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Important Safety Information

WARNING: LIFE-THREATENING RESPIRATORY DEPRESSION; IONSYS® REMS; ADDICTION, ABUSE, AND MISUSE; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of IONSYS®. Monitor for respiratory depression, especially during initiation of IONSYS®. Only the patient should activate IONSYS® dosing.

IONSYS Risk Evaluation and Mitigation Strategy (REMS) Program

  • IONSYS® is for use only in patients in the hospital. Discontinue treatment with IONSYS® before patients leave the hospital.
  • Because of the risk of respiratory depression from accidental exposure, IONSYS® is available through a restricted program called the IONSYS® REMS Program. Healthcare facilities that dispense IONSYS® must be certified in this program and comply with the REMS requirements.

Addiction, Abuse, and Misuse

IONSYS® exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing, and monitor regularly for development of these behaviors or conditions.

Cytochrome P450 3A4 Interaction

The concomitant use of IONSYS® with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving IONSYS® and any CYP3A4 inhibitor or inducer.

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 IONSYS® 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.

Contraindications

Warnings and Precautions

Adverse Reactions

Most common adverse reactions (frequency ≥2%) were headache, hypotension, nausea, vomiting, anemia, dizziness, application site reaction-erythema, pruritus, and urinary retention.

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