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WARNING

IMPORTANCE OF PROPER PATIENT SELECTION, DOSING, and POTENTIAL FOR ABUSE

Reports of serious adverse events, including deaths in patients treated with ACTIQ have been reported. Deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients) and/or improper dosing. The substitution of ACTIQ for any other fentanyl product may result in fatal overdose.

ACTIQ is indicated only for the management of breakthrough cancer pain in patients with malignancies 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 of transdermal fentanyl/hour, at least 30 mg of oral oxycodone daily, at least 8 mg oral hydromorphone daily, at least 25 mg oral oxymorphone daily, or an equianalgesic dose of another opioid for a week or longer.

ACTIQ is not indicated for use in opioid non-tolerant patients including those with only as needed (PRN) prior exposure.

Life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients. Deaths have occurred in opioid non-tolerant patients.

ACTIQ is contraindicated in the management of acute or postoperative pain including headache/migraine.

Special care must be used when dosing ACTIQ. If the breakthrough pain episode is not relieved 15 minutes after completion of the ACTIQ unit, patients may take ONLY ONE additional dose using the same strength and then must wait at least 4 hours before taking another dose [see DOSAGE AND ADMINISTRATION].

ACTIQ contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. ACTIQ can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing ACTIQ in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion. Schedule II opioid substances which include morphine, oxycodone, hydromorphone, oxymorphone, and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression.

Patients and their caregivers must be instructed that ACTIQ contains a medicine in an amount which can be fatal to a child. Death has been reported in children who have accidentally ingested ACTIQ. All units must be kept out of the reach of children and opened units properly discarded [see WARNINGS AND PRECAUTIONS, PATIENT INFORMATION, and HOW SUPPLIED/Storage and Handling].

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.

The concomitant use of ACTIQ with strong and moderate cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression [see DRUG INTERACTIONS].

Because of the risk for misuse, abuse, addiction, and overdose, ACTIQ is available only through a restricted distribution program, required by the Food and Drug Administration, called the ACTIQ REMS Program (Risk Evaluation and Mitigation Strategy). Under the ACTIQ REMS Program, healthcare professionals (who prescribe to outpatients), as well as outpatients, pharmacies and distributors must enroll in the program to prescribe, receive, dispense, and distribute ACTIQ, respectively. [See WARNINGS AND PRECAUTIONS] Further information is available at www.actiqandfentorarems.com or by calling 1-888-688-6885.