April 30, 2016
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Ionsys

"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...

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Ionsys

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)




PATIENT INFORMATION

IONSYS® Important Device Instructions

1. EXPLANATION OF STANDARDIZED MEDICAL DEVICE SYMBOLS

Standardized symbols refer to specific warnings, features, or classifications of the device component of IONSYS® (fentanyl iontophoretic transdermal system). See Table 1 for the symbols and meaning of these symbols.

Table 1: Standardized Medical Device Symbols for IONSYS

Symbol Meaning
Do not reuse - Illustration Do not reuse
Operating instructions - Illustration Operating instructions
Caution - Illustration Caution
IP54 Dust-protected Protected against splashing water
Type body floating - Illustration Type body floating (BF) applied part*
Electrostatic discharge - Illustration Electrostatic discharge (ESD) sensitivity
Magnetic resonance (MR) unsafe - Illustration Magnetic resonance (MR) unsafe
Radio frequency (RF) transmitter - Illustration Radio frequency (RF) transmitter

*Body floating (BF) refers to a device that comes into contact with the patient's body and allows for electrical conductivity.

2. SYSTEM COMPONENTS AND STRUCTURE

Each IONSYS (see Figure 1) is composed of a plastic top housing that contains the battery and electronics and a red plastic bottom housing containing two hydrogel reservoirs and a polyisobutylene skin adhesive. Only one of the hydrogels (the anode, located under the dosing button) contains fentanyl HCl, along with inactive ingredients. The other hydrogel (the cathode) contains only pharmacologically inactive ingredients. The bottom housing has a red tab that is used only for IONSYS removal from the skin and during disposal. A siliconized clear, plastic release liner covers the hydrogels and must be removed and discarded prior to placement on the skin. IONSYS is powered by a 3-volt lithium battery.

Figure 1 : IONSYS® (fentanyl iontophoretic transdermal system)

SYSTEM COMPONENTS - Illustration

* Light is off or on (blinks and displays red or green color light).

3. IONSYS TROUBLESHOOTING

IONSYS delivers an on-demand dose of fentanyl over 10 minutes. The Normal IONSYS Feedback table (see Table 2) below illustrates normal audible and visual feedback from IONSYS upon assembly and during patient use.

Table 2: Normal IONSYS Feedback During Assembly and Patient Use

Mode Audible Feedback Visual Feedback (Light) Visual Feedback (Digital Display)
Assemble IONSYS by snapping the two parts together A single audible beep Light will blink RED momentarily and then start blinking GREEN at a slow rate Display will flash “88” and then transition to steady “0” indicating that IONSYS is ready for use and 0 doses have been delivered
Ready Mode: IONSYS is ready and awaiting patient request for dose None Light will blink GREEN at a slow rate Display will show the number of doses delivered (steady; not flashing)
Patient initiates a dose by pressing and releasing the button twice within 3 seconds A single audible beep indicates the start of delivery of each dose The light changes from blinking GREEN at a slow rate to blinking GREEN at a fast rate The display alternates between a walking circle and the number of doses delivered
10-minute dose is complete -IONSYS returns to Ready Mode None Light changes from blinking GREEN at a fast rate to blinking GREEN at a slow rate Display will show the number of doses delivered (steady; not flashing)
End of Use: 24 hours or 80 doses have been completed None None. Light will be Off. Display will flash the number of doses delivered

If IONSYS does not appear to function immediately, instruct the patient to attempt to initiate a dose again by firmly pressing and releasing the button twice within 3 seconds (i.e., double-press). A single audible beep will be emitted immediately, confirming that IONSYS is functional. Anytime during use, if IONSYS does not function properly, instruct the patient to call a staff member. Refer to the Error Messages table (see Table 3) for possible problems and appropriate course of action. Error messages provide information (e.g., blinking lights, audible beeps) about problems that may occur during operation of IONSYS.

Table 3: IONSYS Error Messages: Blinking Lights and Audible Beeps

Error Message/Feedback Probable Cause Action Required
Error Message - Illustration Low battery or defective IONSYS
  1. Do not use IONSYS.
  2. Dispose of IONSYS.
  3. Place a new IONSYS on a different skin site.
Error Message - Illustration Poor skin contact
  1. If IONSYS appears to be loose or lifting from skin, secure IONSYS to patient’s skin by pressing the edges with fingers or securing with non-allergenic tape.
  2. If using tape, apply it along the long edges to secure IONSYS to patient’s skin. Do not cover 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.
Error Message - Illustration System error
  1. Remove IONSYS from patient.
  2. Hold down dosing button until beeping stops and display goes blank.
  3. Dispose of IONSYS.
  4. Place a new IONSYS on a different skin site.
Error Message - Illustration End of use (24 hours or 80 doses elapsed)
  1. Remove IONSYS from patient.
  2. Hold down dosing button until display goes blank.
  3. Dispose of IONSYS.
  4. Place a new IONSYS on a different skin site.

