INDICATIONS AND USAGE（适应症）

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.

DOSAGE（服用剂量）

Select patients for the treatment of AML with XOSPATA based on the presence of FLT3 mutations in the blood or bone marrow.

Recommended Dosage

The recommended starting dose of XOSPATA is 120 mg orally once daily with or without food. Response may be delayed. In the absence of disease progression or unacceptable toxicity, treatment for a minimum of 6 months is recommended to allow time for a clinical response.

Do not break or crush XOSPATA tablets. Administer XOSPATA tablets orally about the same time each day. If a dose of XOSPATA is missed or not taken at the usual time, administer the dose as soon as possible on the same day, and at least 12 hours prior to the next scheduled dose. Return to the normal schedule the following day. Do not administer 2 doses within 12 hours.

ADVERSE REACTIONS（不良反应）

Differentiation syndrome

Posterior reversible encephalopathy syndrome

Prolonged QT interval

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/b5ff59aa-9c0d-49a8-9053-1f179b482383/spl-doc?hl=gilteritinib

Xospatainformation