WARNING: ADDICTION, ABUSE,
AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; AND EXPOSURE TO HEAT
Addiction, Abuse, and Misuse
Fentanyl transdermal system exposes patients and other users to the risks of opioid addiction, abuse,
and misuse, which can lead to overdose and death. Assess each patient’s risk
prior to prescribing fentanyl transdermal system, and monitor all patients
regularly for the development of these behaviors or conditions.
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory
depression may occur with use of fentanyl transdermal system, even when used as
recommended. Monitor for respiratory depression, especially during initiation
of fentanyl transdermal system or following a dose increase. Because of the
risk of respiratory depression, fentanyl transdermal system is contraindicated
for use as an as-needed analgesic, in non-opioid tolerant patients, in acute
pain, and in postoperative pain.
Deaths due to a fatal overdose of fentanyl have occurred
when children and adults were accidentally exposed to fentanyl transdermal
system. Strict adherence to the recommended handling and disposal instructions
is of the utmost importance to prevent accidental exposure.
Neonatal Opioid Withdrawal Syndrome
Prolonged use of
fentanyl transdermal system during pregnancy can result in neonatal opioid
withdrawal syndrome, which may be life-threatening if not recognized and
treated, and requires management according to protocols developed by
neonatology experts. If opioid use is required for a prolonged period in a
pregnant woman, advise the patient of the risk of neonatal opioid withdrawal
syndrome and ensure that appropriate treatment will be available.
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. In addition, discontinuation of
a concomitantly used cytochrome P450 3A4 inducer may result in an increase in
fentanyl plasma concentration. Monitor patients receiving fentanyl transdermal
system and any CYP3A4 inhibitor or inducer.
Exposure To Heat
Exposure of the fentanyl transdermal system application site and
surrounding area 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 may increase fentanyl absorption and has resulted
in fatal overdose of fentanyl and death. 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.