"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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- Patient Information:
Details with Side Effects
IONSYS™ is indicated for the short-term management of acute postoperative pain in adult patients requiring opioid analgesia during hospitalization. Patients should be titrated to an acceptable level of analgesia before initiating treatment with IONSYS™ is not intended for home use and is, therefore, inappropriate for use in patients once they have been discharged from the hospital. It is not recommended for patients under the age of 18 years (see WARNINGS and PRECAUTIONS).
DOSAGE AND ADMINISTRATION
Patients should be titrated to comfort before initiating IONSYS™. Patients must have access to supplemental analgesia. IONSYS™ should be applied to intact, non-irritated and non-irradiated skin on the chest or upper outer arm.
IONSYS™ provides 40 mcg dose of fentanyl per activation on-demand. It is important to instruct patients how to operate IONSYS™ to self-administer doses of fentanyl as needed to manage their acute, short-term, postoperative pain. Only the patient should administer doses from IONSYS™. Each on-demand dose is delivered over a 10-minute period. To initiate administration of a fentanyl dose, the patient must press the button twice firmly within 3 seconds. An audible tone (beep) indicates the start of delivery of each dose; the red light remains on throughout the 10-minute dosing period.
Patients on chronic opioid therapy or with a history of opioid abuse may require higher analgesic doses in the post-operative period than are available from IONSYS™. Therefore, these patients should be evaluated frequently to ensure they are receiving adequate analgesia.
A maximum of six 40-mcg doses per hour can be administered by IONSYS™. The maximum amount of fentanyl that can be administered from a single IONSYS™ system over 24 hours is 3.2 mg (eighty 40-mcg doses). Each IONSYS™ system operates for 24 hours or until 80 doses have been administered, whichever occurs first. Up to three consecutive IONSYS™ systems may be used sequentially, each applied to a different skin site for a maximum of 72 hours of therapy for acute, short-term, postoperative pain.
IONSYS™ Testing Instructions for the Pharmacist or Other Health Care Professional (To be Performed Prior to Dispensing)
Each IONSYS™ should be tested before it is dispensed to a patient. The following functionality test should be performed by the pharmacist or pharmacy technician with IONSYS™ still in its sealed pouch:
- Hold the unopened foil pouch that contains the IONSYS™ system
- IONSYS™ button side is indicated on the pouch label
- Run a finger along the system until you feel the recessed button on one end
- Firmly press and release the button twice within 3 seconds (i.e., double-CLICK)
- Listen for a single audible tone (beep), confirming that the IONSYS™ system is functional and can be dispensed. If no tone is heard, the system is not functioning and should not be dispensed.
- The pharmacist should sign the front of pouch after performing a functionality test. The sticker on the back is intended for use by the registered Nurse (RN).
After a single audio tone is emitted based on this functionality test, a normally operating IONSYS™ system will also beep for 15 seconds after 4 minutes. This indicates that IONSYS™ is not in contact with the skin. Therefore, a functional system is confirmed by a single beep and/or 15 seconds of beeps after pressing the button. If a nurse or other health care professional performs the functionality test, and the system is applied to a patient within 4 minutes of having completed the test, the system will deliver the remainder of the 10-minute dose. For example, if the system is applied to the patient 3 minutes after the completion of the functionality test (i.e. when single beep is emitted), the system will deliver a 7-minute dose for this dose only. If a system is applied after the series of beeps is completed at 4 minutes, the system will deliver a 10-minute dose upon each activation.
If neither the single beep emitted upon double-pressing the dosing button nor the 15 second beeping after 4 minutes are heard, the system may be nonfunctional (see Troubleshooting.) For questions about IONSYS™, including product returns, please call Ortho-McNeil, Inc at 1-800-526-7736. Any nonfunctional system returned to the manufacturer should be returned in its intact package.
Do not open the pouch of a non-functional system and do not dispense it to a patient.
No drug is delivered from the system unless IONSYS™ is applied to the skin. Therefore, 80 doses and 24 hours of use are still available after the functionality test is performed.
Method of Application
IONSYS™ should be applied to intact, non-irritated, and non-irradiated skin on the chest or upper outer arm. IONSYS™ should not be placed on abnormal skin sites, such as scars, burns, tattoos, etc. Any excessive hair at the application site should be clipped (not shaved) before system application. Wipe the application site with a standard alcohol swab and allow the skin to dry completely before applying IONSYS™. Do not use any soaps, oils, lotions, or any other agents that might irritate the skin or alter its absorption characteristics.
The sticker on the back of the pouch is intended for use by the registered nurse (RN). Fields on the sticker are provided for the nurse to write in the time and date IONSYS™ is applied to the patient. This sticker should be transferred from the pouch label to the IONSYS™ system that will be applied to the patient, in order to provide information to the next nurse on staff regarding when the 24-hour clock on IONSYS™ will expire.
To open the pouch containing IONSYS™, use scissors to cut along the dotted line of the pouch.
