Vanflyta
Vanflyta (quizartinib) is a targeted medication used to treat people with acute myeloid leukemia (AML) with a specific mutation in a protein called Fms-like tyrosine kinase 3 (FLT3). It’s taken by mouth daily, but your dose and how long you take it depends on where your are in the treatment process. Some common side effects of Vanflyta (quizartinib) include diarrhea, nausea, and mouth sores.
What is Vanflyta (quizartinib)?
What is Vanflyta (quizartinib) used for?
Acute myeloid leukemia (AML) with a FTL3 mutation
How Vanflyta (quizartinib) works
People with AML have gene changes (mutations) in their blood cells that turn the cells cancerous. One such mutation is in the FLT3 gene. Cells with this mutation end up making mutated FLT3 kinase proteins. These proteins send signals to cells to tell them to grow uncontrollably, which causes the cancer to spread.
Vanflyta (quizartinib) is a type of targeted therapy called a FLT3 kinase inhibitor. It works by blocking the FLT3 kinase from sending these signals. When these signals are blocked, the cancer can’t grow and spread as well.
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What are the side effects of Vanflyta (quizartinib)?
Common Side Effects
- Lower white blood cell counts (up to 60%)
- Changes in electrolyte levels in blood (up to 59%)
- Higher liver enzyme levels in blood (up to 51%)
- Neutropenic fever (44%)
- Diarrhea (42%)
- Mouth sores (38%)
- Nausea (34%)
- Stomach pain (30%)
- Infection (up to 30%)
- Headache (28%)
- Higher creatinine phosphokinase in blood (26%)
- Vomiting (25%)
Other Side Effects
- Lower appetite
- Nosebleeds
- Trouble sleeping
- Eye irritation, itching, pain
Serious Side Effects
- Changes in heart rhythm: lightheadedness, blurry vision, fainting, seizures, loss of consciousness
- Infection: fever over 100.4 Fahrenheit, chills, weakness, muscle aches, cough
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
- Infection—fever, chills, cough, or sore throat
- Low magnesium level—muscle pain or cramps, unusual weakness or fatigue, fast or irregular heartbeat, tremors
- Low potassium level—muscle pain or cramps, unusual weakness or fatigue, fast or irregular heartbeat, constipation
- Unusual bruising or bleeding
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Diarrhea
- Eye irritation or itching
- Headache
- Nausea
- Pain, redness, or swelling with sores inside the mouth or throat
- Trouble sleeping
- Vomiting
Pros and cons of Vanflyta (quizartinib)
Pros
Targeted treatment option for people with a specific FLT3 mutation
Taken by mouth, so good for people who don’t like needles
Can be taken with or without food
Cons
Interacts with several other medications
Can cause serious heart rhythm changes
Not safe during pregnancy or breastfeeding
Pharmacist tips for Vanflyta (quizartinib)
Some people with AML might have a stem cell transplant after they start treatment. If you’re going to receive a stem cell transplant, you should stop taking Vanflyta (quizartinib) 7 days before the pre-transplant treatment (also called the conditioning regimen) begins.
You can take Vanflyta (quizartinib) with or without food. You should take it at the same time every day, and take the tablets whole. Do not crush or chew them.
You might experience some diarrhea while taking Vanflyta (quizartinib). Ask your provider if you can taken an over-the-counter medication, like loperamide (Imodium A-D), to help manage diarrhea.
If you have diarrhea after starting Vanflyta (quizartinib), it’s important to drink a lot of fluids, but try to avoid sugary sports drinks because they can make diarrhea worse.
Contact your provider right away if you have signs of dehydration, such as dry skin and urinating less often, from diarrhea. Dehydration can lead to lower electrolyte levels in the blood. Lower electrolytes can raise your risk of heart problems with Vanflyta (quizartinib).
Vanflyta (quizartinib) might cause nausea. Your provider will recommend antiemetic medications you can take to prevent and treat nausea. But, they might recommend you avoid certain ones, such as ondansetron (Zofran), because they might cause worsen heart rhythm problems. Since Vanflyta (quizartinib) can cause this side effect too, the risk is higher if you take two medications that cause it. Talk to your provider about which antiemetic medications are safe for you to take.
Tell your provider before you start any new medications while you’re taking Vanflyta (quizartinib). There are some medications that you should avoid taking with Vanflyta (quizartinib) because they might affect the level of Vanflyta (quizartinib) in your body, which can affect how well the medication works or affect your risk of side effects.
Ask your provider about the best way to handle and throw away Vanflyta (quizartinib) safely. Anticancer medications can be harmful to people who handle or come in contact with them. Store Vanflyta (quizartinib) in a safe place away from children and pets.
Females who are taking Vanflyta (quizartinib) should avoid breastfeeding during treatment and for one month after the last dose. We don’t know whether Vanflyta (quizartinib) is found in breast milk and whether it affects breastfed babies, but there’s a possible risk of harm to a baby.
