ASH Clinical News December 2014 | Page 21

IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Hemorrhage - 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 anti-platelet or anti-coagulant 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.

patients treated with IMBRUVICA®. The most frequent second primary
malignancy was non-melanoma skin cancer (range, 4 to 8%).
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®. 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.
ADVERSE REACTIONS

The most common adverse reactions (≥20%) in the clinical
trials were thrombocytopenia (56%), neutropenia (51%),
diarrhea (51%), anemia (37%), fatigue (28%), musculoskeletal
pain (28%), upper respiratory tract infection (28%), rash (26%),
Infections - Fatal and non-fatal infections have occurred with
nausea (25%), and pyrexia (24%). Approximately 5% of
®
IMBRUVICA . Twenty-six percent of patients with CLL had
patients receiving IMBRUVICA® discontinued treatment
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infections Grade 3 or greater NCI Common Terminology Criteria
due to adverse events. These included infections, subdural
for Adverse Events (CTCAE). Monitor patients for fever and
hematomas, and diarrhea. Adverse events leading to dose
infections and evaluate promptly.
reduction occurred in approximately 6% of patients.
Cytopenias - Treatment-emergent Grade 3 or 4 cytopenias
DRUG INTERACTIONS
including neutropenia (range, 23 to 29%), thrombocytopenia
CYP3A Inhibitors - Avoid concomitant administration with
(range, 5 to 17%), and anemia (range, 0 to 9%) occurred in
strong or moderate inhibitors of CYP3A. If a moderate CYP3A
patients treated with IMBRUVICA®. Monitor complete blood
inhibitor must be used, reduce the IMBRUVICA® dose.
counts monthly.
CYP3A Inducers - Avoid co-administration with strong
Atrial Fibrillation - Atrial fibrillation and atrial flutter
CYP3A inducers.
(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 new-onset dyspnea should have an ECG
performed. If atrial fibrillation persists, consider the risks and
benefits of IMBRUVICA® treatment and dose modification.
Second Primary Malignancies - Other malignancies (range,
5 to 10%) including carcinomas (range, 1 to 3%) have occurred in

© Pharmacyclics, Inc. 2014
© Janssen Biotech, Inc. 2014
11/14 PRC-00659

SPECIFIC POPULATIONS
Hepatic Impairment - Avoid use in patients with baseline
hepatic impairment.
Please review the Brief Summary of full Prescribing
Information on the following page.

To learn more, visit us at

www.IMBRUVICA.com