ASH Clinical News October 2015 | Page 9

IMBRUVICA® (ibrutinib) is the first and only
FDA-approved therapy for use in patients
with Waldenström’s macroglobulinemia (WM)
IMBRUVICA® is approved for use in 4 indications
IMBRUVICA® is indicated for the treatment of patients with
Mantle cell lymphoma (MCL) who have received at least one prior therapy.

Accelerated approval was granted for this indication based on overall response rate. Continued approval
for this indication may be contingent upon verification of clinical benefit in confirmatory trials.

Chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.
Chronic lymphocytic leukemia with 17p deletion.
Waldenström’s macroglobulinemia (WM).

ADVERSE REACTIONS
The most common adverse reactions (≥25%) in patients with
B-cell malignancies (MCL, CLL, WM) were thrombocytopenia*
(57%, 52%, 43%), neutropenia* (47%, 51%, 44%), diarrhea
(51%, 48%, 37%), anemia* (41%, 36%, 13%), fatigue (41%,
28%, 21%), musculoskeletal pain (37%, 28%†, NA‡), bruising
(30%, 12%†, 16%†), nausea (31%, 26%, 21%), upper respiratory
tract infection (34%, 16%, 19%), and rash (25%, 24%†, 22%†).
*Based on adverse reactions and/or laboratory measurements
(noted as platelets, neutrophils, or hemoglobin decreased).
†
Includes multiple ADR terms.
‡
Not applicable; no associated ADRs.
The most common Grade 3 or 4 non-hematological adverse
reactions (≥5%) in MCL patients were pneumonia (7%),
abdominal pain (5%), atrial fibrillation (5%), diarrhea (5%),
fatigue (5%), and skin infections (5%).
Approximately 6% (CLL), 14% (MCL), and 11% (WM) of patients
had a dose reduction due to adverse events.
Approximately 5% (CLL), 9% (MCL), and 6% (WM) of patients
discontinued due to adverse events. Most frequent adverse
© Pharmacyclics LLC 2015
© Janssen Biotech, Inc. 2015
06/15 PRC-01166

events leading to discontinuation were infections, subdural
hematomas, and diarrhea in CLL patients and subdural
hematoma (1.8%) in MCL patients.

DRUG INTERACTIONS
CYP3A Inhibitors - Avoid co-administration with strong and
moderate CYP3A inhibitors. If a moderate CYP3A inhibitor must be
used, reduce the IMBRUVICA® dose.
CYP3A Inducers - Avoid co-administration with strong
CYP3A inducers.
SPECIFIC POPULATIONS
Hepatic Impairment - Avoid use in patients with moderate
or severe baseline hepatic impairment. In patients with mild
impairment, reduce IMBRUVICA® dose.
Please review the Brief Summary of full Prescribing
Information on the following pages.

To learn more, visit

www.IMBRUVICA.com