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Submitted URL: http://www.vanflytarems.com/
Effective URL: https://www.vanflytarems.com/
Submission: On October 12 via manual from US — Scanned from DE
Effective URL: https://www.vanflytarems.com/
Submission: On October 12 via manual from US — Scanned from DE
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</form>Text Content
* Prescribing Information
* Medication Guide
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VANFLYTA® Risk Evaluation and Mitigation Strategy (REMS)
The purpose of the VANFLYTA REMS is to mitigate the serious risks of QT
prolongation, Torsades de Pointes, and cardiac arrest by educating prescribers
on the optimal risk mitigation strategies including QTc interval monitoring,
electrolyte monitoring and repletion, avoidance of concomitant QTc prolonging
medications, and dose modifications/dose interruptions when indicated.
Prescribers
Prescribers must be certified in the VANFLYTA REMS to treat Patients with
VANFLYTA.
Learn More
Pharmacies
Pharmacies must become certified in the VANFLYTA REMS to dispense VANFLYTA to
Patients.
Learn More
What is the VANFLYTA REMS?
A Risk Evaluation and Mitigation Strategy (REMS) is a program required by the
Food and Drug Administration (FDA) to manage known or potential serious risks
associated with a drug product. The FDA has determined that a REMS is necessary
to ensure that the benefits of VANFLYTA outweigh its risks. 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
modification/dose interruptions when indicated.
Indication
VANFLYTA ® (quizartinib) is a kinase inhibitor indicated in combination with
standard cytarabine and anthracycline induction and cytarabine consolidation,
and as maintenance monotherapy following consolidation chemotherapy, for the
treatment of adult patients with newly diagnosed acute myeloid leukemia (AML)
that is FLT3 internal tandem duplication (ITD)-positive as detected by an
FDA-approved test.
Limitations of Use:
VANFLYTA is not indicated as maintenance monotherapy following allogeneic
hematopoietic stem cell transplantation (HSCT); improvement in overall survival
with VANFLYTA in this setting has not been demonstrated.
Contraindications:
VANFLYTA is contraindicated in patients with severe hypokalemia, severe
hypomagnesemia, long QT syndrome, or in patients with a history of ventricular
arrythmias or Torsades de Pointes.
Reporting Adverse Reactions
To report side effects during the use of VANFLYTA, contact Daiichi Sankyo, Inc.
at 1-877-4DS-PROD (1-877-437-7763) and/or to FDA at www.fda.gov/medwatch or call
1-800-FDA-1088.
ALL Patients treated with VANFLYTA should receive a Patient Wallet Card.
Patients should carry the Wallet Card at all times to remind them of the signs
and symptoms related to QT prolongation and Torsades de Pointes, and when to
seek immediate medical attention. Patients should share this card with all their
healthcare providers to inform them of their VANFLYTA treatment and when to
contact the patient's oncologist.
Resources for Prescribers
* Prescriber Training Program
* Knowledge Assessment
* Prescriber Enrollment Form
* Patient Wallet Card
Resources for Pharmacies
* Pharmacy Enrollment Form
Resources for Patients
* Patient Wallet Card
Have Questions?
Contact the VANFLYTA REMS by calling 1-855-212-6670
* Terms and Conditions
* Privacy Policy
* Contact Us
This site is published by Daiichi Sankyo, Inc., which is solely responsible for
its contents. This site is intended for use by healthcare professionals in the
United States and Puerto Rico. Daiichi Sankyo, Inc. recognizes that the internet
is a global communications medium: however, laws, regulatory requirements, and
medical practices for pharmaceutical products vary from country to country. The
Prescribing Information included here may not be appropriate for use outside the
United States and Puerto Rico.
Third party trademarks used herein are trademarks of their respective owners.