ASH Clinical News April 2016 | Page 54
NOW APPROVED FOR FRONTLINE CLL
MAKE IMBRUVICA®
THE FIRST STEP IN CLL
No chemotherapy required
CLL
IMBRUVICA® is a once-daily
oral therapy indicated for
• Chronic lymphocytic leukemia (CLL)
• Chronic lymphocytic leukemia
with 17p deletion
National Comprehensive
Cancer Network® (NCCN®)
NCCN
recommendations
for ibrutinib2
Category 2A
Category 1
• Frontline CLL without del 17p
- Patients age ≥70 years
- Younger patients with significant comorbidities
• Frail patient with significant comorbidity
• All R/R CLL without del 17p
• CLL with del 17p
- Frontline therapy
- R/R therapy
Category 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Hemorrhage - Fatal bleeding events have occurred in patients treat ed 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 26% 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%) occurred in patients treated with 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 dose modification.
Hypertension - Hypertension (range, 6% to 17%) has occurred in patients treated
with IMBRUVICA® with a median time to onset of 4.5 months (range, 0.03 to 18.40
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 03/16 PRC-01538