The First and Only FDA-Approved Oral Treatment for Relapsed or Refractory FLT3m+ AML1,2

Dosage and Administration


The Recommended Starting Dose of XOSPATA1

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120 mg once daily

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Three 40 mg tablets

Tablets shown are not actual size.

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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 response1
  • Do not break, crush, or chew XOSPATA tablets. Take whole with a cup of water1
  • Administer XOSPATA tablets orally at about the same time each day1
  • If a dose of XOSPATA is missed or not taken at the usual time1:
    • 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
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XOSPATA may be taken at home1

  • Assess blood counts and blood chemistries, including creatine phosphokinase:
    • Prior to initiating treatment with XOSPATA
    • At least once weekly for the first month
    • Once every other week for the second month
    • Once monthly for the duration of therapy
  • Perform an ECG prior to initiation of treatment with XOSPATA, on Days 8 and 15 of the first cycle, and prior to the start of the next 2 subsequent cycles
  • Differentiation syndrome: If differentiation syndrome is suspected, administer systemic corticosteroids and initiate hemodynamic monitoring until symptom resolution and for a minimum of 3 days. Interrupt XOSPATA if severe signs and/or symptoms persist for more than 48 hours after initiation of corticosteroids and resume XOSPATA when signs and symptoms improve to Grade 2 or lower
  • Posterior reversible encephalopathy syndrome: Discontinue XOSPATA
  • QTc interval >500 msec: Interrupt XOSPATA and resume at 80 mg dose when QTc interval returns to within 30 msec of baseline or ≤480 msec
  • QTc interval increased by >30 msec on ECG on Day 8 of first cycle: Confirm with ECG on Day 9 and, if confirmed, consider dose reduction to 80 mg
  • Pancreatitis: Interrupt XOSPATA until pancreatitis is resolved and resume at 80 mg dose
  • Other Grade ≥3 toxicity considered related to treatment: Interrupt XOSPATA until toxicity resolves or improves to Grade 1 and resume at 80 mg dose

AML=acute myeloid leukemia; ECG=electrocardiogram; FLT3=FMS-like tyrosine kinase 3; m+=mutation-positive; QTc=corrected cardiac ventricular repolarization.

References: 1. XOSPATA [package insert]. Northbrook, IL: Astellas Pharma US, Inc. 2. Ballesta-López O, Solana-Altabella A, Megías-Vericat JE, Martínez-Cuadrón D, Montesinos P. Gilteritinib use in the treatment of relapsed or refractory acute myeloid leukemia with a FLT3 mutation. Future Oncol (Epub) 09-25-2020.