WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTION WITH CYTOCHROME P450 3A4; and RISKS FROM CONCOMITANT USE WITH BENSubstance Abuse, Abuse, and MisuseROXICODONE exposes patients and other users to the dangers of opioid addiction, abuse, and misuse, all of which can result in death from overdose. Prior to providing ROXICODONE, assess each patient’s risk and monitor all patients periodically for the development of certain behaviors and conditions.
Risk Assessment and Mitigation Strategy for Opioid Analgesics (REMS)
The Food and Drug Administration (FDA) requires a REMS for opioid analgesics to verify that the benefits outweigh the dangers of addiction, abuse, and misuse. Pharmaceutical companies that have approved opioid analgesic products are required to 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 caregivers on the safe use, serious risks, storage, and disposal of these products with each prescription; • emphasize to patients and caregivers the importance of reading the Medication Guide each time it is provided by their pharmacist; and • consider additional tools to improve patient, household, and community safety.
Life-Threatening Respiratory Depression
ROXICODONE may cause serious, life-threatening, or deadly respiratory depression. Keep an eye out for respiratory depression, especially when starting ROXICODONE or increasing the dose.
Consumption by Accident
Accidental ROXICODONE ingestion, particularly by youngsters, can result in a lethal ROXICODONE overdose.
Syndrome of Neonatal Opioid Withdrawal
Prolonged use of ROXICODONE during pregnancy can result in newborn opioid withdrawal syndrome, which can be fatal if not diagnosed and treated promptly, and needs therapy according to neonatology-specific procedures. If prolonged opioid use is necessary in a pregnant woman, inform her about the danger of neonatal opioid withdrawal syndrome and ensure that proper therapy is available.
Interaction with Cytochrome P450 3A4
Concurrent usage of ROXICODONE and all cytochrome P450 3A4 inhibitors may result in an increase in plasma oxycodone concentrations, which may exacerbate or prolong unpleasant responses and may result in potentially deadly respiratory depression. Additionally, stopping a concurrently utilized cytochrome P450 3A4 inducer may result in a rise in the plasma levels of oxycodone. Patients receiving ROXICODONE and any CYP3A4 inhibitor or inducer should be closely monitored.
Consequences of Concurrent Use with Benzodiazepines or Other Central Nervous System Depressants
Concurrent use of opioids with benzodiazepines or other CNS depressants, such as alcohol, may result in extreme drowsiness, respiratory depression, coma, or death.
Concurrent administration of ROXICODONE with benzodiazepines or other CNS depressants should be reserved for individuals who do not respond to alternate therapeutic alternatives.
Keep dosages and durations to a minimum.
Maintain an eye out for signs and symptoms of respiratory depression and sedation in patients.