Approved Risk Evaluation and Mitigation Strategies (REMS)

Dsuvia (sufentanil)

NDA #209128

REMS last update: 12/19/2023

• View the Dsuvia Prescribing Information at DailyMed
• View Dsuvia's Regulatory Information at Drugs@FDA

• Goals
• Summary
• REMS Materials
• Assessment Plan
• Update history

What is the purpose of the REMS?

The goal of the DSUVIA REMS is to mitigate the risk of respiratory depression resulting from accidental exposure by

1. ensuring that DSUVIA is dispensed only to patients in certified medically supervised healthcare settings.

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

Healthcare settings that dispense DSUVIA must:

To become certified to dispense	Be able to manage acute opioid overdose, including respiratory depression. Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS Program on behalf of the healthcare setting. Have the authorized representative enroll in the REMS Program by completing the Healthcare Setting Enrollment Form and submitting it to the REMS Program. Train all relevant staff that DSUVIA must not be dispensed for use outside of the certified healthcare setting. Train all relevant staff involved in administration of DSUVIA to refer to the Directions for Use prior to administration. Establish processes and procedures to verify that DSUVIA is not dispensed for use outside of the certified healthcare setting.
To maintain certification to dispense	Have a new authorized representative enroll in the REMS Program by completing the Healthcare Setting Enrollment Form if the authorized representative changes.
At all times	Not dispense DSUVIA for use outside the certified healthcare setting. Not distribute, transfer, loan or sell DSUVIA. Maintain records of staff training. Maintain records of all processes and procedures including compliance with those processes and procedures. Comply with audits by Vertical Pharmaceuticals, LLC or a third party acting on behalf of Vertical Pharmaceuticals, LLC to ensure that all processes and procedures are in place and are being followed.

Wholesalers-distributors that distribute DSUVIA must:

To be able to distribute	Establish processes and procedures to ensure that DSUVIA is distributed only to certified healthcare settings. Train all relevant staff involved in distributing DSUVIA on the processes and procedures to verify the healthcare settings are certified.
At all times	Distribute only to certified healthcare settings. Maintain and submit records of all shipments of DSUVIA to Vertical Pharmaceuticals, LLC. Comply with audits carried out by Vertical Pharmaceuticals, LLC or a third party acting on behalf of Vertical Pharmaceuticals, LLC to ensure that all processes and procedures are in place and are being followed.

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.

Material Name	Material Name Link
Healthcare Setting Enrollment Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Dsuvia_2023_12_19_Healthcare_Setting_Enrollment_Form.pdf
REMS Document (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Dsuvia_2023_12_19_REMS_Document.pdf
REMS Full (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Dsuvia_2023_12_19_REMS_Full.pdf
REMS Program Website (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Dsuvia_2023_12_19_REMS_Website.pdf

Assessment Plan

This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters, and posted here as they become available.

What updates have been made to the REMS?

Date	Summary of change
12/19/2023	Changes in the application holder name to reflect transfer of application ownership
04/21/2022	Modified to make changes to the auditing of healthcare settings to annually audit all certified healthcare settings (or a maximum of 400), that have received at least one shipment of Dsuvia in the past 6 months.
11/02/2018	Approval of 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.