gilteritinib

What is the most important information I should know about gilteritinib?

Gilteritinib can cause a condition called differentiation syndrome, which affects blood cells and can be fatal if not treated. This condition may occur within 2 days to 3 months after you start taking gilteritinib.

What is gilteritinib?

Gilteritinib is used to treat acute myeloid leukemia (AML) in adults with an abnormal FLT3 gene. Your doctor will test you for this gene.

Gilteritinib is given after other cancer treatments did not work or have stopped working.

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

What should I discuss with my healthcare provider before taking gilteritinib?

Tell your doctor if you have ever had:

• heart problems;
• long QT syndrome (in you or a family member); or
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).

Before you take this medicine, your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

• If you are a woman, do not use gilteritinib if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.
• If you are a man, use effective 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 while either the mother or the father is using gilteritinib.

How should I take gilteritinib?

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

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results.

You may take gilteritinib with or without food.

It may take several months before you receive the full benefit of taking gilteritinib. Your doctor will determine how long to treat you with this medicine.

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

What happens if I miss a dose?

Take the missed dose on the same day you remember it. Skip the missed dose if your next dose is due in less than 12 hours. Do not use two doses within a 12-hour period.

What happens if I overdose?

What should I avoid while taking gilteritinib?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of gilteritinib?

Gilteritinib can cause a condition called differentiation syndrome, which affects blood cells and can be fatal if not treated. This condition may occur within 2 days to 3 months after you start taking gilteritinib.

• fever, cough, trouble breathing;
• bone pain;
• rapid weight gain; or
• swelling in your arms, legs, underarms, groin, or neck.

• headache, confusion, change in mental status, vision loss, seizure (convulsions);
• fever, chills, cough with mucus, chest pain;
• flu symptoms, mouth and throat ulcers;
• severe pain in your upper stomach spreading to your back, nausea and vomiting;
• a light-headed feeling, like you might pass out; or
• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out).

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• nausea, vomiting, diarrhea, constipation;
• pain or sores in the mouth or throat;
• cough, shortness of breath;
• headache, dizziness;
• eye problems;
• muscle or joint pain;
• low blood pressure;
• swelling of your arms or legs;
• fever, tiredness;
• decreased urination;
• rash; or
• abnormal liver function tests.

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.

What other drugs will affect gilteritinib?

Other drugs may affect gilteritinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about gilteritinib.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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