AstraZenica
Calquence
First Line of 
Treatment
page 6 of 7
4C
(near CLL-SLL)
CALQUENCE® (acalabrutinib) tablets, for oral use
4
12 months. The median duration of exposure to idelalisib was 
11.5 months with 72% of patients on treatment for greater than 
6 months and 48% of patients on treatment for greater than 
12 months. Eighty-three percent of patients completed 6 cycles of 
bendamustine and rituximab product.
Table 11: Common Adverse Reactions (≥ 15% Any Grade) with 
CALQUENCE in Patients with CLL (ASCEND)
Body System
Adverse Reaction*
CALQUENCE
N=154
Idelalisib plus 
Rituximab 
Product 
N=118
Bendamustine 
plus Rituximab 
Product
N=35
All 
Grades 
(%)
Grade 
≥ 3  
(%)
All 
Grades 
(%)
Grade 
≥ 3  
(%)
All 
Grades 
(%)
Grade 
≥ 3  
(%)
Infections 
Infection†
56
15‡
65
28‡
49
11
Upper respiratory 
tract infection§
29
1.9
26
3.4
17
2.9
Lower respiratory 
tract infectiona
23
6
26
15
14
6
Blood and lymphatic system disordersb
Neutropeniac
48
23
79
53
80
40
Anemiad
47
15
45
8
57
17
Thrombocytopeniae 
33
6
41
13
54
6
Lymphocytosisf
26
19
23
18
2.9
2.9
Nervous system disorders
Headache
22
0.6
6
0
0
0
Gastrointestinal disorders
Diarrheag
18
1.3
49
25
14
0
Vascular disorders
Hemorrhageh
16
1.3
5
1.7
6
2.9
General disorders 
Fatiguei
15
1.9
13
0.8
31
6
Musculoskeletal and connective tissue disorders
Musculoskeletal 
painj
15
1.3
15
1.7
2.9
0
*Per NCI CTCAE version 4.03.
† Includes any adverse reactions involving infection or febrile neutropenia.
‡ Includes 1 fatal case in the CALQUENCE monotherapy arm and 1 fatal case in the 
Idelalisib plus Rituximab arm.
§ Includes upper respiratory tract infection, rhinitis and nasopharyngitis.
a Includes pneumonia, lower respiratory tract infection, bronchitis, bronchiolitis, 
tracheitis, and lung infection.
b Derived from adverse reaction and laboratory data.
c Includes neutropenia, neutrophil count decreased, and related laboratory data.
d Includes anemia, red blood cell decreased, and related laboratory data.
e  Includes thrombocytopenia, platelet count decreased, and related laboratory data.
f  Includes lymphocytosis, lymphocyte count increased and related laboratory data.
g Includes colitis, diarrhea, and enterocolitis.
h Includes hemorrhage, hematoma, hemoptysis, hematuria, menorrhagia, 
hemarthrosis, and epistaxis.
i  Includes asthenia, fatigue, and lethargy.
j Includes back pain, musculoskeletal chest pain, musculoskeletal pain, 
musculoskeletal discomfort, pain in extremity, myalgia, spinal pain and bone pain.
Other clinically relevant adverse reactions (all grades incidence 
< 15%) in recipients of CALQUENCE included:
•  Skin and subcutaneous disorders: bruising (10%), rash (9%)
•  Neoplasms: second primary malignancy (12%), non-melanoma 
skin cancer (6%)
•  Musculoskeletal and connective tissue disorders: arthralgia (8%)
•  Cardiac disorders: atrial fibrillation or flutter (5%), hypertension 
(3.2%)
•  Infection: herpesvirus infection (4.5%)
Table 12: Select Non-Hematologic Laboratory Abnormalities 
(≥ 10% Any Grade), New or Worsening from Baseline in Patients 
Receiving CALQUENCE  (ASCEND)
Laboratory
Abnormalitya
CALQUENCE 
N=154
Idelalisib plus 
Rituximab 
Product
N=118
Bendamustine 
plus Rituximab 
Product
N=35
All 
Grades 
(%)
Grade  
≥ 3 
(%)
All 
Grades 
(%)
Grade  
≥ 3 
(%)
All 
Grades 
(%)
Grade 
≥ 3 
(%)
Uric acid increase
15
15
11
11
23
23
ALT increase
15
1.9
59
23
26
2.9
AST increase
13
0.6
48
13
31
2.9
Bilirubin increase
13
1.3
16
1.7
26
11
Per NCI CTCAE version 5.
a Excludes electrolytes.
