Xospata Dosage
Generic name: GILTERITINIB FUMARATE 40mg
Dosage form: tablet
Drug class: Multikinase inhibitors
Medically reviewed by Drugs.com. Last updated on Apr 29, 2022.
Patient Selection
Select patients for the treatment of AML with XOSPATA based on the presence of FLT3 mutations in the blood or bone marrow [see Clinical Studies (http://www.fda.gov/CompanionDiagnostics.
2.2 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.
2.3 Dosage Modifications
Assess blood counts and blood chemistries, including creatine phosphokinase, prior to the initiation of XOSPATA, 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.
Interrupt dosing or reduce dose for toxicities as per Table 1.
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Adverse Reaction |
Recommended Action |
Differentiation Syndrome |
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Posterior Reversible Encephalopathy Syndrome |
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QTc interval greater than 500 msec |
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QTc interval increased by >30 msec on ECG on day 8 of cycle 1 |
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Pancreatitis |
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Other Grade 3* or higher toxicity considered related to treatment. |
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