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Cephalon Reinforces Important Prescribing and Dosing Information for FENTORA

FRAZER, Pa., Sept. 13 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) today communicated with healthcare professionals to clarify the appropriate patient selection, dosing and administration for FENTORA(R) (fentanyl buccal tablet) [C-II]. The company is sharing this information with the medical community to reinforce the appropriate prescribing and use of the medication.

The letter, issued in collaboration with the U.S. Food and Drug Administration (FDA), was in response to recently reported serious adverse events, including some deaths in patients who were not appropriate candidates for FENTORA. These events appear to have occurred as a result of improper use in patients who were not already taking opioids around-the-clock (opioid nontolerant); improper dosing of the medication; and/or improper substitution of FENTORA for other fentanyl-based medications.

The letter has been sent to physicians, pharmacists, managed care organizations, and other healthcare professionals and it emphasizes the need to adhere to the FENTORA prescribing information, including the following:

-- FENTORA is indicated only for the management of breakthrough pain in

patients with cancer who are already receiving and who are tolerant to

opioid therapy for their underlying persistent cancer pain.

-- FENTORA must only be prescribed to patients who are routinely taking

around-the-clock opioids. FENTORA should not be prescribed to patients

for acute pain, postoperative pain, headache/migraine, or sports


-- Only one tablet per episode should be taken once a dose is established

and patients must wait at least four hours before taking another dose


-- FENTORA is not bioequivalent to or a generic version of ACTIQ(R) (oral

transmucosal fentanyl citrate) [C-II]; therefore, FENTORA should not be

substituted for ACTIQ or any other fentanyl-containing pa

SOURCE Cephalon, Inc.
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