Actiq (oral transmucosal fentanyl citrate) is indicated only for the management of breakthrough cancer pain in patients 16 and older with malignancies 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 morphine/day, at least 25 mcg transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg 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 taking chronic opiates. For this reason, Actiq is contraindicated in the management of acute or postoperative pain.

Actiq is intended to be used only in the care of cancer patients and only by oncologists and pain specialists who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.

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.

Dose Titration

Starting Dose: Individually titrate Actiq to a dose that provides adequate analgesia and minimizes side effects. The initial dose of Actiq to treat episodes of breakthrough cancer pain is 200 mcg. Patients should be prescribed an initial titration supply of six 200 mcg Actiq units, thus limiting the number of units in the home during titration. Patients should use up all units before increasing to a higher dose.

From this initial dose, closely follow patients and change the dosage level until the patient reaches a dose that provides adequate analgesia using a single Actiq dosage unit per breakthrough cancer pain episode. If signs of excessive opioid effects appear before the unit is consumed, the dosage unit should be removed from the patient's mouth immediately, disposed of properly, and subsequent doses should be decreased. Patients should record their use of Actiq over several episodes of breakthrough cancer pain and review their experience with their physicians to determine if a dosage adjustment is warranted.

Redosing Within a Single Episode: Until the appropriate dose is reached, patients may find it necessary to use an additional Actiq unit during a single episode. Redosing may start 15 minutes after the previous unit has been completed (30 minutes after the start of the previous unit). While patients are in the titration phase and consuming units which individually may be subtherapeutic, no more than two units should be taken for each individual breakthrough cancer pain episode.

Increasing the Dose: If treatment of several consecutive breakthrough cancer pain episodes requires more than one Actiq per episode, consider an increase in dose to the next higher available strength. At each new dose of Actiq during titration, it is recommended that six units of the titration dose be prescribed. Evaluate each new dose of Actiq used in the titration period over several episodes of breakthrough cancer pain (generally 1-2 days) to determine whether it provides adequate efficacy with acceptable side effects. The incidence of side effects is likely to be greater during this initial titration period compared to later, after the effective dose is determined.

Actiq Titration Process
See BOXED WARNING

Dosage Adjustment

Increase the dose of Actiq when patients require more than one dosage unit per breakthrough cancer pain episode for several consecutive episodes. When titrating to an appropriate dose, prescribe small quantities (six units) at each titration step. Once a successful dose has been found (i.e., an average episode is treated with a single unit), patients should limit consumption to four or fewer units per day. Consider increasing the around-the-clock opioid dose used for persistent cancer pain in patients experiencing more than four breakthrough cancer pain episodes daily.

Administration of Actiq

Open the blister package with scissors immediately prior to product use. The patient should place the Actiq unit in his or her mouth between the cheek and lower gum, occasionally moving the drug matrix from one side to the other using the handle. The Actiq unit should be sucked, not chewed. A unit dose of Actiq , if chewed and swallowed, might result in lower peak concentrations and lower bioavailability than when consumed as directed [see CLINICAL PHARMACOLOGY].

The Actiq unit should be consumed over a 15-minute period. Longer or shorter consumption times may produce less efficacy than reported in Actiq clinical trials. If signs of excessive opioid effects appear before the unit is consumed, remove the drug matrix from the patient's mouth immediately and decrease future doses.

Discontinuation of Actiq

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

Each dosage unit has white to off-white color and is a solid drug matrix on a handle. Each strength is marked on the individual solid drug matrix and the handle tag. Actiq is available in 200 mcg, 400 mcg , 600 mcg , 800 mcg, 1200 mcg and 1600 mcg strengths [see HOW SUPPLIED, Storage and Handling].

Storage and Handling

Actiq is supplied in individually sealed child-resistant blister packages. The amount of fentanyl contained in Actiq can be fatal to a child. Patients and their caregivers must be instructed to keep Actiq out of the reach of children [see BOXED WARNING - Warnings: Importance Of Proper Patient Selection and Potential For Abuse, WARNINGS And PRECAUTIONS, and Patient Counseling Information].

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.) Protect Actiq from freezing and moisture. Do not use if the blister package has been opened.

Disposal of Actiq

Patients must be advised to dispose of any units remaining from a prescription as soon as they are no longer needed. While all units should be disposed of immediately after use, partially consumed units represent a special risk because they are no longer protected by the child resistant blister package, yet may contain enough medicine to be fatal to a child [see Patient Counseling Information].

A temporary storage bottle is provided as part of the Actiq Welcome Kit [see Patient Counseling Information]. This container is to be used by patients or their caregivers in the event that a partially consumed unit cannot be disposed of promptly. Instructions for usage of this container are included in the Medication Guide.

Patients and members of their household must be advised to dispose of any units remaining from a prescription as soon as they are no longer needed. Instructions are included in Patient Counseling Information and in the Medication Guide. If additional assistance is required, call Cephalon, Inc. at 1-800-896-5855.

How Supplied

Actiq is supplied in six dosage strengths. Each unit is individually wrapped in a child-resistant, protective blister package. These blister packages are packed 30 per shelf carton for use when patients have been titrated to the appropriate dose.

Each dosage unit has a white to off-white color. The dosage strength of each unit is marked on the solid drug matrix, the handle tag, the blister package and the carton. See blister package and carton for product information.

Note: Colors are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing.

Manufactured by: Cephalon, Inc., Salt Lake City, UT 84116. FDA Rev date: 2/7/2007

Bookmark this page: