1.1. Adults

Fentanyl citrate intranasal spray as well as oral transmucosal lozenges, buccal tablets, sublingual tablets, sublingual spray, and transdermal patches are FDA-approved for managing breakthrough cancer pain in patients already receiving and tolerant to opioid therapy for persistent cancer pain. Patients are considered opioid tolerant if they are taking around-the-clock opioids consisting of at least 60 mg of oral morphine daily, 25 mcg of transdermal fentanyl/hour, 30 mg of oral oxycodone daily, 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid daily for a week or longer^1-11.

Because of the risk of abuse, addiction, misuse, and overdose, all intranasal and oral fentanyl dosage forms are obtained solely through a restricted distribution program, the Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Management Strategy (REMS) Access program, in which only outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors who have registered for the program can prescribe, dispense, and/or obtain intranasal and oral fentanyl^{1-5, 7-11}.

Due to pharmacokinetic differences between intranasal, oral transmucosal, buccal, sublingual, and transdermal fentanyl citrate formulations, these products are not interchangeable on a mcg per mcg basis and should not be substituted on a mcg for mcg basis as enhanced or attenuated pharmacologic effects could occur^1-11.