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Xospata
Gilteritinib (as Fumarate)
$34060.00
40mg · 84 tablets · 3 months supply
BrandBranded medicine· By Astellas Pharma
$11353.33 per month
How long a supply?
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Annual cost
$136240a year at this pack size
Prescription required
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FDA boxed warningDifferentiation syndrome
Patients treated with XOSPATA have experienced symptoms of differentiation syndrome, which can be fatal or life-threatening if not treated. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, or renal dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.
Patients treated with XOSPATA have experienced symptoms of differentiation syndrome, which can be fatal if not treated. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.
About Xospata
Overview
Xospata contains gilteritinib (as fumarate), a kinase inhibitor supplied as tablets. It is used to treat adults with acute myeloid leukemia (AML) that has returned or has not responded to treatment and has a FLT3 mutation detected by an FDA-approved test. It works by blocking enzymes, including FLT3, involved in signals that help leukemia cells grow and multiply.
What it treats
Acute myeloid leukemia (AML) in adults whose disease has returned or has not responded to treatment and has a FLT3 mutation detected by an FDA-approved test.
Safety information
Side effects
Common side effects include increased liver enzymes on blood tests, muscle or joint pain, tiredness or feeling unwell, fever, inflammation of the mouth or other mucous membranes, swelling, rash, diarrhea not caused by infection, shortness of breath, nausea, cough, constipation, eye problems, headache, dizziness, low blood pressure, vomiting and reduced kidney function. Serious side effects that warrant contacting a doctor include differentiation syndrome, posterior reversible encephalopathy syndrome (PRES, a condition affecting the brain), a prolonged QT interval (a change in the heart’s electrical activity) and pancreatitis (inflammation of the pancreas). Low potassium or magnesium levels must be corrected before and during treatment. Xospata can harm an unborn baby. Contact your doctor if you are pregnant or become pregnant during treatment, and use effective contraception.
FDA boxed warning
Differentiation syndrome
Patients treated with XOSPATA have experienced symptoms of differentiation syndrome, which can be fatal or life-threatening if not treated. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, or renal dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.
Patients treated with XOSPATA have experienced symptoms of differentiation syndrome, which can be fatal if not treated. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Do not take Xospata if you are allergic to gilteritinib or any of its other ingredients. Severe allergic reactions, including anaphylaxis, have occurred. Xospata requires caution because of the risk of: • Posterior reversible encephalopathy syndrome (PRES), a brain condition that requires stopping treatment if it develops. • QT interval prolongation, a change in the heart’s electrical activity. Low potassium or magnesium levels must be corrected before and during treatment. • Pancreatitis (inflammation of the pancreas), which may require treatment changes. Xospata can harm an unborn baby. Effective contraception is needed during treatment. Do not breastfeed while taking Xospata.
Interactions
Ask your doctor to check your other medicines for interactions with Xospata. Avoid medicines that both induce P-gp and strongly induce CYP3A. Your doctor should consider alternatives to strong CYP3A inhibitors. If these medicines must be used with Xospata, you will need more frequent monitoring for side effects. Medicines known as P-gp, BCRP or OCT1 substrates can also interact with gilteritinib. Your doctor may need to adjust these medicines. Do not make changes yourself.
Using Xospata
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store below 25°C in a dry place, in the original pack, away from direct light and moisture. Do not keep it in a bathroom. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label XOSPATA (GILTERITINIB) TABLET [ASTELLAS PHARMA US, INC.] (DailyMed, retrieved 19 September 2026).
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