IMBRUVICA® significantly improved
progression-free survival vs chlorambucil1
IMBRUVICA® achieved an 84% reduction in risk of progression
or death vs chlorambucil in frontline CLL ≥65 years1
Progression-free survival
RESONATE™-2 was a Phase 3 trial of IMBRUVICA® vs chlorambucil in frontline CLL patients
≥65 years (N=269). Primary endpoint was PFS assessed by an Independent Review Committee
per revised IWCLL criteria.1
Adverse reactions ≥20% across 3 CLL registration studies
•
•
•
•
Thrombocytopenia (53%)
Diarrhea (48%)
Neutropenia (46%)
Anemia (37%)
•
•
•
•
Musculoskeletal pain (32%)
Fatigue (29%)
Bruising (25%)
Nausea (24%)
• Rash (23%)
• Pyrexia (21%)
• Cough (20%)
ADVERSE REACTIONS
DRUG INTERACTIONS
The most common adverse reactions (≥20%) in patients with B-cell malignancies
(MCL, CLL, WM) were thrombocytopenia* (57%, 53%, 43%), diarrhea
(51%, 48%, 37%), anemia* (41%, 37%, 13%), neutropenia* (47%, 46%, 44%),
musculoskeletal pain (37%, 32%†, NA‡), fatigue (41%, 29%, 21%), bruising
(30%, 25%†, 16%†), nausea (31%, 24%, 21%), rash (25%, 23%†, 22%†),
and upper respiratory tract infection (34%, 19%, 19%).
CYP3A Inhibitors - Avoid coadministration with strong and moderate CYP3A
inhibitors. If a moderate CYP3A inhibitor must be used, reduce the IMBRUVICA® dose.
CYP3A Inducers - Avoid coadministration with strong CYP3A inducers.
*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-hematologic adverse reactions (≥5%) in MCL
patients were pneumonia (7%), abdominal pain (5%), atrial fibrillation (5%), diarrhea
(5%), fatigue (5%), and skin infections (5%).
Approximately 4% (CLL), 14% (MCL), and 11% (WM) of patients had a dose reduction
due to adverse reactions.
Approximately 4%-10% (CLL), 9% (MCL), and 6% (WM) of patients discontinued
due to adverse reactions. Most frequent adverse reactions leading to discontinuation
were pneumonia, subdural hematomas, and atrial fibrillation (1% each) in CLL
patients and subdural hematoma (1.8%) in MCL patients.
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SPECIFIC POPULATIONS
Hepatic Impairment - Avoid use in patients with moderate or severe baseline hepatic
impairment. In patients with mild impairment, reduce IMBRUVICA® dose.
Please see the Brief Summary on the following pages.
References: 1. IMBRUVICA® (ibrutinib) Prescribing Information. Pharmacyclics LLC 2016.
2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology
(NCCN Guid VƖ