Ország: Tajvan
Nyelv: kínai
Forrás: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
Filgotinib maleate
衛采製藥股份有限公司 台北市長安東路一段十八號九樓 (89283375)
L04AA45
膜衣錠
Filgotinib maleate (1013009600) (equivalent to 200 mg filgotinib)MG
PVC/PCTFE/Alu鋁箔盒裝
製 劑
須由醫師處方使用
Bushu Pharmaceuticals Ltd. Kawagoe Factory 1 Takeno, Kawagoe, Saitama, 350-0801, Japan JP
filgotinib
1.可用於單一療法或與methotrexate合併使用,治療患有中至重度活動性類風濕性關節炎且對至少一種疾病緩解型抗風濕藥物(DMARDs)無法產生適當治療反應或無法耐受之成人病人。2.用於治療患有中度至重度活動性潰瘍性結腸炎,且對傳統療法或生物製劑無法產生適當治療反應、失去治療反應或無法耐受的成人病人。
有效日期: 2027/01/03; 英文品名: Jyseleca 200 mg Film-Coated Tablets
2022-01-03
1. ® 200 Jyseleca ® 200 mg Film-Coated Tablets 2. Jyseleca maleate filgotinib Janus 酶 JAK Filgotinib maleateN- 5- { 4- [ 1,1-Dioxidothiomorpholin-4-yl methyl ] phenyl } [ 1,2,4 ] triazolo [ 1,5-a ] pyridin-2-yl cyclopropanecarboxamide2Z -but-2-enedioate Filgotinib maleate C 21 H 23 N 5 O 3 S • C 4 H 4 O 4 541.6filgotinib 425.5 Filgotinib maleate N N N NH O N S O O CO H 2 CO H 2 Jyseleca 200GSI200 200 filgotinib 254 filgotinib maleate 200 152 6.1 3. 178 GSI200 4. 4.1 methotrexate DMARDs 4.2 200 1 4.4 1 ANC ANC < 1 10 9 cells/L ANC ALC ALC < 0.5 10 9 cells/L ALC Hb Hb < 8 g/dL Hb 12 75 100 [ CrCl ] ≥ 60 / CrCl 15 < 60 / 100 filgotinib CrCl < 15 / filgotinib 5.2 Child-Pugh A B Child-Pugh C filgotinib 5.2 Filgotinib 18 Jyseleca 5.2 4.3 6.1 TB 4.4 4.6 4.4 f i l g o t i n i b a z a t h i o p r i n e c i c l o s p o r i n tacrolimus DMARDs bDMARDs JAK filgotinib filgotinib 4.8 filgotinib TB filgotinib • • TB • • TB ; • underlying conditions filgotinib filgotinib filgotinib filgotinib 75 filgotinib TB Filgotinib TB 4.3 TB latent TB filgotinib TB TB 疱 4.8 疱 filgotinib filgotinib C CHCV RNA B B HBV DNA HBV HBV HBV ; HBV-DNA filgotinib filgotinib ® 200 JYSELECA ® 200 MG FILM-COATED TABLETS 028209 NMSC filgotinib filgotinib filgotinib NMSCs 5.3 filgotinib ≤ 1% ANC < 1 10 9 cells/L 4.8 ALC < 0.5 10 9 cells/L ANC < 1 10 9 cells/L ALC < 0.5 10 9 cells/L < 8 g/dL 4.2 f i l g o t i n i b filgotinib filgotinib dose-dependent HDL LDL 4.8 filgotinib statin LDL 4.2 JAK filgotinibDVT PE DVT/PE DVT/PE prolonged immobilization JAK DVT/PE filgotinib galactose intolerance 酶 total lactase deficiency -glucose-galactose malabsorption 4.5 filgotinib Filgotinib 酶 2 CES2 fenofibrate carvedilol diltiazem simvastatin Filgotinib Filgotinib 酶 P450 CYP UDP- 酶 UGT filgotinib CYP2B6 CYP1A2 filgotinib GS-829845 P-gp BCRP digoxin filgotinib filgotinib CYP1A2 CYP1A2 filgotinib CYP1A2 filgotinib CYP1A2 filgotinib GS-829845 OATP1B1 OATP1B3 OATP1B1 OATP1B3 filgotinib OATP1B1 OATP1B3 OATP1B1 OATP1B3 valsartanstatins filg Olvassa el a teljes dokumentumot