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WARNING

POTENTIAL FOR ABUSE and IMPORTANCE OF PROPER PATIENT SELECTION

ABSTRAL contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. ABSTRAL (fentanyl sublingual tablets) can be abused in a manner similar to other opioid agonists, legal or illicit. Consider the potential for abuse when prescribing or dispensing ABSTRAL (fentanyl sublingual tablets) 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.

Serious adverse events, including deaths, in patients treated with other oral transmucosal fentanyl products 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 ABSTRAL for any other fentanyl product may result in fatal overdose.

ABSTRAL (fentanyl sublingual tablets) is indicated only for the management of breakthrough pain in cancer patients 18 years of age and older 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 of oral morphine/daily, or at least 25 mcg transdermal fentanyl/hour, or at least 30 mg of oral oxycodone daily, or 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.

ABSTRAL (fentanyl sublingual tablets) is contraindicated in opioid non-tolerant patients and is contraindicated in the management of acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room. Life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients. Deaths have occurred in opioid non-tolerant patients treated with other fentanyl products.

When prescribing, do not convert patients on a mcg per mcg basis from another fentanyl product to ABSTRAL (fentanyl sublingual tablets) . Patients beginning treatment with ABSTRAL (fentanyl sublingual tablets) must begin with titration from the 100 mcg dose [See DOSAGE AND ADMINISTRATION].

When dispensing, do not substitute an ABSTRAL prescription for other fentanyl products. Differences exist in the pharmacokinetics of ABSTRAL compared to other fentanyl products that could result in clinically important differences in the amount of fentanyl absorbed and could result in fatal overdose.

Special care must be used when dosing ABSTRAL (fentanyl sublingual tablets) . If the breakthrough pain episode is not relieved patients must wait at least 2 hours before treating another episode of breakthrough pain with ABSTRAL [See DOSAGE AND ADMINISTRATION].

ABSTRAL (fentanyl sublingual tablets) 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.

Patients and their caregivers must be instructed that ABSTRAL (fentanyl sublingual tablets) contains a medicine in an amount which can be fatal in children, in individuals for whom it is not prescribed, and in those who are not opioid tolerant. All packs must be kept out of the reach of children [see PATIENT INFORMATION, CONTRAINDICATIONS and HOW SUPPLIED/Storage and Handling].

The concomitant use of ABSTRAL with 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, ABSTRAL (fentanyl sublingual tablets) is available only through a restricted program, required by the Food and Drug Administration, called the ABSTRAL (fentanyl sublingual tablets) REMS (Risk Evaluation and Mitigation Strategy). Under the ABSTRAL (fentanyl sublingual tablets) REMS, healthcare professionals who prescribe to outpatients, outpatients, pharmacies and distributors must enroll in the program to prescribe, receive, dispense, and distribute ABSTRAL, respectively. [see WARNINGS AND PRECAUTIONS]. Further information is available at www.abstral (fentanyl sublingual tablets) rems.com or by calling 1-888-227-8725.