Vanflyta

Generic name: Quizartinib
Dosage form: oral tablet

Usage of 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.

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.

Before taking Vanflyta

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.

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.

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.

Disclaimer

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