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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

  • Significant respiratory depression
  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
  • Known or suspected gastrointestinal obstruction, including paralytic ileus
  • Hypersensitivity to fentanyl, cetylpyridinium chloride (e.g., Cepacol®), or any components of IONSYS®

Warnings and Precautions

  • Risk of Injury During MRI: IONSYS® contains metal parts and must be removed before an MRI. Monitor patients with inadvertent MRI exposure while wearing IONSYS® for signs of central nervous system and respiratory depression.
  • Risk of Use During Other Procedures or Near Certain Equipment: Remove IONSYS® before cardioversion, defibrillation, X-ray, CT, or diathermy. Avoid contact with synthetic materials (such as carpeted flooring). Avoid exposing IONSYS® to electronic security systems. Use of IONSYS® near communications equipment and RFID transmitters can damage IONSYS®. If exposure occurs and IONSYS® does not appear to function normally, remove and replace with a new IONSYS®.
  • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, and Debilitated Patients: Monitor patients closely, particularly when initiating IONSYS® and when IONSYS® is used concomitantly with other drugs that depress respiration. Alternatively, consider the use of non-opioid analgesics in these patients.
  • Serotonin Syndrome: Potential life-threatening condition associated with concomitant use of fentanyl and serotonergic drugs, which include selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, tricyclic antidepressants, triptans, 5-HT3 receptor antagonists, drugs that affect the serotonergic neurotransmitter system and drugs that impair metabolism of serotonin, including monoamine oxidase inhibitors, linezolid and IV methylene blue. Symptoms include mental status changes, autonomic instability, neuromuscular aberrations, and/or gastrointestinal symptoms. Discontinue IONSYS® if serotonin syndrome is suspected.
  • Adrenal Insufficiency: Cases have been reported with opioid use (usually >1 month). Presentation and symptoms are non-specific but include nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Confirm diagnosis with testing as soon as possible and, if confirmed, treat with physiologic replacement of corticosteroids and wean patient off of opioid.
  • Severe Hypotension: IONSYS® may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients, especially in patients with compromised ability to maintain blood pressure. Monitor during dosage initiation. Avoid the use of IONSYS® in patients with circulatory shock.
  • Risk of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury or Impaired Consciousness: In patients who may be susceptible to the intracranial effects of CO2 retention, IONSYS® may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Monitor for sedation and respiratory depression, particularly when initiating therapy. IONSYS® is not suitable for use in patients who are not alert and able to follow directions. Avoid use of IONSYS® in patients with impaired consciousness or coma.
  • Use in Patients with Gastrointestinal Conditions: Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.
  • Increased Risk of Seizures in Patients with Seizure Disorders: Fentanyl may increase frequency of seizures in these patients. Monitor patients for worsened seizure control.
  • Topical Skin Reactions: Topical skin reactions may occur with use of IONSYS® and are typically limited to the site application area. Remove IONSYS® and discontinue further use if a severe skin reaction is observed.
  • Bradycardia: IONSYS® may produce bradycardia in some patients. Closely monitor patients with bradyarrhythmias for changes in heart rate, particularly when initiating therapy.
  • Withdrawal: Avoid the use of mixed agonist/antagonist or partial agonist analgesics in patients who are receiving IONSYS®. Do not abruptly discontinue IONSYS®.
  • Hepatic Impairment and/or Renal Impairment: Monitor for signs of sedation and respiratory depression.
  • Neonatal Opioid Withdrawal Syndrome: Prolonged use of IONSYS® during pregnancy can result in withdrawal in the neonate, which can be life-threatening. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using opioids for a prolonged period of this risk and ensure that appropriate treatment will be available.

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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