Country: Tajwan
Lingwa: Ċiniż
Sors: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
Ibrutinib
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)
L01EL01
膠囊劑
Ibrutinib (1013005100) MG
塑膠瓶裝(HDPE)
製 劑
須由醫師處方使用
CILAG AG. HOCHSTRASSE 201 CH-8200 SCHAFFHAUSEN SWITZERLAND CH
ibrutinib
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。
有效日期: 2028/08/30; 英文品名: "Switzerland" Imbruvica Capsules 140mg
2018-08-30
“ ” ® 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 Aqra d-dokument sħiħ