FDA Approves Single REMS for Transmucosal Immediate-Release Fentanyl Products

The FDA announced that it has approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) products. This new shared system will replace the individual REMS and allow prescribers and pharmacies to enroll into just one system. TIRF medicines, which include Abstral (ProStrakan), Actiq (Cephalon), Fentora (Cephalon), Lazanda (Archimedes), and Onsolis (Meda), are narcotic pain medicines called opioids used to manage pain in adults with cancer who routinely take other opioid pain medicines around-the-clock.

Several TIRF products already have an individual REMS in place. Prescribers and pharmacies already enrolled in an individual REMS program for at least one TIRF medicine will automatically be transitioned to the shared TIRF REMS Access program. Healthcare professionals who prescribe TIRF medicines that will only be used in an inpatient setting (hospitals, hospices, or long-term care facilities) will not be required to enroll in the TIRF REMS Access program. Similarly, patients who receive TIRF medicines in an inpatient setting are not required to enroll in the program. Long-term care and hospice patients who obtain their medications from outpatient pharmacies must still be enrolled.

For more information, visit www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm284717.htm.