Drug Information for FENTORA CII (fentanyl buccal tablet) (Cephalon): DOSAGE AND ADMINISTRATION

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  • 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 Dosing.)

    It is important to minimize the number of strengths available to patients at any time to prevent confusion and possible overdose.

  • Dosing

    • Initial Dose
      • For opioid-tolerant patients not being converted from Actiq, the initial dose of FENTORA is always 100 mcg.
      • For patients being converted from Actiq, prescribers must use the Initial Dosing Recommendations table below (Table 7). The doses of FENTORA in this table are starting doses and not intended to represent equianalgesic doses to Actiq. Patients must be instructed to stop the use of Actiq and dispose of any remaining units.
        Table 7. Initial Dosing Recommendations for Patients on Actiq
        Current Actiq Dose(mcg) Initial FENTORA Dose(mcg)
        200100 mcg tablet
        400100 mcg tablet
        600200 mcg tablet
        800200 mcg tablet
        12002 x 200 mcg tablets
        16002 x 200 mcg tablets
      • For patients converting from Actiq doses equal to or greater than 600 mcg, titration should be initiated with the 200 mcg FENTORA tablet and should proceed using multiples of this tablet strength.
      • In cases where the breakthrough pain episode is not relieved after 30 minutes, patients may take ONLY ONE additional dose using the same strength for that episode. Thus patients should take a maximum of two doses of FENTORA for any episode of breakthrough pain.
      • Patients MUST wait at least 4 hours before treating another episode of breakthrough pain with FENTORA.
    • Titration
      • From an initial dose, patients should be closely followed by the prescriber and the dosage strength changed until the patient reaches a dose that provides adequate analgesia with tolerable side effects. 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.
      • Patients whose initial dose is 100 mcg and who need to titrate to a higher dose, can be instructed to use two 100-mcg tablets (one on each side of the mouth in the buccal cavity) with their next breakthrough pain episode. If this dosage is not successful, 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). Titrate using multiples of the 200-mcg FENTORA tablet for doses above 400 mcg (600 mcg and 800 mcg). Note: Do not use more than 4 tablets simultaneously.
      • In cases where the breakthrough pain episode is not relieved after 30 minutes, patients may take ONLY ONE additional dose of the same strength for that episode. Thus patients should take a maximum of two doses of FENTORA for any breakthrough pain episode. During titration, one dose of FENTORA may include administration of 1 to 4 tablets of the same dosage strength (100 mcg or 200 mcg).
      • Patients MUST wait at least 4 hours before treating another episode of breakthrough pain with FENTORA. To reduce the risk of overdosing during titration, patients should have only one strength of FENTORA tablets 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.
    • Maintenance Dosing
      • Once titrated to an effective dose, patients should generally use only ONE FENTORA tablet of the appropriate strength per breakthrough pain episode.
      • On occasion when the breakthrough pain episode is not relieved after 30 minutes, patients may take ONLY ONE additional dose using the same strength for that episode.
      • Patients MUST wait at least 4 hours before treating another episode of breakthrough pain with FENTORA.
      • Dosage adjustment of FENTORA may be required in some patients in order to continue to provide adequate relief of breakthrough pain.

    Generally, the FENTORA dose should be increased only when a single administration of the current dose fails to adequately treat the breakthrough pain episode for several consecutive episodes.

    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.

  • 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.

  • Opening the Blister Package

    • Patients should be instructed not to open the blister until ready to administer FENTORA.
    • A single blister unit should be separated from the blister card by bending and tearing 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 more importantly, because this increases the risk of accidental exposure to the tablet.
  • Tablet Administration

  • Once the tablet is removed from the blister unit, the patient should immediately place the entire FENTORA tablet in the buccal cavity (above a rear molar, between the upper cheek and gum). Patients should not 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.

    It is recommended that patients alternate sides of the mouth when administering subsequent doses of FENTORA.

  • Drug Information Provided by National Library of Medicine (NLM).
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