Serious, life-threatening, or fatal respiratory depression may occur with use of BELBUCA. consider other tools to improve patient, household, and community safety.emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and.counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,.complete a REMS-compliant education program,.Healthcare providers are strongly encouraged to Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers.

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. Risk Evaluation and Mitigation Strategy (REMS) Assess each patientвЂ™s risk prior to prescribing BELBUCA, and monitor regularly for these behaviors and conditions. 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 DEPRESSANTSД«ELBUCA exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Strategies to reduce the risk include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug. Consider these risks when prescribing or dispensing BELBUCA.

Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.

Abuse or misuse of BELBUCA by swallowing may cause choking, overdose, and death.

Consider prescribing naloxone for the emergency treatment of opioid overdose.

Patients at increased risk may be prescribed opioids such as BELBUCA, but use in such patients necessitates intensive counseling about the risks and proper use of BELBUCA, along with intensive monitoring for signs of addiction, abuse, or misuse. The potential for these risks should not, however, prevent the proper management of pain in any given patient. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression).

Assess each patientвЂ™s risk for opioid addiction, abuse, or misuse prior to prescribing BELBUCA and monitor all patients receiving BELBUCA for the development of these behaviors and conditions.

Addiction can occur at recommended dosages and if the drug is misused or abused.

Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed BELBUCA. As an opioid, BELBUCA exposes users to the risks of addiction, abuse, and misuse. BELBUCA contains buprenorphine, a Schedule III controlled substance.BELBUCA is not indicated as an as-needed (prn) analgesic.Д«ELBUCA 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.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 В® (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.

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