Addiction, Abuse, and Misuse; Life-Threatening Respiratory Depression; Neonatal Opiod Withdrawal Syndrome; and Risks From Concomitant Use With Benzodiazepines or Other Central Nervous System (CNS) Depressants

Addiction, Abuse, and Misuse

• OLINVYK 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 before prescribing OLINVYK, and monitor all patients regularly for the development of behaviors or conditions [see Warnings and Precautions (5.1)].

Life-Threatening Respiratory Depression

• Serious, life-threatening, or fatal respiratory depression may occur with use of OLINVYK.  Monitor for respiratory depression, especially during initiation of OLINVYK or following a dose increase [see Warnings and Precautions (5.2)].

Neonatal Opioid Withdrawal Syndrome

• Prolonged use of OLINVYK 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 [see Warnings and Precautions (5.3)].

Risk From Concomitant Use With Benzodiazepines Or Other CNS Depressants

• Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions (5.4), Drug Interactions (7)].
• Reserve concomitant prescribing of OLINVYK 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.