克瘤康膠囊100毫克

Country: Taiwan

Language: Chinese

Source: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

Active ingredient:

acalabrutinib

Available from:

臺灣阿斯特捷利康股份有限公司 台北市大安區敦化南路二段207號21樓 (16440975)

ATC code:

L01EL02

Pharmaceutical form:

膠囊劑

Composition:

acalabrutinib (1013008800) MG

Units in package:

ALU-ALU鋁箔盒裝

Class:

製　劑

Prescription type:

須由醫師處方使用

Manufactured by:

ASTRAZENECA AB SE-151 85 SODERTALJE SWEDEN SE

Therapeutic area:

acalabrutinib

Therapeutic indications:

1.先前曾接受至少一種治療的被套細胞淋巴瘤 (Mantle Cell Lymphoma, MCL) 成年病人。2.慢性淋巴球性白血病 (Chronic Lymphocytic Leukemia, CLL) 或小淋巴球性淋巴瘤 (Small Lymphocytic Lymphoma, SLL) 成年病人。

Product summary:

有效日期: 2026/03/25; 英文品名: Calquence Capsules 100mg

Authorization date:

2021-03-25

Patient Information leaflet

100
CALQUENCE
® CAPSULES 100 MG
028047
1
1.1
MCL
Mantle Cell Lymphoma, MCL
Overall response rate
1.2
CLLSLL
Chronic lymphocytic leukemia, CLL
Small lymphocytic lymphoma, SLL
2
2.1
CALQUENCE
MCL
CLL
SLL CALQUENCE
100 mg
12
CALQUENCE
Obinutuzumab
CLL
SLL CALQUENCE
100 mg
12
28
1
CALQUENCE obinutuzumab
2
6
obinutuzumab
CALQUENCE
obinutuzumab
CALQUENCE
CALQUENCE
3
CALQUENCE
2.2
CALQUENCE
8.6
12.3
2.3
CYP3A
1
7
1
CYP3A
CYP3A
CALQUENCE
CYP3A
7
CALQUENCE
CYP3A
100 mg
CYP3A
CALQUENCE
12
200 mg
PPI
7
H2
H2
2
CALQUENCE
7
*
2 7
2.4
2
3
CALQUENCE
2
=100 mg
12
3
3
4
4
7
CALQUENCE
1 baseline
100 mg
12
CALQUENCE
CALQUENCE
1
100 mg
CALQUENCE
CALQUENCE
NCI CTCAE
obinutuzumab
obinutuzumab
3
100 mg
4
11
5
5.1
CALQUENCE
CALQUENCE
1029
19%
3
11%
6% 3
4 neutropenic infection
1.9%
CALQUENCE
B
Pneumocystis jiroveci
Epstein-Barr
cytomegalovirusPML
5.2
CALQUENCE
CALQUENCE
1029
3.0%
3
0.1%
22%
CALQUENCE
CALQUENCE
2.7% major
hemorrhage
CALQUENCE
3.6%
CALQUENCE
CALQUENCE 3-7
5.3
CALQUENCE 3
4 23%8%7%
7%
12%
4
2.4
5.4
CALQUENCE
1029
12%
6%
5.5
CALQUENCE
1029
1.1%
3
4.1%
6
• 5.1
• 5.2
• 5.3
• 5.4
• 5.5
6.1
1029
CALQUENCE
100
mg
12 6
820
CALQUENCE
2
209
CALQUENCE
obinutuzumab
CALQUENCE 88%
6 79%
1029 pooled safety population
≥
30%
MCL
LY-004
124
MCL
CALQUENCE
100
mg
12
14.1
CALQUENCE
16.6
0.1
26.6
91
73.4%
CALQUENCE
≥
6 74
59.7%
≥
1
≥
20%
1
25%16%20%15%
19%
3
2%
1.6% 6.5%
3
4
CALQUENCE
MCL
3
LY-004
≥
5% MCL
*
*
CALQUENCE
N=124
%
≥
3
%
39
1.6
31
3.2
19
0. 8
15
1.6
15
-
13
1.6
28
0.8
21
0.8
a
21
-
b
18
0.8
c
8
0.8
6
-
*
NCI CTCAE 4.03
a
b
c
4
LY-004
≥
20% MCL
*
CALQUENCE
N=124
%
≥
3
%
46
10
44
12
36
15
*
NCI CTCAE 4.03
4.8%
1.5
3
511
CLL
CALQUENCE
100 mg
12
obinutuzumab 14.2
CLL
≥
30%
ELEVATE-TN
CLL CALQUENCE
obinutuzumab CALQUENCE+G
CALQUENCE obinutuzumab
chlorambucil
GClb
14.2
CALQUENCE+G
CALQUENCE
obinutuzumab
CALQUENCE
2
1
obinutuzumab
6
CALQUENCE
1
1
CALQUENCE
12
CALQUENCE
65
18
65
CIRS > 6
30
69 mL/min
酶
≤
3
ULN
≤
ULN
1.5
warfarin
K
C A L Q U E N C E + G
C A L Q U E N C E
CALQUENCE
27.7 0.3
40
95%
92%
6
89