Reports of serious adverse events, including deaths in patients treated with
FENTORA have been reported. Deaths occurred as a result of improper patient selection
(e.g., use in opioid non-tolerant patients) and/or improper dosing. The
substitution of FENTORA for any other fentanyl product may result in fatal overdose.
FENTORA is indicated only for the management of breakthrough pain in adult patients
with cancer who are already receiving and
who are tolerant to around-the-clock opioid therapy for their underlying persistent
cancer pain. Patients considered opioid tolerant are those
who are taking around-the-clock medicine consisting of at least 60 mg of oral morphine
daily, at least 25 mcg/hour of transdermal fentanyl, at least 30 mg of oral oxycodone
daily, at least 8 mg of oral hydromorphone daily, at least 25 mg oxymorphone daily,
or an equianalgesic dose of another opioid daily for a week or longer.
FENTORA is contraindicated in the management of acute or postoperative pain
including headache/migraine. FENTORA is not indicated for use in opioid non-tolerant
patients including those with only as needed (PRN) prior exposure to opioids.
Life-threatening respiratory depression could occur at any dose in opioid non-tolerant
patients. Deaths have occurred in opioid non-tolerant patients.
When prescribing, do not convert patients on a mcg per mcg basis from any other
fentanyl products to FENTORA. Carefully consult the Initial Dosing Recommendations
table. [See Dosage and Administration (2.1)]
When dispensing, do not substitute a FENTORA prescription for other fentanyl
products. Substantial differences exist in the pharmacokinetic profile of FENTORA
compared to other fentanyl products that result in clinically important differences
in the extent of absorption of fentanyl. As a result of these differences, the substitution
of FENTORA for any other fentanyl product may result in fatal overdose.
Special care must be used when dosing FENTORA. If the breakthrough pain episode
is not relieved after 30 minutes, patients may take ONLY one additional dose using
the same strength and must wait at least 4 hours before taking another dose. [See
Dosage and Administration (2.1)]
FENTORA contains fentanyl, an opioid agonist and a Schedule II controlled substance,
with an abuse liability similar to other opioid analgesics. FENTORA can be abused
in a manner similar to other opioid agonists, legal or illicit. This should be considered
when prescribing or dispensing FENTORA in situations where the physician or pharmacist
is concerned about an increased risk of misuse, abuse or diversion. Schedule II
opioid substances which include morphine, oxycodone, hydromorphone, oxymorphone,
and methadone have the highest potential for abuse and risk of fatal overdose due
to respiratory depression.
Patients and their caregivers must be instructed that FENTORA contains a medicine
in an amount which can be fatal to a child. Patients and their caregivers must be
instructed to keep all tablets out of the reach of children. [See Patient Counseling
Information (17.1) and How Supplied/Storage and Handling (16.1)]
FENTORA is intended to be used only in the care of opioid tolerant cancer patients
and only by healthcare professionals who are knowledgeable of and skilled in the
use of Schedule II opioids to treat cancer pain.
The concomitant use of FENTORA with CYP3A4 inhibitors may result in an increase
in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression
[see Drug Interactions (7)].
Because of the risk for misuse, abuse, addiction, and overdose, FENTORA is available
only through a restricted distribution program, required by the Food and Drug Administration,
called the FENTORA REMS Program (Risk Evaluation
and Mitigation Strategy). Under the FENTORA REMS
Program, healthcare professional (who prescribe to outpatients), as well as outpatients,
pharmacies and distributors must enroll in the program to prescribe, receive, dispense,
and distribute FENTORA, respectively. [See Warnings and Precautions (5.11)]
Further information is available at www.actiqandfentorarems.com or by calling 1-888-688-6885.