Quizartinib

IMPORTANT WARNING:

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 medicine 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.

Are there OTHER USES for this medicine?

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

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.

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.

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.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. If you vomit after taking quizartinib, do not take another dose of quizartinib and just continue the normal dosing schedule with the next dose.

What SIDE EFFECTS can this medicine cause?

Quizartinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• nausea or vomiting, abdominal pain, or upset stomach
• sores or ulcers inside or around the mouth
• headache
• decreased appetite
• nose bleeds
• difficulty sleeping
• irritated or itchy eyes

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• cough, fever, fast or difficulty breathing
• confusion or disorientation
• fatigue

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before starting therapy to make sure quizartinib is right for you and during therapy to check your body's response to quizartinib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.