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fentanyl iontophoretic transdermal system
Overview
What is IONSYS?
What does IONSYS look like?
What are the available doses of IONSYS?
Iontophoretic transdermal system provides up to 80 doses (40 mcg each) of fentanyl per activation on-demand. (
)
What should I talk to my health care provider before I take IONSYS?
Hepatic impairment and/or renal impairment
8.6
8.7
How should I use IONSYS?
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]:
IONSYS is:
What interacts with IONSYS?
Sorry No Records found
What are the warnings of IONSYS?
Sorry No Records found
What are the precautions of IONSYS?
Sorry No Records found
What are the side effects of IONSYS?
Sorry No records found
What should I look out for while using IONSYS?
IONSYS is contraindicated in patients with:
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
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
What might happen if I take too much IONSYS?
Clinical Presentation
Acute overdose with IONSYS can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations
.
Treatment of Overdose
In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life support techniques.
The opioid antagonists naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to fentanyl overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to fentanyl overdose.
Because the duration of opioid reversal is expected to be less than the duration of action of fentanyl in IONSYS, carefully monitor the patient until spontaneous respiration is reliably reestablished. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information.
In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist may precipitate acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist.
How should I store and handle IONSYS?
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 . 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.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 . 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.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 . 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.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 . 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.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 . 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.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 . 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.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
IONSYS contains fentanyl, an opioid agonist whose principal therapeutic action is analgesia. Fentanyl interacts predominantly with the μ-opioid receptor. These μ-binding sites are discretely distributed in the human brain, spinal cord, and other tissues.
Non-Clinical Toxicology
IONSYS is contraindicated in patients with: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
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
Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, including fentanyl, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status Carbon dioxide (CO ) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.
While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of IONSYS, the risk is greatest during the initiation of therapy. Monitor patients closely for respiratory depression, especially within the first 24‑72 hours of initiating therapy with IONSYS.
Accidental exposure to the hydrogel component of IONSYS, especially in children, can result in respiratory depression and death due to an overdose of fentanyl.
Following accidental contact with IONSYS or its components, immediately rinse the affected area thoroughly with water. Do not use soap, alcohol, or other solvent because they may enhance the drug’s ability to penetrate the skin. The individual exposed should be monitored for signs of respiratory or central nervous system depression.
If IONSYS is not handled correctly using gloves, healthcare professionals are at risk of accidental exposure to a fatal overdose of fentanyl.
IONSYS is for hospital use only. Use of IONSYS outside of the hospital setting can lead to accidental exposure in others for whom it is not prescribed, causing fatal respiratory depression. Prior to the patient leaving the hospital, medical personnel must remove IONSYS and dispose of it properly.
The following serious adverse reactions are described elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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