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.

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.

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.

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.

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.

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.

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.

FAQs | BELBUCA® (buprenorphine buccal film), CIII

EXPAND ALLCOLLAPSE ALL

What is severe and persistent pain?

Severe and persistent pain is pain that lasts longer than 6 months. It can impact daily activities, sleep, even relationships and work.
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How do you treat or manage severe and persistent pain?

Treatment for severe and persistent pain is not as simple as finding a one-size-fits-all solution. There are many treatment options to help severe and persistent pain. You and your healthcare provider will work together to determine what works best for you.
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Why consider a long-acting opioid?

You and your healthcare provider may decide you need to move beyond your current treatment if your medications or therapies are not reducing your pain level enough, you are losing sleep because of pain, you are frequently using a short-acting opioid, or you need treatment for severe and persistent pain for an extended treatment period.
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What is BELBUCA?

BELBUCA is a strong prescription pain medicine (buprenorphine) 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.
BELBUCA is 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.
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What is buprenorphine?

BELBUCA contains a medication called buprenorphine. Buprenorphine is a long-acting opioid that stays in your system longer than short-acting opioids. This means BELBUCA can be taken every 12 hours, instead of every 4 to 6 hours like many short-acting opioids.
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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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Why is BELBUCA a buccal film?

The BELBUCA buccal film technology helps the medicine, buprenorphine, get into your body more quickly than when it is swallowed. When swallowed, buprenorphine is significantly less effective at treating your pain. Do not chew, swallow, snort, or inject BELBUCA. This will result in uncontrolled delivery of buprenorphine and may cause you to overdose and die.
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How do I know if I am taking the right dose or strength of BELBUCA?

BELBUCA has 7 dose strengths that will help you and your healthcare provider find your optimal dose. An optimal dose is the amount that provides the relief you need while minimizing side effects. It may take a few adjustments to find your optimal dose, so remember to talk to your doctor frequently.
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.
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How do I apply BELBUCA?
Before you begin, make sure the inside of your mouth is moist, either by 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.
Peel and tear open the package to carefully remove the film. Place the film on your finger. Press the yellow side against the inside of your cheek. It may take a few times to get accustomed to using BELBUCA.
Do not apply BELBUCA if the package seal is broken or the film is cut, damaged, or changed in any way.
+
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.
+
Can I eat, drink, or talk when the buccal film is in my mouth?

Do not eat or drink until the buccal 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 buccal 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.
+
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. If you chew or swallow the buccal film, it may not be as effective or may cause choking, overdose, or death. As such, be careful not to chew or swallow the film.
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How should I dispose of BELBUCA?
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.
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How much does BELBUCA cost?

The cost of BELBUCA varies based on your insurance plan. BELBUCA offers copay assistance to eligible commercially insured patients and is dedicated to helping patients access the medication they need. Restrictions apply. Please see eligibility criteria on the back of the card.
Visit our Savings page to download a Belbuca copay card.
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Please see full Prescribing Information, including Boxed Warning on Addiction, Abuse, and Misuse, and other serious risks. Speak to your healthcare provider if you have questions about BELBUCA.

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

Life-Threatening Respiratory Depression

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.

Frequently asked questions about BELBUCA® (buprenorphine buccal film)

Frequently asked questions about
BELBUCA^® (buprenorphine buccal film)