To be prescribed only by health care providers knowledgeable in use of potent opioids for management of chronic pain.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. 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.If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Prolonged use of BELBUCA during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated.Accidental exposure to BELBUCA, especially in children, can result in fatal overdose of buprenorphine.Instruct patients on proper administration of BELBUCA to reduce the risk. Monitor closely, especially upon initiation or following a dose increase. Serious, life-threatening, or fatal respiratory depression may occur.
To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products.Assess patient's risk before prescribing, and monitor regularly for these behaviors and conditions. BELBUCA exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death.
BELBUCA 300 MCG FULL
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 DEPRESSANTS See full prescribing information for complete boxed warning.
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