Important Safety Information
WARNING: HOSPITAL USE ONLY; LIFE-THREATENING RESPIRATORY DEPRESSION; IONSYS REMS; ADDICTION, ABUSE, AND MISUSE; and CYTOCHROME P450 3A4 INTERACTION
Life Threatening Respiratory Depression
- Use of IONSYS may result in potentially life-threatening respiratory depression and death as a result of the active drug, fentanyl. Only the patient should activate IONSYS dosing.
- Accidental exposure to an intact IONSYS or to the hydrogel component, especially by children, through contact with skin or contact with mucous membranes, can result in a fatal overdose of fentanyl.
- IONSYS is for use only in patients in the hospital. Discontinue treatment with IONSYS before patients leave the hospital.
IONSYS Risk Evaluation and Mitigation Strategy (REMS) Program
- Because of the potentially life-threatening respiratory depression resulting from accidental exposure, IONSYS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the IONSYS REMS Program.
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 effects 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.
- Significant respiratory depression
- Acute or severe bronchial asthma
- Known or suspected paralytic ileus and GI obstruction
- Hypersensitivity to fentanyl, cetylpyridinium chloride (e.g., Cepacol®), or any components of IONSYS
Warnings and Precautions
Most common (frequency ≥2%) adverse reactions are headache, hypotension, nausea, vomiting, anemia, dizziness, application site reaction-erythema, pruritus, and urinary retention.