Ibrutinib requires medical supervision because inhibition of BTK affects pathways involved in normal immune and cellular functions.
Hemorrhage
Fatal bleeding events have occurred with IMBRUVICA. Concomitant anticoagulant or antiplatelet treatment can increase major hemorrhage risk.
Infections
Serious bacterial, viral and fungal infections have occurred. Opportunistic infections including PJP and PML have been reported. Fever and other infection symptoms should be evaluated promptly.
Cardiac arrhythmias and cardiac failure
Serious arrhythmias, atrial fibrillation, cardiac failure and sudden cardiac death have occurred. Patients with cardiac risk factors may have greater risk.
Hypertension
Blood pressure should be monitored during treatment because hypertension is a recognized adverse effect.
Cytopenias
Low platelet, neutrophil and red-cell counts can occur. Current labeling recommends complete blood counts monthly.
Second primary malignancies
Additional malignancies, including skin cancers and other carcinomas, have been reported in patients receiving IMBRUVICA.
Hepatotoxicity
Drug-induced liver injury, including severe and fatal cases, has been reported in postmarketing experience.
Tumor lysis syndrome
Tumor lysis syndrome can occur, particularly when there is a high tumor burden or rapid response to treatment.
CYP3A interactions
Strong or moderate CYP3A inhibitors can increase ibrutinib concentrations. Strong CYP3A inducers can reduce concentrations and should generally be avoided. Grapefruit and Seville oranges should also be avoided according to current U.S. labeling.
Pregnancy
Ibrutinib can cause fetal harm based on its mechanism and animal data. Pregnancy should be discussed with the treating healthcare professional before treatment.
Breastfeeding
Current U.S. labeling advises against breastfeeding during IMBRUVICA treatment.
Surgery
Because of bleeding risk, planned surgery should be discussed with the treating team. Current labeling recommends considering withholding treatment for at least 3 to 7 days before and after surgery depending on bleeding risk.