Tibsovo Disease Interactions

Patients treated with ivosidenib can develop QTc prolongation and ventricular arrhythmias. Concomitant use of ivosidenib with drugs known to prolong the QTc interval (e.g., antiarrhythmic medicines, fluoroquinolones, triazole antifungals, 5-hydroxytryptamine-3 [5-HT3] receptor antagonists) and CYP450 3A4 inhibitors may increase the risk of QTc interval prolongation. ECGs and electrolytes should be monitored. In patients with congenital long QTc syndrome, congestive heart failure, or electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval, more frequent monitoring may be necessary. Treatment should be interrupted if QTc increases to greater than 480 and less than 500 msec. Ivosidenib should be interrupted and the dosage should be reduced if QTc increases to greater than 500 msec. Ivosidenib should be permanently discontinued in patients who develop QTc interval prolongation with signs/symptoms of life-threatening arrhythmia.

The pharmacokinetics and safety of ivosidenib in patients with severe renal dysfunction (estimated GFR less than 30 mL/min/1.73 m2, Modification of Diet in Renal Disease [MDRD]), renal dysfunction requiring dialysis, or severe liver dysfunction (Child-Pugh C) are unknown. The risks and potential benefits should be considered before starting ivosidenib in patients with preexisting severe renal dysfunction, preexisting severe liver dysfunction, or who are requiring dialysis. Caution is advised in these patients.