安立適膠囊150毫克

Country: Taívan

Tungumál: kínverska

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

Virkt innihaldsefni:

Alectinib HCl

Fáanlegur frá:

台灣中外製藥股份有限公司 台北市松山區敦化北路260號3樓 (23060795)

ATC númer:

L01ED03

Lyfjaform:

膠囊劑

Samsetning:

Alectinib HCl (1013006110) (equivalent to Alectinib......150mg)MG

Einingar í pakka:

鋁箔盒裝

Tegund:

製　劑

Gerð lyfseðils:

須由醫師處方使用

Framleitt af:

BUSHU PHARMACEUTICALS LTD. MISATO FACTORY 950 HIROKI OHAZA MISATO-MACHI KODAMA-GUN SAITAMA-KEN, JAPAN JP

Lækningarsvæði:

alectinib

Ábendingar:

ALECENSA®適用於治療ALK陽性的晚期非小細胞肺癌(NSCLC)患者。

Vörulýsing:

有效日期: 2027/01/21; 英文品名: ALECENSA 150mg capsules

Leyfisdagur:

2017-01-21

Upplýsingar fylgiseðill

1
ALECENSA
®
ALK
NSCLC
2
2.1
ALK
NSCLC
ALK
ALECENSA
®
ALK
ALK
1
14
2.2
ALECENSA
®
600
12.3
ALECENSA
®
Child-Pugh C
ALECENSA
450
8.7
12.3
ALECENSA
®
ALECENSA
®
ALECENSA
®
2.3
ALECENSA
®
1
1.
ALECENSA
®
600
450
300
300
ALECENSA
®
2
2.
ALECENSA
®
A
ALECENSA
®
ALT
AST
5
ULN
2
ULN
3
ULN
1
ALT
AST
3
ULN
2
ULN
ALECENSA
®
3
ULN
1.5
ULN
1
ILD
/
pneumonitis
ALECENSA
®
3
1.5
ULN
1
4
ALECENSA
®
ALECENSA
®
60 bpm
60 bpm
ALECENSA
®
60 bpm
1
ALECENSA
®
30
89
/
alectinib
M4
30
/
alectinib
300
ALECENSA
®
alectinib
M4
AUC
inf
Child-Pugh B
[
90
CI
]
1.36
[
0.947,1.96
]
Child-Pugh
C
[
90
CI
]
1.76
[
0.984,3.15
]
Alectinib
M4
C
max
ALECENSA
®
450
2.2
8.7
Alectinib
ALECENSA
®
CYP3A
posaconazole
CYP3A
rifampin
esomeprazole
alectinib
M4
Alectinib
ALECENSA
®
midazolam
CYP3A
repaglinide
CYP2C8
alectinib
M4
CYP1A2
2B6
2C9
2C19
2D6
alectinib
M4
P-gp
BCRP
Alectinib
OATP1B1
OATP1B3
OAT1
OAT3
OCT2
13
13.1
alectinib
Alectinib
Ames
alectinib
14
ALK
NSCLC
ALECENSA
®
ALK
NSCLC
ALEX
ECOG PS
0-2
Ventana ALK D5F3 CDx
ALK
14
QTc
> 470 ms
1:1
ALECENSA
®
600
crizotinib
250
ECOG PS 0/1 vs. 2
vs.
CNS
vs.
RECIST v1.1
PFS
IRC
PFS
IRC
RECIST v1.1
CNS
ORR
DOR
OS
CNS
IRC
CNS
CNS-ORR
CNS
CNS-DOR
3 0 3
ALECENSA
®
n = 1 5 2
c r i z o t i n i b
n=151
56%
56
18-91
50%
46%
1%
3%
92%
63%
40% n=122
CNS
43
IRC
CNS
ALEX
ALECENSA
®
PFS
IRC
CNS
crizotinib
ALECENSA
®
CNS
crizotinib
45% vs. ALECENSA
®
12%
ALEX
7
1
7.
ALEX
IRC
ALECENSA
N=152
CRIZOTINIB
N=151
%
63 41%
92 61%
%
51 34%
82 54%
%
12 8%
10 7%
95% CI
25.7 19.9, NE
10.4 7.7, 14.6
95% CI
a
0.53 0.38, 0.73
74%
60% CNS
65%
CNS
43%
36%
34%
NP28673
138
52
22
79
10%
65
67%
26%
56%
32%
ECOG PS
0
59%
ECOG PS
1
98%
99%
IV
96%
80%
61% CNS
73%
CNS
51%
38%
30%
NP28761
NP28673
9
NP28761
IRC
17
NP28673
21
IRC
2
NP28761
3
NP28673
9.
NP28761
NP28673
NP28761 N=87
NP28673 N=138
IRC*
IRC*
95% CI
42.5%
32.0 53.6
52.9%
41.9 63.7
44.9%
36.5 53.6
51.4%
42.8 60
37
46
62
71
95% CI
14.9
7.5
13.3
8.8 18.2
15.2
11.2 24.9
13.7
11.0 20.3
*
20
NP28761
16
NP28673
IRC
IRC
NP28761
NP28673
50
CNS
RECIST v1.1
CNS
ORR
10
34