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The goals of the VANFLYTA REMS are to mitigate the serious risks of QT prolongation, Torsades de
Pointes, and cardiac arrest by ensuring that:
Prescribers are able to identify the unique QT prolonging mechanism of VANFLYTA.
Prescribers are able to identify the risk factors that are associated with Torsades de Pointes and cardiac arrest with VANFLYTA.
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.
Review the following: Prescriber Training Program.
Successfully complete the Knowledge Assessment and submit it to the REMS.
Enroll in the REMS by completing and submitting the Prescriber Enrollment
Form to the REMS.
Before treatment
initiation (first dose)
Counsel the patient on how to recognize and respond to signs and symptoms
related to QT prolongation, Torsades de Pointes, and cardiac arrest, the need
to report any symptoms suggestive of QT prolongation, Torsades de Pointes,
and cardiac arrest to their Prescriber or emergency room provider
immediately, and the need to carry the Patient Wallet Card at all times.
At discharge
Complete the Patient Wallet Card and provide the Patient Wallet Card to the
patient.
At all times
Report serious adverse events suggestive of QT prolongation, Torsades de
Pointes, and cardiac arrest to Daiichi Sankyo, Inc.
Patients who are prescribed VANFLYTA:
Before treatment
initiation
Receive counseling from the prescriber on how to recognize and respond to
signs and symptoms related to QT prolongation, Torsades de Pointes, and
cardiac arrest, the need to report any symptoms suggestive of QT
prolongation, Torsades de Pointes, and cardiac arrest to your doctor or
emergency room provider immediately, and the need to carry the Patient
Wallet Card at all times.
At discharge
Receive the Patient Wallet Card.
At all times
Have the Patient Wallet Card with you and inform other healthcare providers
about treatment with VANFLYTA
Pharmacies that dispense VANFLYTA must:
To become certified
to dispense
Designate an Authorized Representative to carry out the certification process
and oversee implementation and compliance with the REMS requirements on
behalf of the pharmacy.
Have the Authorized Representative review the Pharmacy Guide.
Have the Authorized Representative enroll in the REMS by completing the
Pharmacy Enrollment Form and submitting it to the REMS.
Train all relevant staff involved in dispensing VANFLYTA on the REMS
requirements using the Pharmacy Guide.
Establish processes and procedures to verify the prescriber is certified.
Before dispensing
Verify the prescriber is certified through the processes and procedures
established as a requirement of the REMS.
To maintain
certification to
dispense
If there is a change in the Authorized Representative, have the new
Authorized Representative review the Pharmacy Guide and enroll in the
REMS by completing the Pharmacy Enrollment Form.
At all times
Report serious adverse events suggestive of QT prolongation, Torsades de
Pointes, and cardiac arrest to Daiichi Sankyo, Inc.
Do not distribute, transfer, loan, or sell VANFLYTA except to certified
pharmacies.
Maintain records of staff’s completion of training.
Maintain records that processes and procedures are in place and are being
followed.
Maintain records of all VANFLYTA dispenses and transfers and provide data
to the REMS.
Comply with audits carried out by Daiichi Sankyo, Inc. or a third party acting
on behalf of Daiichi Sankyo, Inc. to ensure that all training, processes, and
procedures are in place and are being followed.
Wholesalers-Distributors and Other Entities that distribute VANFLYTA must:
To be able to
distribute
Establish processes and procedures to ensure that VANFLYTA is distributed
only to certified pharmacies and other entities authorized to distribute
VANFLYTA.
Train all relevant staff involved in distribution on the REMS requirements.
At all times
Distribute only to certified pharmacies and other entities authorized to
distribute VANFLYTA.
Maintain records that all processes and procedures are in place and are
being followed.
For wholesalers-distributors: Maintain records of drug distribution and
provide these records daily to Daiichi Sankyo for submission to the REMS.
For other entities that distribute VANFLYTA: Maintain records of drug
distribution and provide data to Daiichi Sankyo.
Comply with audits carried out by Daiichi Sankyo, Inc. or a third party acting
on behalf of Daiichi Sankyo, Inc. 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. For a specific Medication Guide of a product in the Vanflyta REMS, see the DailyMed link(s).
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
04/29/2026
Modified to add a Pharmacy Guide, update to the Pharmacy Enrollment form to identify additional pharmacy types,
update the Prescriber Training Program to provide clarity for reporting
responsibilities, and update the Prescriber Enrollment form to provide clarity for
reporting responsibilities.
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.
