Vanflyta (quizartinib) is an oral Kinase inhibitor that may be used to treat adults with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive, in combination with standard treatments (cytarabine and anthracycline induction and cytarabine consolidation and maintenance). Your healthcare provider will perform a test to make sure that Vanflyta is right for you.

Acute myeloid leukemia (AML) is a cancer that affects the blood and bone marrow. Several gene mutations have been identified in AML, with FLT3 mutations being the most common. Approximately 80% of FLT3 mutations in AML are FLT3-ITD (internal tandem duplications) and these patients typically have a poor prognosis with an increased risk of relapse and a shorter overall survival.

Vanflyta is a highly potent FLT3 inhibitor that selectively blocks the receptor tyrosine kinase FLT3, preventing downstream FLT3 receptor signaling and blocking FLT3-ITD-dependent cell proliferation, slowing the progression of AML and improving overall survival. Vanflyta was specifically developed for patients with FLT3-ITD-positive AML.

Vanflyta was FDA-approved on 20 July 2023.

Vanflyta carries a Boxed Warning for QT interval prolongation, torsades de pointes, and cardiac arrest. Patients should have electrocardiograms and levels of serum electrolytes monitored, and treatment reduced, interrupted, or permanently discontinued as appropriate. It is only available only through a restricted program called the Vanflyta Risk Evaluation and Mitigation Strategy (REMS).

Vanflyta may cause embryo-fetal toxicity. Females who can become pregnant should use effective birth control during treatment with Vanflyta and for 7 months after the last dose. Males with female partners who can become pregnant should use effective birth control during treatment and for 4 months after the last dose.

Should not be used in patients with severe hypokalemia, severe hypomagnesemia, long QT syndrome (QTcF >450ms), or in patients with a history of ventricular arrhythmias or torsades de pointes.

Reduce the dosage when using with strong CYP3A4 inhibitors. Avoid with strong or moderate CYP3A inducers.

You should not use if you are allergic to quizartinib or any of the inactive ingredients in the tablet.

To make sure Vanflyta is safe for you, tell your doctor if you have ever had:

• heart problems.
• low blood levels of potassium or magnesium.
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

It is not known if Vanflyta is safe and effective in children.

Do not take VANFLYTA if you have very low potassium, very low magnesium, long QT syndrome, or a history of ventricular arrhythmias or torsades de pointes.

Pregnancy

Vanflyta can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment.

If you can become pregnant, your healthcare provider will perform a pregnancy test 7 days before you start treatment with Vanflyta. Females who can become pregnant should use effective birth control (contraception) during treatment and for 7 months after the last dose.

Males with female partners who can become pregnant should use effective birth control during treatment and for 4 months after the last dose.

Talk to your healthcare provider about birth control methods you can use during this time.

Vanflyta may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.

Breastfeeding

It is not known if Vanflyta passes into breast milk. Do not breastfeed during treatment and for 1 month after the last dose.

How do I take Vanflyta?

Take Vanflyta orally (by mouth) once a day at approximately the same time each day.

You may take it with or without food. Swallow the tablets whole. Do not cut, crush, or chew.

Take it exactly as your healthcare provider tells you to. Do not change your dose or stop taking Vanflyta unless your healthcare provider tells you to.

Take your dose as soon as possible on the same day. Take your next dose at your usual time on the next day. Do not take 2 doses on the same day to make up for a missed dose.

If you vomit after taking a dose of Vanflyta, do not take another dose. Take your next dose at your usual time the next day.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.