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Actiq (Fentanyl Citrate Oral Transmucosal) - Indications and Dosage

 
 



INDICATIONS AND USAGE

(See BOX WARNING and CONTRAINDICATIONS)

Actiq is indicated only for the management of breakthrough cancer pain in patients 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, 50 mcg transdermal fentanyl/hour, or an equianalgesic dose of another opioid for a week or longer.

Because life-threatening hypoventilation could occur at any dose in patients not taking chronic opiates, Actiq is contraindicated in the management of acute or postoperative pain. This product must not be used in opioid non-tolerant patients.

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.

Actiq should be individually titrated to a dose that provides adequate analgesia and minimizes side effects. 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 (see DOSAGE AND ADMINISTRATION).

Patients and their caregivers must be instructed that Actiq contains a medicine in an amount that can be fatal to a child. Patients and their caregivers must be instructed to keep all units out of the reach of children and to discard opened units properly in a secured container.

DOSAGE AND ADMINISTRATION

ACTIQ IS CONTRAINDICATED IN NON-OPIOID TOLERANT INDIVIDUALS.

Actiq should be individually titrated to a dose that provides adequate analgesia and minimizes side effects (see Dose Titration).

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.

Physicians and dispensing pharmacists must specifically question patients and caregivers about the presence of children in the home on a full time or visiting basis and counsel accordingly regarding the dangers to children of inadvertent exposure to Actiq.

ADMINISTRATION OF ACTIQ

The blister package should be opened 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.

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, the drug matrix should be removed from the patient's mouth immediately and future doses should be decreased.

Patients and caregivers must be instructed that Actiq contains medicine in an amount that could be fatal to a child. While all units should be disposed of immediately after use, partially used units represent a special risk and must be disposed of as soon as they are consumed and/or no longer needed. Patients and caregivers should be advised to dispose of any units remaining from a prescription as soon as they are no longer needed (see Disposal Instructions).

DOSE TITRATION

Starting Dose: The initial dose of Actiq to treat episodes of breakthrough cancer pain should be 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, patients should be closely followed and the dosage level changed until the patient reaches a dose that provides adequate analgesia using a single Actiq dosage unit per breakthrough cancer pain episode.

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, an increase in dose to the next higher available strength should be considered. At each new dose of Actiq during titration, it is recommended that six units of the titration dose be prescribed. Each new dose of Actiq used in the titration period should be evaluated 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.

Daily Limit: 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. If consumption increases above four units/day, the dose of the long-acting opioid used for persistent cancer pain should be re-evaluated.

DOSAGE ADJUSTMENT

Experience in a long-term study of Actiq used in the treatment of breakthrough cancer pain suggests that dosage adjustment of both Actiq and the maintenance (around-the-clock) opioid analgesic may be required in some patients to continue to provide adequate relief of breakthrough cancer pain.

Generally, the Actiq dose should be increased when patients require more than one dosage unit per breakthrough cancer pain episode for several consecutive episodes. When titrating to an appropriate dose, small quantities (six units) should be prescribed at each titration step. Physicians should consider increasing the around-the-clock opioid dose used for persistent cancer pain in patients experiencing more than four breakthrough cancer pain episodes daily.

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.

SAFETY 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 BOX WARNING, WARNINGS, PRECAUTIONS, and PATIENT LEAFLET).

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

Actiq should be protected 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 Information for Patients).

A temporary storage bottle is provided as part of the Actiq Welcome Kit (see Information for Patients and Their Caregivers). 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 patient leaflet.

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 Information for Patients and Their Caregivers and in the patient leaflet. If additional assistance is required, referral to the Actiq 800# (1-800-896-5855) should be made.

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.

Patients should be prescribed an initial titration supply of six 200 mcg Actiq units. At each new dose of Actiq during titration, it is recommended that only six units of the next higher dose be prescribed.

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.

Dosage Strength
(fentanyl base)
Carton/Blister
Package Color
NDC Number
200 mcg Gray NDC 63459-502-30
400 mcg Blue NDC 63459-504-30
600 mcg Orange NDC 63459-506-30
800 mcg Purple NDC 63459-508-30
1200 mcg Green NDC 63459-512-30
1600 mcg Burgundy NDC 63459-516-30

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

Rx only.

DEA order form required. A Schedule C-II narcotic.

Manufactured by:

Cephalon, Inc., Salt Lake City, UT 84116, USA

U. S. Patent No. 4,671,953

#1598.01

©2000, 2001 Cephalon, Inc. All rights reserved.

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