Prescription medicine

Gilteritinib Brand names: Xospata

Gilteritinib (Xospata) is a prescription medicine with an FDA approval on record since 2018. No generic is listed in FDA's NDC Directory.

No generic listed
Boxed warning

Check it at the source: the gilteritinib FDA label on DailyMed (effective January 1, 2022, Astellas Pharma US, Inc.); the NDA 211349 record on Drugs@FDA; every gilteritinib label on DailyMed.

Highlights of the record

FDA label of January 1, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

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 [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )]. WARNING: DIFFERENTIATION SYNDROME See full prescribing information for complete boxed warning. 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.

Used for

From the label: indications and usage
XOSPATA is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

Forms and strengths

40 mg

Tablet.

On the market

Earliest approval on file: November 28, 2018 Xospata, Astellas; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Last listed patent: July 1, 2036 Xospata tablets; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded

What is gilteritinib used for?

From the label: indications and usage
XOSPATA is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. ( 1.1 ) 1.1 Relapsed or Refractory Acute Myeloid Leukemia XOSPATA is indicated 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.

Source: FDA drug label (Xospata), Astellas Pharma US, Inc., effective January 1, 2022 (SPL set b5ff59aa-9c0d-49a8-9053-1f179b482383), via openFDA; the full label on DailyMed

What does the patient leaflet for gilteritinib say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about XOSPATA?
XOSPATA may cause serious side effects, including: • Differentiation Syndrome. Differentiation syndrome is a condition that affects your blood cells and may be life-threatening or lead to death if not treated. Differentiation syndrome can happen as early as 1 day after starting XOSPATA and during the first 3 months of treatment. Call your healthcare provider or go to the nearest hospital emergency room right away if you develop any of the following symptoms of differentiation syndrome while taking XOSPATA: o fever o cough o trouble breathing o rash o dizziness or lightheadedness o rapid weight gain o swelling of your arms or legs o decreased urination If you develop any of these symptoms of differentiation syndrome, your healthcare provider may treat you with a corticosteroid medicine and may monitor you in the hospital. See “What are the possible side effects of XOSPATA?” for more information about side effects.

From the patient leaflet: How should I store XOSPATA?
XOSPATA comes in a child resistant package. • Store XOSPATA at room temperature between 68°F to 77°F (20°C to 25°C). • Keep XOSPATA in the original container to protect it from light, moisture, and humidity. • Keep XOSPATA and all medicines out of the reach of children.

Source: FDA drug label (Xospata), Astellas Pharma US, Inc., effective January 1, 2022 (SPL set b5ff59aa-9c0d-49a8-9053-1f179b482383), via openFDA; the full label on DailyMed

Is there a generic for gilteritinib (Xospata)?

No generic gilteritinib is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 8 patents for Xospata tablets: the compound patent runs to November 28, 2032, and the last listed entry to July 1, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2018 earliest approval on file
2036 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the gilteritinib label say about other medicines?

The gilteritinib label names 4 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Dexamethasone	warnings and precautions	If differentiation syndrome is suspected, initiate dexamethasone 10 mg IV every 12 hours (or an equivalent dose of an alternative oral or IV corticosteroid) and hemodynamic monitoring until improvement.
Escitalopram	drug interactions	Drugs that Target 5HT2B Receptor or Sigma Nonspecific Receptor Concomitant use of gilteritinib may reduce the effects of drugs that target the 5HT 2B receptor or the sigma nonspecific receptor (e.g., escitalopram, fluoxetine, sertraline).
Fluoxetine	drug interactions	Drugs that Target 5HT2B Receptor or Sigma Nonspecific Receptor Concomitant use of gilteritinib may reduce the effects of drugs that target the 5HT 2B receptor or the sigma nonspecific receptor (e.g., escitalopram, fluoxetine, sertraline).
Sertraline	drug interactions	Drugs that Target 5HT2B Receptor or Sigma Nonspecific Receptor Concomitant use of gilteritinib may reduce the effects of drugs that target the 5HT 2B receptor or the sigma nonspecific receptor (e.g., escitalopram, fluoxetine, sertraline).

Check gilteritinib against other medicines

Source: FDA drug label (Xospata), Astellas Pharma US, Inc., effective January 1, 2022 (SPL set b5ff59aa-9c0d-49a8-9053-1f179b482383), via openFDA; the full label on DailyMed

What next?

Check an interaction: what two or more labels say about each other