Dosage of Gilteritinib

1. Patient Selection  

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

2. 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.  

FDA,2022.01