Ivosidenib (Tibsovo) is a targeted isocitrate dehydrogenase-1 (IDH1) inhibitor that has demonstrated significant efficacy in the treatment of IDH1-mutated acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), and cholangiocarcinoma.

What Are the Precautions for Ivosidenib (Tibsovo) Administration?

Confirmation of Genetic Testing

Before administration, the IDH1 mutation status must be confirmed using an FDA-approved detection method, which is a fundamental prerequisite for the drug to take effect.

The testing scope should cover common mutation types such as R132C, R132H, and R132G to avoid ineffective treatment.

Assessment of Underlying Diseases

Cardiac function: Measure the baseline QTc interval via electrocardiogram and exclude patients with congenital long QT syndrome.

Electrolyte levels: Focus on evaluating serum potassium, calcium, and magnesium concentrations, and correct any imbalances.

Neurological system: Record the presence of underlying peripheral neuropathy.

Hepatic and renal function: Clarify the Child-Pugh classification and eGFR value. Patients with severe hepatic or renal insufficiency need a careful assessment of the benefit-risk ratio.

Prevention and Management of Differentiation Syndrome

As the most severe adverse drug reaction, its incidence rate ranges from 15% to 25% in AML patients.

Clinical manifestations include fever, dyspnea, pleural effusion, hypotension, peripheral edema, etc.

If suspected, dexamethasone (10 mg administered intravenously every 12 hours) and hemodynamic monitoring should be initiated immediately. If symptoms persist for 48 hours, the drug should be suspended until improvement is achieved.

Management of Cardiotoxicity

During treatment, if the QTc interval exceeds 480 milliseconds, administration must be interrupted immediately, and electrolyte disorders should be actively corrected.

If the QTc interval is > 500 milliseconds, the dose should be reduced to 250 mg once daily, and electrocardiographic follow-up should be performed weekly.

Administration in Special Populations

Pregnant women: Animal studies have shown embryotoxicity; reliable contraceptive measures should be taken during treatment.

Lactating women: Breastfeeding is prohibited during treatment and within 1 month after the last dose.

Elderly patients: Patients aged ≥ 75 years account for 35% of the treated population; enhanced monitoring of hepatic, renal, and cardiac functions is required.

Medication Monitoring for Ivosidenib (Tibsovo)

Monitoring of Laboratory Indicators

Hematology: Test the complete blood count weekly in the first month of treatment, with a focus on monitoring the dynamic changes of white blood cells, platelets, and hemoglobin.

Biochemical indicators: Regularly monitor liver enzymes, bilirubin, creatinine, uric acid, and other indicators.

Monitoring of Clinical Manifestations

Gastrointestinal symptoms: 35%–42% of patients experience diarrhea, nausea, and other symptoms, which require timely symptomatic treatment.

Body weight and edema: Monitor daily body weight changes and extremity edema to alert against fluid retention.