Starting
BELBUCA® (buprenorphine buccal film), CIII for around-the-clock pain relief when other treatments are not enough

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.

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.

Peel, Place, Press


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.

Peel the foil to open the Belbuca packaging

1 Peel

  • With clean, dry fingers, peel open the foil package. Fold along the dotted line at the top of the package and tear at the perforation
  • You can also use scissors to carefully cut along the dotted line
place the film on your fingers

2 Place

  • Wet the inside of your cheek with your tongue or with water
  • Carefully remove the BELBUCA film from the foil package and
  • Place the film 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. Hold it in place for 5 seconds, and then take your finger away
  • Leave BELBUCA on the inside of your cheek until fully dissolved, usually within 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
  • Avoid touching or moving BELBUCA buccal film with your tongue or finger after it is in place
  • After BELBUCA is completely dissolved, rinse your mouth with water and swallow. Wait at least 1 hour before brushing your teeth
GET ANSWERS TO BELBUCA FAQs

APPROVED USE

*BELBUCA® (buprenorphine buccal film) CIII 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 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)

APPROVED USE

*BELBUCA® (buprenorphine buccal film) CIII 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 or call 911 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. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.
  • 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 taking BELBUCA, tell your healthcare provider if you have a history of:

  • head injury, seizures
  • heart rhythm problems (long QT syndrome)
  • liver, kidney, thyroid problems
  • tooth problems, including a history of cavities
  • pancreas or gallbladder problems
  • problems urinating
  • abuse of street or prescription drugs, alcohol addiction, opioid overdose, 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.
  • Living in a household where there are small children or someone who has abused street or prescription drugs.
  • 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.

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.

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.
  • After BELBUCA is completely dissolved, rinse your mouth with water and swallow. Wait for at least one hour before brushing teeth.
  • Report any problems with your teeth immediately to your healthcare provider and schedule an appointment with a dentist. Tell your dentist that you have started taking BELBUCA.
  • 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/drugs/safe-disposal-medicines/disposal-unused-medicines-what-you-should-know 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 or call 911 right away 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 on Addiction, Abuse, and Misuse, and other serious risks, and Medication Guide, or speak to your healthcare provider if you have questions about BELBUCA.

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