Nidanib, kemikali ni.Orukọ kemikali 1 h - indole - 6 - carboxylic acid, 2, 3 - dihydro - 3 - [[4 - (methyl [(4 - methyl - 1 - piperazine) acetyl] amino] phenyl] amino] benzene heartland ti methyl] - 2 - oxygen -, methyl ester, (z) - isẹgun, ọja yi ti lo lati toju idiopathic ẹdọforo fibrosis (IPF).
Nidanib ti ṣe iwadi awọn alaisan 1,529 pẹlu idiopathic pulmonary fibrosis (IPF) ni awọn idanwo ile-iwosan pupọ.Awọn data ailewu ti a gbekalẹ da lori lafiwe ti awọn alaisan 1061 ti a fun nidanib 150 miligiramu lẹmeji lojoojumọ ati placebo ni ipele 52-ọsẹ meji 3, laileto, afọju-meji, awọn iwadii iṣakoso ibibo (INPULSIS-1 ati INPULSIS-2).Awọn iṣẹlẹ ikolu ti o wọpọ julọ ti o ni nkan ṣe pẹlu lilo nidanib pẹlu gbuuru, ríru ati ìgbagbogbo, irora inu, isonu ti ounjẹ, pipadanu iwuwo, ati awọn enzymu ẹdọ ti o ga.Jọwọ tọka si [Awọn iṣọra] fun iṣakoso awọn aati ikolu ti o baamu.Isọri Ẹran ara eleto (SOC) ti MedDRA n pese akopọ ti awọn aati ikolu ati ipinya igbohunsafẹfẹ.
Nidanib jẹ sobusitireti fun P-gp (wo Pharmacokinetics).Ninu iwadi kan pato ti awọn ibaraenisepo oogun, iṣakoso apapọ ti ketoconazole, inhibitor P-gp ti o lagbara, ifihan ti o pọ si nidanib si awọn akoko 1.61 nipasẹ agbegbe labẹ ọna (AUC) ati awọn akoko 1.83 nipasẹ ifọkansi ti o ga julọ (Cmax).
Ninu iwadi ibaraenisepo oogun pẹlu P-gp inducer rifampicin ti o lagbara, ifihan si nidanib dinku si 50.3%, bi a ṣe wọn nipasẹ agbegbe ti o wa labẹ ọna (AUC), nigba ti a ba ni idapo pẹlu rifampicin ni akawe pẹlu Nidanib nikan.Nipa ifọkansi ti o ga julọ (Cmax), o dinku si 60.3%.
Nigbati a ba nṣakoso ni apapo pẹlu ọja yii, awọn inhibitors P-gp ti o lagbara (fun apẹẹrẹ, ketoconazole tabi erythromycin) le ṣe alekun ifihan si nidanib.Ni awọn iṣẹlẹ wọnyi, ifarada alaisan si nidanib yẹ ki o ṣe abojuto ni pẹkipẹki.Ṣiṣakoso awọn aati ikolu le nilo idaduro, idinku iwọn lilo, tabi dawọ itọju pẹlu ọja yii (wo [Lilo ati iwọn lilo]).
Awọn oludasilẹ agbara P-gp (fun apẹẹrẹ, rifampicin, carbamazepine, phenytoin ati St. John's wort) le dinku ifihan si nidanib.Awọn akojọpọ omiiran pẹlu ko si tabi idinku P-gp fifa irọbi yẹ ki o gbero.