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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 [see WARNINGS AND PRECAUTIONS], 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.
- 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.
DOSAGE AND ADMINISTRATION
Important Administration Instructions
IONSYS IS FOR HOSPITAL USE ONLY BY PATIENTS UNDER MEDICAL SUPERVISION AND DIRECTION. PRIOR TO THE PATIENT LEAVING THE HOSPITAL, MEDICAL PERSONNEL MUST REMOVE IONSYS AND DISPOSE OF IT PROPERLY [see Administration of IONSYS and Disposal of IONSYS].
ONLY THE PATIENT MAY ACTIVATE IONSYS.
ONLY ONE IONSYS MAY BE APPLIED AT A TIME. If inadequate analgesia is achieved with one IONSYS, either provide additional supplemental analgesic medication or replace with an alternate analgesic medication.
IONSYS should be prescribed only by persons knowledgeable in the administration of potent opioids and in the management of patients receiving potent opioids for treatment of pain. Patients treated with IONSYS should be under the supervision of medical personnel with expertise in the detection and management of hypoventilation including close observation, supportive measures, and use of opioid antagonists, depending on the patient's clinical status [see OVERDOSAGE].
To reduce the risk for shock, avoid contact with synthetic materials (such as carpeted flooring) while assembling IONSYS and avoid exposing IONSYS to electronic security systems [see WARNINGS AND PRECAUTIONS].
Depending on the rated maximum output power and frequency of the transmitter, the recommended separation distance between IONSYS and communications equipment or a Radio Frequency Identification (RFID) transmitter ranges between 0.12 and 23 meters [see WARNINGS AND PRECAUTIONS].
See IONSYS Important Device Instructions for additional details, including information on troubleshooting device malfunction, recommended separation distances, and electromagnetic compatibility
IONSYS (see Figure 1A) is for use only after patients have been titrated to an acceptable level of analgesia using another opioid analgesic. Apply one IONSYS to healthy, unbroken/intact, non-irritated, and non-irradiated skin on the chest or upper outer arm ONLY.
IONSYS provides a 40 mcg dose of fentanyl per activation. 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. Allow only the patient to self-administer doses of IONSYS. Each on-demand dose is delivered over a 10-minute period.
To initiate administration of IONSYS, the patient must press and release the button twice within 3 seconds. One single audible beep indicates the start of delivery of each dose. The green light will start blinking rapidly and the digital display will alternate between a walking circle and the number of doses delivered. When the 10-minute dose is complete, the green light will blink at a slow rate and the display will show the number of doses delivered (see Figure 1B).
Figure 1A: IONSYS Components
Figure 1B: Assembled IONSYS
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 over 24 hours is 3.2 mg (eighty 40-mcg doses). Each IONSYS operates up to 24 hours or 80 doses, whichever comes first. Use one IONSYS at a time for up to 24 hours or 80 doses, whichever comes first. IONSYS may be used for a maximum of 3 days (72 hours) of therapy for acute postoperative pain, with each subsequent IONSYS applied to a different skin site [see Administration of IONSYS].
After the 24 hours have elapsed, or 80 doses have been delivered, IONSYS will not deliver any additional doses. The light and audible beep will not function. The digital display will continue to show the number of doses delivered for an additional 12 hours. If the patient tries to initiate a dose, IONSYS will ignore the dose request.
Administration Of IONSYS
For SINGLE-USE only: operates up to 24 hours or 80 doses, whichever comes first.
FOR TRANSDERMAL USE ONLY
Preparation Of Patient Site
1. Choose healthy, unbroken skin on the upper outer arm or chest ONLY (see Figure 2). IONSYS may only be applied to one of the three sites shown in Figure 2.
2. Clip excessive hair if necessary. Do not shave as this may irritate skin.
3. Clean the site with alcohol and let it dry. Do not use soaps, lotions, or other agents.
Assembly Of IONSYS
DO NOT USE IONSYS IF THE SEAL ON THE TRAY OR DRUG UNIT POUCH IS BROKEN OR DAMAGED.
ALWAYS WEAR GLOVES WHEN HANDLING IONSYS.
Complete these steps before applying IONSYS to the patient:
- Open the tray by peeling back the tray lid (see Figure 3a). Remove the foil (drug) pouch and the Controller. Open the pouch containing the Drug Unit starting at the pre-cut notch and then carefully tearing along the top of the pouch.
- Remove the Drug Unit from the pouch and place on a hard, flat surface.
- Align the matching shapes of the Controller and the Drug Unit (see Figure 3b).
- Press on both ends of the device to ensure that the snaps at both ends are fully engaged (see Figure 3c). You should hear one or two clicks when the snaps are fully engaged (see Figure 3d).
- Once assembled, the digital display of the Controller will complete a short self-test during which there will be one audible beep, the red light will blink once, and the digital display will flash the number “88”. At the end of the self-test, the display will show the number “0” and a green light will blink at a slow rate to indicate IONSYS is ready for application (see Figure 3e).
Figure 3a, 3b, 3c, 3d and 3e
Application Of IONSYS
ALWAYS WEAR GLOVES WHEN HANDLING IONSYS.
Peel off and discard only the clear plastic liner covering the adhesive and hydrogels (see Figure 4a). 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 IONSYS for disposal [see Disposal of IONSYS].
Press and hold IONSYS firmly in place, with the sticky side down, onto patient's skin for at least 15 seconds (see Figure 4b). Press with your fingers around the edges to be sure IONSYS adheres to the skin. Do not press the dosing button.
