Grade 3 or greater infections occurred in 21% of 1,476 patients who received IMBRUVICA ® in clinical trials. Infections: Fatal and non-fatal infections (including bacterial, viral, or fungal) have occurred with IMBRUVICA ® therapy. Monitor for signs and symptoms of bleeding.Ĭonsider the benefit-risk of withholding IMBRUVICA ® for at least 3 to 7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding. Consider the risks and benefits of anticoagulant or antiplatelet therapy when co-administered with IMBRUVICA ®. The addition of antiplatelet therapy with or without anticoagulant therapy increased this percentage to 4.4%, and the addition of anticoagulant therapy with or without antiplatelet therapy increased this percentage to 6.1%. Across clinical trials, 3.1% of 2,838 patients who received IMBRUVICA ® without antiplatelet or anticoagulant therapy experienced major hemorrhage. Use of either anticoagulant or antiplatelet agents concomitantly with IMBRUVICA ® increases the risk of major hemorrhage. The mechanism for the bleeding events is not well understood. Bleeding events of any grade including bruising and petechiae occurred in 39%, and excluding bruising and petechiae occurred in 23% of patients who received IMBRUVICA ®, respectively. Major hemorrhage (≥ Grade 3, serious, or any central nervous system events e.g., intracranial hemorrhage, gastrointestinal bleeding, hematuria, and post procedural hemorrhage) occurred in 4.2% of patients, with fatalities occurring in 0.4% of 2,838 patients who received IMBRUVICA ® in 27 clinical trials. Hemorrhage: Fatal bleeding events have occurred in patients who received IMBRUVICA ®.
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