View the Adasuve Prescribing Information and Medication Guide at DailyMed.
REMS last update: 10/19/2016
View Adasuve's Regulatory Information at Drugs@FDA
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.
Healthcare settings that dispense Adasuve must
|To become certified to dispense||
|After administering; at least every 15 minutes for a minimum of one hour||
|To maintain certification to dispense, if the healthcare setting designates a new authorized representative||
|To maintain certification to dispense, within three years from the date of initial certification, every three years thereafter.||
|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:
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.