Oliceridine Fumarate
Class: Opiate Agonists
Chemical Name: N-[(3-methoxythiophen-2-yl)methyl]-2-[(9R)-9-pyridin-2-yl-6-oxaspiro[4.5]decan-9-yl]ethanamine
Molecular Formula: C22H30N2O2S•C4H4O4
Brands: Olinvyk
Warning
- Addiction, Abuse, and Misuse
Risk of addiction, abuse, and misuse, which can lead to overdosage and death. Assess each patient’s risk for addiction, abuse, and misuse before prescribing oliceridine; monitor all patients regularly for development of these behaviors or conditions. (See Addiction, Abuse, and Misuse under Cautions.)
- Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation of therapy and following dosage increases. (See Respiratory Depression under Cautions.)
- Neonatal Opiate Withdrawal
Prolonged maternal use of opiates during pregnancy can result in neonatal withdrawal syndrome, which may be life-threatening if not recognized and treated. Advise women who require such therapy during pregnancy of this risk and ensure appropriate treatment will be available. (See Pregnancy under Cautions.)
- Concomitant Use with Benzodiazepines or Other CNS Depressants
Concomitant use of opiate agonists with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
Reserve concomitant use of opiate analgesics and benzodiazepines or other CNS depressants for patients in whom alternative treatment options are inadequate; use lowest effective dosages and shortest possible duration of concomitant therapy and monitor closely for respiratory depression and sedation. (See Specific Drugs under Interactions.)
Introduction
Opiate agonist.
Uses for Oliceridine Fumarate
Acute Pain
Relief of acute pain that is severe enough to require an IV opiate analgesic; because of the risks of addiction, abuse, and misuse associated with opiates even at recommended dosages, reserve for use in patients for whom alternative treatment options (e.g., nonopiate analgesics, opiate-containing fixed combinations) have not been, or are not expected to be, adequate or tolerated.
Pivotal efficacy studies evaluated oliceridine administered as patient-controlled analgesia (PCA) for postoperative pain for periods of ≤48 hours.
In symptomatic treatment of acute pain, reserve opiate analgesics for pain resulting from severe injuries, severe medical conditions, or surgical procedures, or when nonopiate alternatives for relieving pain and restoring function are expected to be ineffective or are contraindicated. Use smallest effective dosage for shortest possible duration since long-term opiate use often begins with treatment of acute pain. Optimize concomitant use of other appropriate therapies. (See Managing Opiate Therapy for Acute Pain under Dosage and Administration.)
