Cephalon, Inc. (Nasdaq: CEPH) 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 injuries.
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 of FENTORA.
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 pain medication.
Cephalon also is proactively working with the FDA to emphasize the appropriate patient selection, dosing and administration in the FENTORA label and Risk Minimization Action Plan (RiskMAP).