Electromagnetic Compatibility testing for Immunity, specifically, Electrostatic Discharge (ESD) testing, demonstrated contact discharges to the hydrogel touch points caused IONSYS to shut down in a safe mode in several cases. A safe mode is a mode in which the controller cannot be activated; thereby, unable to dispense the drug. Therefore, IONSYS that shut down due to an ESD event are non-operable and deemed defective. These ESD events only occurred during the task of assembling the controller and drug units together.

4. ELECTROMAGNETIC COMPATIBILITY

IONSYS is designed to be used only in a hospital environment. In this environment IONSYS was not shown to interfere with nearby electronic equipment, and is immune to interference from other electronic equipment. IONSYS was tested in compliance with IEC 60601-1-2 at test levels for a hospital environment. Table 4, Table 5, and Table 6 list tests performed and provide guidance on the environment.

Some diagnostic or therapeutic procedures (such as MRI, cardioversion, defibrillation, X-ray, CT, or diathermy), and some electronic security systems can exceed the test levels shown in the tables. Remove IONSYS before exposure to MRI, cardioversion, defibrillation, X-ray, CT, or diathermy. IONSYS contains radio-opaque components and may interfere with an X-ray image or CT scan. Avoid exposing IONSYS to electronic security systems. Electrostatic discharge can exceed the test levels shown in the tables. Avoid contact with synthetic materials (such as carpeted flooring) to reduce the possibility of electrostatic discharge. Communications equipment (such as base stations for radio telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast and Radio), and Radio Frequency Identification (RFID) transmitters, can exceed the test levels shown in the tables.

Minimize exposure to sources of electromagnetic radiation by adhering to the separation distances found in Table 6. If exposure to the procedures, electronic security systems, electrostatic discharge, communications equipment, or RFID systems occurs, and if IONSYS does not appear to function normally as described in Table 2, IONSYS should be removed and replaced with a new IONSYS.

Table 4: Guidance and Manufacturer's Declaration – Electromagnetic Emissions

IONSYS is intended for use in the electromagnetic environment specified below. The health care provider should assure that IONSYS is used in such an environment.
Emission Test Compliance Electromagnetic Environment - Guidance
RF emissions CISPR 11 Group 1 IONSYS uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11 Class B IONSYS is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. NOTE: IONSYS is indicated for hospital use only.

Table 5: Guidance and Manufacturer's Declaration – Electromagnetic Immunity

IONSYS is intended for use in the electromagnetic environment specified below. The health care provider should assure that IONSYS is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment -Guidance
Electrostatic Discharge (ESD) IEC 61000-4-2 ± 6kV contact ± 8kV air ± 6kV contact ± 8kV air Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Static discharge - Illustration
Power frequency (50/60Hz) magnetic field IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical hospital environment.(a) IONSYS is MR UNSAFE. Remove IONSYS before an MRI procedure. MR unsafe - Illustration
Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz 3 V/m 80 MHz to 2.5 GHz RF communications equipment and RFID transmitters should be used no closer to IONSYS than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.a
Recommended separation distance:
d=1.2 √P 150 KHz to 800 MHz
d=2.3 √P 800 MHz to 2.5 GHz
Where P is the maximum power output of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
Interference may occur in the vicinity of equipment marked with the following symbol: RF - Illustration
a Field strengths, as determined by an electromagnetic site survey, must be less than the stated compliance level. Remove IONSYS to prevent exposure to field strengths that exceed the stated compliance level.

Table 6: Recommended Separation Distances between RF Transmitters and IONSYS

IONSYS is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The health care provider can help prevent electromagnetic interference by maintaining a minimum distance (meters) between RF transmitters and IONSYS as recommended below, according to the maximum output power (watts) of the transmitter.
Rated maximum output power of transmitter (watts) Separation distance according to frequency of transmitter (meters)
150 kHz to 800 MHz 800 MHz to 2.5 GHz
0.01 0.12 0.23
0.1 0.38 0.73
1 1.2 2.3
10 3.8 7.3
100 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE: For 1W RFID transmitters, the recommended separation distance is 2.3 meters.
NOTE: At 800 MHz, the separation distance for the higher frequency range applies.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

For questions about IONSYS, including product returns, call 1-877-488-6835.

IONSYS®
(eye-AHN-sis)
(fentanyl iontophoretic transdermal system)

Important:

  • IONSYS is only for use in the hospital. Do not leave the hospital with an IONSYS on your skin.
  • IONSYS can cause life-threatening breathing problems or death if it is used other than described in the section “How do I use IONSYS?” below.
  • Keep IONSYS out of the reach of children.

