Starting
BELBUCA® (buprenorphine buccal film) for severe and persistent 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 severe and persistent 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 severe and persistent 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 relief for your severe and persistent pain and 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.

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.

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

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.

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 severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine when other pain 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 to be taken on an “as needed” basis.

IMPORTANT SAFETY INFORMATION ABOUT BELBUCA®

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BELBUCA

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.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of BELBUCA, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of BELBUCA are essential. 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

APPROVED USE

*BELBUCA® (buprenorphine buccal film) CIII is:

  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine when other pain 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 to be taken on an “as needed” basis.

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
  • pancreas or gallbladder problems
  • problems urinating
  • tooth problems, including a history of cavities
  • abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems

IMPORTANT SAFETY INFORMATION about BELBUCA®

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BELBUCA

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.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of BELBUCA, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of BELBUCA are essential. 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.

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 of BELBUCA and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.

Neonatal Opioid Withdrawal Syndrome (NOWS)

If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of NOWS, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery.

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription.

Tell your healthcare provider if you are:

  • noticing your pain getting worse. If your pain gets worse after you take BELBUCA, do not take more of BELBUCA without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking BELBUCA.
  • pregnant or planning to become pregnant. Prolonged use of BELBUCA during pregnancy can cause withdrawal symptoms in your newborn baby that could be lifethreatening 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.

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/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 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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