德邁特膜衣錠225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:

Tepotinib Hydrochloride Hydrate

可用日期:

台灣默克股份有限公司 台北市內湖區堤頂大道2段89號6樓 (23526610)

ATC代码:

L01EX21

药物剂型:

膜衣錠

组成:

Tepotinib Hydrochloride Hydrate (1013009200) (equivalent to 225 mg tepotinib)MG

每包单位数:

鋁箔盒裝

类:

製　劑

处方类型:

須由醫師處方使用

厂商:

Merck Healthcare KGaA FRANKFURTER STRASSE 250, 64293 DARMSTADT, GERMANY DE

治疗领域:

tepotinib

疗效迹象:

適用於治療帶有導致間質上皮轉化因子外顯子14跳讀式突變(MET exon 14 skipping mutation)的轉移性之非小細胞肺癌(NSCLC)成人病人。

產品總結:

有效日期: 2026/09/08; 英文品名: TEPMETKO film-coated Tablets 225 mg

授权日期:

2021-09-08

资料单张

1.
TEPMETKO
-14
MET exon 14 skipping mutation
NSCLC
[
12
]
2.
2.1
METEX14
MET
14
TEPMETKO
MET
14
2.2
TEPMETKO
450
[
10.3
]
TEPMETKO
8
TEPMETKO
2.3
TEPMETKO
225
TEPMETKO
225
TEPMETKO
1
1
TEPMETKO
ILD /
pneumonitis
[
5.1
]
ILD
TEPMETKO
ILD
TEPMETKO
ALT
/
AST
[
5.2
]
3
TEPMETKO
ALT/AST
7
TEPMETKO
TEPMETKO
4
TEPMETKO
ALT
/
AST
[
5.2
ALT
/
AST
3
2
TEPMETKO
ALT
/
AST
[
5.2
]
3
TEPMETKO
7
TEPMETKO
TEPMETKO
4
TEPMETKO
[
6.1
]
3
TEPMETKO
TEPMETKO
4
TEPMETKO
3.
225
M
4.
5.
5.1
ILD /
PNEUMONITIS
TEPMETKO
ILD/
[
6.1
]
TEPMETKO
2.2%
ILD/
3
4
0.9%
ILD/
TEPMETKO
I L D /
ILD/
TEPMETKO
I L D /
TEPMETKO
[
2.3
]
5.2
TEPMETKO
13%
TEPMETKO
AST/ALT Grade 3
4 ALT/AST
4.2%
0.2%
0.7%
ALT/AST
TEPMETKO
Grade 3
ALT/AST
30 1~178
ALT/AST
Grade 3
ALT/AST
A L T
A S T
TEPMETKO
TEPMETKO
[
2.3
]
5.3
–
TEPMETKO
tepotinib
450
[
AUC
]
TEPMETKO
1
[
8.1, 8.3
]
6.
•
/
[
5.1
]
•
[
5.2
]
6.1
448
T E P M E T K O
4 5 0
VISION
TEPMETKO
255
METex14
NSCLC 448
TEPMETKO
32%
6 12%
1
VISION
255
METex14
NSCLC
TEPMETKO
450
[
12
]
T E P M E T K O
4 5 %
treatment-emergent
2%
7%
pneumonia
5%
3 . 9 %
3 . 9 %
3.5%
2%
2%
fluid overload
0.4%
TEPMETKO
20%
treatment-emergent adverse event
TEAE
TEPMETKO
TEAE
> 1%
5%
2%
1.6%
1.6%
1.2%
TEPMETKO
44%
TEAE
TEPMETKO
2%
TEAE
23%
6%
4.3%
ALT
3.1%
2.4%
TEPMETKO
30%
TEAE
TEPMETKO
2%
TEAE
19%
2.7%
2.7%
TEPMETKO
TEAE
≥
20%
3
4
≥
2%
ALT
AST
2
VISION
TEAE
2 VISION 10%
METEX14
NSCLC
TEAE
TEPMETKO
N=255
%
3
4
%
a
70
9
b
27
1.6
27
0.8
26
0.4
c
16
0.8
16
0
d
13
1.2
e
24
2.4
f
20
2
g
15
0.4
13
5
16
1.2
h
11
3.9
a
b
c
d
e
f
g
h
TEPMETKO
10%
TEAE
ILD
3
VISION
3 VISION
TEPMETKO
≥
20%
TEPMETKO
1
1
4
%
3
4
%
76
9
55
0.4
50
1.6
ALT
44
4.1
AST
35
2.5
31
8
25
1.6
24
5
23
4.6
48
11
27
2
23
0.8
1
207
246
TEPMETKO
20%
18%
3.7%
3
4
TEPMETKO
21
31%
7.
7.1
TEPMETKO
CYP3A
P
CYP3A
P
TEPMETKO
CYP3A
P
tepotinib
[
10.3
]
TEPMETKO
TEPMETKO
CYP3A
P
CYP3A
CYP3A
TEPMETKO
CYP3A
tepotinib
[
10.3
]
TEPMETKO TEPMETKO
CYP3A
7.2 TEPMETKO
P
Tepotinib
P
TEPMETKO
P
[
10.3
]
P
TEPMETKO
P
P
P
8.
8.1
[
10.1
]
TEPMETKO
TEPMETKO
tepotinib
450
[
AUC
]
2–4%
15–20%
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