IONSYS® (fentanyl iontophoretic transdermal system) Device components - Illustration

What is IONSYS? IONSYS:

  • contains the prescription medicine, fentanyl. Fentanyl is a very strong narcotic pain medicine (opioid).
  • is only used in the hospital for adults with short-term pain after surgery
  • is a patient-controlled medicine system that sticks to the skin. It will be applied by your healthcare provider on your upper outer arm or chest.

Do not use IONSYS if you are allergic to:

  • fentanyl
  • Cepacol (cetylpiridinum chloride)

Your healthcare provider:

  • will tell you about IONSYS and teach you how to use it.
  • will put IONSYS on the skin (of your chest or upper outer arm) after your surgery
  • will control pain from your surgery with other pain medicines until you are awake enough to use IONSYS
  • will check you for side effects from IONSYS.
  • must replace your IONSYS as needed. You should not replace your IONSYS yourself.
  • will remove your IONSYS before you leave the hospital. Do not leave the hospital with an IONSYS on your skin.

How do I use IONSYS?

  • You can push the IONSYS dosing button when you are experiencing pain or just before you do an activity that may increase your pain - such as physical therapy or getting out of bed.
  • To get a dose of pain medicine from IONSYS, press and release the dosing button twice within 3 seconds.

Press and release the dosing button - Illustration

  • When you push the dosing button you will hear a single beep and the green light will start blinking quickly. The green light will continue to blink quickly for the 10 minutes it takes to deliver a dose of IONSYS.
  • During this time, IONSYS will not deliver another dose even if you press the dosing button again.
  • IONSYS can only be activated every 10 minutes.
  • When IONSYS is finished delivering a dose, the green light will start blinking slowly. This means you can give yourself more pain medicine, if needed. Just press and release the dosing button twice within 3 seconds like you did before. The digital display will tell your healthcare provider how many doses you have received. Each IONSYS may be used for up to 24 hours or a maximum of 80 doses, whichever comes first.
  • If IONSYS starts beeping at any time tell your healthcare provider right away.
  • Tell your healthcare provider right away if:
    • you have any questions about IONSYS
    • you are still having pain
    • IONSYS falls off your skin
    • you have trouble using IONSYS

Your healthcare provider will check your IONSYS to make sure it is working properly.

Do not:

  • Do not let anyone else press the IONSYS dosing button for you. You are the only person who should push the dosing button.
  • Do not touch IONSYS if it falls off of your skin. Tell your healthcare provider right away if your IONSYS comes off of your skin. Rinse your hands with water (do not use soap) right away if you accidentally touch the sticky side of IONSYS, and tell your healthcare provider right away.
  • Do not let others touch IONSYS.
  • Do not remove or replace IONSYS yourself.
  • Do not leave the hospital with an IONSYS on your skin. Make sure your healthcare provider removes your IONSYS before you leave the hospital.
  • IONSYS is MR Unsafe and should not be brought into an MRI environment.

Manufactured, Distributed and Marketed by: The Medicines Company 8 Sylvan Way Parsippany, NJ 07054 Revised (Draft) April 2015 Part No. 306-0001 Software Version 205-0002, SB-SWC-002 Rev. 5, IT101 Controller Software, Version 1.6.715

Instructions for Use and Disposal

IONSYS®
fentanyl iontophoretic transdermal system, 40mcg/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 Guide for Patients

IONSYS REMS Safety Brochure: Guide for Nurses and Pharmacists

Device components - Illustration

1. Prepare Patient Site

  • ONLY 1 IONSYS system should be applied at any given time.
    1. Choose healthy, unbroken skin on the upper outer arm or chest ONLY (see Figure 1a).
    2. Clip excessive hair if necessary. Do not shave—this irritates skin.
    3. Clean with alcohol and let dry. Do not use soaps, lotions, or other agents.
    4. When replacing an IONSYS system, the new system must be applied to a different site on the upper outer arm or chest.

Figure 1a

Application area - Illustration

2. Assemble IONSYS

  • Always wear gloves when handling IONSYS.
  • Complete this step before applying IONSYS to patient.
    • a. Peel back tray lid (see Figure 2a). Remove foil pouch and the controller.
    • b. Remove drug unit from foil pouch and place on a hard, flat surface (see Figure 2b).

Figure 2a and 2b

Assembling IONSYS - Illustration

c. Align the matching shapes (see Figure 2c).

Figure 2c

Align the matching shapes - Illustration

5. Verify Proper Use of IONSYS

  • Remember that ONLY the patient should press the dosing button.
  • Remove before MRI or radiographic procedures as medically necessary.
  • 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).

Figure 5

Verifying proper use - Illustration

6. Remove IONSYS from Patient and Dispose

  • Follow your institution's procedures for handling narcotics or refer to the PI for more information.
  • Always wear gloves when handling IONSYS.
  • Important: If drug gel contacts your skin, thoroughly rinse area with water. Do not use soap.
    • a. With gloves on, remove IONSYS from the patient (see Figure 6a).
    • b. Pull the red tab to separate the red housing containing the drug (see Figure 6b).
    • c. Fold the red housing in half and dispose per your institution's procedures or flush down the toilet (see Figure 6c).
    • d. Hold down dosing button until display goes blank and dispose in waste designated for batteries.

