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Cephalon Receives FDA Approval for Risk Evaluation and Mitigation Strategy for FENTORA and ACTIQ
Date:7/21/2011

s properly discarded [see Warnings And Precautions (5.3), Patient Counseling Information (17.5, 17.6), and How Supplied/Storage And Handling (16.2)].

ACTIQ is intended to be used only in the care of cancer patients and only by oncologists and pain specialists who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.

The concomitant use of ACTIQ with strong and moderate cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression [see Drug Interactions (7)].

WARNINGS: IMPORTANCE OF PROPER PATIENT SELECTION, DOSING, and POTENTIAL FOR ABUSE

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 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 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
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SOURCE Cephalon, Inc.
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