ASH Clinical News November 2016 | Page 10

#1 PRESCRIBED ORAL CLL THERAPY.*
MORE THAN 20,000 PATIENTS TREATED SINCE APPROVAL1†

MAKE IMBRUVICA®
YOUR FIRST STEP
Approved in frontline CLL with or without 17p deletion2

CLL
SLL

IMBRUVICA® is a once-daily oral therapy indicated for:
• Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)2
• CLL/SLL with 17p deletion2

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 benefit-risk of withholding IMBRUVICA® for at least 3 to 7 days pre- and
postsurgery depending upon the type of surgery and the risk of bleeding.
Infections - Fatal and nonfatal infections have occurred with IMBRUVICA® therapy.
Grade 3 or greater infections occurred in 14% to 29% of patients. Cases of
progressive multifocal leukoencephalopathy (PML) have occurred in patients treated
with IMBRUVICA®. Evaluate patients for fever and infections and treat appropriately.
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%) based on laboratory measurements occurred in patients treated with
single agent 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, hypertension, 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 new-onset
dyspnea should have an ECG performed. Atrial fibrillation should be managed
appropriately and if it persists, consider the risks and benefits of IMBRUVICA®
treatment and follow dose modification 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 antihypertensive
medications and/or initiate antihypertensive treatment as appropriate.
Second Primary Malignancies - Other malignancies (range, 5% 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, 4% to 13%).
Tumor Lysis Syndrome - Tumor lysis syndrome has been infrequently reported
with IMBRUVICA® therapy. Assess the baseline risk (eg, high tumor burden) and
take appropriate precautions. Monitor patients closely and treat as appropriate.
Embryo-Fetal Toxicity - Based on findings in animals, IMBRUVICA® can cause fetal
harm when administered to a pregnant woman. Advise women to avoid becoming
pregnant while taking IMBRUVICA® and for 1 month after cessation of therapy. If
this drug is used during pregnancy or if the patient becomes pregnant while taking
this drug, the patient should be apprised of the potential hazard to a fetus.

© Pharmacyclics LLC 2016 © Janssen Biotech, Inc. 2016 10/16 PRC-02243