抑癌特膜衣錠 5 毫克

Valsts: Taivāna

Valoda: ķīniešu

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

Aktīvā sastāvdaļa:

AXITINIB

Pieejams no:

輝瑞大藥廠股份有限公司 台北市信義區松仁路100號42、43樓 (37199708)

ATĶ kods:

L01EK01

Zāļu forma:

膜衣錠

Kompozīcija:

AXITINIB (1013003200) MG

Vienības iepakojumā:

鋁箔盒裝;;塑膠瓶裝

Klase:

製　劑

Receptes veids:

須由醫師處方使用

Ražojis:

PFIZER MANUFACTURING DEUTSCHLAND GMBH BETRIEBSSTATTE FREIBURG, MOOSWALDALLEE 1, 79090 FREIBURG, GERMANY DE

Ārstniecības joma:

axitinib

Ārstēšanas norādes:

治療已接受過sunitinib或cytokine治療失敗的晚期腎細胞癌病患。

Produktu pārskats:

有效日期: 2027/11/13; 英文品名: INLYTA Film-Coated Tablets 5 mg

Autorizācija datums:

2012-11-13

Lietošanas instrukcija

1
INLYTA
sunitinib
cytokine
(
RCC
)
2
2.1
INLYTA
5
12 INLYTA
12.3
INLYTA
2.2
5
INLYTA
2
(
[
CTCAE
] )
7
7
INLYTA
10
INLYTA
(
)
INLYTA
5
5
3
2
CYP3A4/5
INLYTA
CYP3A4/5
(
ketoconazole
itraconazole
clarithromycin
atazanavir
indinavir
nefazodone
nelfinavir
ritonavir
saquinavir
telithromycin
voriconazole
)
CYP3A4/5
CYP3A4/5
CYP3A4/5
INLYTA
CYP3A4/5
INLYTA
axitinib
(
AUC
)
INLYTA
(
3-5
)
CYP3A4/5
7.1
12.3
(
Child-Pugh A
)
INLYTA
(
Child-Pugh
B
)
INLYTA
(
Child-Pugh C
)
INLYTA
5.12
8.6
12.3
3
INLYTA 1
Pfizer
1 XNB
INLYTA 5
Pfizer
5 XNB
4
5
5.1
INLYTA
RCC
145/359
(
40%
)
INLYTA
103/355
(
29%
)
sorafenib
56/359
(
16%
)
INLYTA
39/355
(
11%
)
sorafenib
3/4
2/359
(
< 1%
)
INLYTA
sorafenib
(
> 150 mmHg > 100 mmHg
)
INLYTA
INLYTA
4
1/359
(
< 1%
)
INLYTA
INLYTA
sorafenib
6.1
INLYTA
INLYTA
INLYTA
INLYTA
INLYTA
INLYTA
2.2
5.2
(
)
INLYTA
RCC
4/359
(
1%
)
INLYTA
4/355
(
1%
)
sorafenib
3/4
1/359
(
< 1%
)
INLYTA
sorafenib
6.1
INLYTA
17/715
(
2%
)
(
)
2
INLYTA
12
INLYTA
5.3
(
)
INLYTA
RCC
11/359
(
3%
)
INLYTA
2/355
(
1%
)
sorafenib
9/359
(
3%
)
INLYTA
2/355
(
1%
)
sorafenib
3/4
(
)
1/359
(
< 1%
)
INLYTA
sorafenib
INLYTA
22/715
(
3%
)
INLYTA
6
INLYTA
5.4
INLYTA
RCC
58/359
(
16%
)
INLYTA
64/355
(
18%
)
sorafenib
INLYTA
(
6%
)
(
3%
)
(
2%
)
(
2%
)
5/359
(
1%
)
INLYTA
11/355
(
3%
)
sorafenib
3/4
(
)
1/359
(
< 1%
)
INLYTA
(
)
3/355
(
1%
)
sorafenib
INLYTA
INLYTA
5.5
INLYTA
RCC INLYTA
6/359
(
2%
)
sorafenib
3/355
(
1%
)
INLYTA
2/359
(
1%
)
sorafenib
1/355
(
< 1%
)
3/4 INLYTA
2/359
(
1%
)
sorafenib
1/355
(
< 1%
)
INLYTA
INLYTA
5.6
INLYTA
RCC
1/359
(
< 1%
)
INLYTA
sorafenib
INLYTA
5/715
(
1%
)
4/715
(
1%
)
INLYTA
5.7
INLYTA
RCC
69/359
(
19%
)
INLYTA
29/355
(
8%
)
sorafenib
4/359
(
1%
)
INLYTA
4/355
(
1%
)
sorafenib
(
TSH
)
< 5 µU/mL
79/245
(
32%
)
INLYTA
25/232
(
11%
)
sorafenib
TSH ≥ 10 µU/mL
6.1
INLYTA
5.8
(
VEGF
)
INLYTA
2
INLYTA
2
INLYTA
INLYTA
5.9
INLYTA
RCC
1/359
(
< 1%
)
INLYTA
(
RPLS
)
sorafenib
6.1
INLYTA
RPLS
RPLS
RPLS
RPLS
INLYTA
RPLS
INLYTA
5.10
INLYTA
RCC
39/359
(
11%
)
INLYTA
26/355
(
7%
)
sorafenib
11/359
(
3%
)
INLYTA
6/