Quizartinib is used in adults alone or in combination with other cancer treatments to treat acute myeloid leukemia.

Quizartinib is available only from a certified pharmacy under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

Quizartinib may also be used for purposes not listed in this medication guide.

You should not use quizartinib if you are allergic to it, or if you have:

• very low magnesium level;
• very low potassium level;
• long QT syndrome; or
• history of ventricular arrhythmias or torsades de pointes.

Tell your doctor if you have or have ever had:

• heart problems; or
• low blood levels of potassium or magnesium.

Quizartinib can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, you will need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 7 months after your last dose.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 4 months after your last dose.
• Tell your doctor right away if a pregnancy occurs.

Pregnancy may be less likely to occur while the mother or the father is using this medicine. Both men and women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

Do not breastfeed while using this medicine, and for at least one month after your last dose.

Use Quizartinib (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Quizartinib can cause a serious heart problem, especially if you use certain medicines at the same time. Call your doctor right away if you have irregular heartbeat, a light-headed feeling, like you might pass out, or have diarrhea or vomiting.

Your dose may be decreased and your treatment may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• nausea, vomiting, stomach pain, upset stomach, diarrhea, loss of appetite;
• fungal infections;
• sepsis (a severe reaction to an infection);
• eye irritation;
• nosebleeds;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• herpes infection;
• trouble sleeping;
• low levels of platelets in your blood;
• an electrolyte imbalance (such as low blood levels of potassium or magnesium);
• changes in liver function tests;
• an abnormal electrocardiogram or ECG (sometimes called an EKG); or
• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Avoid taking an herbal supplement containing St. John's wort.