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Fatal bleeding events have occurred in patients who received Ibrutinib.
Consider the benefit-risk of withholding Ibrutinib for at least 3 to 7 days pre- and postsurgery depending upon the type of surgery and the risk of bleeding.
Consider prophylaxis according to standard of care in patients who are at increased risk for opportunistic infections. Monitor and evaluate patients for fever and infections and treat appropriately.
Evaluate cardiac history and function at baseline, and monitor patients for cardiac arrhythmias and cardiac function. Obtain further evaluation (e.g., ECG, echocardiogram) as indicated for patients who develop symptoms of arrhythmia (e.g., palpitations, lightheadedness, syncope, chest pain), new onset dyspnea, or other cardiovascular concerns. Manage cardiac arrhythmias and cardiac failure appropriately, follow dose modification guidelines, and consider the risks and benefits of continued Ibrutinib treatment.
Monitor blood pressure in patients treated with Ibrutinib, initiate or adjust anti-hypertensive medication throughout treatment with Ibrutinib as appropriate, and follow dosage modification guidelines for Grade 3 or higher hypertension.
from FDA，2024.05
