This site is intended for U.S. health care professionals only.

Overview
IONSYS® (fentanyl iontophoretic transdermal system) CII

Indication and Usage

IONSYS® (fentanyl iontophoretic transdermal system) CII, contains fentanyl, an opioid agonist. IONSYS® is indicated for the short-term management of acute postoperative pain severe enough to require an opioid analgesic in the hospital and for which alternative treatments are inadequate.

Limitations of Use:

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve IONSYS® for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):

  • Have not been tolerated, or are not expected to be tolerated,
  • Have not provided adequate analgesia, or are not expected to provide adequate analgesia.

IONSYS®

  • Only for use in patients who are alert enough and have adequate cognitive ability to understand the directions for use.
  • Not for home use. IONSYS® is for use only in patients in the hospital. Discontinue treatment with IONSYS® before patients leave the hospital.
  • For use after patients have been titrated to an acceptable level of analgesia using alternate opioid analgesics.

IONSYS® Risk Evaluation and Mitigation Strategy (REMS) Program

IONSYS® is available only through a restricted program called the IONSYS® REMS Program to mitigate the risk of respiratory depression resulting from accidental exposure to persons for whom it is not prescribed.

Notable requirements of theIONSYS® REMS Program include the following:

  • Healthcare facilities that dispense and administer IONSYS® must be certified in the IONSYS® REMS Program and comply with the REMS requirements
  • Hospitals must only dispense IONSYS® for hospital use

Further information about the IONSYS® REMS Program is available at www.IONSYSREMS.com or by calling 1-877-488-6835.

For more information please ask The Medicines Company representative.

Active Drug: Fentanyl HCI

Application Site1: Upper outer arm or chest

Application site for upper outer arm or chest for IONSYS(R) (fentanyl iontophoretic transdermal system) CII


Front View

Application site for upper outer arm or chest for IONSYS(R) (fentanyl iontophoretic transdermal system) CII


Front View

  1. IONSYS® [ prescribing information], Parsippany, NJ: The Medicines Company; 2016.

System Design

System design and exploded view diagram IONSYS(R) (fentanyl iontophoretic transdermal system) CII

System design and exploded view diagram IONSYS(R) (fentanyl iontophoretic transdermal system) CII

  1. Data on file. The Medicines Company.
  2. IONSYS® [ prescribing information], Parsippany, NJ: The Medicines Company; 2016.

Iontophoretic Transdermal Delivery

Iontophoresis: Low-intensity electric current transports 40 mcg fentanyl per activation through skin into systemic circulation over 10 minutes1

Mechanism of delivery illustration and exploded view of IONSYS(R) (fentanyl iontophoretic transdermal system) CII

Mechanism of delivery illustration and exploded view of IONSYS(R) (fentanyl iontophoretic transdermal system) CII

  1. IONSYS® [ prescribing information], Parsippany, NJ: The Medicines Company; 2016.

Pharmacokinetics: Serum Fentanyl Concentration Following 40 mcg
IONSYS® (fentanyl) Compared To IV Fentanyl

First Hour of a Representative Treatment1*

First hour of treatment and dosing graph for IONSYS(R) (fentanyl iontophoretic transdermal system) CII

First hour of treatment and dosing graph for IONSYS(R) (fentanyl iontophoretic transdermal system) CII

*IONSYS® 40 mcg: 2 sequential doses over 20 minutes every hour for 23 hours and 20 minutes; IV fentanyl: 80 mcg dose over 20 minutes every hour for 23 hours and 20 minutes.

  1. IONSYS® [ prescribing information], Parsippany, NJ: The Medicines Company; 2016.


Last Hour and Upon Termination of a Representative Treatment1*

Last hour of treatment and dosing for IONSYS(R) (fentanyl iontophoretic transdermal system) CII

Last hour of treatment and dosing for IONSYS(R) (fentanyl iontophoretic transdermal system) CII

*IONSYS® 40 mcg: 2 sequential doses over 20 minutes every hour for 23 hours and 20 minutes; IV fentanyl: 80 mcg dose over 20 minutes every hour for 23 hours and 20 minutes.

  1. IONSYS® [ prescribing information], Parsippany, NJ: The Medicines Company; 2016.

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.

www.ionsys.com

This site is intended for U.S. Healthcare Professionals. If you are a U.S. Healthcare Professional, click OK to continue.

Ok
Cancel