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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.
Successfully complete the Knowledge Assessment and submit it to the REMS.
| Knowledge Assessment |
Enroll in the REMS by completing and submitting the Prescriber Enrollment
Form to the REMS.
| Prescriber Enrollment Form |
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.
| Patient Wallet Card |
At discharge
Complete the Patient Wallet Card and provide the Patient Wallet Card to the
patient.
| Patient Wallet Card |
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.
| Patient Wallet Card |
Have the Patient Wallet Card with you and inform other healthcare providers
about treatment with VANFLYTA
| Patient Wallet Card |
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 enroll in the REMS by completing the
Pharmacy Enrollment Form and submitting it to the REMS.
| Pharmacy Enrollment Form |
Train all relevant staff involved in dispensing on the REMS requirements.
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 enroll in the REMS by completing the Pharmacy
Enrollment Form.
| 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 that processes and procedures are in place and are being
followed.
Maintain records of all VANFLYTA dispenses 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.
Wholesaler-Distributors that distribute VANFLYTA must:
To be able to
distribute
Establish processes and procedures to ensure that VANFLYTA is distributed
only to certified pharmacies.
Train all relevant staff involved in distribution on the REMS requirements.
At all times
Distribute only to certified pharmacies.
Maintain records that all processes and procedures are in place and are
being followed.
Maintain records of drug distribution and provide these records on a daily
basis to Daiichi Sankyo for submission 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 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).
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.
