VANFLYTA Access Central is now VANFLYTA4U. Our commitment to helping patients receive their prescribed VANFLYTA treatment remains the same. Learn More

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Please see Full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

This information is intended for US healthcare professionals and/or healthcare professionals involved in healthcare reimbursement only.

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Call the preferred specialty pharmacy with questions about VANFLYTA prescriptions and patient support.

Biologics (1-800-850-4306) or Onco360 (1-877-662-6633)
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Important Safety Information SEE MORE

WARNING: QT PROLONGATION, TORSADES DE POINTES, and CARDIAC ARREST

  • VANFLYTA prolongs the QT interval in a dose- and concentration-related manner. Prior to VANFLYTA administration and periodically, monitor for hypokalemia or hypomagnesemia, and correct deficiencies. Perform electrocardiograms (ECGs) to monitor the QTc at baseline, weekly during induction and consolidation therapy, weekly for at least the first month of maintenance, and periodically thereafter.
  • Torsades de pointes and cardiac arrest have occurred in patients receiving VANFLYTA. Do not administer VANFLYTA to patients with severe hypokalemia, severe hypomagnesemia, or long QT syndrome.
  • Do not initiate treatment with VANFLYTA or escalate the VANFLYTA dose if the QT interval corrected by Fridericia’s formula (QTcF) is greater than 450 ms.
  • Monitor ECGs more frequently if concomitant use of drugs known to prolong the QT interval is required.
  • Reduce the VANFLYTA dose when used concomitantly with strong CYP3A inhibitors, as they may increase quizartinib exposure.
  • Because of the risk of QT prolongation, VANFLYTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the VANFLYTA REMS.

Contraindications

  • VANFLYTA is contraindicated in patients with severe hypokalemia, severe hypomagnesemia, long QT syndrome, or in patients with a history of ventricular arrhythmias or torsades de pointes.

Warnings and Precautions

QT Prolongation, Torsades de Pointes, and Cardiac Arrest (See BOXED WARNING)

  • VANFLYTA prolongs the QT interval in a dose- and concentration-dependent manner. The mechanism of QTc interval prolongation is via inhibition of the slow delayed rectifier potassium current, IKs, as compared to all other medications that prolong the QTc interval, which is via the rapid delayed rectifier potassium current, IKr.
  • The level of QTc prolongation with VANFLYTA that predicts the risk of cardiac arrhythmias is unclear. Inhibition of IKs and IKr may leave patients with limited reserve, leading to a higher risk of QT prolongation and serious cardiac arrhythmias, including fatal outcomes. Torsades de pointes, ventricular fibrillation, cardiac arrest, and sudden death have occurred in patients treated with VANFLYTA.
  • Among 1,081 VANFLYTA-treated AML patients in clinical trials, severe cardiac arrhythmias occurred primarily during induction and included torsades de pointes (0.2%), cardiac arrest (0.6%, including 0.4% fatal), and ventricular fibrillation (0.1%).
  • Of the 265 patients who received VANFLYTA in the clinical trial, 2.3% had a QTcF >500 ms and 10% had an increase of >60 ms from baseline. The trial excluded patients with a QTcF ≥450 ms or other factors that increased the risk of QT prolongation or arrhythmic events (eg, NYHA Class III/IV congestive heart failure, hypokalemia, or a family history of long QT interval syndrome).
  • Avoid use in patients who are at significant risk of developing torsades de pointes, including uncontrolled or significant cardiac disease, recent myocardial infarction, heart failure, unstable angina, bradyarrhythmias, tachyarrhythmias, uncontrolled hypertension, high-degree atrioventricular block, severe aortic stenosis, or uncontrolled hypothyroidism.
  • During induction and consolidation, perform an ECG prior to initiation and then once weekly during VANFLYTA treatment or more frequently as clinically indicated. During maintenance, perform ECGs prior to initiation, once weekly for at least the first month following dose initiation and escalation, and as clinically indicated thereafter.
  • Perform ECG monitoring of the QT interval more frequently in patients who are at significant risk of developing QT interval prolongation and torsades de pointes, or following dose escalation.
  • Monitor and correct hypokalemia and hypomagnesemia prior to and during treatment. Maintain electrolytes in the normal range. Monitor electrolytes and ECGs more frequently in patients who experience diarrhea or vomiting.
  • Reduce the VANFLYTA dose if QTc increases to greater than 480 ms and less than 500 ms. Interrupt and reduce the VANFLYTA dose if QTc increases to greater than 500 ms. Permanently discontinue VANFLYTA in patients who develop recurrent QTc greater than 500 ms or QTc interval prolongation with signs or symptoms of life-threatening arrhythmia.

VANFLYTA REMS

  • Requirements include:
    • Prescribers must be certified in the VANFLYTA REMS by enrolling and completing training.
    • Prescribers must counsel patients receiving VANFLYTA about the risk of QT prolongation, torsades de pointes, and cardiac arrest, and provide patients with a Patient Wallet Card.
    • Pharmacies that dispense VANFLYTA must be certified with the VANFLYTA REMS and must verify prescribers are certified through the VANFLYTA REMS.
    • Further information is available at www.VANFLYTAREMS.com or by telephone at 1-855-212-6670.

Embryo-Fetal Toxicity

  • Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with VANFLYTA and for 7 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with VANFLYTA and for 4 months after the last dose.

Adverse Reactions

  • The most common (>20%) adverse reactions, including laboratory abnormalities, were lymphocytes decreased (60%), potassium decreased (59%), albumin decreased (53%), phosphorus decreased (52%), alkaline phosphatase increased (51%), magnesium decreased (44%), febrile neutropenia (44%), diarrhea (42%), mucositis (38%), nausea (34%), calcium decreased (33%), abdominal pain (30%), sepsis (30%), neutropenia (29%), headache (28%), creatine phosphokinase increased (26%), vomiting (25%), and upper respiratory tract infection (21%).

Drug Interactions

  • Strong CYP3A Inhibitors: Reduce the VANFLYTA dose due to increased quizartinib concentrations.
  • Strong or Moderate CYP3A Inducers: Avoid concomitant use due to decreased quizartinib concentrations.

Use in Specific Populations

  • Advise women not to breastfeed during treatment with VANFLYTA and for one month after the last dose.

Indication

VANFLYTA® (quizartinib) is 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.

To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc., at 1-877-437-7763 or the FDA at 1-800-FDA-1088 or fda.gov/medwatch.

Please see full Full Prescribing Information, including Boxed WARNINGS, and Medication Guide.