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

XOSPATA is the first and only monotherapy that can be administered as1:

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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.

  • Administer XOSPATA tablets orally at about the same time each day
  • Do not break or crush XOSPATA tablets. Take whole with a cup of water
  • 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

  • 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

Adverse Reactions The most frequent non-hematological serious adverse reactions (≥5%) reported in patients were pneumonia (19%), sepsis (13%), fever (13%), dyspnea (7%) and renal impairment (5%). Overall, 22 of 292 patients (8%) discontinued XOSPATA treatment permanently due to an adverse reaction. The most common adverse reactions (>1%) leading to discontinuation were pneumonia (2%), sepsis (2%) and dyspnea (1%). The most common adverse reactions (≥20%) were myalgia/arthralgia (42%), transaminase increased (41%), fatigue/malaise (40%), fever (35%), non-infectious diarrhea (34%), dyspnea (34%), edema (34%), rash (30%), pneumonia (30%), nausea (27%), stomatitis (26%), cough (25%), headache (21%), hypotension (21%), dizziness (20%) and vomiting (20%).

Lactation: Advise women not to breastfeed during treatment with XOSPATA and for 2 months after the last dose.

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