INDICATIONS
Gilteritinib 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 AND ADMINISTRATION
Patient Selection
Select patients for the treatment of AML with Gilteritinib based on the presence of FLT3 mutations in the blood or bone marrow. Information on FDA-approved tests for the detection of a FLT3 mutation in AML is available.
Recommended Dosage
The recommended starting dose of Gilteritinib 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 Gilteritinib tablets. Administer Gilteritinib tablets orally about the same time each day. If a dose of Gilteritinib 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.
Dose Modification
Assess blood counts and blood chemistries, including creatine phosphokinase, prior to the initiation of Gilteritinib, at least once weekly for the first month, once every other week for the second month, and once monthly for the duration of therapy. Perform electrocardiogram (ECG) prior to initiation of treatment with Gilteritinib, on days 8 and 15 of cycle 1, and prior to the start of the next two subsequent cycles.
