Ibrutinib Disease Interactions

Fatal and serious cardiac arrhythmias and cardiac failure have occurred with ibrutinib. These adverse reactions occurred in patients with and without preexisting hypertension or cardiac comorbidities; patients with cardiac comorbidities may be at greater risk of these events. Ventricular tachyarrhythmias, atrial fibrillation, and atrial flutter have occurred in patients treated with ibrutinib, especially in patients with acute infections or cardiac risk factors (including hypertension, diabetes mellitus, history of cardiac arrhythmia). Cardiac history and function should be evaluated at baseline, and patients should be monitored for cardiac arrhythmias and cardiac function. Further evaluation (e.g., ECG, echocardiogram) should be obtained as indicated for patients who develop symptoms of arrhythmia (e.g., palpitations, lightheadedness, syncope, chest pain), new onset dyspnea, or other cardiovascular concerns. Cardiac arrhythmias and cardiac failure should be managed appropriately, dosage modification guidelines should be followed, and the risks and benefits of continued ibrutinib treatment should be considered.

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Cases of bleeding (including bruising, petechia, intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and postprocedural hemorrhage), including fatal bleeding events, have been reported in patients treated with ibrutinib. Risk of major hemorrhage is increased in patients receiving antiplatelet or anticoagulant therapy; these patients should be monitored for signs/symptoms of bleeding. It is recommended to consider the benefit-risk of withholding ibrutinib for at least 3 to 7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.

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Cytopenias (including neutropenia, thrombocytopenia, and anemia) have been reported with use of ibrutinib. Care should be taken with patients at risk, and complete blood counts should be monitored monthly.

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Ibrutinib is metabolized in the liver. In patients with B-cell malignancies, ibrutinib should be avoided in those with severe liver dysfunction (Child-Pugh C). The recommended dosage should be reduced when administering ibrutinib to patients with mild or moderate liver dysfunction (Child-Pugh A and B); more frequent monitoring for ibrutinib adverse reactions is recommended for these patients.

In patients with chronic graft-versus-host disease, ibrutinib should be avoided in those with total bilirubin level greater than 3 times the upper limit of normal (3 x ULN), unless of nonhepatic origin or due to Gilbert's syndrome. The recommended dosage should be reduced when administering ibrutinib to patients with total bilirubin level greater than 1.5 to 3 x ULN, unless of nonhepatic origin or due to Gilbert's syndrome.

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The use of ibrutinib may cause hypertension. Blood pressure should be monitored in patients treated with this drug. Antihypertensive medication should be started or adjusted throughout ibrutinib treatment as appropriate, and the dosage modification guidelines should be followed for grade 3 or higher hypertension.

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Fatal and nonfatal infections (including bacterial, viral, or fungal) have occurred with ibrutinib therapy. Cases of progressive multifocal leukoencephalopathy (PML) and Pneumocystis jirovecii pneumonia (PJP) have been reported in patients treated with ibrutinib. Prophylaxis (according to standard of care) should be considered in patients at increased risk for opportunistic infections. Patients should be monitored and evaluated for fever and infections and treated appropriately.

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The use of ibrutinib in patients with mild to moderate renal dysfunction (CrCl greater than 25 mL/min [as estimated by Cockcroft-Gault equation]) is not expected to influence on the exposure to ibrutinib. Caution and close monitoring are recommended in patients with severe renal dysfunction and in patients on dialysis as no data are available for these patients.

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Tumor lysis syndrome has been reported with ibrutinib therapy infrequently. The baseline risk (e.g., high tumor burden) should be assessed and appropriate precautions should be taken. Patients should be monitored closely and treated as appropriate.

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