"山德士"福坦注射劑250毫克/5毫升

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:

FULVESTRANT

可用日期:

台灣山德士藥業股份有限公司 臺北市中山區民生東路3段2號8樓 (90003886)

ATC代码:

L02BA03

药物剂型:

注射劑

组成:

FULVESTRANT (1010000900) MG

每包单位数:

注射針筒;;盒裝

类:

製　劑

处方类型:

限由醫師使用

厂商:

FAREVA Unterach GmbH MONDSEESTRASSE 11, 4866 UNTERACH AM ATTERSEE, AUSTRIA AT

治疗领域:

fulvestrant

疗效迹象:

治療己接受輔助抗雌激素療法，但疾病仍復發，或使用抗雌激素療法但疾病仍惡化的停經婦女，且其雌激素受體為陽性的局部晚期或轉移性乳癌。

產品總結:

有效日期: 2025/04/08; 英文品名: Fulvestrant Sandoz 250mg/5ml Solution for Inejction

授权日期:

2020-04-08

资料单张

“
”
250/5
FULVESTRANT SANDOZ 250MG/5ML SOLUTION FOR INJECTION
(FULVESTRANT)
027851
5fulvestrant 250
()
500 mg500 mg
Fulvestrant
(≥30 mL/min)(< 30 mL/min)
()
fulvestrant
fulvestrant
()
fulvestrant
5()(1-2/)
fulvestrant
•
• ()
• ()
fulvestrant
(
)
(
30 mL/min)fulvestrant
()
Fulvestrant
()Fulvestrant
fulvestrant
fulvestrant
fulvestrant
fulvestrant
() ()
midazolam (CYP3A4)
fulvestrantCYP3A4rifampin (CYP3A4)
ketoconazole (CYP3A4
)fulvestrant
CYP3A4fulvestrant ()
fulvestrant
fulvestrant ()
fulvestrant ()
fulvestrant
()fulvestrant
fulvestrantFulvestrantFulvestrantfulvestrant
fulvestrant (
)
Fulvestrant ()
Fulvestrantfulvestrant ()
(ALT,
AST, ALP)
(ADR) fulvestrant 500 mg fulvestrant 250 mg CONFIRM (D6997C00002
)FINDER 1 (D6997C00004
)FINDER 2 (D6997C00006 ) NEWEST (D6997C00003 )fulvestrant 500 mg
(SOC)(
≧
1/10)(
≧
1/100
<1/10)(
≧
1/1000
<1/100)
1
(SOC)
>10%
(
≧
1 - < 10%)
(
≧
0.1% - < 1%)
a
a
a
a
b
(ALT, AST, ALP)
a
a
c
c
γ
-GT
a
Fulvestrant
b
C
(CONFIRM, FINDER1, FINDER2, NEWEST)95%3/560 (560
)
“
” ()
fulvestrant ()
ATC
L02BA03
Fulvestrant(ER)(estradiol)Fulvestrant(trophic actions)
()(ER)
fulvestrantERER(progesterone
receptor)fulvestrant 500 mg
ERKi67fulvestrant 250 mg
(D6997C00002CONFIRM)
736423(AE
anti-estrogen subgroup)
313aromatase(AIaromatase inhibitor subgroup)fulvestrant 500 mg
fulvestrant 250 mg
(PFS)
(ORR)
(CBR)
(OS)
Fulvestrant 500 mg
PFSfulvstrant 250 mg75%OSfulvstrant 250 mgfulvestrant 500 mgOS4.1
19% [HR=0.8195% CI0.69-0.96p=0.016 (p)]2
2 CONFIRM(PFS)
FULVESTRANT 500
MG
(N=362)
FULVESTRANT 250
MG
(N=374)
(FULVESTRANT 500 MG/FULVESTRANT 250 MG)
(HAZARD RATIO)
95% CI
P
PFS
K-M
6.5
5.5
0.80
0.68, 0.94
0.006
-AE (n=423)
8.6
5.8
0.76
0.62, 0.94
0.013
-AI (n=313)
a
5.4
4.1
0.85
0.67, 1.08
0.195
OS
b
K-M
26.4
22.3
0.81
0.69, 0.96
0.016
c
-AE (n=423)
30.6
23.9
0.79
0.63, 0.99
0.038
c
-AI (n=313)
a
24.1
20.8
0.86
0.67, 1.11
0.241
c
FULVESTRANT 500
MG
(N=362)
FULVESTRANT 250
MG
(N=374)
(FULVESTRANT 500 MG/FULVESTRANT 250 MG)
95% CI
ORR
d
OR(%)
13.8
14.6
0.94
0.57, 1.55
-AE (n=296)
18.1
19.