MONOTHERAPY ADVERSE REACTIONS

Demonstrated safety profile1

Non-Hematologic ARs in ≥10% in patients with WM1

iNNOVATE™ Monotherapy Arm, Study 1118 trials (N=94)1

Median duration of treatment was 11.7 months for Study 1118 and 33 months for iNNOVATE™

Body SystemAdverse ReactionsAll Grades (%)Grade 3 or Higher (%)
Gastrointestinal disordersDiarrhea382
Nausea210
Stomatitis*150
Constipation121
Gastroesophageal reflux disease120
Skin and subcutaneous tissue disorders Bruising*281
Rash*211
Vascular disordersHemorrhage*280

Hypertension*

144
General disorders and administrative site conditionsFatigue182
Pyrexia122
Musculoskeletal and connective tissue disordersMusculoskeletal pain*210
Muscle spasms190
Infections and infestationsUpper respiratory tract infection190
Skin infection*183
Sinusitis*160
Pneumonia*135
Nervous system disordersHeadache140
Dizziness130
Respiratory, thoracic and mediastinal disordersCough130

 The body system and individual ADR preferred terms are sorted in descending frequency order.
*Includes multiple ADR terms.

Treatment-emergent hematologic laboratory abnormalities in patients with WM

iNNOVATE™ Monotherapy Arm, Study 1118 trials (N=94)1

Median duration of treatment was 11.7 months for Study 1118 and 33 months for iNNOVATE™

 All Grades (%)Grade 3 or 4 (%)
Platelets decreased3811
Neutrophils decreased4316
Hemoglobin decreased216

Treatment-emergent Grade 4 thrombocytopenia (4%) and neutropenia (7%) occurred in patients.

Discontinuation and dose reduction rates in the WM trials

  • 5% of patients discontinued due to ARs
  • 14% of patients had a dose reduction due to ARs


ADR=adverse drug reaction, AR=adverse reaction, WM=Waldenström's macroglobulinemia.

References: 1IMBRUVICA® (ibrutinib) Prescribing Information. 2Data on file.