VANFLYTA- quizartinib tablet, film coated
Daiichi Sankyo Inc.
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MEDICATION GUIDE VANFLYTA (van-FLITT-ah) (quizartinib) tablets |
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This Medication Guide has been approved by the U.S. Food and Drug Administration. | Issued: 7/2023 | |
What is the most important information I should know about VANFLYTA? VANFLYTA may cause serious side effects, including:
You will receive a VANFLYTA Patient Wallet Card from your healthcare provider. Carry the VANFLYTA Patient Wallet Card with you at all times and show it to all of your healthcare providers. The VANFLYTA Patient Wallet Card lists signs and symptoms of QT prolongation and torsades de pointes. Get medical help right away if you develop any of the signs and symptoms listed on the VANFLYTA Patient Wallet Card. You may need to be treated in a hospital. See "What are the possible side effects of VANFLYTA?" for more information about side effects. |
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What is VANFLYTA?
VANFLYTA is a prescription medicine used in combination with certain chemotherapy medicines and alone as maintenance therapy to treat adults with newly diagnosed acute myeloid leukemia (AML) with a FLT3-ITD mutation. Your healthcare provider will perform a test to make sure that 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. |
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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 you take VANFLYTA, tell your healthcare provider about all of your medical conditions, including if you:
Especially tell your healthcare provider if you take St. John's wort. You should not take St. John's wort during treatment with VANFLYTA. |
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How should I take VANFLYTA?
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What are the possible side effects of VANFLYTA? VANFLYTA may cause serious side effects, including: The most common side effects of VANFLYTA include: |
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Your healthcare provider will do blood tests and ECGs before you start and during treatment with VANFLYTA. Your healthcare provider may tell you to decrease your dose, temporarily stop, or permanently stop taking VANFLYTA if you develop certain side effects during treatment with VANFLYTA. 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. 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. |
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How should I store VANFLYTA?
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General information about the safe and effective use of VANFLYTA.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use VANFLYTA for a condition for which it is not prescribed. Do not give VANFLYTA to other people even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about VANFLYTA that is written for health professionals. |
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What are the ingredients in VANFLYTA?
Active ingredient: quizartinib Inactive ingredients:
VANFLYTA® is a registered trademark of Daiichi Sankyo Company, Ltd. Copyright © 2023, Daiichi Sankyo, Inc. USMG-VAN-C1-0723-r001 For more information about VANFLYTA, ask your healthcare provider or pharmacist, visit http://www.vanflyta.com, or call 1-877-437-7763. |