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

tients. Deaths have occurred in opioid non-tolerant patients.

ACTIQ is contraindicated in the management of acute or postoperative pain including headache/migraine.

When prescribing, do not convert patients on a mcg per mcg basis to ACTIQ from other fentanyl products.

When dispensing, do not substitute an ACTIQ prescription for other fentanyl products. Substantial differences exist in the pharmacokinetic profile of ACTIQ 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 ACTIQ for any other fentanyl product may result in fatal overdose.

Special care must be used when dosing ACTIQ. If the breakthrough pain episode is not relieved 15 minutes after completion of the ACTIQ unit, patients may take ONLY ONE additional dose using the same strength and then must wait at least 4 hours before taking another dose [see Dosage And Administration (2.2)].

ACTIQ contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics.  ACTIQ can be abused in a manner similar to other opioid agonists, legal or illicit.  This should be considered when prescribing or dispensing ACTIQ 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 ACTIQ contains a medicine in an amount which can be fatal to a child. Death has been reported in children who have accidentally ingested ACTIQ. All units must be kept out of the reach of children and opened unit
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SOURCE Cephalon, Inc.
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