Dosage Regimen and Modifications

The standard dosage for TIBSOVO is 500 mg taken once daily, with or without food, but avoiding high-fat meals. Tablets should be swallowed whole, not split or crushed. For patients with AML or MDS, treatment continues until disease progression or unacceptable toxicity, with a minimum 6-month duration to assess response. Dose interruptions or reductions are required for QTc prolongation (>480 msec), differentiation syndrome, or Grade ≥3 adverse reactions. When co-administered with strong CYP3A4 inhibitors (e.g., itraconazole), the dose is reduced to 250 mg daily. If a dose is missed, it should be taken ≥12 hours before the next scheduled dose.