A Once-Daily Oral Monotherapy for Patients With Relapsed or Refractory FLT3m+ AML1

XOSPATA is the first monotherapy that can be administered as1:

XOSPATA Support Solutions Logo

A once-daily oral dose that may
be taken at home

The Recommended Starting Dose of XOSPATA1

  • once daily icon

    120 mg once daily

  • three-tablets icon

    Three 40 mg tablets
    Tablets shown are not actual size.

  • fork and knife icon

    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, crush or chew XOSPATA tablets. Take whole with a cup of water
  • Administer XOSPATA tablets orally at 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

Monitoring1

  • Assess blood counts and blood chemistries, including creatine phosphokinase:
    • Prior to initiating treatment with XOSPATA
    • At least once a week 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

Dose Modifications for XOSPATA-Related Toxicities1

  • 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
Select Safety Information

Posterior Reversible Encephalopathy Syndrome (PRES) 1% of 319 patients treated with XOSPATA in the clinical trials experienced posterior reversible encephalopathy syndrome (PRES) with symptoms including seizure and altered mental status. Symptoms have resolved after discontinuation of XOSPATA. A diagnosis of PRES requires confirmation by brain imaging, preferably magnetic resonance imaging (MRI). Discontinue XOSPATA in patients who develop PRES.

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