Figure 4a and 4b
Occasionally, IONSYS may loosen from the skin; if this occurs, secure it to patient's skin by pressing the edges with fingers or securing with a non-allergenic tape to be sure that all edges make complete contact with the skin. If using tape, apply tape along the long edges to secure IONSYS to patient's skin (see Figure 4c). Do not tape over the button, the light, or the digital display. Do not tape if evidence of blistered or broken skin.
After taping, if IONSYS beeps again, remove and dispose. Place a new IONSYS on a different skin site. Each IONSYS may be used for up to 24 hours from the time it is assembled or until 80 doses have been administered, whichever comes first.
Operation Of IONSYS
A recessed button is located on the top housing of IONSYS. To initiate administration of a fentanyl dose, the patient must press and release the button twice within 3 seconds. IONSYS should only be activated by the patient. One single audible beep indicates the start of delivery of each dose. The green light will start blinking rapidly and the digital display will alternate between a walking circle (see Figure 5) and the number of doses delivered.
Each dose will be delivered over 10-minutes. During this time IONSYS is locked-out and will not respond to additional button presses. When the 10-minute dose is complete, the green light will return to a slow rate of blinking and the display will show the number of doses delivered. IONSYS is now ready to be used again by the patient. The next dose cannot begin until the previous 10minute delivery cycle is complete. Pressing the button during delivery of a dose will not result in additional drug being administered.
A healthcare professional must observe the first dose administered to ensure that the patient understands how to operate IONSYS and that IONSYS is working properly.
Each IONSYS will cease functioning at the end of 24 hours of use, or after 80 doses have been administered, whichever comes first. The green light will turn off and the number of doses delivered will flash on and off. The flashing digital display may be turned off by pressing and holding the dosing button for 6 seconds.
See IONSYS Important Device Instructions for additional details, including information on troubleshooting device malfunction.
Removal Of IONSYS
ALWAYS WEAR GLOVES WHEN HANDLING IONSYS.
IONSYS may be removed at any time. However, once IONSYS has been removed, the same IONSYS must not be reapplied.
At the end of 24 hours of use, or after 80 doses have been delivered, IONSYS will deactivate and should be removed from the patient's skin. With gloves on, remove IONSYS from the patient (see Figure 6).
IONSYS contains two hydrogels (see Figure 4a), one of which contains fentanyl [see DESCRIPTION]. Ensure both hydrogels remain with the removed IONSYS. If the hydrogel becomes separated from IONSYS 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 analgesia a new IONSYS should be applied. In this case, IONSYS should be applied to a new skin site on the upper outer arm or chest.
One of the hydrogels contains fentanyl; take care not to touch the exposed hydrogel compartments or the adhesive (see Figure 4a). If a hydrogel drug reservoir is touched accidentally, rinse the area thoroughly with water (do not use soap).
Disposal Of IONSYS
ALWAYS WEAR GLOVES WHEN HANDLING IONSYS.
Contact with the hydrogels contained in IONSYS can result in a fatal overdose of fentanyl. Handle the used IONSYS by the sides and top while avoiding contact with the hydrogel. Dispose of IONSYS in accordance with state and federal regulations for controlled substances. The used red bottom housing (see Figure 7a) of IONSYS contains a significant amount of fentanyl that could cause a fatal overdose of fentanyl.
To dispose of a used IONSYS:
- With gloves on, pull the red tab to separate the red bottom housing containing fentanyl from IONSYS (see Figure 7a).
- Fold the red housing in half with the sticky side facing in (see Figure 7b).
- Dispose of the folded over red housing containing the residual fentanyl per the institution's procedures for disposal of Schedule II drugs or by flushing it down the toilet.
- Hold down dosing button until the display goes blank and then dispose of the remaining part of IONSYS containing electronics in waste designated for batteries.
Figure 7a and 7b
Discontinuation Of IONSYS
To discontinue use of IONSYS, remove and dispose of IONSYS according to the preceding directions. Do not abruptly discontinue IONSYS in a physically-dependent patient [see WARNINGS AND PRECAUTIONS, Drug Abuse and Dependence].
Conversion From IONSYS To Alternate Analgesics
Upon discontinuation of IONSYS, if upon evaluation, conversion to an alternate analgesic is required, titrate the dose of the new analgesic, based upon the patient's report of pain, until adequate analgesia has been obtained, keeping in mind that the serum fentanyl concentration will decrease slowly following removal of IONSYS [see CLINICAL PHARMACOLOGY, WARNINGS AND PRECAUTIONS]. During the period of converting analgesics, monitor the patient for signs of respiratory and central nervous system depression.
Dosage Forms And Strengths
Iontophoretic transdermal system provides up to 80 doses (40 mcg each) of fentanyl per activation ondemand [see DESCRIPTION and Storage and Handling].
Storage And Handling
IONSYS (fentanyl iontophoretic transdermal system) is packaged in a sealed tray containing one Controller and one pouched Drug Unit for assembly. For distribution, there are six sealed trays per carton.
NDC 65293-011-01 (each individual tray contains one Drug
Unit and one Controller)
NDC 65293-011-06 (carton of six trays containing IONSYS)
ACCIDENTAL CONTACT WITH THE HYDROGELS (ON THE ADHESIVE SIDE OF IONSYS) CAN RESULT IN FATAL OVERDOSE OF FENTANYL. THEREFORE, THE IONSYS MUST ONLY BE HANDLED WHILE WEARING GLOVES.
If there is accidental contact with 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 [see WARNINGS AND PRECAUTIONS].
IONSYS should be stored at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Assemble and use immediately after removal from the individually sealed package. Do not use if the seal on the Tray or Drug Unit pouch is broken or damaged.
Manufactured, Distributed and Marketed by: The Medicines Company, 8 Sylvan Way, Parsippany, NJ 07054. Revised: Dec 2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/18/2017
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