Fentanyl Transmucosal Products (Abstral, Actiq, Fentora, Lazanda, Onsolis; generics) - New Class-Wide Risk Management Program
March 13, 2012
FDA implemented a class-wide risk evaluation and mitigation strategy (REMS) for fentanyl transmucosal presentations on March 12, 2012. The Transmucosal Immediate-Release Fentanyl (TIRF) program is the first class-wide REMS to be implemented for opioids and includes the following fentanyl products: fentanyl sublingual tablet (Abstral), fentanyl citrate oral transmucosal lozenge (Actiq) and generic equivalents, fentanyl citrate buccal tablet (Fentora), fentanyl nasal spray (Lazanda), fentanyl buccal (Onsolis), and fentanyl sublingual spray (Subsys). The TIRF REMS program includes the following components:
- Medication Guide requirement: A Medication Guide must be distributed to the patient each time transmucosal fentanyl is dispensed;
- Prescriber education and enrollment; and
- Formal documentation of patient education and consent.
The individual REMS for transmucosal fentanyl products have been replaced with the TIRF REMS program. Drug distributors, prescribers, and pharmacies now only need to enroll in the one system. Until the TIRF program went into effect, these parties had to enroll in multiple individual REMS programs. When the TIRF REMS program went into effect, those who were enrolled in any individual transmucosal fentanyl REMS program were automatically enrolled in the TIRF program. REMS enrollment is not required for healthcare providers prescribing these products only for inpatient use.
The TIRF REMS program does not limit the indications for which physicians can prescribe these products. Physicians will still be able to prescribe these agents for off-label uses. The intent of the TIRF REMS program is not to limit the drugs' use to specific indications, but rather to encourage patient education and appropriate use of the medications.
FDA plans to implement another class-wide REMS for long acting and extended release opioids in early 2012 although the exact date is not yet known.
FDA requires the distribution of Medication Guides for drugs determined to be a serious and significant public health concern. Distribution requirements and exceptions (eg, certain inpatient care situations) for Medication Guides are addressed in an FDA Guidance Document: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm. Medication Guide distribution requirements are stricter for medications with a Risk Evaluation and Mitigation Strategy (REMS) that includes Elements To Assure Safe Use (ETASU) with specific requirements for providing and reviewing the Medication Guide: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm#Additional_REMS_information. A complete list of drugs that require a Medication Guide as part of the FDA-regulated product labeling is available online at: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.
Additional information is available at the following links:
- FDA Press Release – December 29, 2011:
- Transmucosal Fentanyl REMS program questions and answers:
- TIRF REMS program website:
March 13, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.