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

IONSYS® (fentanyl iontophoretic transdermal system) CII
Instructions for Use and Disposal

View of IONSYS(R) (fentanyl iontophoretic transdermal system) CII

IONSYS fentanyl iontophoretic transdermal system, 40 mcg/activation.

For single use only. Up to 24 hours or 80 doses, whichever comes first.

Refer to the Prescribing Information (PI) and the following educational materials for more information about IONSYS:

  • IONSYS Medication Guide
  • IONSYS REMS Safety Brochure: Guide for Nurses and Pharmacists
  1. Prepare Patient Site
    1. Instructions Step 1: Prepare patient site for IONSYS(R) (fentanyl iontophoretic transdermal system) CIIONLY 1 IONSYS system should be applied at any given time.
    2. Choose healthy, unbroken skin on the upper outer arm or chest ONLY (see Figure 1a).
    3. Clip excessive hair if necessary. Do not shave—this irritates skin.
    4. Clean with alcohol and let dry. Do not use soaps, lotions, or other agents.
    5. When replacing an IONSYS system, the new system must be applied to a different site on the upper outer arm or chest.
  2. Assemble IONSYS
    1. Instructions Step 2a: assembly for IONSYS(R) (fentanyl iontophoretic transdermal system) CIIAlways wear gloves when handling IONSYS.
    2. Complete this step before applying IONSYS to patient.
    3. Peel back tray lid (see Figure 2a). Remove foil pouch and the controller.
    4. Instructions Step 2b: Assembly from foil pouch for IONSYS(R) (fentanyl iontophoretic transdermal system) CIIRemove drug unit from foil pouch and place on a hard, flat surface (see Figure 2b).
    5. Instructions Step 2c: Assembly and alignment of matching shapes for IONSYS(R) (fentanyl iontophoretic transdermal system) CIIAlign the matching shapes (see Figure 2c).
    6. Instructions Step 2d: Assembly with two clicks for IONSYS(R) (fentanyl iontophoretic transdermal system) CIIPress on both ends of the device to ensure that snaps at both ends are fully engaged (see Figure 2d).
    7. Instructions Step 2e: Assembly and system self-test digital display reads 0 for IONSYS(R) (fentanyl iontophoretic transdermal system) CIIWait for system to complete self-test and the digital display to read “0” (see Figure 2e).
  3. Train Patient on Proper Use of IONSYS
    1. Refer to the IONSYS Medication Guide to counsel your patient on the safe use of IONSYS.
  4. Apply IONSYS to Patient
    1. Instructions Step 4a: Always wear gloves when handling IONSYS(R) (fentanyl iontophoretic transdermal system) CIIAlways wear gloves when handling IONSYS.
    2. Peel off clear liner and apply IONSYS to the prepared site (see Figure 4a).
    3. Instructions Step 4b: Hold onto patients for 15 seconds by pressing edges with fingers for IONSYS(R) (fentanyl iontophoretic transdermal system) CIIPress and hold IONSYS onto patient for 15 seconds by pressing the edges with fingers (see Figure 4b). Do not press dosing button.
    4. If IONSYS is not securely adhered, see IONSYS Troubleshooting – Poor skin contact.
  5. NOTE: Ensure proper display orientation by reading “Doses Delivered” printed below the digital display.

  6. Verify Proper Use of IONSYS
    1. Remember that ONLY the patient should press the dosing button.
    2. Remove before MRI or radiographic procedures as medically necessary.

    Instructions Step 5: Verify proper use of IONSYS(R) (fentanyl iontophoretic transdermal system) CII

    • Patient will initiate a dose by pressing and releasing the button twice in 3 seconds.
    • Each dose will be delivered over 10 minutes. During this time IONSYS is locked-out and will not respond to additional button presses.
    • During the 10 minutes the light will blink green at a fast rate and the display will alternate between a walking circle and the number of doses delivered (see Figure 5).
  7. Remove IONSYS from Patient and Dispose
    1. Follow your institution’s procedures for handling narcotics or refer to the PI for more information.
    2. Always wear gloves when handling IONSYS.
    3. Important: If drug gel contacts your skin, thoroughly rinse area with water. Do not use soap.
    4. Instructions Step 6a: Removal from patient using gloves for IONSYS(R) (fentanyl iontophoretic transdermal system) CIIWith gloves on, remove IONSYS from the patient (see Figure 6a).
    5. Instructions Step 6b: Removal by pulling red tab to separate red housing for IONSYS(R) (fentanyl iontophoretic transdermal system) CIIPull the red tab to separate the red housing containing the drug (see Figure 6b).
    6. Instructions Step 6c: Removal by folding in half and dispose per institution procedures for IONSYS(R) (fentanyl iontophoretic transdermal system) CIIFold the red housing in half and dispose per your institution’s procedures or flush down the toilet (see Figure 6c).
    7. Hold down dosing button until display goes blank and dispose in waste designated for batteries.

IONSYS Troubleshooting

After successful assembly or anytime during use:

If you see or hear this...
...then do this:
Trouble shooting visual and audio guide for IONSYS(R) (fentanyl iontophoretic transdermal system) CII
Poor Skin Contact
  1. If IONSYS appears to be loose or lifting from skin, secure it to the patient’s skin by pressing the edges with fingers or securing with nonallergenic tape.
  2. If using tape, apply it along the long edges to secure IONSYS to patient’s skin. Do not cover the button or display.
  3. After taping, if IONSYS beeps again, remove and dispose. Place a new IONSYS on a different skin site.
  4. Do not tape if evidence of blistered or broken skin.
Trouble shooting visual and audio guide for IONSYS(R) (fentanyl iontophoretic transdermal system) CII Trouble shooting visual and audio guide for IONSYS(R) (fentanyl iontophoretic transdermal system) CII
Low Battery or Defective System
  1. Do not use the system.
  2. Dispose of IONSYS per instructions in section 6.
  3. Place a new IONSYS on a different skin site.
System Error
  1. Remove from patient.
  2. Hold down dosing button until beeping stops and display goes blank.
  3. Dispose of IONSYS per instructions in section 6.
  4. Place a new IONSYS on a different skin site.
Trouble shooting visual and audio guide for IONSYS(R) (fentanyl iontophoretic transdermal system) CII
End-of-Use (80 doses or 24 hours)
  1. Remove from patient.
  2. Hold down dosing button until display goes blank.
  3. Dispose of IONSYS per instructions in section 6.
  4. Place a new IONSYS on a different skin site.

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