IONSYS™ (fentanyl iontophoretic transdermal system)

The device is powered and ready to administer a dose. A dose can be administered by pressing the dose button on the top of the device two times in a window of 3 seconds between button presses. No fentanyl is delivered in this mode until a dose is initiated. If the unit reaches the 24-hour limit or 80 doses, it will enter End-of-Use. If the unit fails self-test or has low battery, it will sound an ALERT and enter End-of-Life.

Delivery of a dose of fentanyl. The dosing period is 10 minutes long and delivers 40 mcg of medicine to the patient. During this period, the dose button is disabled, the LED flashes green, and the display indicates that it is in a dosing mode due to the 'walking' LCD animation alternating with the current doses administered. If the unit senses poor skin contact, it will stop dosing, enter Standby mode, then return to Ready mode. If the unit reaches the 24-hour limit or 80 doses, it will enter End-of-Use. If the unit senses compromised skin (i.e. an open wound), it will sound an ALERT and enter End-of-Life.

When a dose is initiated BUT the device does not detect proper contact with the patient's skin after 4 minutes, the unit will stop dosing, enter Standby mode and inform the patient. This is indicated by audible beeping along with a flashing red LED. The device will enter Standby mode for 15 seconds, the dose count will not increment, and the device can re-administer a dose after it returns to Ready mode after 15 seconds.

After 80 doses are administered or 24 hours pass since activation, the device will enter End-of-Use mode. The device will no longer administer any doses, the LCD will flash the total number of doses administered, and the LED does not flash. After 12 hours in End-of-Use, the device will enter End-of-Life mode automatically. Holding down the dose button for 6 seconds will turn off the unit.

An ALERT condition can occur by sensing compromised skin mid-dose, from a low battery, or after 12 hours from End-of-Use. It will flash the current dose amount on the LCD, the LED will contintually blink red and an audible continuous beep will play. This indicates that the device has reached EOL (end-of-life). No doses may be administered. Holding down the dose button for 6 seconds will turn off the unit.

custom

Life Threatening Respiratory Depression

Use of IONSYS may result in potentially life-threatening respiratory depression and death as a result of the active drug, fentanyl. Only the patient should activate IONSYS dosing.

Accidental exposure to an intact IONSYS or to the hydrogel component, especially by children, through contact with skin or contact with mucous membranes, can result in a fatal overdose of fentanyl.

IONSYS is for use only in patients in the hospital. Discontinue treatment with IONSYS before patients leave the hospital.

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 effects 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.

Warnings and Precautions

Interactions with CNS depressants: Hypotension, profound sedation, coma, respiratory depression, and death may result if IONSYS is used concomitantly with alcohol or other central nervous system (CNS) depressants (e.g., sedatives, anxiolytics, hypnotics, neuroleptics, other opioids). Monitor patients closely if co-administration is required.

Risk of Injury During MRI: IONSYS contains metal parts and must be removed and properly disposed of before a Magnetic Resonance Imaging (MRI) procedure. Monitor any patients wearing IONSYS with inadvertent exposure to an MRI for signs of central nervous system and respiratory depression.

Risk of IONSYS Use During Other Procedures or Near Certain Equipment: Use of IONSYS during cardioversion, defibrillation, X-ray, CT, or diathermy can damage IONSYS and should be removed and properly disposed of before these procedures. Avoid contact with synthetic materials (such as carpeted flooring) to reduce the possibility of electrostatic discharge and damage to IONSYS. Avoid exposing IONSYS to electronic security systems to reduce the possibility of damage to IONSYS. Use of IONSYS near communications equipment (e.g., base stations for radio telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast radio) and Radio Frequency Identification (RFID) transmitters can damage IONSYS. If exposure to the above procedures, electronic security systems, electrostatic discharge, communications equipment, or RFID transmitters occurs, and if IONSYS does not appear to function normally, remove IONSYS and replace with a new IONSYS.

Topical Skin Reactions: Topical skin reactions may occur with use of IONSYS and are typically limited to the site application area. If a severe skin reaction is observed, remove IONSYS and discontinue further use.

Use in Elderly, Cachectic, and Debilitated Patients: Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients. Monitor such patients closely especially when IONSYS is used concomitantly with other drugs that depress respiration.

Use in Patients with Chronic Pulmonary Disease: Monitor patients with significant chronic obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression for respiratory depression, particularly when initiating therapy with IONSYS. Consider the use of alternative non-opioid analgesics in these patients if possible.