Increases in creatinine to 1.5 to 3 times ULN occurred in 1.3% of 
patients who received CALQUENCE.
AMPLIFY
The safety of CALQUENCE in patients with previously untreated 
CLL was evaluated in a randomized, multicenter, open-label study 
(AMPLIFY), in which 291 patients received CALQUENCE plus 
venetoclax (AV), and 259 patients received Investigator’s choice of 
FCR/BR (fludarabine plus cyclophosphamide plus rituximab or 
bendamustine plus rituximab) [see Clinical Studies (14.3) in the 
full Prescribing Information].
Among patients who received AV, 96% were exposed for 6 months 
or longer and 91% were exposed for greater than one year. The 
median duration of exposure to CALQUENCE was 12.9 months 
(range: 1 to 18 months) and to venetoclax was 11.1 months (range: 
2 to 14 months).
Serious adverse reactions occurred in 25% of patients receiving AV. 
The most common serious adverse reactions (≥ 2%) were COVID-19 
including COVID-19 pneumonia (9%), second primary malignancies 
(2.7%), and neutropenia (2.1%). Fatal adverse events occurred in 
3.4% of patients. The most common fatal adverse events included 
COVID-19 and COVID-19 pneumonia.
Treatment discontinuation of CALQUENCE due to adverse reactions 
occurred in 8% of patients receiving AV. The most common adverse 
reaction (≥ 2%) leading to treatment discontinuation was COVID-19 
pneumonia (2.1%). Dose reduction of CALQUENCE occurred in 6% 
of patients. Neutropenia was the only adverse reaction leading to 
dose reduction that occurred in ≥ 1% of patients.
Table 13 and Table 14 summarize select adverse reactions and 
laboratory abnormalities observed in patients treated in AMPLIFY.
Table 13: Adverse Reactions* (≥ 15% Any Grade) in Patients 
with Previously Untreated CLL Who Received CALQUENCE plus 
Venetoclax in AMPLIFY
Body System
Adverse Reactions*
CALQUENCE plus 
Venetoclax  
N = 291
Investigator’s 
choice of  
FCR or BR
N = 259
All 
Grades 
(%)
Grade
3 or 4 
(%)
All 
Grades 
(%)
Grade
3 or 4 
(%)
Nervous system disorders
Headache
35
1.4
8
0.4
Gastrointestinal disorders
Diarrhea
33
1.7
11
0.4
Nausea
15
0
36
0
Musculoskeletal and connective tissue disorders
Musculoskeletal pain a
25
0.7
14
0.8
Infections
COVID-19
21
6
3.9
1.5
General disorders
Fatigue b
18
0.3
17
1.5
Skin and subcutaneous tissue disorders
Bruising c
17
0
1.5
0
Rash d
16
1
16
1.5
*Excludes laboratory terms.
a Includes back pain, bone pain, musculoskeletal chest pain, musculoskeletal 
pain, musculoskeletal discomfort, myalgia, neck pain, pain in extremity, 
spinal pain, non-cardiac chest pain and pain in jaw.
b Includes fatigue and asthenia.
c Includes increased tendency to bruise, contusion, and ecchymosis.
d Includes rash, dermatitis, and other related terms.
Clinically relevant adverse reactions in < 15% of patients receiving 
CALQUENCE plus Venetoclax included upper respiratory tract 
infections, lower respiratory tract infection, arthralgia, pneumonia, 
hemorrhage, dizziness, constipation, vomiting, second primary 
malignancy and hypertension.