Figure 6a, 6b and 6c

Removing IONSYS from Patient - Illustration

IONSYS Troubleshooting

After successful assembly or anytime during use:

Error message - Illustration

Poor Skin Contact
a. If IONSYS appears to be loose or lifting from skin, secure it to patient's skin by pressing the edges with fingers or securing with nonallergenic tape.
b. If using tape, apply it along the long edges to secure IONSYS to patient's skin. Do not cover the button or display.

c. After taping, If IONSYS beeps again, remove and dispose. Place a new IONSYS on a different skin site.
d. Do not tape if evidence of blistered or broken skin.

Error message - Illustration Low Battery or Defective System
a. Do not use the system.

b. Dispose of IONSYS per instructions in section 6.
c. Place a new IONSYS on a different skin site.

Instructions for Use and Disposal

IONSYS®
fentanyl Iontophoretic transdermal system, 40mcg/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 Guide for Patients

IONSYS REMS Safety Brochure: Guide for Nurses and Pharmacists

Device components - Illustration

1. Prepare Patient Site

  • ONLY 11ONSYS system should be applied at any given time.
    1. Choose healthy, unbroken skin on the upper outer arm or chest ONLY (see Figure 1a).
    2. Clip excessive hair if necessary. Do not shave—this irritates skin.
    3. Clean with alcohol and let dry. Do not use soaps, lotions, or other agents.
    4. When replacing an IONSYS system, the new system must be applied to a different site on the upper outer arm or chest.

Figure1a

IONSYS® (fentanyl iontophoretic transdermal system) Figure 1a Illustration

2. Assemble IONSYS

  • Always wear gloves when handling IONSYS.
  • A Complete this step before applying IONSYS to patient.
    1. Peel back tray lid (see Figure 2a). Remove foil pouch and the controller.
    2. Remove drug unit from foil pouch and place on a hard, flat surface (see Figure 2b).
    3. Align the matching shapes (see Figure 2c).
    4. Press on both ends of the device to ensure that snaps at both ends are fully engaged (see Figure 2d).
    5. Wait for system to complete self test and the digital display to read “0” (see Figure 2e).

Figure 2a and 2b

IONSYS® (fentanyl iontophoretic transdermal system) Figure 2a and 2b Illustration

Figure 2c, 2d and 2e

IONSYS® (fentanyl iontophoretic transdermal system) Figure 2c, 2d and 2e Illustration

3. Train Patient on Proper Use of IONSYS

  • Refer to the IONSYS Guide for Patients to counsel your patient on the safe use of IONSYS.

4. Apply IONSYS to Patient

  • Always wear gloves when handling IONSYS.
    1. Peel off clear liner and apply IONSYS to the prepared site (see Figure 4a).
    2. Press and hold IONSYS onto patient for 15 seconds by pressing the edges with fingers (see Figure 4b). Do not press dosing button.
    3. If IONSYS is not securely adhered, see IONSYS Troubleshooting - Poor skin contact.

NOTE: Ensure proper display orientation by reading “Doses Delivered” printed below the digital display.

Figure 4a and 4b

IONSYS® (fentanyl iontophoretic transdermal system) Figure 4a and 4b Illustration

5. Verify Proper Use of IONSYS

  • Remember that ONLY the patient should press the dosing button.
  • Remove before MRI or radiographic procedures as medically necessary.
  • 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).

Figure 5

IONSYS® (fentanyl iontophoretic transdermal system) Figure 5 Illustration

6. Remove IONSYS from Patient and Dispose

  • Follow your institution's procedures for handling narcotics or refer to the PI for more information.
  • Always wear gloves when handling IONSYS.
  • Important: If drug gel contacts your skin, thoroughly rinse area with water. Do not use soap.

Figure 6a, 6b and 6c

IONSYS® (fentanyl iontophoretic transdermal system) Figure 6a, 6b and 6c Illustration

a. With gloves on, remove IONSYS from the patient (see Figure 6a).

b. Pull the red tab to separate the red housing containing the drug (see Figure 6b).

c. Fold the red housing in half and dispose per your institution's procedures or flush down the toilet (see Figure 6c).

d. 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:
Error message - Illustration PoorSkin Contact
  1. If IONSYS appears to be loose or lifting from skin, secure it to patient’s skin by pressing the edges with Angers 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.
Error message - Illustration 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.
Error message - Illustration 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.
IONSYS® (fentanyl iontophoretic transdermal system) Figure 4 Illustration 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.

Last reviewed on RxList: 9/8/2015
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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