Drug Interaction Report

MONITOR CLOSELY: Coadministration of tovorafenib and drugs that interfere with platelet function or coagulation may potentiate the risk of bleeding complications. Major hemorrhagic events, such as tumor hemorrhage, gastrointestinal hemorrhage, subdural hemorrhage, intracranial tumor hemorrhage, and hemoptysis have been reported during tovorafenib therapy. In the safety evaluation of tovorafenib monotherapy in 137 patients with pediatric low-grade glioma harboring a BRAF alteration, serious bleeding events (Grade 3 or 4) were reported in 5% of patients, including a Grade 5 tumor hemorrhage in one patient.

MANAGEMENT: Concomitant use of other medications that interfere with platelet function or coagulation should be considered cautiously in patients treated with tovorafenib. Close clinical and laboratory observation for bleeding complications is recommended during therapy. Patients should be advised to promptly report any signs and symptoms of bleeding to their physician. Refer to the product labeling for guidance on tovorafenib dosage adjustments in patients with Grade 2 to 4 hemorrhage.