WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION
ERRORS, ABUSE POTENTIAL
Fatal respiratory depression has occurred in patients treated with oral transmucosal fentanyl citrate, including following use in opioid nontolerant patients and improper dosing. The substitution of oral transmucosal fentanyl citrate for any other fentanyl product may result in fatal overdose.
Due to the risk of respiratory depression, oral transmucosal fentanyl citrate is contraindicated in the management of acute or postoperative pain including headache/migraine and in opioid non-tolerant patients.
Death has been reported in children who have accidentally ingested oral transmucosal fentanyl citrate. Oral transmucosal fentanyl citrate must be kept out of reach of children.
The concomitant use of oral transmucosal fentanyl citrate with CYP3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression.
Substantial differences exist in the pharmacokinetic profile of oral transmucosal fentanyl citrate 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 oral transmucosal fentanyl citrate.
- When dispensing, do not substitute an oral transmucosal fentanyl citrate prescription for other fentanyl products.
Oral transmucosal fentanyl citrate contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. Oral transmucosal fentanyl citrate can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing oral transmucosal fentanyl citrate 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, oral transmucosal fentanyl citrate 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. Further information is available at www.TIRFREMSaccess.com or by calling 1-866-822-1483.