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*BELBUCA® (buprenorphine buccal film) is indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.
Limitations of Use
CONTRAINDICATIONS
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.
WARNINGS AND PRECAUTIONS
Addiction, Abuse, and Misuse
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 and reassess all 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, 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 of 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.
Life-Threatening Respiratory Depression
Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose:
Risks due to Interactions with Benzodiazepines or Other Central Nervous System Depressants
Neonatal Opioid Withdrawal Syndrome (NOWS)
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)
Healthcare providers are strongly encouraged to do all of the following:
To obtain further information on the opioid analgesic REMS and for a list of accredited REMS CME/CE, call 1-800-503-0784, or log on to www.opioidanalgesicrems.com. The FDA Blueprint can be found at www.fda.gov/OpioidAnalgesicREMSBlueprint.
Opioid-Induced Hyperalgesia and Allodynia
Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients
Adrenal Insufficiency
Severe Hypotension
Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness
Hepatotoxicity
Risk of Use in Patients with Gastrointestinal Conditions
Increased Risk of Seizures in Patients with Seizure Disorders
Dental Adverse Events
QTc Prolongation
Anaphylactic/Allergic Reactions
Withdrawal
Risks of Driving and Operating Machinery
Risk of Overdose in Patients with Moderate or Severe Hepatic Impairment
Risks of Use in Cancer Patients with Oral Mucositis
ADVERSE REACTIONS
See full Prescribing Information, including Boxed Warning on Addiction, Abuse and Misuse and other serious risks, accompanying this piece or at BELBUCA.com/pi.
To report SUSPECTED ADVERSE REACTIONS, contact Collegium Pharmaceutical, Inc. at 1-855-331-5615 or FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch.