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Important
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Important Safety Information
What is the most important information I should know about VANFLYTA® (quizartinib)?
VANFLYTA may cause serious side effects, including changes in the electrical activity of your heart (QT prolongation), torsades de pointes, and your heart stopping (cardiac arrest). QT prolongation can cause irregular heartbeats that can be life-threatening or lead to death.
- Your healthcare provider will check your heart’s electrical activity with an electrocardiogram (ECG) and will do blood tests to check your potassium and magnesium levels before and during treatment.
- Call your healthcare provider right away if you have any of the following: irregular heartbeat, dizziness, lightheadedness, fainting (even briefly), chest pain, diarrhea, or vomiting. You may need hospital care. Always carry the VANFLYTA Patient Wallet Card provided by your healthcare provider.
- Because of the risk of QT prolongation, torsades de pointes, and cardiac arrest, VANFLYTA is available only through a restricted program called the VANFLYTA Risk Evaluation and Mitigation Strategy (REMS).
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.
Before taking VANFLYTA, tell your healthcare provider about all of your medical conditions, including if you: have any heart problems, have low blood levels of potassium or magnesium, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. VANFLYTA may harm your baby. Do not breastfeed during treatment with VANFLYTA and for 1 month after the last dose.
- If you are female and able to become pregnant, your healthcare provider will do a pregnancy test within 7 days before starting treatment. You should use effective birth control (contraception) during treatment and for 7 months after your last dose. Tell your healthcare provider right away if you become pregnant or think you may be pregnant.
- If you are male with a female partner who can become pregnant, use effective birth control during treatment and for 4 months after your last dose.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VANFLYTA may interact with other medicines, which can cause side effects. Especially tell your healthcare provider if you take St. John’s wort. Do not take St. John’s wort during treatment with VANFLYTA.
What are the most common side effects of VANFLYTA?
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, nosebleed, herpes virus infections, trouble sleeping, abnormal electrocardiogram (QT prolongation), upset stomach, low red blood cell counts (anemia), and eye irritation.
Your healthcare provider will do blood tests and ECGs before you start and during treatment. If you develop certain side effects while taking VANFLYTA, your healthcare provider may decrease your dose, pause treatment, or stop treatment permanently.
VANFLYTA may affect fertility in both females and males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about your fertility.
These are not all the possible side effects of VANFLYTA. Call your doctor for medical advice about side effects. You are encouraged to report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What is VANFLYTA?
VANFLYTA is a prescription medicine used with certain chemotherapy medicines and alone as maintenance therapy to treat adults with newly diagnosed acute myeloid leukemia (AML) that has a FLT3-ITD mutation. Your healthcare provider will test for this mutation to determine if VANFLYTA is right for you. VANFLYTA is not for use alone as maintenance therapy after a hematopoietic stem cell transplant. It is not known if VANFLYTA is safe and effective in children.
Please see Full Prescribing Information, including Boxed WARNINGS, and Medication Guide.
