Ivosidenib

Indications and Usage

Ivosidenib is FDA approved for the treatment of patients with a susceptible IDH1 mutation as detected by an FDA-approved test in:

• Newly diagnosed acute myeloid leukemia (AML)
  • In combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy 
• Relapsed or refractory AML
  • For the treatment of adult patients with relapsed or refractory AML
• Relapsed or refractory myelodysplastic syndromes (MDS) 
  • For the treatment of adult patients with relapsed or refractory myelodysplastic syndromes 
     

Side effects needing medical attention

The most common adverse reactions including laboratory abnormalities (≥ 25%) in patients with AML are leukocytes decreased, diarrhea, hemoglobin decreased, platelets decreased, glucose increased, fatigue, alkaline phosphatase increased, edema, potassium decreased, nausea, vomiting, phosphate decreased, decreased appetite, sodium decreased, leukocytosis, magnesium decreased, aspartate aminotransferase increased, arthralgia, dyspnea, uric acid increased, abdominal pain, creatinine increased, mucositis, rash, electrocardiogram QT prolonged, differentiation syndrome, calcium decreased, neutrophils decreased, and myalgia.

The most common adverse reactions including laboratory abnormalities in patients with relapsed or refractory MDS are creatinine increased, hemoglobin decrease, joint stiffness, albumin decreased, aspartate aminotransferase increased, fatigue, diarrhea, cough, sodium decreased, mucositis, decreased appetite, muscle pain, phosphate decreased, itching, and rash.