Šalis: Taivanas
kalba: kinų
Šaltinis: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
Idelalisib
香港商吉立亞醫藥有限公司台灣分公司 臺北市信義區松仁路32號10樓之1、36號10樓之1 (54376860)
膜衣錠
主成分 (per tablet) ; Idelalisib (1013005900) MG
HDPE瓶裝
製 劑
須由醫師處方使用
GILEAD SCIENCES IRELAND UC IDA BUSINESS & TECHNOLOGY PARK, CARRIGTOHILL COUNTY CORK, IRELAND IE
(1) Zydelig 合併rituximab 適用於治療因患有其他合併症(co-morbidities)而被認定適合單獨使用rituximab 治療(不適合使用化學治療)的復發性慢性淋巴球性白血病患者。(2) Zydelig 適用於治療先前曾接受至少兩種全身性療法治療的復發性濾泡型B細胞非何杰金氏淋巴瘤(follicular lymphoma)患者。(3) Zydelig 適用於治療先前曾接受至少兩種全身性療法治療的復發性小淋巴球性淋巴瘤(small lymphocytic lymphoma)患者。
註銷日期: 2016/11/24; 註銷理由: 自請註銷; 有效日期: 2021/08/05; 英文品名: ZYDELIG Tablets 150MG
已註銷
2016-08-05
100 GSI 100 4 5 5.1 Zydelig PCP/ PJP CMV 6.1 Zydelig Zydelig PCR 2.2 5.8 5.2 Zydelig 14% / ALT AST 5 6.1 12 26% ALT AST Zydelig Zydelig 3 2 ALT AST 3 4 1 3 ALT AST 3 ALT AST 5 Zydelig AST ALT 2.2 5.3 Zydelig 14% 3 6.1 Zydelig Zydelig Zydelig 1 1 2.2 5.4 PNEUMONITIS Zydelig Zydelig X 5% Zydelig Zydelig Zydelig 5.5 Zydelig Zydelig 5.6 Zydelig rituximab bendamustine TEN Zydelig ≥ 3 Zydelig 5.7 Zydelig Zydelig 5.8 Zydelig 31% 3 4 6.1 3 2 1.0 Gi/L 2.2 5.9 Zydelig 150 12 idelalisib 8.1 Zydelig Zydelig 1 8.6 6 Zydelig • 5.1 • 5.2 • 5.3 • 5.4 • 5.5 • 5.6 • 5.7 • 5.8 6.1 1 Zydelig 218 CLL 8 rituximab Zydelig 150 Zydelig 5 54 49% Zydelig + rituximab Zydelig ≥ 2% 17% 9% 8% 5% 5% 11 10% Zydelig / 39 35% 16 15% 酶 Zydelig + rituximab 3 pneumocystis jiroveri pneumonia rituximab 1 2 3 Zydelig + rituximab + rituximab 2 ≥ 5% CLL Zydelig ≥ 2% Zydelig + R N=110% + R N=108% ≥ 3 ≥ 3 2825 0 2321 0 1413 0 98 0 a 2321 65 1716 0 76 0 11 0 76 22 22 0 1110 11 55 0 3835 33 1817 11 2321 22 1716 0 87 0 22 0 b 2018 44 76 11 c 2523 1816 1918 1413 65 0 22 0 d 98 87 44 44 76 11 33 11 98 0 44 0 65 0 33 22 87 11 44 11 a b c d R rituximab 3 ≥ 10% CLL Zydelig ≥ 5% Zydelig + R N=110% + R N=108% 3-4 3-4 6660 4137 5551 2927 2220 109 1312 44 2725 2018 109 55 AL T 3835 98 1110 11 AST 2725 65 1514 0 GGT 2926 22 1514 33 6256 33 3734 0 5954 87 5046 22 1211 0 55 0 2220 22 1615 76 CTCAE 4.03 R rituximab 146 Zydelig Zydelig 150 6.1 0.3 26.4 73 50% 15% 11% 9% 78 53% 11% 11% 酶 10% 4 10% Zydelig 5 4 Zydelig 150 BID ≥ 10% Zydelig N=146% ≥ 3 a 6847 2014 4229 21 b 3826 32 2215 21 4430 21 4128 32 1712 32 1510 32 1812 0 c 3725 2316 4229 11 2517 64 d 3121 43 1812 0 1611 11 2416 11 1712 0 a b c d 5 Zydelig 150 BID Zydelig Monotherapy N=146% • Zydelig PCP/PJP CMV Zydelig Zydelig PCR 2.2 5.1 • Zydelig 14% / Zydelig 2.2 5.2 • Zydelig 14% Zydelig 2.2 5.3 • Zydelig Zydelig 2.2 5.4 • Zydelig Zydelig 2.2 5.5 1 1.1 Z y d e l i g r i t u x i m a b rituximab CLL 1.2 B Zydelig B Fellicular L ymphoma 14.2 1.3 Zydelig Small L ymphocyti Perskaitykite visą dokumentą