Hypotensive Effect: IONSYS may cause severe hypotension, including orthostatic hypotension and syncope in ambulatory patients. There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume, or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics). Monitor these patients after initiating IONSYS. Avoid the use of IONSYS in patients with circulatory shock as IONSYS may cause vasodilation that can further reduce cardiac output and blood pressure.

Patients with Head Injury or Increased Intracranial Pressure: IONSYS is not suitable for use in patients who are not alert and able to follow directions. Monitor patients using IONSYS who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors) for signs of sedation and respiratory depression, particularly when initiating therapy with IONSYS. Avoid use of IONSYS in patients with impaired consciousness or coma. IONSYS may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Opioids may obscure the clinical course of patients with head injury.

Use in Patients with Gastrointestinal Conditions: IONSYS is contraindicated in patients with gastrointestinal obstruction, including paralytic ileus. Fentanyl may cause spasm of the sphincter of Oddi. Monitor patients with biliary tract disease, including acute pancreatitis for worsening symptoms. Opioids may cause increases in serum amylase.

Use in Patients with Convulsive or Seizure Disorders: IONSYS may aggravate convulsions in patients with convulsive disorders and may induce or aggravate seizures in some clinical settings. Monitor patients with a history of seizure disorders for worsened seizure control during IONSYS therapy.

Bradycardia: IONSYS may produce bradycardia in some patients. Monitor patients with bradyarrhythmias closely for changes in heart rate, particularly when initiating therapy with IONSYS.

Hepatic Impairment: Insufficient data are available on the use of IONSYS in patients with impaired hepatic function. Monitor for signs of sedation and respiratory depression in patients with hepatic impairment.

Renal Impairment: A clinical pharmacology study with intravenous fentanyl in patients undergoing kidney transplantation has shown that patients with high blood urea nitrogen level had low fentanyl clearance. Monitor for signs of sedation and respiratory depression in patients with renal impairment.

SYSTEM SPECIFICATIONS
Active Ingredient	Fentanyl HCl
Absorption route:	Transdermal (iontophoresis)
Activation:	Patient double-clicks on-demand dosing button (twice within 3 seconds)
Dosing:	Pre-programmed 40 micrograms delivered over 10-minute dosing period*
Maximum dose rate:	6 doses per hour
Lockout period*:	10 minutes (coincides with dosing period)
Doses available per unit:	80
Dispensing life:	24 hours or 80 doses, whichever comes first
*(10 minute period is shortened to 18 seconds in this app for demonstration purposes)

SYSTEM SPECIFICATIONS

Active Ingredient

Fentanyl HCl

Absorption route:

Transdermal (iontophoresis)

Activation:

Patient double-clicks on-demand dosing button (twice within 3 seconds)

Dosing:

Pre-programmed 40 micrograms delivered over 10-minute dosing period*

Maximum dose rate:

6 doses per hour

Lockout period*:

10 minutes (coincides with dosing period)

Doses available per unit:

Dispensing life:

24 hours or 80 doses, whichever comes first

*(10 minute period is shortened to 18 seconds in this app for demonstration purposes)

FEATURES
On-demand dosing button Light-emitting diode (LED) that indicates: When a dose is being delivered (Green) When there is an error (Red)

FEATURES

On-demand dosing button
Light-emitting diode (LED) that indicates:
- When a dose is being delivered (Green)
- When there is an error (Red)

Ready Mode

Dosing

Dosing

Poor Skin Contact

Poor Skin Contact

End of Use

End of Life

Powering On

custom

Ready for Dose Initiation

Administering Dose...

Administering Dose...

NO dose being delivered

NO dose being delivered

80 doses or 24 hours

ALERT mode

custom

Important Safety Information

Life Threatening Respiratory Depression

IONSYS Risk Evaluation and Mitigation Strategy (REMS) Program

Addiction, Abuse, and Misuse

Cytochrome P450 3A4 Interaction

Warnings and Precautions

Adverse Reactions

Please see Full Prescribing Information at www.IONSYS.com

SYSTEM SPECIFICATIONS

FEATURES

Ready for Dose Initiation Administering Dose... Administering Dose... NO dose being delivered NO dose being delivered 80 doses or 24 hours ALERT mode custom

Important Safety Information

Life Threatening Respiratory Depression

IONSYS Risk Evaluation and Mitigation Strategy (REMS) Program

Addiction, Abuse, and Misuse

Cytochrome P450 3A4 Interaction

Warnings and Precautions

Adverse Reactions

Please see Full Prescribing Information at www.IONSYS.com

SYSTEM SPECIFICATIONS

FEATURES

Ready for Dose Initiation

Administering Dose...

Administering Dose...

NO dose being delivered

NO dose being delivered

80 doses or 24 hours

ALERT mode

custom