Table 14: Laboratory Abnormalities (≥ 15% Any Grade), New or 
Worsening from Baseline in Patients with Previously Untreated 
CLL Who Received CALQUENCE plus Venetoclax in AMPLIFY
Laboratory Abnormality
CALQUENCE 
plus  
Venetoclax a
Investigator’s 
choice of  
FCR or BR a
All 
grade 
(%)
Grade
3 or 4 
(%)
All 
grade 
(%)
Grade
3 or 4 
(%)
Hematologic Abnormalities
Neutrophils decreased
78
38
80
53
Lymphocytes decreased
56
12
92
73
Platelets decreased
43
5
59
15
Hemoglobin decreased
35
7
56
8
Laboratory Abnormality
CALQUENCE 
plus  
Venetoclax a
Investigator’s 
choice of  
FCR or BR a
All 
grade 
(%)
Grade
3 or 4 
(%)
All 
grade 
(%)
Grade
3 or 4 
(%)
Chemistry Abnormalities
Glucose increased
74
0
84
0
Calcium decreased
30
0.7
25
2.3
ALT increased
26
3.1
28
1.6
Urate increased
25
25
23
23
LDH increased
24
0
40
0
Potassium increased
22
2.4
12
3.1
AST increased
22
1.4
28
1.6
ALP increased
20
0
15
0
Glucose decreased
20
0.3
5
0
Creatinine increased
19
0.3
12
0.8
Sodium increased
15
0.3
9
0.4
a The denominator used to calculate the rate varied between 256 and 290 
based on the number of patients with a baseline value and at least one 
post-treatment value.
Grade 4 laboratory abnormalities in > 15% of patients treated with 
CALQUENCE plus Venetoclax include absolute neutrophil count 
decreased (15%).
Postmarketing Experience 
The following adverse reactions have been identified during 
post-approval use of CALQUENCE. Because these reactions are 
reported voluntarily from a population of uncertain size, it is not 
always possible to reliably estimate their frequency or establish a 
causal relationship to drug exposure.
• Cardiac disorders: ventricular arrhythmias
•  Hepatobiliary disorders: drug-induced liver injury
DRUG INTERACTIONS 
Effect of Other Drugs on CALQUENCE
Strong CYP3A Inhibitors
Clinical Effect
Co-administration of CALQUENCE with a strong 
CYP3A inhibitor increased acalabrutinib plasma 
concentrations [see Clinical Pharmacology (12.3) 
in the full Prescribing Information]. Increased 
acalabrutinib concentrations may result in 
increased toxicity.
Prevention or 
Management
Avoid co-administration of CALQUENCE with 
strong CYP3A inhibitors. Alternatively, if the  
inhibitor will be used short-term, interrupt 
CALQUENCE [see Dosage and Administration  
(2.2) in the full Prescribing Information].
Moderate CYP3A Inhibitors
Clinical Effect
Co-administration of CALQUENCE with a  
moderate CYP3A inhibitor may increase 
acalabrutinib plasma concentration [see Clinical 
Pharmacology (12.3) in the full Prescribing 
Information]. Increased acalabrutinib  
concentrations may result in increased toxicity.
Prevention or 
Management
Reduce the dosage of CALQUENCE when  
co-administered with a moderate CYP3A  
inhibitor [see Dosage and Administration (2.2)  
in the full Prescribing Information].
Strong CYP3A Inducers
Clinical Effect
Co-administration of CALQUENCE with a strong 
CYP3A inducer decreased acalabrutinib plasma 
concentration [see Clinical Pharmacology (12.3) 
in the full Prescribing Information]. Decreased 
acalabrutinib concentrations may reduce 
CALQUENCE activity.
Prevention or 
Management
Avoid co-administration of CALQUENCE with 
strong CYP3A inducers. If co-administration is 
unavoidable, increase the dosage of CALQUENCE 
[see Dosage and Administration (2.2) in the full 
Prescribing Information].
Table 14: Laboratory Abnormalities (≥ 15% Any Grade), New or 
Worsening from Baseline in Patients with Previously Untreated 
CLL Who Received CALQUENCE plus Venetoclax in AMPLIFY 
(cont’d)

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