思得適錠 100毫克

国家: 台湾

语言: 中文

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

有效成分:

Idelalisib

可用日期:

香港商吉立亞醫藥有限公司台灣分公司 臺北市信義區松仁路32號10樓之1、36號10樓之1 (54376860)

药物剂型:

膜衣錠

组成:

主成分 () ; Idelalisib (1013005900) MG

每包单位数:

HDPE瓶裝

类:

製　劑

处方类型:

須由醫師處方使用

厂商:

GILEAD SCIENCES IRELAND UC IDA BUSINESS & TECHNOLOGY PARK, CARRIGTOHILL COUNTY CORK, IRELAND IE

疗效迹象:

(1)復發性慢性淋巴球性白血病(2)復發性濾泡型B細胞菲何杰金氏淋巴瘤(3)復發性小淋巴球性淋巴瘤

產品總結:

註銷日期: 2016/11/24; 註銷理由: 自請註銷; 有效日期: 2021/08/05; 英文品名: ZYDELIG Tablets 100MG

授权状态:

已註銷

授权日期:

2016-08-05

资料单张

100
GSI
100
4
5
5.1
Zydelig
PCP/
PJP
CMV
6.1
Zydelig
Zydelig
PCR
2.2
5.8
5.2
Zydelig
14%
/
ALT
AST
5
6.1
12
26%
ALT
AST
Zydelig
Zydelig
3
2
ALT
AST
3
4
1
3
ALT
AST
3
ALT
AST
5
Zydelig
AST
ALT
2.2
5.3
Zydelig
14%
3
6.1
Zydelig
Zydelig
Zydelig
1
1
2.2
5.4
PNEUMONITIS
Zydelig
Zydelig
X
5%
Zydelig
Zydelig
Zydelig
5.5
Zydelig
Zydelig
5.6
Zydelig
rituximab
bendamustine
TEN
Zydelig
≥
3
Zydelig
5.7
Zydelig
Zydelig
5.8
Zydelig
31%
3
4
6.1
3
2
1.0 Gi/L
2.2
5.9
Zydelig
150
12
idelalisib
8.1
Zydelig
Zydelig
1
8.6
6
Zydelig
•
5.1
•
5.2
•
5.3
•
5.4
•
5.5
•
5.6
•
5.7
•
5.8
6.1
1
Zydelig
218
CLL
8
rituximab
Zydelig 150
Zydelig
5
54 49%
Zydelig + rituximab
Zydelig
≥
2%
17%
9%
8%
5%
5%
11
10%
Zydelig
/
39
35%
16
15%
酶
Zydelig + rituximab
3
pneumocystis jiroveri pneumonia
rituximab
1
2
3
Zydelig + rituximab
+ rituximab
2
≥
5% CLL
Zydelig
≥
2%
Zydelig + R
N=110%
+ R
N=108%
≥
3
≥
3
2825
0
2321
0
1413
0
98
0
a
2321
65
1716
0
76
0
11
0
76
22
22
0
1110
11
55
0
3835
33
1817
11
2321
22
1716
0
87
0
22
0
b
2018
44
76
11
c
2523
1816
1918
1413
65
0
22
0
d
98
87
44
44
76
11
33
11
98
0
44
0
65
0
33
22
87
11
44
11
a
b
c
d
R
rituximab
3
≥
10% CLL
Zydelig
≥
5%
Zydelig + R
N=110%
+ R
N=108%
3-4
3-4
6660
4137
5551
2927
2220
109
1312
44
2725
2018
109
55
AL
T
3835
98
1110
11
AST
2725
65
1514
0
GGT
2926
22
1514
33
6256
33
3734
0
5954
87
5046
22
1211
0
55
0
2220
22
1615
76
CTCAE
4.03
R
rituximab
146
Zydelig
Zydelig 150
6.1
0.3
26.4
73 50%
15%
11%
9%
78
53%
11%
11%
酶
10%
4
10%
Zydelig
5
4
Zydelig 150
BID
≥
10%
Zydelig
N=146%
≥
3
a
6847
2014
4229
21
b
3826
32
2215
21
4430
21
4128
32
1712
32
1510
32
1812
0
c
3725
2316
4229
11
2517
64
d
3121
43
1812
0
1611
11
2416
11
1712
0
a
b
c
d
5
Zydelig 150
BID
Zydelig Monotherapy
N=146%
•
Zydelig
PCP/PJP
CMV
Zydelig
Zydelig PCR
2.2
5.1
•
Zydelig
14%
/
Zydelig
2.2
5.2
•
Zydelig
14%
Zydelig
2.2
5.3
•
Zydelig
Zydelig
2.2
5.4
•
Zydelig
Zydelig
2.2
5.5
1
1.1
Z y d e l i g
r i t u x i m a b
rituximab
CLL
1.2
B
Zydelig
B
Fellicular L
ymphoma
14.2
1.3
Zydelig
Small L
ymphocyti