WARNING: ABUSE POTENTIAL, RESPIRATORY DEPRESSION and DEATH, ACCIDENTAL EXPOSURE, CYTOCHROME P450 3A4 INTERACTION, AND EXPOSURE TO HEAT
Fentanyl transdermal system contains fentanyl, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. Fentanyl transdermal system can be abused in a manner similar to other opioid agonists, legal or illicit. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Assess patients for their clinical risks for opioid abuse or addiction prior to prescribing fentanyl transdermal system and then routinely monitor all patients for signs of misuse, abuse and addiction during treatment.
Respiratory Depression and Death
Respiratory depression and death may occur with use of fentanyl transdermal system, even when fentanyl transdermal system has been used as recommended and not misused or abused. Proper dosing and titration are essential and fentanyl transdermal system should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Fentanyl transdermal system is contraindicated for use in conditions in which the risk of life-threatening respiratory depression is significantly increased, including use as an as-needed analgesic, use in non-opioid tolerant patients, acute pain, and postoperative pain. Monitor for respiratory depression, especially during the first two applications following initiation of dosing, or following an increase in dosage.
Death and other serious medical problems have occurred when children and adults were accidentally exposed to fentanyl transdermal system. Advise patients about strict adherence to the recommended handling and disposal instructions in order to prevent accidental exposure.
Cytochrome P450 3A4 Interaction
The concomitant use of fentanyl transdermal system 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. Monitor patients receiving fentanyl transdermal system and any CYP3A4 inhibitor.
Exposure To HeatThe fentanyl transdermal system application site and surrounding area must not be exposed to direct external heat sources, such as heating pads or electric blankets, heat or tanning lamps, sunbathing, hot baths, saunas, hot tubs, and heated water beds. Exposure to heat may increase fentanyl absorption and there have been reports of overdose and death as a result of exposure to heat. Patients wearing fentanyl transdermal systems who develop fever or increased core body temperature due to strenuous exertion are also at risk for increased fentanyl exposure and may require an adjustment in the dose of fentanyl transdermal system to avoid overdose and death.