Bleeding Risk, Procedural Safety, and Concurrent Anticoagulation

Dr. Chieh-Lung Cheng reports a gastrointestinal bleeding event in one patient that resolved with dose reduction, allowing continued therapy. Dr. Motoo Nagane, from a neurosurgical perspective, reports little to no bleeding toxicity and no intracranial hemorrhage in practice, with the only events being subcutaneous purpura in very elderly patients on concurrent anticoagulation. Dr. Christian Grommes adds that lumbar punctures for spinal fluid collection were performed during the tirabrutinib studies without holding the drug and without inducing subdural hemorrhage, characterizing spinal taps as minor interventions not requiring interruption, though larger surgical procedures do warrant stopping the agent. Dr. Nagane notes that Japanese trials excluded patients on anticoagulants or antiplatelets, so trial data did not capture that interaction, but in practice tirabrutinib can be prescribed with a single antiplatelet agent such as aspirin, with greater caution for anticoagulants. Dr. Lakshmi Nayak summarizes that concurrent antiplatelet or anticoagulant use warrants monitoring rather than exclusion, closes the program, and reiterates that tirabrutinib remains investigational in the United States, has not been approved by the FDA, and is the subject of an ongoing Phase 3 trial.