Approved Risk Evaluation and Mitigation Strategies (REMS)
REMS@FDA
Contact Us | REMS Resources |
Ionsys (fentanyl iontophoretic transdermal system)
NDA #021338
REMS last update: 10/03/2018
What is the purpose of the REMS?
The goal of the IONSYS REMS is to mitigate the risk of respiratory depression resulting from accidental exposure to persons for whom it is not prescribed by:
- Ensuring dispensing to patients in certified hospitals only; and
- Informing healthcare providers of the serious risk of respiratory depression resulting from accidental exposure.
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
Hospitals that dispense Ionsys must
To become certified to dispense |
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After certification, within 3 weeks |
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To maintain certification to dispense, within 4 weeks of designating a new authorized representative |
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To maintain certification to dispense, every 3 years from initial enrollment |
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At all times |
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Wholesalers that distribute Ionsys must
To be able to distribute |
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At all times |
|
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 Ionsys REMS, see the DailyMed link(s).Material Name | Material Name Link |
---|---|
Dear Healthcare Provider Letters (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2018_10_03_Dear_Healthcare_Provider_Letters.pdf |
Dear Hospital Pharmacy Letter (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2018_10-03_Dear_Hospital_Pharmacy_Letter.pdf |
Guide for Nurses and Pharmacists (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2018_10_03_Guide_for_Nurses_and_Pharmacists.pdf |
Hospital Enrollment Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2018_10_03_Hospital_Enrollment_Form.pdf |
Knowledge Assessment (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2018_10_03_Knowledge_Assessment.pdf |
REMS Document (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2018_10-03_REMS_Document.pdf |
REMS Full (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2018_10_03_REMS_Full.pdf |
REMS Website Screenshots (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Ionsys_2018_10_03_REMS_Website_Screenshots.pdf |
What updates have been made to the REMS?
Date | Summary of change |
---|---|
10/03/2018 | Modified to change the timing of the audits of the certified hospitals. |
03/29/2017 | Modified to align to labeling approved on December 16, 2016 and make additional minor modifications in the REMS document and materials. |
11/12/2015 | Modified to:
|
04/30/2015 | 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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