Nidanib, ke khemikhale.Lebitso la lik'hemik'hale 1 h - indole - 6 - carboxylic acid, 2, 3 - dihydro - 3 - [[[4 - (methyl [(4 - methyl - 1 - piperazine) acetyl] amino] phenyl] amino] benzene heartland of methyl] - 2 - oksijene -, methyl ester, (z) - Clinically, sehlahisoa sena se sebelisetsoa ho phekola idiopathic pulmonary fibrosis (IPF).
Nidanib e ithutile bakuli ba 1,529 ba nang le idiopathic pulmonary fibrosis (IPF) litekong tse ngata tsa bongaka.Lintlha tsa polokeho tse hlahisitsoeng li thehiloe papisong ea bakuli ba 1061 ba fuoeng nidanib 150 mg habeli ka letsatsi le placebo nakong ea libeke tse 3 tsa libeke tse 52, lithuto tse laoloang ka mokhoa o sa reroang, tse sa boneng habeli, tse laoloang ke placebo (INPULSIS-1 le INPULSIS-2).Liketsahalo tse mpe ka ho fetisisa tse amanang le tšebeliso ea nidanib li ne li kenyelletsa letšollo, ho nyekeloa ke pelo le ho hlatsa, bohloko ba mpeng, ho lahleheloa ke takatso ea lijo, ho lahleheloa ke boima ba 'mele, le li-enzyme tse phahameng tsa sebete.Ka kopo sheba ho [Litlhokomelo] bakeng sa taolo ea litlamorao tse tsamaellanang le tsona.The Systematic Organ Classification (SOC) ea MedDRA e fana ka kakaretso ea karabelo e mpe le ho hlopha khafetsa.
Nidanib ke substrate ea P-gp (sheba Pharmacokinetics).Phuputsong e khethehileng ea litšebelisano tsa lithethefatsi, tsamaiso e kopanetsoeng ea ketoconazole, e matla ea P-gp inhibitor, e eketsehile ho pepesehela nidanib ho makhetlo a 1.61 ka sebaka se tlas'a lekhalo (AUC) le linako tsa 1.83 ka mahloriso a phahameng (Cmax).
Thutong ea tšebelisano ea lithethefatsi le rifampicin e matla ea P-gp, ho pepesetsoa nidanib ho theohile ho isa ho 50.3%, joalo ka ha ho lekantsoe ka sebaka se ka tlas'a mokokotlo (AUC), ha se kopantsoe le rifampicin bapisoa le Nidanib feela.Ka khatello e phahameng (Cmax), e theohetse ho 60.3%.
Ha e sebelisoa hammoho le sehlahisoa sena, li-inhibitors tse matla tsa P-gp (mohlala, ketoconazole kapa erythromycin) li ka eketsa ho pepeseha ha nidanib.Maemong ana, mamello ea mokuli ho nidanib e lokela ho beoa leihlo ka hloko.Taolo ea litlamorao tse mpe e kanna ea hloka ho emisoa, ho fokotsa litekanyetso, kapa ho khaotsa kalafo ka sehlahisoa sena (bona [Tšebeliso le litekanyetso]).
Li-inducers tse matla tsa P-gp (mohlala, rifampicin, carbamazepine, phenytoin le St. John's wort) li ka fokotsa ho pepeseha ha nidanib.Metsoako e meng e nang le che kapa e fokolang ea P-gp e lokela ho nkoa.