Source: FDA, National Drug Code (US) Revision Year: 2019
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.
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 (14)].
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.
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.
Table 1. Dosage Modifications for XOSPATA-Related Toxicities*
| Adverse Reaction | Recommended Action |
|---|---|
| Differentiation Syndrome | • If differentiation syndrome is suspected, administer systemic corticosteroids and initiate hemodynamic monitoring until symptom resolution and for a minimum of 3 days [see Warnings and Precautions (5.1)]. • Interrupt XOSPATA if severe signs and/or symptoms persist for more than 48 hours after initiation of corticosteroids [see Warnings and Precautions (5.1)]. • Resume XOSPATA when signs and symptoms improve to Grade 2* or lower. |
| Posterior Reversible Encephalopathy Syndrome | • Discontinue XOSPATA. |
| QTc interval greater than 500 msec | • Interrupt XOSPATA. • Resume XOSPATA at 80 mg when QTc interval returns to within 30 msec of baseline or less than or equal to 480 msec. |
| QTc interval increased by >30 msec on ECG on day 8 of cycle 1 | • Confirm with ECG on day 9. • If confirmed, consider dose reduction to 80 mg. |
| Pancreatitis | • Interrupt XOSPATA until pancreatitis is resolved. • Resume XOSPATA at 80 mg. |
| Other Grade 3* or higher toxicity considered related to treatment. | • Interrupt XOSPATA until toxicity resolves or improves to Grade 1*. • Resume XOSPATA at 80 mg. |
* Grade 1 is mild, Grade 2 is moderate, Grade 3 is serious, Grade 4 is life-threatening.
Store XOSPATA tablets at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Keep in original container until dispensed. Protect from light, moisture and humidity.
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