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Approved Risk Evaluation and Mitigation Strategies (REMS)

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:

  1. Ensuring dispensing to patients in certified hospitals only; and
  2. 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 See Disclaimer page regarding links to external sites

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

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:

  1. Make editorial changes to the REMS document and the following REMS appended materials:Ionsys REMS Knowledge Assessment, Ionsys REMS Safety Brochure: Guide for Nurses and Pharmacists, and Ionsys REMS Hospital Enrollment Form.
  2. Add functionality to the Ionsys REMS website that allows for Authorized Representatives, nurses, and pharmacists to log in and access educational materials and the Ionsys REMS Knowledge Assessment as well as the ability to link user accounts with the corresponding Authorized Representative.
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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