"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
FENTORA is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg/hr of transdermal fentanyl, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily, at least 25 mg oral oxymorphone daily, or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids while taking FENTORA.
This product must not be used in opioid non-tolerant patients because life-threatening hypoventilation and death could occur at any dose in patients not on a chronic regimen of opioids. 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.
Limitations of Use
As a part of the TIRF REMS Access program, FENTORA may be dispensed only to outpatients enrolled in the program [see WARNINGS AND PRECAUTIONS]. For inpatient administration of FENTORA (e.g., hospitals, hospices, and long-term care facilities that prescribe for inpatient use), patient and prescriber enrollment is not required.
DOSAGE AND ADMINISTRATION
Healthcare professionals who prescribe FENTORA on an outpatient basis must enroll in the TIRF REMS Access program and comply with the requirements of the REMS to ensure safe use of FENTORA [see WARNINGS AND PRECAUTIONS].
As with all opioids, the safety of patients using such products is dependent on health care professionals prescribing them in strict conformity with their approved labeling with respect to patient selection, dosing, and proper conditions for use.
It is important to minimize the number of strengths available to patients at any time to prevent confusion and possible overdose.
FENTORA is not bioequivalent with other fentanyl products. Do not convert patients on a mcg per mcg basis from other fentanyl products. There are no conversion directions available for patients on any other fentanyl products other than Actiq. (Note: This includes oral, transdermal, or parenteral formulations of fentanyl.) All patients should be titrated from the 100 mcg dose.
Patients on Actiq
The initial dose of FENTORA is always 100 mcg with the only exception being patients already using Actiq.
a. For patients being converted from Actiq, prescribers must use the Initial Dosing Recommendations for Patients on Actiq table below (Table 1). 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 1: Initial Dosing Recommendations for Patients
|Current Actiq Dose (mcg)||Initial FENTORA Dose*|
|200||100 mcg tablet|
|400||100 mcg tablet|
|600||200 mcg tablet|
|800||200 mcg tablet|
|1200||2 x 200 mcg tablets|
|1600||2 x 200 mcg tablets|
|*From this initial dose, titrate patient to effective dose.|
b. 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.
All Other Patients
The initial dose of FENTORA is 100 mcg.
- 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.
- 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 overdose during titration, patients should have only one strength of FENTORA tablets available at any 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 Storage and Handling]. Dispose of any unopened FENTORA tablets remaining from a prescription as soon as they are no longer needed.
- 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. 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 around-the-clock opioid used for persistent pain should be re-evaluated.
- Once an effective dose is determined using the titration scheme outlined above, an alternate route of administration is sublingual (placing the tablet under the tongue.)
Administration of FENTORA
Opening the Blister Package
- Instruct patients not to open the blister until ready to administer FENTORA.
- Separate a single blister unit from the blister card by bending and tearing apart at the perforations.
- Bend the blister unit along the line where indicated.
- Peel back the blister backing to expose the tablet. Patients should NOT attempt to push the tablet through the blister as this may cause damage to the tablet.
- Do not store the tablet 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.
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) or place the entire FENTORA tablet under the tongue. Patients should not split the tablet.
The FENTORA tablet should not be crushed, sucked, chewed or swallowed whole, as this will result in lower plasma concentrations than when taken as directed.
The FENTORA tablet should be left between the cheek and gum or under the tongue 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 in the buccal cavity.
Discontinuation of FENTORA
For patients requiring discontinuation of opioids, a gradual downward titration is recommended because it is not known at what dose level the opioid may be discontinued without producing the signs and symptoms of abrupt withdrawal.
Dosage Forms And Strengths
FENTORA tablets are flat-faced, round, beveled-edge in shape; are white in color; and are available in 100 mcg, 200 mcg, 400 mcg, 600 mcg and 800 mcg strengths as fentanyl base. Each tablet strength is marked with a unique identifier [see Storage and Handling].
Storage 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, OVERDOSAGE, and PATIENT INFORMATION]
Store at 20 to 25°C (68 to 77°F) with excursions permitted between 15° and 30°C (59° to 86°F) until ready to use. (See USP Controlled Room Temperature.)
Protect FENTORA 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 [see PATIENT INFORMATION]. If additional assistance is required, call Teva Pharmaceuticals at 1-800-896-5855.
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 Teva Pharmaceuticals at 1-800896-5855.
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 'C', and the other side of each dosage strength is uniquely identified by the debossing on the tablet as described in the table below. In addition, the dosage strength is indicated on the blister package and the carton. See blister package and carton for product information.
|Dosage Strength||Debossing||Carton/Blister Package Color||NDC Number|
|100 mcg||1||Blue||NDC 63459-541-28|
|200 mcg||2||Orange||NDC 63459-542-28|
|400 mcg||4||Sage green||NDC 63459-544-28|
|600 mcg||6||Magenta (pink)||NDC 63459-546-28|
|800 mcg||8||Yellow||NDC 63459-548-28|
Note: Carton/blister package colors are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing.
Distributed By: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. Revised: 02/2013
Last reviewed on RxList: 3/12/2013
This monograph has been modified to include the generic and brand name in many instances.
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