Quizartinib

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

Quizartinib can only be obtained from a certified pharmacy through a special program. You must be registered in the program and understand the risks and benefits of quizartinib.

Quizartinib may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Do not change your dose or stop taking the medicine without your doctor's advice.

Quizartinib is usually taken once per day with or without food at the same time each day.

If you vomit shortly after taking quizartinib, do not take another dose. Take your next dose as scheduled.

Swallow the tablet whole and do not crush, chew, or break it.

You may need medical tests before and during your treatment with quizartinib to check your heart function using an electrocardiograph or ECG (sometimes called an EKG).

Your blood will be tested before and during treatment with quizartinib.

Store at room temperature away from moisture and heat.

Quizartinib can lead to a serious heart issue, especially if you take certain medicines at the same time. Call your doctor immediately if you experience an irregular heartbeat, feel light-headed as if you might faint, or have diarrhea or vomiting.

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

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 confirm 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 can get pregnant. Keep using birth control for at least 4 months after your last dose.
• Tell your doctor right away if you become pregnant.

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.

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 an irregular heartbeat, feel light-headed like you might pass out, or have diarrhea or vomiting.

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

Common side effects of quizartinib 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.

Take the medicine as soon as you remember, but if it is nearly time for your next dose, skip the missed dose. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Sometimes it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines less effective.