ASH Clinical News Advances in Hematology Research & Patient Care: Hi | Page 5

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

DRUG INTERACTIONS

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%†).

CYP3A Inhibitors - Avoid co-administration with strong and
moderate CYP3A inhibitors. If a moderate CYP3A inhibitor must
be used, reduce the IMBRUVICA® dose.

*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
events leading to discontinuation were infections, subdural
hematomas, and diarrhea in CLL patients and subdural
hematoma (1.8%) in MCL patients.
© Pharmacyclics LLC 2015
© Janssen Biotech, Inc. 2015
06/15 PRC-01209

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