# 1 PRESCRIBED THERAPY IN FRONTLINE † AND PREVIOUSLY TREATED CLL 1 ‡
TAKE CONTROL OF CLL / SLL WITH YOUR FIRST STEP : IMBRUVICA ® ( ibrutinib )
Proven results across key efficacy endpoints : PFS and OS 2
†
Based on market share data from IMS from November 2016 to April 2017 .
‡
Based on market share data from IMS from May 2014 to April 2017 .
CLL SLL
IMBRUVICA ® ( ibrutinib ) is a kinase inhibitor indicated for the treatment of adult patients with :
• Chronic lymphocytic leukemia ( CLL )/ Small lymphocytic lymphoma ( SLL ) 2
• CLL / SLL with 17p deletion 2
IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS
Hemorrhage : Fatal bleeding events have occurred in patients treated with IMBRUVICA ® . Grade 3 or higher bleeding events ( intracranial hemorrhage [ including 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 and patients should be monitored for signs of bleeding .
Consider the benefi t-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 ( including bacterial , viral , or fungal ) have occurred with IMBRUVICA ® therapy . Grade 3 or greater infections occurred in 14 % to 29 % of patients . Cases of progressive multifocal leukoencephalopathy ( PML ) and Pneumocystis jirovecii pneumonia ( PJP ) have occurred in patients treated with IMBRUVICA ® . 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 .
Cytopenias : Treatment-emergent Grade 3 or 4 cytopenias including neutropenia ( range , 13 to 29 %), thrombocytopenia ( range , 5 to 17 %), and anemia ( range , 0 to 13 %) based on laboratory measurements occurred in patients with B-cell malignancies treated with single agent IMBRUVICA ® .
Monitor complete blood counts monthly .
Cardiac Arrhythmias : Fatal and serious cardiac arrhythmias have occurred with IMBRUVICA ® therapy . Grade 3 or greater ventricular tachyarrhythmias occurred in 0 to 1 % of patients , and Grade 3 or greater atrial fi brillation and atrial fl utter occurred in 0 to 6 % of patients . These events have occurred particularly in patients with cardiac risk factors , hypertension , acute infections , and a previous history of cardiac arrhythmias .
Periodically monitor patients clinically for cardiac arrhythmias . Obtain an ECG for patients who develop arrhythmic symptoms ( e . g ., palpitations , lightheadedness , syncope , chest pain ) or new onset dyspnea . Manage cardiac arrhythmias appropriately , and if it persists , consider the risks and benefi ts of IMBRUVICA ® treatment and follow dose modifi cation guidelines .
Hypertension : Hypertension ( range , 6 to 17 %) has occurred in patients treated with IMBRUVICA ® with a median time to onset of 4.6 months ( range , 0.03 to 22 months ). Monitor patients for new onset hypertension or hypertension that is not adequately controlled after starting IMBRUVICA ® . Adjust existing anti-hypertensive medications and / or initiate anti-hypertensive treatment as appropriate .
Second Primary Malignancies : Other malignancies ( range , 3 to 16 %) including non-skin carcinomas ( range , 1 to 4 %) have occurred in patients treated with IMBRUVICA ® . The most frequent second primary malignancy was non-melanoma skin cancer ( range , 2 to 13 %).
Tumor Lysis Syndrome : Tumor lysis syndrome has been infrequently reported with IMBRUVICA ® therapy . Assess the baseline risk ( e . g ., high tumor burden ) and take appropriate precautions .
Monitor patients closely and treat as appropriate .