Brukinsa Disease Interactions

Serious cardiac arrhythmias have been reported with zanubrutinib. Atrial fibrillation and atrial flutter have occurred in patients treated with zanubrutinib monotherapy. Care should be exercised when using this agent in patients with cardiac risk factors, hypertension, and acute infections as they may be at increased risk of cardiac arrhythmias. It is recommended to monitor for signs/symptoms of cardiac arrhythmias, manage appropriately, and consider the risks and benefits of continued treatment with zanubrutinib.

Fatal and serious hemorrhage have occurred in patients with hematological malignancies treated with zanubrutinib monotherapy. Bleeding has occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Special care should be taken when this agent is coadministered with antiplatelet or anticoagulant medications as coadministration may further increase the risk of hemorrhage. It is recommended to monitor for signs/symptoms of bleeding and to discontinue zanubrutinib if intracranial hemorrhage of any grade occurs. The benefit-risk of withholding zanubrutinib for 3 to 7 days before and after surgery (depending on the type of surgery and the risk of bleeding) should be considered.

Cytopenias (including neutropenia, thrombocytopenia, and anemia [based on laboratory measurements]) were reported in patients treated with zanubrutinib monotherapy. Care should be taken when using this agent in patients with hematological abnormalities. It is recommended to monitor complete blood counts during therapy and interrupt treatment, reduce the dose, or discontinue zanubrutinib as warranted. Growth factor or transfusions should be used as treatment, as needed.

The safety of zanubrutinib has not been evaluated in patients with severe liver dysfunction (Child-Pugh C); dosage modification of zanubrutinib is recommended in these patients. The recommended dosage for patients with severe liver dysfunction is 80 mg orally twice a day. No dosage modification is recommended in patients with mild to moderate liver dysfunction (Child-Pugh A and B). Patients with liver dysfunction should be monitored for zanubrutinib adverse reactions.

Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients with hematological malignancies treated with zanubrutinib monotherapy. Infections due to hepatitis B virus reactivation have occurred. Prophylaxis for herpes simplex virus, Pneumocystis jirovecii pneumonia, and other infections according to standard of care should be considered in patients who are at increased risk for infections. Patients should be monitored and evaluated for fever or other signs/symptoms of infection and treated appropriately.

The effect of dialysis on zanubrutinib pharmacokinetics is unknown. Patients on dialysis should be monitored for zanubrutinib adverse reactions. No dosage modification is recommended in patients with mild, moderate, or severe renal dysfunction (CrCl at least 15 mL/min, estimated by Cockroft-Gault).