My pain, my life—Rethink relief with BELBUCA®

Watch the videos below to hear real patients talk about how BELBUCA® has helped them.


Beth's concerns

Beth has struggled with chronic back pain for 10 years. She shares that her previous opioid medications were causing drowsiness, a lack of balance, and concerns with driving. She feels BELBUCA® has helped her get back to her life.

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My pain started around 2007, just having some backaches, things like that. I mentioned it to my doctor and they put me on medication for it, but nothing … it wasn’t getting better. I was sent to a chiropractor, physical therapy, but the problem just continued. I did have concerns about taking an opioid for chronic pain because of what you hear. And I did do research on things and there are side effects. And those things would happen to me when I would take certain pills. You get woozy and drowsy; I didn’t want to drive. Things like that. So, it was causing that issue too. I couldn’t even drive myself places if I took medication. With the medication I was taking, I wasn’t getting the coverage I needed, and I just felt like I was increasing the number of pills, and I didn’t want to do that. When I was on the regimen for my prior medications, I never wanted to change it because I was so afraid that if I stopped what I was doing my pain would get worse. That was always a fear I had of changing medication because you do become comfortable with what you’re taking, you’re kind of “I’ll deal with the pain that comes along.” I just didn’t want to make any more changes. And when the doctor suggested BELBUCA® at first, I didn’t want to do it. And he said people are having a lot of good things happen with this. He says, “My patients who are taking it, they are saying great things. Why don’t we just give it a try?” And I said, “Okay we’ll try it.” And it was … I have no complaints. It’s been great. I take BELBUCA® in the morning when I get up. And usually I try to take it within 12 hours of that, 12 hours after. So twice a day. You just hold it in place for like 5 seconds and it adheres and you just go on. It’s real easy. My life before BELBUCA®, when I was really starting with the chronic pain, I was so used to going on walks with my husband, we liked to bicycle, we loved to go to the boardwalk and take walks, go to the beach on the weekends, and that all stopped because I couldn’t deal with the back pain. I just never knew when it was going to hit hard. And I was so afraid of being in a position where I couldn’t get home. We had been on vacation in South Carolina, and my back was so bad that it just took away our whole vacation from us. I ended up in the hospital 3 times. Once, then we tried different medications. But the BELBUCA®, since I’ve been taking that, even my husband has said, “You’re pulling me now to the beach. You’re the one making these decisions, let’s go.” He said it’s so nice because it wasn’t like that for so long. It was something we really missed out on. We just got to take a wonderful trip, the 2 of us, we went away. I just felt so good. And I’m like, I’m ready to travel, I’m ready to do those things again. And we did, we had a great time. So, it’s making a big difference for us.

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

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www.bdsi.com or call 1-877-579-4578.Medication GuideFull Prescribing Information
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