Approved Risk Evaluation and Mitigation Strategies (REMS)

Vanflyta (quizartinib)

NDA #216993

REMS last update: 07/20/2023

• View Vanflyta's Regulatory Information at Drugs@FDA

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

What is the purpose of the REMS?

The goals of the VANFLYTA REMS are to mitigate the serious risks of QT prolongation, Torsades de Pointes, and cardiac arrest by ensuring that:

1. Prescribers are able to identify the unique QT prolonging mechanism of VANFLYTA.
2. Prescribers are able to identify the risk factors that are associated with Torsades de Pointes and cardiac arrest with VANFLYTA.
3. Prescribers are able to identify the importance of providing risk mitigation measures including QTc interval monitoring, electrolyte monitoring and repletion, avoidance of concomitant QTc prolonging medications, and dose modifications/dose interruptions when indicated.

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

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
07/20/2023	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.