Indication
Acute myeloid leukemia, with presence of IDH1 mutation
Dose
Acute myeloid leukemia, with presence of IDH1 mutation
- Dose – Oral: 500 mg once daily continuously until disease progression or unacceptable toxicityGiven in combination with azacitidine
Supplied
Available as 250 mg tablets. Tablets contain lactose. Tablets should NOT be crushed or broken. Store at room temperature in original bottle with desiccant and protect from light and moisture.
Pharmacological Category
Isocitrate Dehydrogenase-1 (IDH1) Inhibitor
Administration
Take with or without food, but avoid taking with high fat meal
Missed Dose
If a dose is missed, patients should be instructed to take it as soon as they can if it is within 12 hours of the missed dose. If it is over 12 hours since the missed dose, patients should skip the missed dose and resume with the next scheduled dose. Do not take a double dose to make up for a missed dose.
Adverse Effects
Common: Nausea, Vomiting, Diarrhea, QT prolongation, Differentiation syndrome, Edema, Rash, Electrolyte imbalances, Neutropenia, Thrombocytopenia, Arthralgias, Fatigue.
Less Common: Dizziness, Peripheral neuropathy.
The adverse effects listed above are not exhaustive. Please refer to the relevant product monograph for full details.
Monitoring Parameters
Baseline before treatment: CBC & differential, serum creatinine, total bilirubin, AST, ALP, ALT, electrolytes, QTc.
During treatment:
Weekly for the first month: CBC & differential, serum creatinine, total bilirubin, AST, ALP, ALT, electrolytes
Bi-weekly for the second month: CBC & differential, serum creatinine, total bilirubin, AST, ALP, ALT, electrolytes
Monthly after first two months: CBC & differential, serum creatinine, total bilirubin, AST, ALP, ALT, electrolytes
ECG – Assess QTc weekly for the first three weeks of treatment, then monthly thereafter
Drug Interactions
This drug can impact or be impacted by metabolic enzymes for absorption and excretion. Many drugs can also affect or be affected by these enzymes, so please consult with pharmacy to assess for interactions.
May increase the risk for QT interval prolongation. Avoid concurrent therapy with drugs associated with QTc prolongation and/or Torsades de pointes, if possible. If unavoidable, monitor for QT prolongation or cardiac arrhythmias.
Avoid grapefruit, grapefruit juice, Seville oranges, or Seville orange juice.
Current drug interaction databases should be consulted for more information.
Clinical Pearls
Avoid in pregnancy and lactation.
Differentiation syndrome has been reported in patients treated with ivosidenib. Symptoms and clinical findings may include fever, dyspnea, pleural effusion, pericardial effusion, pulmonary infiltrate, hypotension, rapid weight gain, peripheral edema, rash, and renal dysfunction. Differentiation syndrome can be fatal if not treated. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.
References
Servier CanadaInc. Tibsovo. Product Monograph. In: Health Canada, Drug Product Database. Available at: https://pdf.hres.ca/dpd_pm/00076398. PDF Published July 19/2024. Accessed February 24th 2025.
Lexicomp. Ivosidenib Monograph. In: Lexi-Drugs. Hudson, Ohio: Lexi-Comp, Inc. Accessed February 24th, 2025.
