Approved Risk Evaluation and Mitigation Strategies (REMS)

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Transmucosal Immediate-Release Fentanyl (TIRF) Products
Shared System REMS
REMS last update: 12/21/2015

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 Therapeutics, 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 product-specific 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) products for outpatient use

To be able to prescribe TIRF products
  • Review the prescribing information for a TIRF product.
  • Complete the TIRF REMS Access Education Program, including the knowledge assessment and submit the successfully completed knowledge assessment to the sponsor.
  • Enroll in the REMS by completing and submitting the Prescriber Enrollment Form.
Before writing the first prescription for a patient
  • Counsel the patient about the risks, benefits, and appropriate use of TIRF medicines using the Medication Guide.
  • Provide the patient with a copy of the Medication Guide.
  • Enroll the patient by completing and submitting the TIRF REMS Access Patient-Prescriber Agreement Form. Provide a completed copy of the form to the patient and retain a completed copy in the patient’s record.
Before writing each prescription after the first prescription
  • If a new TIRF product is prescriber for a patient: counsel the patient using the Medication Guide.
  • If a new TIRF product is prescriber for a patient: provide the patient with a copy of the Medication Guide for a TIRF product.
While patient is being treated with TIRF products
  • At all follow-up visits: assess the patient for appropriateness of the dose of TIRF medicine and for signs of misuse and abuse.
Ongoing
  • Re-enroll in the TIRF REMS program every two years by completing and submitting the Prescriber Enrollment Form.
  • Re-enroll the patient in the TIRF REMS program every two years by completing and submitting the Patient-Prescriber Agreement Form.

Patients who receive Transmucosal Immediate Release Fentanyl (TIRF) products

To be able to receive a TIRF product
  • Enroll in the REMS by completing the Patient-Prescriber Agreement Form with the prescriber.
Before receiving the initial TIRF product
  • Receive counseling from the prescriber using the Medication Guide.
  • Receive counseling on the proper disposal of the partially used or unneeded TIRF medicine remaining from the prescription, and to dispose of the TIRF medicine as soon as it’s no longer needed.
While taking the TIRF product
  • Do not give medicine to anyone else, even if they have the same symptoms, since it may harm them or even cause death.
Ongoing
  • Inform the prescriber if the TIRF medicine does not relieve my pain.
  • Store the TIRF medicine in a safe place away from children and teenagers because accidental use by a child, or anyone for whom it was not prescribed, is a medical emergency that can cause death.

Chain and Independent Outpatient pharmacies that dispense Transmucosal Immediate Release Fentanyl (TIRF) products

To be able to dispense TIRF products
  • Designate an authorized representative to carry out the certification process on behalf of the pharmacy.
  • Have the authorized representative complete the TIRF REMS Access Education Program, including the knowledge assessment and submit the successfully completed knowledge assessment to the sponsor.
  • 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.
  • Enroll in the REMS by completing and submitting the appropriate enrollment form: Independent Outpatient Pharmacy Enrollment Form or the Chain Outpatient Pharmacy Enrollment Form.
Before dispensing a TIRF product
  • Obtain authorization to dispense by obtaining a unique authorization code through their pharmacy management system.
  • Provide the patient with a copy of the Medication Guide.
Ongoing
  • Re-enroll in the TIRF REMS program every two years.
  • Do not distribute, transfer, loan, or sell product.
  • Maintain records of relevant staff training.

Closed System Outpatient pharmacies that dispense Transmucosal Immediate Release Fentanyl (TIRF) products

To be able to dispense TIRF products
  • Designate an authorized representative to carry out the certification process on behalf of the pharmacy.
  • Have the authorized representative complete the TIRF REMS Access Education Program, including the knowledge assessment and submit the successfully completed knowledge assessment to the sponsor.
  • 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.
  • Enroll in the REMS by completing and submitting the Closed System Outpatient Pharmacy Enrollment Form.
Before dispensing TIRF a product
  • Obtain authorization to dispense by contacting the TIRF REMS Access program by phone or fax.
  • Provide the patient with a copy of the Medication Guide.
Ongoing
  • Re-enroll in the TIRF REMS program every two years.
  • Do not distribute, transfer, loan, or sell product.
  • Maintain records of relevant staff training.

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

To be able to dispense TIRF products
  • Designate an authorized representative to carry out the certification process on behalf of the pharmacy.
  • Have the authorized representative complete the TIRF REMS Access Education Program, including the knowledge assessment and submit the successfully completed knowledge assessment.
  • 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 that ensure appropriate patient selection and compliance with the requirements of the TIRF REMS Access program.
  • Enroll in the REMS by completing and submitting the Inpatient Pharmacy Enrollment Form.
Ongoing
  • Re-enroll in the TIRF REMS program every two years.
  • Do not distribute, transfer, loan, or sell product.
  • Do not dispense a TIRF product 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 Letters (Inpatient) (PDF)
Dear Pharmacy Letters (Outpatient) (PDF)
Distributor Enrollment Form (PDF)
Frequently Asked Questions (FAQs) (PDF)
Knowledge Assessment (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)
REMS document (PDF)
REMS full (PDF)
The TIRF REMS Access Program Overview (Chain Outpatient Pharmacy) (PDF)
The TIRF REMS Access Program Overview (Closed System Outpatient Pharmacy) (PDF)
The TIRF REMS Access Program Overview (Independent Outpatient Pharmacy) (PDF)
The TIRF REMS Access Program Overview (Inpatient Pharmacy) (PDF)
TIRF REMS Access Education Program (PDF)
TIRF REMS Access Patient and Caregiver Overview (PDF)
TIRF REMS Access Prescriber Program Overview (PDF)
TIRF REMS Access Website (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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