Gilteritinib

Gilteritinib is used to treat acute myeloid leukemia (AML) in adults who have an abnormal FLT3 gene. Your doctor will check for this gene.

Gilteritinib is given after other cancer treatments have failed or are no longer effective.

Gilteritinib 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.

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

Gilteritinib is usually given once per day. Take this medicine with a full glass of water, at the same time each day.

You may take gilteritinib with or without food.

Do not crush, chew, or break a gilteritinib tablet. Swallow it whole.

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.

Store this medicine in the original container at room temperature, away from moisture and heat.

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

Seek medical help right away if you have symptoms of differentiation syndrome: fever, cough, trouble breathing, bone pain, rapid weight gain, or swelling in your arms, legs, underarms, groin, or neck.

You should not use gilteritinib if you are allergic to it.

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 gilteritinib, your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Gilteritinib can harm an unborn baby or cause birth defects if the mother or the father is using this medicine.

• 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.

Do not breastfeed while using this medicine, and for at least 2 months after your last dose.

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

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

Seek medical help immediately if you have symptoms of differentiation syndrome:

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

Gilteritinib may cause serious side effects. Call your doctor right away if you have:

• 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 stopped permanently if you have certain side effects.

Common side effects of gilteritinib 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 the FDA at 1-800-FDA-1088.

Usual Adult Dose for Acute Myeloid Leukemia:

120 mg orally once a day until disease progression or unacceptable toxicityComments:-Response may be delayed. In the absence of disease progression or unacceptable toxicity, patients should be treated for a minimum of 6 months to allow time for a clinical response.-Select patients for the treatment of AML with this drug based on the presence of FLT3 mutations in the blood or bone marrow.Use: For the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with an FMS-like tyrosine kinase 3 (FLT3) mutation.

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.

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

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

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.

• What type of leukemia is Xospata (gilteritinib) used to treat?