ASH Clinical News FINAL_ACN_3.14_FULL_ISSUE_DIGITAL | Page 128

#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 effi cacy 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.
Atrial Fibrillation: Atrial fi brillation and atrial fl utter (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
fi brillation. Periodically monitor patients clinically for atrial fi brillation. Patients who
develop arrhythmic symptoms (e.g., palpitations, lightheadedness) or new onset
dyspnea should have an ECG performed. Atrial fi brillation should be managed
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.
Embryo-Fetal Toxicity: Based on fi ndings 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
© Pharmacyclics LLC 2017 © Janssen Biotech, Inc. 2017 10/17 PRC-03138