCA is against the law.
  • Store BELBUCA securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

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.

IMPORTANT SAFETY INFORMATION about BELBUCA®

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 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 regularly for these behaviors and conditions.

Risk Evaluation and Mitigation Strategy (REMS)

To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the FDA has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to

  • complete a REMS-compliant education program,
  • counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,
  • emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and
  • consider other tools to improve patient, household, and community safety.

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 poses a significant risk of overdose and death.

Accidental Exposure

Accidental exposure to even one dose of BELBUCA, especially in 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. 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.

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.

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.

When taking 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.
  • Dispose of expired, unwanted, or unused BELBUCA by removing the BELBUCA film from the foil packaging, and promptly flushing down the toilet (if a drug takeback option is not readily available). Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

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

Please see full Prescribing Information, including Boxed Warning, and Medication Guide, or speak to your healthcare provider if you have questions about BELBUCA.

Manufactured for: BioDelivery Sciences International, Inc.