What is the most important information I should know about VANFLYTA?
VANFLYTA may cause serious side effects, including:
- Changes in the electrical activity of your heart called QT prolongation, torsades de pointes, and your heart stopping (cardiac arrest).
- QT interval prolongation can cause 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
- 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.
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.
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VANFLYTA is available only 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 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.
Learn more about the VANFLYTA REMS at www.VANFLYTAREMS.com
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.
notice any of the signs
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serious side effects
What are the most common side effects of VANFLYTA?
Some side effects you may experience could include:
- Diarrhea
- Mouth sores
- Nausea
- Stomach (abdominal) pain
- Serious infection throughout the body and organs (sepsis)
- Headache
- Vomiting
- Upper respiratory tract infections
- Decreased appetite
- Fungal infections
- Nosebleed
- Herpesvirus infections
- Trouble sleeping
- Upset stomach
- Eye irritation
Some side effects may not be noticeable, but your doctor can monitor them through tests. These may 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
- Low platelet counts
- Abnormal electrocardiogram (QT prolongation)
- Low red blood cell counts (anemia)
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 are encouraged to report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.
