Vanflyta

Pronunciation: van-FLITT-ah
Generic name: quizartinib
Dosage form: oral tablet
Drug class: Multikinase inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Jul 21, 2023.

What is Vanflyta?

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.

Warnings

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.

Before taking this medicine

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.

What happens if I miss a dose?

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.

What happens if I overdose?

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

Vanflyta side effects

Vanflyta may cause serious side effects, including:

changes in the electrical activity of your heart called QT prolongation, torsades de pointes, and irregular heartbeats that can be life-threatening or lead to death.

Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) and will also do blood tests to check your potassium and magnesium levels before and during treatment with Vanflyta. Tell your healthcare provider right away if you have an irregular heartbeat or feel dizzy, lightheaded, faint, or have diarrhea or vomiting.

The most common side effects of Vanflyta include:

low white blood cell counts
changes in levels of electrolytes in the blood
changes in liver function tests
low white blood cell counts with fever
diarrhea
mouth sores
nausea
stomach (abdominal) pain
serious infection throughout the body and organs (sepsis)
headache
vomiting
upper respiratory tract infections
low platelet counts
decreased appetite
fungal infections
nosebleeds
herpesvirus infections
trouble sleeping
abnormal electrocardiogram (QT prolongation)
upset stomach
low red blood cell counts (anemia)
eye irritation.

These are not all the possible side effects of Vanflyta. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Only available through a restricted program called the Vanflyta Risk Evaluation and Mitigation Strategy (REMS) due to the risk of QT prolongation, torsades de pointes, and cardiac arrest. You will receive a Patient Wallet Card from your healthcare provider. Carry it with you at all times and show it to all of your healthcare providers. Get medical help right away if you develop any of the signs and symptoms of QT prolongation and torsades de pointes listed on the card. You may need to be treated in a hospital.

What other drugs will affect Vanflyta?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your doctor about all your other medicines, especially:

QT interval prolonging drugs, such as haloperidol, amiodarone, amitriptyline, ondansetron, citalopram, methadone, sumatriptan, fluoroquinolones
Strong CYP3A Inhibitors, such as clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, or tipranavir
Strong or Moderate CYP3A Inducers such as apalutamide, carbamazepine, enzalutamide, fosphenytoin, lumacaftor, phenobarbital, phenytoin, rifampin (rifampicin), dexamethasone, efavirenz
St John’s Wort

This list is not complete. Other drugs may interact with Vanflyta, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Storage

Store at room temperature between 68°F and 77°F (20°C and 25°C).

Keep out of the reach of children.

Ingredients

Active ingredient: quizartinib

Inactive ingredients:

Tablet core: hydroxypropyl betadex, microcrystalline cellulose, and magnesium stearate.
Tablet coating: hypromellose, talc, triacetin, and titanium dioxide. The 26.5 mg tablet coating also contains ferric oxide.

Tablets are available in 17.7mg and 26.5mg strengths.