iNNOVATE™: SUPPORTING AND ESTABLISHED SAFETY AND TOLERABILITY PROFILE

Adverse Reactions in WM Patients in the iNNOVATE™ Trial1

iNNOVATE™ trial (n=150)

ARs in ≥10% of patients and ≥2% higher in the IMBRUVICA® arm in patients with WM1

Median duration of exposure for IMBRUVICA® + rituximab was 25.8 months; median duration of placebo + rituximab was 15.5 months1

 
 IMBRUVICA® + R (n=75)Placebo + R (n=75)
Body SystemAdverse ReactionsAll Grades (%)Grade 3 or Higher (%)All Grades (%)Grade 3 or Higher (%)
Subcutaneous tissue disordersBruising*37150
Rash*241110
Musculoskeletal and connective tissue disordersMusculoskeletal pain*354213
Arthralgia243111
Muscle spasms170121
Vascular disordersHemorrhage*323174
Hypertension*201354
Gastrointestinal disordersDiarrhea280151
Nausea210120
Dyspepsia16010
Constipation131111
Infections and infestationsPneumonia*191353
Skin infection*17330
Urinary tract infection13000
Bronchitis12370
Influenza12071
Viral upper respiratory tract infection11070
General disorders and administration site conditionsPeripheral edema170121
Respiratory, thoracic and mediastinal disordersCough170110
Blood and lymphatic system disordersNeutropenia*1612114
Cardiac disordersAtrial fibrillation151231
Nervous system disordersDizziness11070
Psychiatric disordersInsomnia11040
Metabolism and nutrition disordersHypokalemia11011

Includes multiple ADR terms.

Includes one event with fatal outcome.

Long Term Safety

In a long-term safety analysis over 5 years of 1,284 patients with B-cell malignancies treated for a median of 36 months (range, 0 to 98 months), the cumulative rate of hypertension increased over time. The prevalence for Grade 3 or greater hypertension was 4% (year 0-1), 7% (year 1-2), 9% (year 2-3), 9% (year 3-4), and 9% (year 4-5); the overall incidence for the 5-year period was 11%.1

ADR=adverse drug reaction, AR=adverse reaction, CLL=chronic lymphocytic leukemia, SLL=small lymphocytic lymphoma, WM=Waldenström's Macroglobulinemia.

Reference: 1IMBRUVICA® (ibrutinib) Prescribing Information.