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WARNING

RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE POTENTIAL

RESPIRATORY DEPRESSION

Fatal respiratory depression has occurred in patients treated with immediate-release transmucosal fentanyl, including following use in opioid non-tolerant patients and improper dosing. The substitution of ONSOLIS for any other fentanyl product may result in fatal overdose.

Due to the risk of respiratory depression, ONSOLIS is contraindicated in the management of acute or postoperative pain including headache/migraine and in opioid non-tolerant patients. [see CONTRAINDICATIONS] ONSOLIS must be kept out of reach of children. [See PATIENT INFORMATION and HOW SUPPLIED/Storage and Handling]

The concomitant use of ONSOLIS with CYP3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression [see DRUG INTERACTIONS].

MEDICATION ERRORS

Substantial differences exist in the pharmacokinetic profile of ONSOLIS compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl that could result in fatal overdose.

• When prescribing, do not convert patients on a mcg per mcg basis from any other fentanyl products to ONSOLIS.
• When dispensing, do not substitute an ONSOLIS prescription for other fentanyl products.

ABUSE POTENTIAL

ONSOLIS contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. ONSOLIS can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing ONSOLIS in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion.

Because of the risk for misuse, abuse, addiction, and overdose, Onsolis is available only through a restricted program required by the Food and Drug Administration, called a Risk Evaluation and Mitigation Strategy (REMS). Under the Transmucosal Immediate Release Fentanyl (TIRF) REMS Access program, outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors must enroll in the program [see WARNINGS AND PRECAUTIONS]. Further information is available at www.TIRFREMSAccess.com or by calling 1-866-822-1483.