sp;5
Respiratory, thoracic and mediastinal disorders Cough 22 2
Dyspnea 21 2
Nervous system disorders Dizziness 19 0
Headache 13 0
Psychiatric disorders Anxiety 16 2
Table 12: Treatment-Emergent Hematologic Laboratory Abnormalities in Patients with MZL in Study 1121 (N=63)
Percent of Patients (N=63)
All Grades (%) Grade 3 or 4 (%)
Platelets Decreased 49 6
Hemoglobin Decreased 43 13
Neutrophils Decreased 22 13
Chronic Graft versus Host Disease
The data described below reflect exposure to IMBRUVICA in an open-label clinical trial (Study 1129) that included 42 patients with cGVHD after failure of first line corticosteroid therapy and required additional therapy.
The most commonly occurring adverse reactions in the cGVHD trial (≥ 20%) were fatigue, bruising, diarrhea, thrombocytopenia, stomatitis, muscle spasms, nausea, hemorrhage, anemia, and pneumonia. Atrial fibrillation occurred in one patient (2%) which was Grade 3.
Twenty-four percent of patients receiving IMBRUVICA in the cGVHD trial discontinued treatment due to adverse reactions. The most common adverse reactions leading to discontinuation were fatigue and pneumonia. Adverse reactions leading to dose reduction occurred in 26% of patients.
Adverse reactions and laboratory abnormalities described below in TABLES 13 and 14 reflect exposure to IMBRUVICA with a median duration of 4.4 months in the cGVHD trial.
Table 13: Non-Hematologic Adverse Reactions in ≥ 10% of Patients with cGVHD (N=42)
Body System Adverse Reaction All Grades
(%) Grade 3 or 4
(%)
The system organ class and individual ADR preferred terms are sorted in descending frequency order.
* Includes multiple ADR terms.
General disorders and administration site conditions Fatigue 57 12
Pyrexia 17 5
Edema peripheral 12 0
Skin and subcutaneous tissue disorders Bruising* 40 0
Rash* 12 0
Gastrointestinal disorders Diarrhea 36 10
Stomatitis* 29 2
Nausea 26 0
Constipation 12 0
Musculoskeletal and connective tissue disorders Muscle spasms 29 2
Musculoskeletal pain* 14 5
Vascular disorders Hemorrhage* 26 0
Infections and infestations Pneumonia* 21 10
Upper respiratory tract infection 19 0
Sepsis* 10 10
Nervous system disorders Headache 17 5
Injury, poisoning and procedural complications Fall 17 0
Respiratory, thoracic and mediastinal disorders Cough 14 0
Dyspnea 12 2
Metabolism and nutrition disorders Hypokalemia 12 7
Table 14: Treatment-Emergent Hematologic Laboratory Abnormalities in Patients with cGVHD (N=42)
Percent of Patients (N=42)
All Grades (%) Grade 3 or 4 (%)
Platelets Decreased 33 0
Neutrophils Decreased 10 10
Hemoglobin Decreased 24 2
Additional Important Adverse Reactions
Cardiac Arrhythmias
In randomized controlled trials (n=1227; median treatment duration of 13.1 months for patients treated with IMBRUVIC |
