AIFA Agenzia Italiana del Farmaco
Note Important on (ibrutinib)
Ibrutinib increases the risk of severe and fatal cardiac arrhythmias and heart failure. Patients of advanced age, with ECOG (Eastern Cooperative Oncology Group) performance status ≥ 2 or cardiac comorbidities, may have an increased risk of cardiac events, including sudden fatal cardiac events.
Before initiating treatment with ibrutinib, a clinical evaluation of history and cardiac function should be performed.
In patients with risk factors for cardiac events, the benefits and risks should be weighed before initiating treatment with ; Alternative treatment should be considered.
Patients should be monitored closely during treatment for signs of deterioration in cardiac function and be clinically managed if they occur.
Ibrutinib should be discontinued following any new manifestation or worsening of Grade 2 heart failure or Grade 3 cardiac arrhythmias.Treatment can be resumed following the new dose adjustment recommendations.
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Source — https://www.univadis.it/viewarticle/nota-informativa-importante-su-imbruvica-ibrutinib