Xospata Adverse Reactions

The safety evaluation of gilteritinib is based on 319 patients (including 246 patients in the ADMIRAL trial) with relapsed or refractory AML who received at least one dose of 120 mg gilteritinib daily (see PHARMACOLOGY: Pharmacodynamics under Actions). At the time of final analysis cutoff, the median duration of exposure to gilteritinib was 111 days (range 4 to 1320 days).
The most common adverse reactions (≥10%) were alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased, diarrhea, fatigue, nausea, constipation, cough, peripheral edema, dyspnea, blood alkaline phosphatase increased, dizziness, hypotension, pain in extremity, asthenia, blood creatine phosphokinase increased, arthralgia and myalgia.
The most frequent serious adverse reactions (≥2%) reported in patients were acute kidney injury, diarrhea, ALT increased, dyspnea, AST increased, hypotension and differentiation syndrome.
Tabulated summary of adverse reactions: Adverse reactions observed during clinical studies are listed as follows by frequency category. Frequency categories are defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Within each grouping, adverse reactions are presented in order of decreasing frequency. (See Tables 6, 7 and 8.)

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