DISCOVERING HOW FAR THERAPY CAN GO
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Hemorrhage - Fatal bleeding events have occurred in patients
treated with IMBRUVICA®. Grade 3 or higher bleeding events
(subdural hematoma, gastrointestinal bleeding, hematuria, and
post-procedural hemorrhage) have occurred in up to 6% of patients.
Bleeding events of any grade, including bruising and petechiae,
occurred in approximately half of patients treated with IMBRUVICA®.
The mechanism for the bleeding events is not well understood.
IMBRUVICA® may increase the risk of hemorrhage in patients
receiving antiplatelet or anticoagulant therapies. Consider 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.
Infections - Fatal and non-fatal infections have occurred with
IMBRUVICA® therapy. Grade 3 or greater infections occurred
in 14% to 26% of patients. Cases of progressive multifocal
leukoencephalopathy (PML) have occurred in patients treated with
IMBRUVICA®. Monitor patients for fever and infections and evaluate
promptly.
Cytopenias - Treatment-emergent Grade 3 or 4 cytopenias including
neutropenia (range, 19 to 29%), thrombocytopenia (range, 5 to
17%), and anemia (range, 0 to 9%) occurred in patients treated with
IMBRUVICA®. Monitor complete blood counts monthly.
Atrial Fibrillation - Atrial fibrillation and atrial flutter (range, 6 to
9%) have occurred in patients treated with IMBRUVICA®, particularly
in patients with cardiac risk factors, acute infections, and a previous
history of atrial fibrillation. Periodically monitor patients clinically for
atrial fibrillation. Patients who develop arrhythmic symptoms (eg,
palpitations, lightheadedness) or n Wr