Addiction, Abuse, and Misuse; Life Threatening Respiratory Depression, Accidental Ingestion; Neonatal Opioid Withdrawal Syndrome; and Interaction with Alcohol; Risk Evaluation and Mitigation Stratgy (REMS)

Addition, Abuse and Misuse

• NUCYNTA® ER 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 [Tradename], and monitor all patients regularly for the development of these behaviors or conditions.
• Consider prescribing naloxone for the emergency treatment of opioid overdose

Life-threatening Respiratory Depression

• Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation of NUCYNTA® ER or following a dose increase. Instruct patients to swallow NUCYNTA® ER tablets whole; crushing, chewing, or dissolving NUCYNTA® ER tablets can cause rapid release and absorption of a potentially fatal dose of tapentadol.
• Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper.

Accidental Exposure

• Accidental [ingestion/exposure] of even one dose of NUCYNTA® ER, especially by children, can result in a fatal overdose of tapentadol.

Neonatal Opioid Withdrawal Syndrome

• Prolonged use of NUCYNTA® ER 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.

Interaction with Alcohol 

• Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking NUCYNTA® ER. The co-ingestion of alcohol with NUCYNTA® ER may result in increased plasma levels and a potentially fatal overdose of tapentadol.

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 opioids and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
• Limit dosages and durations to the minimum required.
• Follow patients for signs and symptoms of respiratory depression and sedation.

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

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 REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to:

• complete a REMS-compliant education program,
• counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,
• emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and
• consider other tools to improve patient, household, and community safety.