Less pain in my
life helps me get
back to living.
Less pain in my life helps me get
back to living.
Talk to your doctor about BELBUCA® – and rethink chronic pain* relief
Now that your doctor has prescribed BELBUCA® for your chronic pain,* learn how to get the most out of your medicine. Download a helpful educational brochure.
You can also scroll down to learn more about medication instructions and the BELBUCA® savings program.
My Pain, My Life—Rethink Relief With BELBUCA®
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.
Just PEEL, PLACE, & PRESS to take BELBUCA®1
BELBUCA® works by sticking to the inside of your cheek and then dissolving completely—usually within 30 minutes. The film will not interfere with your ability to talk or swallow, and has a mild mint taste.
- Make sure your fingers are clean and dry. Tear open the foil package by folding on the dotted line and tearing down at the perforation, or carefully cutting the package with scissors
- Remove the film from the package
- Wet the inside of your cheek by using your tongue or rinsing with water
- Place the film on a dry fingertip with the yellow side facing up
- Press the yellow side against the inside of your cheek and hold in place for 5 seconds
- Leave BELBUCA® on the inside of your cheek until fully dissolved, usually within 30 minutes
Eligible patients pay as little as $0 for BELBUCA®†
This offer is valid for the purchase of BELBUCA® manufactured for BioDelivery Sciences International, Inc. and lawfully purchased from an authorized retailer or distributor in the United States or its territories. This offer is not insurance and is not valid for mail order or prescriptions purchased under Medicaid, Medicare, TRICARE, or similar federal or state programs, or for patients who are Medicare eligible and enrolled in an employer-sponsored group waiver health plan or government-subsidized prescription drug benefit program for retirees. Offer not valid where prohibited by law, taxed, or restricted. Your offer has its own unique ID number. This offer is not transferable, is limited to one per person, and may not be combined with any other offer. Offer must be presented along with a valid prescription for BELBUCA® at the time of purchase. If you lose your card before the first time you use it, simply print or download a new copy at BELBUCA.com and bring it to the pharmacy.
BioDelivery Sciences International, Inc. reserves the right to change or discontinue this offer at any time without notice.
*Pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
†In the 1st month, eligible patients pay $0 up front and save $100 off their copay per prescription on up to 3 prescriptions. In the 2nd month, patients pay $25 up front and save $75 off their remaining copay per prescription on up to 3 prescriptions. In the 3rd to 12th months, patients pay $25 up front and save $75 off their remaining copay per prescription on only 1 prescription per month. Restrictions apply.
BELBUCA® (buprenorphine) buccal film is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations of Use
- Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioid formulations, reserve BELBUCA® for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
- BELBUCA® is not indicated as an as-needed (prn) analgesic.
BELBUCA® is contraindicated in patients with significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment; known or suspected gastrointestinal obstruction, including paralytic ileus; and hypersensitivity (e.g., anaphylaxis) to buprenorphine.
Important Safety Information
(buprenorphine) buccal film, CIII
- 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 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
Marketed by: BioDelivery Sciences International, Inc., Raleigh, NC 27612,
www.bdsi.com or call 1-877-579-4578.
Full Prescribing Information
References: 1. BELBUCA(R) (Prescribing Information). Raleigh, North Carolina: BioDelivery Sciences, Inc.; December 2016.