Страна: Тайвань
Язык: китайский
Источник: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
Tepotinib Hydrochloride Hydrate
台灣默克股份有限公司 台北市內湖區堤頂大道2段89號6樓 (23526610)
L01EX21
膜衣錠
Tepotinib Hydrochloride Hydrate (1013009200) (equivalent to 225 mg tepotinib)MG
鋁箔盒裝
製 劑
須由醫師處方使用
Merck Healthcare KGaA FRANKFURTER STRASSE 250, 64293 DARMSTADT, GERMANY DE
tepotinib
適用於治療帶有導致間質上皮轉化因子外顯子14跳讀式突變(MET exon 14 skipping mutation)的轉移性之非小細胞肺癌(NSCLC)成人病人。
有效日期: 2026/09/08; 英文品名: TEPMETKO film-coated Tablets 225 mg
2021-09-08
1. TEPMETKO -14 MET exon 14 skipping mutation NSCLC [ 12 ] 2. 2.1 METEX14 MET 14 TEPMETKO MET 14 2.2 TEPMETKO 450 [ 10.3 ] TEPMETKO 8 TEPMETKO 2.3 TEPMETKO 225 TEPMETKO 225 TEPMETKO 1 1 TEPMETKO ILD / pneumonitis [ 5.1 ] ILD TEPMETKO ILD TEPMETKO ALT / AST [ 5.2 ] 3 TEPMETKO ALT/AST 7 TEPMETKO TEPMETKO 4 TEPMETKO ALT / AST [ 5.2 ALT / AST 3 2 TEPMETKO ALT / AST [ 5.2 ] 3 TEPMETKO 7 TEPMETKO TEPMETKO 4 TEPMETKO [ 6.1 ] 3 TEPMETKO TEPMETKO 4 TEPMETKO 3. 225 M 4. 5. 5.1 ILD / PNEUMONITIS TEPMETKO ILD/ [ 6.1 ] TEPMETKO 2.2% ILD/ 3 4 0.9% ILD/ TEPMETKO I L D / ILD/ TEPMETKO I L D / TEPMETKO [ 2.3 ] 5.2 TEPMETKO 13% TEPMETKO AST/ALT Grade 3 4 ALT/AST 4.2% 0.2% 0.7% ALT/AST TEPMETKO Grade 3 ALT/AST 30 1~178 ALT/AST Grade 3 ALT/AST A L T A S T TEPMETKO TEPMETKO [ 2.3 ] 5.3 – TEPMETKO tepotinib 450 [ AUC ] TEPMETKO 1 [ 8.1, 8.3 ] 6. • / [ 5.1 ] • [ 5.2 ] 6.1 448 T E P M E T K O 4 5 0 VISION TEPMETKO 255 METex14 NSCLC 448 TEPMETKO 32% 6 12% 1 VISION 255 METex14 NSCLC TEPMETKO 450 [ 12 ] T E P M E T K O 4 5 % treatment-emergent 2% 7% pneumonia 5% 3 . 9 % 3 . 9 % 3.5% 2% 2% fluid overload 0.4% TEPMETKO 20% treatment-emergent adverse event TEAE TEPMETKO TEAE > 1% 5% 2% 1.6% 1.6% 1.2% TEPMETKO 44% TEAE TEPMETKO 2% TEAE 23% 6% 4.3% ALT 3.1% 2.4% TEPMETKO 30% TEAE TEPMETKO 2% TEAE 19% 2.7% 2.7% TEPMETKO TEAE ≥ 20% 3 4 ≥ 2% ALT AST 2 VISION TEAE 2 VISION 10% METEX14 NSCLC TEAE TEPMETKO N=255 % 3 4 % a 70 9 b 27 1.6 27 0.8 26 0.4 c 16 0.8 16 0 d 13 1.2 e 24 2.4 f 20 2 g 15 0.4 13 5 16 1.2 h 11 3.9 a b c d e f g h TEPMETKO 10% TEAE ILD 3 VISION 3 VISION TEPMETKO ≥ 20% TEPMETKO 1 1 4 % 3 4 % 76 9 55 0.4 50 1.6 ALT 44 4.1 AST 35 2.5 31 8 25 1.6 24 5 23 4.6 48 11 27 2 23 0.8 1 207 246 TEPMETKO 20% 18% 3.7% 3 4 TEPMETKO 21 31% 7. 7.1 TEPMETKO CYP3A P CYP3A P TEPMETKO CYP3A P tepotinib [ 10.3 ] TEPMETKO TEPMETKO CYP3A P CYP3A CYP3A TEPMETKO CYP3A tepotinib [ 10.3 ] TEPMETKO TEPMETKO CYP3A 7.2 TEPMETKO P Tepotinib P TEPMETKO P [ 10.3 ] P TEPMETKO P P P 8. 8.1 [ 10.1 ] TEPMETKO TEPMETKO tepotinib 450 [ AUC ] 2–4% 15–20% Прочитать полный документ