(See BOXED WARNING and CONTRAINDICATIONS.)

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.

This product must not be used in opioid non-tolerant patients because life-threatening hypoventilation could occur at any dose in patients not on a chronic regimen of opiates. For this reason, FENTORA is contraindicated in the management of acute or postoperative pain.

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.

Physicians should individualize treatment using a progressive plan of pain management. Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring. (See BOXED WARNING and Dose Titration.)

Patients with hepatic and/or renal impairment

Caution should be exercised for patients with hepatic and/or renal impairment, and the lowest possible dose should be used in these patients. (See PRECAUTIONS.)

Patients receiving CYP3A4 inhibitors

Particular caution should be exercised for patients receiving CYP3A4 inhibitors, and the lowest possible dose should be used in these patients. (See PRECAUTIONS.)

Patients with mucositis

No dose adjustment appears necessary in patients with Grade 1 mucositis. The safety and efficacy of FENTORA when used in patients with mucositis more severe than Grade 1 have not been studied.

Administration of FENTORA

Dose Titration: Patients should be titrated to a dose of FENTORA that provides adequate analgesia with tolerable side effects.

Starting Dose: The initial dose of FENTORA should be 100 mcg.

For patients switching from oral transmucosal fentanyl citrate to FENTORA, the starting dose of FENTORA should be initiated as shown in Table 7 below. (See PHARMACOKINETICS, Absorption.)

Table 7. Dosing Conversion Recommendations

Re-dosing Patients Within a Single Episode: Dosing may be repeated once during a single episode of breakthrough pain if pain is not adequately relieved by one FENTORA dose. Re-dosing may occur 30 minutes after the start of administration of FENTORA and the same dosage strength should be used.

Increasing the Dose: From an initial dose, patients should be closely followed and the dosage strength changed until the patient reaches a dose that provides adequate analgesia with tolerable side effects using a single FENTORA tablet. Patients should record their use of FENTORA over several episodes of breakthrough pain and discuss their experience with their physician to determine if a dosage adjustment is warranted.

Titration should be initiated using multiples of the 100 mcg FENTORA tablet. Patients needing to titrate above 100 mcg can be instructed to use two 100 mcg tablets (one on each side of the mouth in the buccal cavity). If this dose is not successful in controlling the breakthrough pain episode, the patient may be instructed to place two 100 mcg tablets on each side of the mouth in the buccal cavity (total of four 100 mcg tablets). Although not bioequivalent, four 100 mcg FENTORA tablets were found to deliver approximately 12% and 13% higher values for Cmax and AUC_0-inf, respectively, compared to one 400 mcg FENTORA tablet. Consequently, patients converting from four 100 mcg tablets to one 400 mcg FENTORA tablet would be expected to experience a decrease in plasma concentration. The impact of this decrease on pain relief has not been evaluated clinically. Titrate above 400 mcg by 200 mcg increments bearing in mind (1) Using more than 4 tablets simultaneously has not been studied and (2) It is important to minimize the number of strengths available to patients at any time to prevent confusion and possible overdose.

To reduce the risk of overdose during titration, patients should have only one strength FENTORA tablet available at any one time. Patients should be strongly encouraged to use all of their FENTORA tablets of one strength prior to being prescribed the next strength. If this is not practical, unused FENTORA should be disposed of safely. (See DISPOSAL OF FENTORA.) Dispose of any unopened FENTORA tablets remaining from a prescription as soon as they are no longer needed.

Once a successful dose has been established, if the patient experiences greater than four breakthrough pain episodes per day, the dose of the maintenance (around-the-clock) opioid used for persistent pain should be re-evaluated.

Dosage Adjustment: Dosage adjustment of both FENTORA and the maintenance (around-the-clock) opioid analgesic may be required in some patients in order to continue to provide adequate relief of breakthrough pain. Generally, the FENTORA dose should be increased when patients require more than one dose per breakthrough pain episode for several consecutive episodes.

Opening the Blister Package

Patients should be instructed not to open the blister until ready to administer. A single blister unit should be separated from the blister card by tearing it apart at the perforations. The blister unit should then be bent along the line where indicated. The blister backing should then be peeled back to expose the tablet. Patients should NOT attempt to push the tablet through the blister as this may cause damage to the tablet. The tablet should not be stored once it has been removed from the blister package as the tablet integrity may be compromised and because this increases the risk of accidental exposure to the tablet.

Tablet Administration

Patients should remove the tablet from the blister unit and immediately place the entire FENTORA tablet in the buccal cavity (above a rear molar, between the upper cheek and gum). Patients should not attempt to split the tablet.

The FENTORA tablet should not be sucked, chewed or swallowed, as this will result in lower plasma concentrations than when taken as directed.

The FENTORA tablet should be left between the cheek and gum until it has disintegrated, which usually takes approximately 14-25 minutes.

After 30 minutes, if remnants from the FENTORA tablet remain, they may be swallowed with a glass of water.

Dwell time (defined as the length of time that the tablet takes to fully disintegrate following buccal administration), does not appear to affect early systemic exposure to fentanyl.

Safety And Handling

FENTORA is supplied in individually sealed, child-resistant blister packages. The amount of fentanyl contained in FENTORA can be fatal to a child. Patients and their caregivers must be instructed to keep FENTORA out of the reach of children. (See BOXED WARNING, WARNINGS, PRECAUTIONS, and MEDICATION GUIDE )

Store at 20-25ºC (68-77ºF) with excursions permitted between 15° and 30°C (59° to 86°F) until ready to use. (See USP Controlled Room Temperature.)

FENTORA should be protected from freezing and moisture. Do not use if the blister package has been tampered with.

Disposal Of Fentora

Patients and members of their household must be advised to dispose of any tablets remaining from a prescription as soon as they are no longer needed Information is available in the Information for Patients and Caregivers and in the Medication Guide. If additional assistance is required, referral to the FENTORA 800# (1-800-896-5855) should be made.

To dispose of unused FENTORA, remove FENTORA tablets from blister packages and flush down the toilet. Do not flush FENTORA blister packages or cartons down the toilet. If you need additional assistance with disposal of FENTORA, call Cephalon, Inc., at 1-800-896-5855.

Each carton contains 7 blister cards with 4 white tablets in each card. The blisters are child-resistant, encased in peelable foil, and provide protection from moisture. Each tablet is debossed on one side with and the other side of each dosage strength is uniquely identified by the debossing on the tablet as described in the table below. The dosage strength of each tablet is marked on the tablet, the blister package and the carton. See blister package and carton for product information.

Note: Carton/blister package colors are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing.

DEA order form required. A Schedule CII narcotic. Manufactured for: Cephalon, Inc. Frazer, PA 19355 By: CIMA LABS, INC. 10000 Valley View Road, Eden Prairie, MN 55344 and Cephalon, Inc. 4745 Wiley Post Way Salt Lake City, UT 84116. April, 2007. FDA Rev date: 12/5/2007

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