Cephalon Reinforces Important Prescribing and Dosing Information for FENTORA
Cephalon, Inc. today
communicated with healthcare professionals to clarify the appropriate patient
selection, dosing and administration for FENTORA(R) (fentanyl buccal tablet)
[C-II].
From www.cnn.com
By CNN
September 13, 2007
FRAZER, Pa., Sept. 13 /PRNewswire-FirstCall/ -- Cephalon, Inc. 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
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). Healthcare professionals and patients
may contact Cephalon Medical Services at 1-800-895-5855 or visit www.fentora.com
for additional prescribing information.
PHYSICIANS AND OTHER HEALTHCARE PROVIDERS MUST BECOME FAMILIAR WITH THE
IMPORTANT WARNINGS IN THIS LABEL.
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.
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. Patients considered opioid tolerant
are those who are taking at least 60 mg of oral morphine/day, at least 25
mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least
8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid
for a week or longer. Because life-threatening respiratory depression could
occur at any dose in opioid non-tolerant patients, FENTORA is contraindicated
in the management of acute or postoperative pain. This product is not indicated
for use in opioid nontolerant patients.
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
Information for Patients and Caregivers for disposal instructions.)
Due to the higher bioavailability of fentanyl in FENTORA, when converting
patients from other oral fentanyl products, including oral transmucosal fentanyl
citrate (OTFC and Actiq(R)), to FENTORA, do not substitute FENTORA on a mcg
per mcg basis. Adjust doses as appropriate. (See DOSAGE AND ADMINISTRATION.)
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 strong and moderate cytochrome P450
3A4 inhibitors may result in an increase in fentanyl plasma concentrations,
and may cause potentially fatal respiratory depression.
Full prescribing information about FENTORA, including boxed warning, is
available from www.FENTORA.com.
About Cephalon, Inc.
Cephalon, Inc. is an international biopharmaceutical company, recently inducted
in to the World Economic Forum Community of Global Growth Companies. For
20 years, the company has been dedicated to the discovery, development and
commercialization of innovative products in four core therapeutic areas:
central nervous system, pain, oncology and addiction. Cephalon has delivered
a seven-year compound annual growth rate (CAGR) through 2006 greater than
75% and 2006 revenue of $1.760 billion. A member of the Fortune 1000, Cephalon
currently employs approximately 3,000 people in the United States and Europe.
U.S. sites include the company's headquarters in Frazer, Pennsylvania, and
offices, laboratories or manufacturing facilities in West Chester, Pennsylvania,
Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Cephalon's European
headquarters are located in Maisons-Alfort, France.
The company's proprietary products in the United States include: PROVIGIL(R)
(modafinil) Tablets [C-IV), FENTORA, TRISENOX(R) (arsenic trioxide) injection,
AMRIX(TM) (cyclobenzaprine hydrochloride extended-release capsules), VIVITROL(R)
(naltrexone for extended-release injectable suspension), GABITRIL(R) (tiagabine
hydrochloride), NUVIGIL(TM) (armodafinil) Tablets [C-IV] and ACTIQ. The company
also markets numerous products internationally. Full prescribing information
on its U.S. products is available at http://www.cephalon.com or by calling
1-800-896-5855.
In addition to historical facts or statements
of current condition, this press release may contain forward-looking statements.
Forward-looking statements provide Cephalon's current expectations or forecasts
of future events. These may include statements regarding anticipated scientific
progress on its research programs; development of potential pharmaceutical
products,; interpretation of clinical results; manufacturing development
and capabilities; market prospects for its products; sales and earnings
guidance; and other statements regarding matters that are not historical
facts. You may identify some of these forward-looking statements by the
use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or
other words and terms of similar meaning. Cephalon's performance and financial
results could differ materially from those reflected in these forward-looking
statements due to general financial, economic, regulatory and political conditions
affecting the biotechnology and pharmaceutical industries as well as more
specific risks and uncertainties facing Cephalon such as those set forth
in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities
and Exchange Commission. Given these risks and uncertainties, any or all
of these forward-looking statements may prove to be incorrect. Therefore,
you should not rely on any such factors or forward- looking statements. Furthermore,
Cephalon does not intend to update publicly any forward-looking statement,
except as required by law. The Private Securities Litigation Reform Act of
1995 permits this discussion.
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