IMBRUVICA® (ibrutinib) capsules
IMBRUVICA® (ibrutinib) capsules
Table 7: Non-Hematologic Adverse Reactions in ≥ 10% of Patients with
Waldenström’s Macroglobulinemia (N=63) (continued)
Table 4: Treatment-Emergent* Decrease of Hemoglobin, Platelets,
or Neutrophils in Patients with CLL (N=48) in Study 1
Percent of Patients (N=48)
All Grades
Grade 3 or 4
(%)
(%)
71
10
54
27
44
0
Platelets Decreased
Neutrophils Decreased
Hemoglobin Decreased
* Based on laboratory measurements per IWCLL criteria and adverse reactions
Study 2: Adverse reactions and laboratory abnormalities described below in Tables 5 and 6 reflect
exposure to IMBRUVICA with a median duration of 8.6 months and exposure to ofatumumab with a
median of 5.3 months in Study 2.
Table 5: Non-Hematologic Adverse Reactions ≥ 10% Reported in Study 2
System Organ Class
ADR Term
Gastrointestinal disorders
Diarrhea
Nausea
Stomatitis*
Constipation
Vomiting
General disorders and
administration site conditions
Fatigue
Pyrexia
Infections and infestations
Upper respiratory tract
infection
Pneumonia*
Sinusitis*
Urinary tract infection
Skin and subcutaneous tissue
disorders
Rash*
Petechiae
Bruising*
Musculoskeletal and
connective tissue disorders
Musculoskeletal Pain*
Arthralgia
Nervous system disorders
Headache
Dizziness
Injury, poisoning and
procedural complications
Contusion
Eye disorders
Vision blurred
IMBRUVICA
(N=195)
All Grades
Grade 3 or 4
(%)
(%)
Ofatumumab
(N=191)
All Grades
Grade 3 or 4
(%)
(%)
48
26
17
15
14
4
2
1
0
0
18
18
6
9
6
2
0
1
0
1
28
24
2
2
30
15
2
1
16
15
11
10
1
10
1
4
11
13
6
5
2
9
0
1
24
14
12
3
0
0
13
1
1
0
0
0
28
17
2
1
18
7
1
0
14
11
1
0
6
5
0
0
11
0
3
0
10
0
3
0
Subjects with multiple events for a given ADR term are counted once only for each ADR term.
The system organ class and individual ADR terms are sorted in descending frequen 7