Approved Risk Evaluation and Mitigation Strategies (REMS)
Transmucosal Immediate-Release Fentanyl (TIRF) Products
Shared System REMS
REMS last update: 12/23/2020
What medicines are included in the REMS?
Product Name | Application Number | Application Holder | Added to REMS | DailyMed Link | FDA Link |
---|---|---|---|---|---|
Abstral (fentanyl citrate) ( PI and MG at DailyMed , Info at Drugs@FDA ) | NDA 022510 | SENTYNL THERAPS INC | 12/28/2011 | e60f00e9-2cf4-4c20-b570-1c2ea426c8c7 | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=022510 |
Actiq (fentanyl citrate) ( PI and MG at DailyMed , Info at Drugs@FDA ) | NDA 020747 | CEPHALON | 12/28/2011 | 90b94524-f913-48b3-3771-7b2fcffd888a | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=020747 |
Fentora (fentanyl citrate) ( PI and MG at DailyMed , Info at Drugs@FDA ) | NDA 021947 | CEPHALON | 12/28/2011 | 8f549d95-985b-f783-1ebb-ef57bd2ecb05 | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=021947 |
Lazanda (fentanyl citrate) ( PI and MG at DailyMed , Info at Drugs@FDA ) | NDA 022569 | BTCP PHARMA | 12/28/2011 | 39531d0c-db12-4627-81c9-6563076b637b | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=022569 |
Onsolis (fentanyl citrate) ( Info at Drugs@FDA ) | NDA 022266 | BDSI | 12/28/2011 | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=022266 | |
Subsys (fentanyl) ( PI and MG at DailyMed , Info at Drugs@FDA ) | NDA 202788 | BTCP PHARMA | 01/04/2012 | 18a413e9-11e0-4a8f-86c0-d33b37b7b771 | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=202788 |
fentanyl buccal ( PI and MG at DailyMed , Info at Drugs@FDA ) | ANDA 079075 | WATSON LABS | 01/08/2016 | ad7ac196-4c6e-4aab-8742-bdb9f38f4be6 | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=079075 |
fentanyl citrate (Info at Drugs@FDA) | ANDA 207338 | ACTAVIS LABS FL INC | 11/17/2017 | ||
fentanyl citrate ( PI and MG at DailyMed , Info at Drugs@FDA ) | ANDA 078907 | SPECGX LLC | 01/04/2012 | 552ba162-76ed-4bc9-8c2c-fac7a1804da0 | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=078907 |
What is the purpose of the REMS?
The goals of the TIRF REMS are to:- Mitigate the risk of overdose by:
- Requiring documentation of opioid tolerance with every TIRF prescription for outpatient use.
- Requiring inpatient pharmacies to develop policies and procedures to verify opioid tolerance in inpatients who require TIRF medicines while hospitalized.
- Educating prescribers, pharmacists and patients that the safe use of TIRF medicines requires patients to be opioid-tolerant throughout treatment.
- Mitigate the risk of accidental exposure by educating prescribers, pharmacists and patients about proper storage and disposal of TIRF medicines.
- Monitor for accidental exposure, misuse, abuse, addiction, and overdose by enrolling all patients who receive a TIRF medicine for outpatient use into a registry and using surveillance systems and other data sources.
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
Wholesalers-Distributors that distribute TIRF medicines must:
To be able to distribute |
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At all times |
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Healthcare Providers who prescribe TIRF medicines for outpatient use must:
To become certified to prescribe |
|
Before treatment initiation |
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During treatment, before each prescription |
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During treatment, every 2 years |
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Before treatment re-initiation, lapse in treatment of 6 months or longer |
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To maintain certification to prescribe, every 2 years |
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At all times |
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Patients who are prescribed TIRF medicines for outpatient use:
Before treatment initiation |
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Before treatment re-initiation, lapse in treatment of 6 months or longer |
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During treatment, every 2 years |
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At all times |
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Pharmacies that dispense TIRF medicines for outpatient use must:
To become certified to dispense |
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Before dispensing |
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To maintain certification to dispense |
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At all times |
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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. For a specific Medication Guide of a product in the Transmucosal Immediate-Release Fentanyl (TIRF) Products REMS, see the DailyMed link on the Products tab.
Material Name | Material Name Link |
---|---|
Adverse Events of Special Interest Reporting Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Adverse_Events_of_Special_Interest_Reporting_Form.pdf |
Healthcare Provider Letter (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Healthcare_Provider_Letter.pdf |
Inpatient Pharmacy Enrollment Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Inpatient_Pharmacy_Enrollment_Form.pdf |
Inpatient Pharmacy Letter (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Inpatient_Pharmacy_Letter.pdf |
Outpatient Pharmacy Enrollment Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Outpatient_Pharmacy_Enrollment_Form.pdf |
Outpatient Pharmacy Letter (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Outpatient_Pharmacy_Letter.pdf |
Patient Counseling Guide (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Patient_Counseling_Guide.pdf |
Patient Discontinuation Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Patient_Discontinuation_Form.pdf |
Patient Enrollment Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Patient_Enrollment_Form.pdf |
Patient Status and Opioid Tolerance Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Patient_Status_and_Opioid_Tolerance_form.pdf |
Pharmacy Education (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Pharmacy_Education.pdf |
Pharmacy Knowledge Assessment (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Pharmacy_Knowledge_Assessment.pdf |
Prescriber Education (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Prescriber_Education.pdf |
Prescriber Enrollment Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Prescriber_Enrollment_Form.pdf |
Prescriber Knowledge Assessment (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Prescriber_Knowledge_Assessment.pdf |
REMS Document (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_REMS_Document.pdf |
REMS Full (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_REMS_Full.pdf |
REMS Program Website Screenshots (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_REMS_Program_Website_Screenshots.pdf |
Urgent Notification Regarding TIRF Products Stock Letter (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2020_12_23_Urgent_Notification_Regarding_TIRF_Products_Stock_Letter.pdf |
What updates have been made to the REMS?
Date | Summary of change |
---|---|
12/23/2020 | Modified to reflect the following changes to the REMS Program:
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09/07/2017 | Modified to make changes to the REMS document, and appended materials consistent with the safety label changes approved on December 16, 2016, as well as additional minor modifications. |
04/11/2017 | Modified to add the authorized generic and a Medication Guide that is identical to that of the branded product, except that only the authorized generic (fentanyl buccal tablets) is listed as the product name. |
12/21/2015 | Modified to include the new strength of 300mcg per spray in the Medication Guide. |
12/24/2014 | Modified to:
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11/04/2014 | Modified to add the Abstral product to the shared system REMS. |
11/07/2013 | Modified to:
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06/05/2012 | Modified to:
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12/28/2011 | Approval of the REMS. |
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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