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Select patients for treatment with ivosidenib based on the presence of IDH1 mutations.
The recommended dosage of ivosidenib is 500 mg taken orally once daily until disease progression or unacceptable toxicity.
For patients with AML or MDS without disease progression or unacceptable toxicity, continue ivosidenib for a minimum of 6 months to allow time for clinical response.
Administer ivosidenib with or without food.
Do not administer ivosidenib with a high-fat meal.
Do not split, crush, or chew ivosidenib tablets.
Administer ivosidenib tablets orally about the same time each day.
If a dose of ivosidenib is vomited, do not administer a replacement dose; wait until the next scheduled dose is due.
If a dose of ivosidenib is missed or not taken at the usual time, administer the dose as soon as possible 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.
Start ivosidenib administration on Cycle 1 Day 1 in combination with azacitidine 75 mg/m2 subcutaneously or intravenously once daily on Days 1-7 (or Days 1-5 and 8-9) of each 28-day cycle. Refer to the Prescribing Information for azacitidine for additional dosing information.
Obtain an electrocardiogram (ECG) prior to treatment initiation. Monitor ECGs at least once weekly for the first 3 weeks of therapy and then at least once monthly for the duration of therapy. Manage any abnormalities promptly.
Interrupt dosing or reduce dose for toxicities. See Table 1 for dosage modification guidelines.
Assess blood counts and blood chemistries prior to the initiation of ivosidenib, at least once weekly for the first month, once every other week for the second month, and once monthly for the duration of therapy.
Monitor blood creatine phosphokinase weekly for the first month of therapy.
If a strong CYP3A4 inhibitor must be coadministered, reduce the ivosidenib dose to 250 mg once daily. If the strong inhibitor is discontinued, increase the ivosidenib dose (after at least 5 half-lives of the strong CYP3A4 inhibitor) to the recommended dose of 500 mg once daily.
from FDA，2023.10
