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

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

It is not known if Xospata is safe and effective in children.

Do not take Xospata if you are allergic to gilteritinib or any of its inactive ingredients which include: mannitol, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate, hypromellose, talc, polyethylene glycol, titanium dioxide and ferric oxide.

Xospata 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 Xospata.

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.

Before taking this medicine

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

To make sure Xospata is safe for you, 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).

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 Xospata 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 Xospata.

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

Take Xospata exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

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.

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

You may take Xospata with or without food.

Do not crush, chew, or break a Xospata tablet. Swallow the tablet whole.

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

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

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

Usual Adult Dose for Acute Myeloid Leukemia:

120 mg orally once a day until disease progression or unacceptable toxicity

Comments:
-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 a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test.

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

To make sure Xospata is safe for you, 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).

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 Xospata 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 Xospata.

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

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.

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

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 Xospata.

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.

Call your doctor at once 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 permanently discontinued if you have certain side effects.

Common Xospata 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.

Other drugs may interact with 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.