億珂膠囊140毫克

Country: তাইওয়ান

ভাষা: চীনা

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

সক্রিয় উপাদান:

Ibrutinib

থেকে পাওয়া:

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)

এটিসি কোড:

L01EL01

ফার্মাসিউটিকাল ফর্ম:

膠囊劑

রচনা:

Ibrutinib (1013005100) MG

প্যাকেজ ইউনিট:

塑膠瓶裝(HDPE)

শ্রেণী:

製　劑

প্রেসক্রিপশন টাইপ:

須由醫師處方使用

Manufactured by:

AndersonBrecon Inc 4545 ASSEMBLY DRIVE, ROCKFORD, IL 61109 USA US

Therapeutic area:

ibrutinib

থেরাপিউটিক ইঙ্গিত:

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。

পণ্য সারাংশ:

有效日期: 2025/11/13; 英文品名: Imbruvica Capsules 140mg

অনুমোদন তারিখ:

2015-11-13

তথ্য লিফলেট

®
140
IMBRUVICA
® CAPSULES 140MG
026656
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
CLL/SLLIMBRUVICArituximab
obinutuzumab
bendamustine
rituximab
WMIMBRUVICA
rituximab
IMBRUVICA
rituximab
obinutuzumab
IMBRUVICA
rituximab
obinutuzumab
IBRUTINIBcGVHD420cGVHD
cGVHD
IBRUTINIB
IMBRUVICA
IMBRUVICA
IMBRUVICA
2.2
3
43
4
4
IMBRUVICA
1
(
)
IMBRUVICA
140/
140
IMBRUVICA
MCLMZL
=560
CLL/SLLWMCGVHD
=420
560
420
420
280
280
140
IBRUTINIB
IBRUTINIB
2.3 CYP3A
(7.1)
IBRUTINIB
B
• CYP3A
280
(2.2)
• Voriconazole 200
• Posaconazole100100
200
140
(2.2)
• Posaconazole200400
• Posaconazole300
• Posaconazole300
• CYP3A
( 7
)
IBRUTINIB
• CYP3A
420
(2.2)
• Voriconazole 200
• Posaconazole100100
200
280
(2.2)
• Posaconazole200400
• 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
IBRUTINIB3
7
(14)
5.2
IMBRUVICA
(
)
IMBRUVICA1,476
21%
3
(
)
(6.1, 6.2)
IMBRUVICA
(PML)(PJP)
5.3
645IMBRUVICAB
23%3
4
8%3
4
3%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)
IMBRUVICA(HLH)(
)
HLH
HLH
(ferritin)
HLH
HLH
6
●
(5.1)
●
(5.2)
●
(5.3)
●
(5.4)
●
(5.5)
●
(5.6)
●
(5.7)
6.1
IMBRUVICA
6
475
420
174560
4
827420
1,476IMBUVICAB
87%6
(
)
68%1
(
)
1,47