Approved Risk Evaluation and Mitigation Strategies (REMS)

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Transmucosal Immediate-Release Fentanyl (TIRF) Products
Shared System REMS
REMS last update: 04/11/2017

This page reflects the most up-to-date version of this Shared System REMS. The process of making corresponding changes to all REMS in the shared system is underway.

What are Transmucosal Immediate-Release Fentanyl (TIRF) Products products?

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The Transmucosal Immediate-Release Fentanyl (TIRF) Products REMS Program includes the following products:

Product Name Application Number Application Holder Added to REMS
Abstral (fentanyl citrate) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 022510 Sentynl Therapeutics, Inc 12/28/2011
Actiq (fentanyl citrate) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 020747 Cephalon, Inc 12/28/2011
Fentora (fentanyl citrate) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 021947 Cephalon, Inc 12/28/2011
Lazanda (fentanyl citrate) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 022569 DepoMed, Inc. 12/28/2011
Onsolis (fentanyl citrate) ( Info at Drugs@FDA ) NDA 022266 BioDelivery Sciences International, Inc 12/28/2011
Subsys (fentanyl) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 202788 Insys Development CO INC 01/04/2012
fentanyl buccal ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 079075 Watson Laboratories, Inc. 01/08/2016
fentanyl citrate ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 078907 Mallinckrodt, Inc 01/04/2012
fentanyl citrate ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 077312 Par Pharmaceutical, Inc 12/28/2011

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

Healthcare providers who prescribe Transmucosal Immediate Release Fentanyl (TIRF) medicines for outpatient use must

To become certified to prescribe
  • Review the drug’s Prescribing Information for the TIRF product.
  • Successfully complete the Knowledge Assessment that is included in the TIRF REMS Access Education Program, and submit to the REMS program.
  • Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS program.
Before treatment initiation
  • Counsel the patient or their caregiver about the risks, benefits, and appropriate use of TIRF medicines using the Medication Guide.
  • Provide the patient or their caregiver with a Medication Guide for the TIRF medicine to be prescribed.
  • If converting the patient to a different TIRF medicine: counsel the patient or their caregiver about the risks, benefits, and appropriate use of TIRF medicines using the Medication Guide.
  • If converting the patient to a different TIRF medicine: provide the patient or their caregiver with a Medication Guide for the new TIRF medicine.
  • Enroll the patient by completing and submitting the TIRF REMS Access Patient-Prescriber Agreement Form to the REMS Program within ten (10) working days. Provide a completed copy of the form to the patient and retain a completed copy in the patient’s records.
During treatment; before each prescription
  • Provide the patient or their caregiver with a Medication Guide for the TIRF medicine to be prescribed.
  • If converting the patient to a different TIRF medicine: provide the patient or their caregiver with a Medication Guide for the new TIRF medicine.
  • Assess the patient for appropriateness of the dose of the TIRF medicine, and for signs of misuse and abuse.
During treatment; every two years
  • Re-enroll the patient by completing and submitting the TIRF REMS Access Patient-Prescriber Agreement Form to the REMS Program within ten (10) working days. Provide a completed copy of the form to the patient and retain a completed copy in the patient’s records.
To maintain certification to prescribe, every 2 years
  • Review the drug’s Prescribing Information for the TIRF product.
  • Successfully complete the Knowledge Assessment that is included in the TIRF REMS Access Education Program, and submit to the REMS program.
  • Re-enroll in REMS by completing the Prescriber Enrollment Form and submitting it to the REMS program.

Patients who receive Transmucosal Immediate Release Fentanyl (TIRF) medicines

Before the first prescription
  • Enroll in the REMS Program by completing the Patient-Prescriber Agreement Form with the prescriber. Enrollment form will be provided to the REMS program.
  • Receive counseling from the prescriber using the Medication Guide and the TIRF REMS Access Program – An Overview for Patients and Caregivers.
  • Receive counseling from the pharmacist on appropriate use, storage and disposal.
During treatment
  • Adhere to safe use conditions, including, following appropriate use/dosing instructions, contacting the prescriber if TIRF medicine does not relieve pain, and do not change dose and or take more often than directed.
  • Adhere to safe use conditions, including remaining opioid tolerant by continuing around-the clock opioid pain medicine for constant pain. If around-the-clock therapy has stopped, the TIRF medication must be stopped.
  • Adhere to safe use conditions, including not giving the TIRF medicine to anyone else, even if they have the same symptoms, since it may harm them or even cause death.
During treatment; every two years
  • Re-enroll in the REMS Program by completing the Patient-Prescriber Agreement Form with the prescriber. Enrollment form will be provided to the REMS program.
At all times
  • Store the TIRF medicine in a safe place away from children and teenagers.
  • Properly dispose partially used or unneeded TIRF medicine as soon as it’s no longer needed.

