基扶能膜衣錠250毫克

Nazione: Taiwan

Lingua: cinese

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

Principio attivo:

GEFITINIB

Commercializzato da:

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)

Codice ATC:

L01EB01

Forma farmaceutica:

膜衣錠

Composizione:

GEFITINIB (1013000600) MG

Confezione:

ALU-OPA/ALU/PVC 鋁箔盒裝

Classe:

製　劑

Tipo di ricetta:

須由醫師處方使用

Prodotto da:

REMEDICA LTD. AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE , LIMASSOL 3056, CYPRUS CY

Area terapeutica:

gefitinib

Indicazioni terapeutiche:

Gefitinib適用於先前已接受過化學治療後，但仍局部惡化或轉移之肺腺癌病患之第二線用藥。Gefitinib適用於具有EGFR-TK突變之局部侵犯性或轉移性之非小細胞肺癌(NSCLC)病患之第一線治療。

Dettagli prodotto:

有效日期: 2026/03/08; 英文品名: Gefitinib Sandoz Film-coated Tablets 250mg

Data dell'autorizzazione:

2021-03-08

Foglio illustrativo

"250"
250 mggefitinib
GefitinibEGFR-TK(NSCLC)(
)
Gefitinib
Gefitinib
250 mg
12
(
)
(
15)
Gefitinib
()
(
14
)
250 mg() ()
gefitinib
EGFR
GefitinibEGFR
EGFR
(
)
DNA (ctDNA, circulating
tumour DNA)ctDNActDNAEGFR
ctDNAEGFREGFREGFR
(0.2%34.3%)
gefitinib(ILD)(
)gefitinib
gefitinib
(
)
3159gefitinib
12(ILD)(gefitinib)
(PS
≧
2)
≦
50%
(
＜
6)
(
≧
55
)
≦
50%(
≧
65)(
≧
50%)
(
[ALT][AST])(
)
gefitinib
gefitinib
gefitinib
CYP3A4gefitinibCYP3A4(
phenytoin
carbamazepine
rifampicinSt Joh
n’s
)(
)
warfarin(INR)/
(
)
warfarin(PT)INR
pHgefitinib(
)
•
()
(
/
)
gefitinibgefitinib
gefitinib
gefitinib(brain stem glioma)
(incompletely resected supratentorial malignant glioma)45
4
(1
)
(ependymoma)gefitinib
gefitinib
gefitinib
vinorelbinegefitinibvinorelbine
gefitinib
NSAIDs
()
gefitinib
CYP3A4
rifampicin (3A4)
gefitinib
AUCrifampicin83%
()
itraconazole (
CYP3A4)
gefitinib
AUC
80%
ranitidinepH(5)gefitinibAUC47% (
)
warfarinINR/() (
)
Gefitinibgefitinib
()
gefitinib
()
gefitinib
()
20%
(
)
10%ADR (
(Common Toxicity CriteriaCTC)34)3%ADR
ISEL
INTEREST
IPASS
phase III(2462gefitinib)
(ADRs)
1
ADRsCTC
1
/
(≥10%)
●
(34.9%)(CTC
1
2
)(CTC
3
4)
●
(CTC1 )
●
(13.8%)(CTC12)
●
(11.0%)(CTC1)
●
(11.4%)
●
(19.7%)(CTC12)
●
(57.9%)(CTC
1
2
)
●
(17.7%)(CTC1)
(≥1-<10%)
●
(1.8%)
●
(2.0%)(CTC1)
●
(4.3%)
●
(7.9%)(CTC12)
●
(2.7%)
●
(1.5%)
●
(7.7%)
●
(1.1%)
●
(7.9%)
●
(4.7%)
●
(1.1%)
●
(8.7%)
●
* (6.7%)(CTC1)
●
(1.3%)(CTC3-4)
(≥0.1-<1%)
●
(0.1%)
●
(0.2%)
●
** (0.2%)
●
(0.12%)(0.3%)
(≥0.01<0.1%)
●
(Stevens
Johnson syndrome)(0.04%)
●
***
●
***
*gefitinib
()
**
***phase III
(2009
9
)3
phase III(1692)gefitinib(BSC)
(BSC)1
2
(ILD)1%(ILD)
gefitinibgefitinib
(ILD)3%
4%
(3350)
(ILD)gefitinib
5.8%
(
)
12
(ILD)(
)
gefitinib4.0%
2.1%gefitinib
(ILD)(OR)
3.2 (95%(CI) 1.9-5.4)gefitinib
(ILD)(
3.8
95% CI 1.9-7.7)
(2.595% CI 1.1-5.8)
phase III(1217)
gefitinib
carboplatin/paclitaxel
ILDgefitinib2.6%
carboplatin/paclitaxel
1.4% ()
gefitinib
1000 mg
1500 mg
3500 mg