Quizartinib

Quizartinib may cause QT prolongation (an irregular heart rhythm that can lead to fainting, loss of consciousness, seizures, or sudden death). Tell your doctor if you or anyone in your family has or has ever had long QT syndrome (an inherited condition in which a person is more likely to have QT prolongation) or you have or have ever had low levels of potassium or magnesium in your blood, an irregular heartbeat, or heart failure.

Some medications when taken with quizartinib may increase the risk of QT prolongation occurring. Be sure and tell your doctor and pharmacist what medications you are taking before starting quizartinib. If you experience any of the following symptoms, stop taking quizartinib and call your doctor immediately: fast, pounding, or irregular heartbeat; fainting; loss of consciousness; or seizures. Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body’s response to quizartinib. Your doctor also may order electrocardiograms (EKGs, tests that record the electrical activity of the heart) before and during your treatment to be sure that it is safe for you to take quizartinib. Talk to your doctor about the risks of taking quizartinib.

Because of the risk of QT prolongation and sudden cardiac arrest, quizartinib is available only through a restricted program called the VANFLYTA Risk Evaluation and Mitigation Strategy (REMS). Your doctor and pharmacist must be certified and registered with the VAFLYTA REMS program to prescribe and dispense the medication to you.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with quizartinib and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.

🔔 Why is this medication prescribed?

Quizartinib is used with other chemotherapy drugs to treat a certain type of acute myeloid leukemia (AML; a type of cancer of the white blood cells). Quizartinib is in a class of medications called kinase inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply.

🔔 How should this medicine be used?

Quizartinib comes as a tablet to take by mouth. It is usually taken with or without food once a day. Your doctor will determine how long you should take quizartinib. Take quizartinib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take quizartinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Part of the reason for these long wait times and short appointments is due to a nationwide shortage of physicians that is only getting worse. A report by the Association of American Medical Colleges predicts that, due to population growth and specifically growth of the elderly population, the physician shortfall in the U.S. could reach 121,300 by the year 2030.

Swallow the tablets whole; do not split, chew, or crush them.

Your doctor will probably start you on a low dose of quizartinib and gradually increase your dose, after ECG testing to monitor for QT prolongation.

🔔 Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

🔔 What special precautions should I follow?

Before taking quizartinib,

• tell your doctor and pharmacist if you are allergic to quizartinib, any other medications, or any of the ingredients in quizartinib tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking quizartinib. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• Quizartinib may harm the fetus if taken during pregnancy. If you become pregnant while taking quizartinib, call your doctor immediately. For females, you doctor may order a pregnancy test before you start quizartinib. For females, you should use an effective form of contraception during and for 7 months after treatment with quizartinib. For males taking quizartinib, you may be advised to use an effective form of contraception with female partners during treatment and for 4 months after treatment with quizartinib. You should not breastfeed while taking or for 1 month after taking quizartinib.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking quizartinib.

🔔 What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.