Remove and discard only the clear plastic liner covering the adhesive. Take care not to pull on the red tab while removing the clear plastic liner when preparing to apply IONSYS™ to the patient. The red tab is only to be used when separating the IONSYS™ system for disposal. (See disposal)
Press IONSYS™ firmly in place, with the sticky side down, on the skin for at least 15 seconds. Press with your fingers around the outer edges to be sure the system sticks to the skin.
Occasionally, IONSYS™ may loosen; if this occurs a non-allergenic tape may be used to be sure all of the system's edges make complete contact with the skin. Take care not to tape over the button or the red light.
Each IONSYS™ may be used for 24 hours from completion of the first on-demand dose or until 80 doses have been administered, whichever comes first. After the 24 hours have elapsed, or 80 doses have been delivered, IONSYS™ is deactivated and cannot deliver any additional doses i.e. if the patient tries to initiate a dose, the system will not beep and the red LED will not light up continuously. At this time the red LED will continue to flash indicating the approximate number of doses delivered to the patient up until the time the system was deactivated. The LED will continue to flash until the battery in the system is depleted. If additional opioid analgesia is required, a new system should be applied to a different skin site after removal and disposal of the previous system.
A recessed button and red light are located on the top housing of IONSYS™. To initiate a fentanyl dose, the patient should press the button twice within 3 seconds. An audible tone (beep) indicates the start of delivery of each dose; the red light remains on throughout the 10-minute dosing interval. The next dose cannot begin until the previous 10-minute delivery cycle is complete. Pressing the button during delivery of a dose will not result in additional drug being administered. The red light turns off after each 10-minute dose has been delivered.
A healthcare professional should observe the first dose administered to ensure that the patient understands how to operate IONSYS™ and that the system is working properly.
Determining Approximate Number of Doses Delivered
Between doses, the red light will flash in one-second pulses to indicate the approximate number of doses that have been administered up to the present time. Each one-second flash of light indicates administration of up to five doses. Thus, a single one-second flash of light represents 1 to 5 doses; two flashes represent 6 to 10 doses; three flashes represent 11 to 15 doses; and so on up to 16 flashes which represent 76 to 80 doses delivered. The system may also be queried during delivery of an on-demand dose, by a single press of the button. The red light will flash as outlined above to indicate the approximate number of on-demand doses that have been delivered up to the time of the query. This query will not influence dose delivery.
Determining Approximate Dose of Fentanyl Delivered Based on the Number of Red Light Flashes
|No. of light flashes||No. of fentanyl doses delivered||Range (mcg) of fentanyl delivered|
IONSYS™ may be removed at any time. However, once a system has been removed, the same system should not be reapplied.
At the end of 24 hours of use, or after 80 doses have been delivered, the IONSYS™ system will deactivate and should be removed from the patient's skin. Using gloves, remove IONSYS™ by gently lifting the red tab and loosening the system from the skin application site. Ensure both hydrogels remain with the removed IONSYS™ system. If the hydrogel becomes separated from the IONSYS™ system during removal, use gloves or tweezers to remove the hydrogel from the skin and properly dispose of in accordance with state and federal regulations for controlled substances. If the patient requires additional pain relief, a new IONSYS™ system should be applied. In this case, IONSYS™ should be applied to a new skin site on the upper outer arm or chest. Take care not to touch the exposed hydrogel compartments or the adhesive. If a hydrogel drug reservoir is touched accidentally, rinse the area thoroughly with water (do not use soap).
Contact with the hydrogels contained in IONSYS™ can be harmful to humans and animals. Medical staff should handle the removed system carefully and only by the sides and top housing. Disposal should be in accordance with state and federal regulations for controlled substances. The used bottom housing of IONSYS™ contains a significant amount of fentanyl that could be harmful or fatal if ingested and which could be diverted for abuse.
To dispose of a used IONSYS™:
1. Using gloves, pull the red tab to separate the bottom housing from the top housing
2. Fold the bottom hydrogel-containing housing in half with the sticky side facing in.
3. Dispose of the folded over bottom housing, containing the residual fentanyl, by flushing this piece down the toilet. This step should be witnessed by a second health care provider. The used bottom housing of IONSYS™ contains fentanyl that could be harmful or fatal if ingested.
4. Dispose of top housing, containing electronics, according to hospital procedures for battery-containing waste.
5. If the hydrogel accidentally contacts the skin, rinse the affected area thoroughly with water (do not use soap). Contact with the fentanyl hydrogel contained in IONSYS™ can be harmful to humans and animals. Oral ingestion or contact of the hydrogels with mucous membranes may cause serious illness or death. Do not allow hydrogel to touch mouth.
IONSYS™ is designed to deliver each on-demand dose of fentanyl over approximately 10 minutes. Please refer to the Normal System Feedback table below which illustrates normal audio and visual feedback from the IONSYS™ system, both during the in-pouch functionality testing that is performed before the system is dispensed to a patient, and during patient use.