Frequently asked questions about Vanflyta (quizartinib)
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What are the risks and warnings for Vanflyta (quizartinib)?
Vanflyta (quizartinib) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Serious heart problems
Risk factors: Blood electrolyte levels out of balance | Taking other medications that can cause heart rhythm problems | Taking higher dose of Vanflyta (quizartinib) | Having diarrhea or vomiting
Vanflyta (quizartinib) can cause an abnormal heart rhythm called QT prolongation. Though rare, a prolonged QT can lead to a life-threatening heart rhythm problems. Your provider will monitor your heart rhythm with a test called an electrocardiogram (EKG) before you start treatment and weekly or so during treatment. They’ll also monitor the potassium or magnesium levels in your blood through labs because lower levels of these electrolytes can also raise your risk of heart problems. Depending on your EKG result, your provider might pause treatment or change your Vanflyta (quizartinib) dose. Other times, they might ask you to stop the medication altogether. If you’ve an irregular heartbeat, feel dizzy or lightheaded, have a seizure or pass out, seek medical help immediately.
REMS program
Because Vanflyta (quizartinib) can cause serious heart problems, it’s only available through a special program called a Risk Evaluation and Mitigation Strategy (REMS). This program requires your provider and pharmacy to complete special training to prescribe and dispense Vanflyta (quizartinib). The provider must document they discussed the risks of heart problems with you, and that you know when to contact them or seek medical attention if you have symptoms of heart problems. Pharmacies can only dispense Vanflyta (quizartinib) if it was prescribed by a provider certified by the REMS program.
Harm to unborn baby
Risk factors: Pregnancy
Based on the way Vanflyta (quizartinib) works, this medication might cause birth defects or pregnancy loss (miscarriage). If you’re a female who is able to have babies, you should use birth control while taking Vanflyta (quizartinib) and for 7 months after the last dose. If you’re a male who is sexually active with a female who can get pregnant, you should use birth control such as condoms while taking Vanflyta (quizartinib) and for 4 months after the last dose.
Vanflyta (quizartinib) dosage forms
Typical dosing for Vanflyta (quizartinib)
Your provider will determine your dose of Vanflyta (quizartinib) based on which phase of treatment you’re in (e.g., induction, consolidation, or maintenance). For each phase of treatment, the cycles are 28 days long.
Induction: The typical dose is 35.4 mg by mouth once a day for 2 weeks (from Day 8-21) of the 28-day cycle. Your provider might give you up to 2 cycles of induction. You’ll also receive other anticancer medications during this time.
Consolidation: The typical dose is 35.4 mg by mouth once a day for 2 weeks (from Day 6-19) of the 28-day cycle. Your provider might give you up to 4 cycles of consolidation. You’ll also receive other anticancer medications during this time.
Maintenance: The typical dose is either 26.5 mg or 53 mg by mouth once a day, depending on your heart rhythm. Your provider might prescribe up to 36 cycles of maintenance. You won’t receive other anticancer medications during this time, unless otherwise directed by your provider.
How much does Vanflyta (quizartinib) cost?
Vanflyta (quizartinib) contraindications
Severely low potassium or magnesium levels
History of ventricular arrhythmia or torsades de pointes
What are alternatives to Vanflyta (quizartinib)?
Acute myeloid leukemia (AML) with a FTL3 mutation
Acute myeloid leukemia (AML) with a specific mutation (FLT3-positive)
Advanced acute myeloid leukemia (AML) with an FTL3 mutation; previously treated
Vanflyta (quizartinib) images
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References
Best studies we foundAmerican Cancer Society. (n.d.). Stem cell or bone marrow transplant.
American Cancer Society. (2018). What causes acute myeloid leukemia (AML)?
American Cancer Society. (2019). Targeted therapy safety.
American Cancer Society. (2020). Getting a stem cell or bone marrow transplant.
American Cancer Society. (2023). Targeted therapy drugs for acute myeloid leukemia (AML).
Aujla, R. S., et al. (2022). Creatine phosphokinase. StatPearls.
Cohagen, B., et al. (2023). Torsade de Pointes. StatPearls.
Daiichi Sankyo, Inc. (n.d.). Vanflyta® Risk Evaluation and Mitigation Strategy (REMS).
Daiichi Sankyo Inc. (2024). Vanflyta- quizartinib tablet, film coated [package insert]. DailyMed.
Kennedy, V. E., et al. (2020). FLT3 mutations in acute myeloid leukemia: Key concepts and emerging controversies. Frontiers in Oncology.
Leukemia & Lymphoma Society. (n.d.). Chemotherapy and drug therapy.
National Cancer Institute. (2024). Acute myeloid leukemia treatment (PDQ®)–Patient version.
National Comprehensive Cancer Network. (2021). Anemia and neutropenia: Low red and white blood cell counts.
Punnapuzha, S., et al. (2023). Febrile neutropenia. StatPearls.
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