"瑞士"億珂膠囊140毫克

국가: 대만

언어: 중국어

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

유효 성분:

Ibrutinib

제공처:

嬌生股份有限公司 台北市中山區民生東路三段2號10樓及11樓 (30814854)

ATC 코드:

L01EL01

약제 형태:

膠囊劑

구성:

Ibrutinib (1013005100) MG

패키지 단위:

塑膠瓶裝(HDPE)

수업:

製　劑

처방전 유형:

須由醫師處方使用

Manufactured by:

CILAG AG. HOCHSTRASSE 201 CH-8200 SCHAFFHAUSEN SWITZERLAND CH

치료 영역:

ibrutinib

치료 징후:

1. 被套細胞淋巴瘤：適用於先前曾接受至少一種療法治療的被套細胞淋巴瘤Mantle Cell Lymphoma (MCL)成年病人。2. 慢性淋巴球性白血病/小淋巴球性淋巴瘤：適用於治療慢性淋巴球性白血病Chronic Lymphocytic Leukemia (CLL)/小淋巴球性淋巴瘤Small Lymphocytic Lymphoma (SLL)成年病人。 3. 17p缺失性之慢性淋巴球性白血病/小淋巴球性淋巴瘤：適用於治療患有17p缺失性之慢性淋巴球性白血病Chronic Lymphocytic Leukemia (CLL)/小淋巴球性淋巴瘤 (SLL)的成年病人。 4. Waldenström氏巨球蛋白血症：適用於治療Waldenström氏巨球蛋白血症 (Waldenström’s macroglobulinemia (WM))的成年病人。 5. 慢性移植體抗宿主疾病：適用於治療使用一線或多線全身性療法治療失敗後的慢性移植體抗宿主疾病chronic Graft-Versus-Host Disease (cGVHD)成年病人。

제품 요약:

有效日期: 2028/08/30; 英文品名: "Switzerland" Imbruvica Capsules 140mg

승인 날짜:

2018-08-30

환자 정보 전단

“
”
®
140
“
SWITZERLAND
” IMBRUVICA
®
CAPSULES 140MG
“
”
®
140
“
SWITZERLAND
” IMBRUVICA
®
CAPSULES 140MG
“
”
®
140
“
SWITZERLAND
” IMBRUVICA
® CAPSULES 140MG
027499
1
1.1
Mantle Cell
Lymphoma (MCL)
1.2 /
Chronic Lymphocytic Leukemia (CLL)/
Small Lymphocytic Lymphoma (SLL)
1.3 17p/
17pChronic Lymphocytic
Leukemia (CLL)/(SLL)
1.4 Waldenström
Waldenström
(Walden
ström’s m
acroglobulinemia
(WM))
1.5
CD20
Marginal Zone Lymphoma (MZL)
(Overall response rate)
(14.4)
(confirmatory trials)
1.6
chronic Graft-Versus-Host Disease (cGVHD)
2
2.1
IBRUTINIBMCL
MZL560
/Waldenström
IMBRUVICACLL/SLL
WM420
C L L / S L L I M B R U V I C A r i t u x i m a b
obinutuzumabbendamustine
rituximab
WMIMBRUVICA
rituximab
IMBRUVICA
rituximab
obinutuzumab
IMBRUVICA
rituximab
obinutuzumab
IBRUTINIBcGVHD420
cGVHD
cGVHD
IBRUTINIB
IMBRUVICA
IMBRUVICA
IMBRUVICA
2.2
3
43
4
4
IMBRUVICA1
(
)
IMBRUVICA140
/
140
IMBRUVICA
MCLMZL
=560
CLL/SLLWM
CGVHD
=420
560
420
420
280
280
140
IBRUTINIB
IBRUTINIB
2.3 CYP3A
(7.1)
IBRUTINIB
B
• CYP3A
280
(2.2)
• Voriconazole 200
• Posaconazole
100
100
200
140
(2.2)
• Posaconazole200
400
• Posaconazole300
• Posaconazole300
• CYP3A
(
7
)IBRUTINIB
• CYP3A
420
(2.2)
• Voriconazole 200
• Posaconazole100
100
200
280
(2.2)
• Posaconazole200
400
• Posaconazole300
• Posaconazole300
140
(2.2)
• CYP3A
(
7
)IBRUTINIB
CYP3AIMBRUVICA
(2.1)(7.1)
2.4
(Child-Pugh A
)140
(Child-Pugh BC
)
IMBRUVICA
(8.6)(12.3)
3
140ibr 140 mg
4
5
5.1
IMBRUVICA
27
IMBRUVICA2,838
4%
(≥
3
[
]
)
0.4%
IMBRUVICA39%(
)23%
IMBRUVICA
2,838IMBRUVICA
3.1%
4.4%
6.1%
IMBRUVICA
IBRUTINIB
37
(14)
5.2
IMBRUVICA
(
)
IMBRUVICA1,476
21%
3
(
)
(6.1,
6.2)
IMBRUVICA
(PML)(PJP)
5.3
645
IMBRUVICA
B
23%3
4
8%
343%34
5.4
IMBRUVICA
IMBRUVICA1,476
0.2%
3
(
)
4%3
(
)
1%3
(
)
(6.1)
(
)
IMBRUVICA
(2.2)
5.5
IMBRUVICA1,476
19%
8%3
(
)
1,124
5.9(0.0324)
IMBRUVICA
IMBRUVICA
5.6
IMBRUVICA1,476
(
10%)
(
4%)
(6%)
5.7
IMBRUVICA
(
)
5.8 -
IMBRUVICA
ibrutinib
2-20
-
IMBRUVICA
1
(8.1)
5.9
IMBRUVICA
IMBRUVICA
(
)
5.10 (HLH)
IMBRUVIC