Normal System Feedback
|Mode||Audio Feedback||Visual Feedback|
|IONSYS™ functionality testing (performed prior to dispensing to patient):|
| 1. With the IONSYS™ system in its unopened pouch, run a finger
along the system until the recessed dosing button is felt (pouch label indicates
the side on which the button will be located)
2. Firmly press and release the button twice within 3 seconds
|Immediately after step 2 is performed, the system will emit a single beep, indicating a functional system. Approximately four minutes later, the system will also emit a series of short beeps (15 seconds duration). This is normal and does not affect the functionality or life of the product once applied to the patient.||None (system is in opaque foil pouch). Note that if this test were performed with IONSYS™ outside of the pouch and off the patient's body, the red LED would illuminate for 4 minutes and then turn off at the time the 15 seconds beeping starts.|
|During and After Patient Use|
|Initiate administration of a dose by pressing the button twice firmly within 3 seconds.||A single audio tone (beep) indicates the start of delivery of each dose.||The red light remains solidly illuminated throughout each 10- minute dosing period.|
| Advise Patient that when system is flashing, he or she can self-administer
another dose of fentanyl from the system as needed for pain relief
System deactivates after 24 hours have elapsed from time of first dose administered, or if all 80 doses have been used. You may determine the number of doses administered by counting the number of flashes during one series. Each pulse of light represents the administration of 1-5 fentanyl doses (40 mcg each)
| At any time within 24 hours of initiation of first dose from system,
and < 80 doses have been delivered, system displays flashing red light
to give an approximation of the fentanyl doses that have been administered.
Each series of flashes, followed by a 2 second pause, will repeat until
the patient administers the next dose. Each flash of light represents administration
of 1-5 fentanyl doses (40 mcg each)
Displays flashing red light after 24 hours have elapsed from time of initiation of the first dose from system, OR all 80 doses have been delivered. System is deactivated and a new system must be applied to a new skin site if needed
If a system does not appear to function immediately, wait 4 minutes and firmly press and release the button twice within 3 seconds (i.e., double-press). A single audio beep will be emitted immediately, confirming that the IONSYS™ system is functional. If a system is not functioning properly, instruct the patient to call a staff member to observe the next time he/she initiates a dose. Then monitor both the illumination of the red light and any error messages (beeps) that may be provided by the system. Refer to the Error Messages chart below for possible problems and appropriate course of action.
Error messages provide information about problems that may occur during operation of IONSYS™. These messages are in the form of alarms consisting of a series of audible signals or "beeps" as follows:
|Error Message/Feedback||Probable Cause||Action|
|Emits a 15 second series of beeps (this short series of beeps repeats 8 times then stops).||Decreased fentanyl delivery. Could be caused by poor contact between the system and the skin or due to high skin resistance.||Ensure good contact is made between the gels and the skin. Attempt to restart system (up to 3 times). If required, a new system should be applied to a new skin site.|
|Emits a continuous series of beeps that repeat until the battery is depleted (i.e. beeps cannot be shut off).||IONSYS™ placed on compromised skin site, increased output current detected, or low battery voltage.||Remove system from patient. System cannot be restarted. Apply new system to a new site.|
|No single beep emitted, and no solid red light illuminated upon dose activation. Red light is not flashing.||Depleted battery or non-functional system.||Remove system, and if required, a new system should be applied to a new skin site.|
Discontinuation of IONSYS™
To convert patients to another opioid or other analgesic, remove IONSYS™ and titrate the dose of the new analgesic, based upon the patient's report of pain, until adequate analgesia has been obtained, using caution due to the fact that serum fentanyl concentration will decrease slowly following removal of the system (See Figure Ib; WARNINGS). Following cessation of IONSYS™ treatment in clinical trials, patients were typically administered oral analgesics; a small percentage of patients received parenteral opioids.
IONSYS™ is provided as a disposable system providing up to 80 doses (40 mcg each) of fentanyl. Each IONSYS™ is individually packaged in a child-resistant foil pouch. There are five packages per carton.
NDC # 0062-7900-01 (single IONSYS™ system in foil pouch)
NDC # 0062-7900-05 (carton of 5 IONSYS™ systems)
Storage and Handling
Accidental ingestion of the fentanyl hydrogel or contact of the hydrogel with mucous membranes could lead to the absorption of a potentially fatal dose of fentanyl. Therefore, the hydrogels should not come into contact with fingers or mouth.
Avoid direct contact with the fentanyl hydrogel and the adhesive surface during system application and removal. If the hydrogel from the drug reservoir accidentally contacts the skin, the affected area should be rinsed thoroughly with water. Do not use soap, alcohol, or other solvents to remove the hydrogel because they may enhance the drug's ability to penetrate the skin.
IONSYS™ should be stored at 25°C (77°F); excursions permitted to 15 - 30°C (59-86°F). Apply to the skin immediately after removal from the individually sealed package. Do not use if the foil pouch has been broken. For transdermal use only.
For questions about IONSYS™, including product returns please call Ortho-McNeil, Inc. Medical Communications Contact Center at 1-800-526-7736.
Marketed by: Ortho-McNeil, Inc. Raritan, NJ 08869. Manufactured by: ALZA Corporation Mountain View, CA 94043. An ALZA E-TRANS® Technology Product. Revised August 2006.
Last reviewed on RxList: 6/12/2012
This monograph has been modified to include the generic and brand name in many instances.
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