Ibrutinib increases the risk of fatal and serious cardiac arrhythmias and cardiac failure. Patients with advanced age, Eastern Cooperative Oncology Group (ECOG) performance status ≥2, or cardiac co-morbidities may be at greater risk of cardiac events including sudden fatal cardiac events.

Prior to initiating ibrutinib, clinical evaluation of cardiac history and function should be performed. 
In patients with risk factors for cardiac events, benefits and risks should be assessed before initiating treatment with Imbruvica; alternative treatment may be considered.

Patients should be carefully monitored during treatment for signs of deterioration of cardiac function and if this occurs, clinically managed.

Ibrutinib should be withheld for any new onset or worsening grade 2 cardiac failure or grade 3 cardiac arrhythmias. Treatment may be resumed as per new dose modification recommendations.