Chain and independent outpatient pharmacies that dispense Transmucosal Immediate Release Fentanyl (TIRF) medicines must:

To become certified to dispense
  • Be able to enable the pharmacy management system to support communication with the TIRF REMS Access program system, using established telecommunication standards and run the standardized validation test transaction to validate system enhancements.
  • Train relevant staff involved in dispensing of TIRF medicines on the risks associated with TIRF medicines and the requirements of the REMS Program using the TIRF REMS Access Education Program.
  • Designate an authorized representative to carry out the certification process on behalf of the pharmacy.
  • Have the authorized representative successfully complete the Knowledge Assessment that is included in the TIRF REMS Access Education Program and submit to the REMS Program.
  • Have the authorized representative enroll in the REMS by completing the applicable enrollment forms(s): Independent Outpatient Pharmacy Enrollment Form or the Chain Outpatient Pharmacy Enrollment Form.
Before dispensing
  • Provide the patient or their caregiver the Medication Guide.
  • Obtain authorization to dispense each prescription by processing the prescription through the pharmacy management system.
To maintain certification to dispense; every two years
  • Have the authorized representative successfully complete the Knowledge Assessment that is included in the TIRF REMS Access Education Program and submit to the REMS Program.
  • Have the authorized representative enroll in the REMS by completing the applicable enrollment forms(s): Independent Outpatient Pharmacy Enrollment Form or the Chain Outpatient Pharmacy Enrollment Form.
At all times
  • Maintain records of training.
  • Do not distribute, transfer, loan, or sell product.

Closed system outpatient pharmacies that dispense Transmucosal Immediate Release Fentanyl (TIRF) products must

To become certified to dispense
  • Train all relevant staff involved in dispensing TIRF medicines on the risks associated with TIRF medicines and the requirements of the REMS Program using the TIRF REMS Access Education Program.
  • Designate an authorized representative to carry out the certification process on behalf the pharmacy.
  • Have the authorized representative successfully complete the Knowledge Assessment that is included in the TIRF REMS Access Education Program , and submit it to the REMS Program.
  • Have the authorized representative enroll in the REMS program by completing the Closed System Outpatient Pharmacy Enrollment Form.
Before dispensing
  • Counsel the patient and provide the patient with a copy of the Medication Guide.
  • Provide the patient with the Medication Guide.
  • Obtain authorization to dispense by contacting the TIRF REMS Access program for a prescription authorization number.
To maintain certification to dispense; every two years
  • Have the authorized representative successfully complete the Knowledge Assessment that is included in the TIRF REMS Access Education Program , and submit it to the REMS Program.
  • Have the authorized representative enroll in the REMS program by completing the Closed System Outpatient Pharmacy Enrollment Form.
Ongoing
  • Maintain records of training.
  • Do not distribute, transfer, loan, or sell product.

Inpatient pharmacies that dispense Transmucosal Immediate Release Fentanyl (TIRF) products must

To become certified to dispense
  • Train all relevant staff involved in the dispensing of TIRF products on the risks of TIRF and the requirements of the REMS program using the TIRF REMS Access Education Program.
  • Establish processes and procedures to verify the appropriate patient selection and compliance with the requirements of the TIRF REMS Access program.
  • Designate an authorized representative to complete the certification process on behalf of the pharmacy(s).
  • Have the authorized representative successfully complete the Knowledge Assessment that is included in the TIRF REMS Access Education Program, and submit it to the REMS program.
  • Have the authorized representative enroll in the REMS program by completing the Inpatient Pharmacy Enrollment Form.
To maintain certification to dispense; every two years
  • Have the authorized representative successfully complete the Knowledge Assessment that is included in the TIRF REMS Access Education Program, and submit it to the REMS program.
  • Have the authorized representative enroll in the REMS program by completing the Inpatient Pharmacy Enrollment Form.
At all times
  • Do not distribute, transfer, loan, or sell TIRF medicines.
  • Do not dispense for outpatient use.

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers:


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Material Name
Dear Distributor Letter (PDF)
Dear Healthcare Provider Letter (PDF)
Dear Pharmacy Letter (Inpatient) (PDF)
Dear Pharmacy Letter (Outpatient) (PDF)
Distributor Enrollment Form (PDF)
Education Program (PDF)
Frequently Asked Questions (FAQs) (PDF)
Knowledge Assessment (PDF)
Patient and Caregiver Overview (PDF)
Patient Prescriber Agreement Form (PDF)
Pharmacy Enrollment Form (Chain Outpatient Pharmacy) (PDF)
Pharmacy Enrollment Form (Closed System Outpatient Pharmacy) (PDF)
Pharmacy Enrollment Form (Independent Outpatient Pharmacy) (PDF)
Pharmacy Enrollment Form (Inpatient Pharmacy) (PDF)
Prescriber Enrollment Form (PDF)
Prescriber Program Overview (PDF)
Program Overview (Chain Outpatient Pharmacy) (PDF)
Program Overview (Closed System Outpatient Pharmacy) (PDF)
Program Overview (Independent Outpatient Pharmacy) (PDF)
Program Overview (Inpatient Pharmacy) (PDF)
REMS document (PDF)
REMS full (PDF)
REMS Website Screenshot (PDF)

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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