IMBRUVICA® (ibrutinib):
#1 PRESCRIBED THERAPY IN
FRONTLINE * AND PREVIOUSLY
TREATED CLL 1†
*Based on market share data from IMS from November 2016 to February 2018.
† Based on market share data from IMS from July 2014 to February 2018.
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 3% of patients, with fatalities
occurring in 0.3% of 1,124 patients exposed to IMBRUVICA ® in clinical trials.
Bleeding events of any grade, including bruising and petechiae, occurred in
44% 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 24% of 1,124 patients exposed to IMBRUVICA ® in clinical
trials. 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 (23%), thrombocytopenia (8%), and anemia (3%) 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 0.2% of patients, and Grade 3 or greater atrial fi brillation and
atrial fl utter occurred in 4% of 1,124 patients exposed to IMBRUVICA ®
in clinical trials. 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 of any grade occurred in 12% of 1,124 patients
treated with IMBRUVICA ® in clinical trials. Grade 3 or greater hypertension
occurred in 5% of patients with a median time to onset of 5.9 months
(range, 0.03 to 24 months).
Monitor blood pressure in patients treated with IMBRUVICA ® and initiate or
adjust anti-hypertensive medication throughout treatment with IMBRUVICA ®
as appropriate.
Second Primary Malignancies: Other malignancies (10%) including
non-skin carcinomas (4%) have occurred in 1,124 patients treated with
IMBRUVICA ® in clinical trials. The most frequent second primary malignancy
was non-melanoma skin cancer (6%).
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.