67630-00-6 Tert-butoxycarbonyl-4-NO2-fenylalanine-estyl ester

Nidanib, ni imiti.Izina ryimiti 1 h - indole - 6 - acide karubike, 2, 3 - dihydro - 3 - [[[4 - (methyl - 2 - ogisijeni -, methyl ester, (z) - Mu ivuriro, iki gicuruzwa gikoreshwa mu kuvura indwara ya fibrosis idasanzwe (IPF).
Nidanib yakoze ubushakashatsi ku barwayi 1.529 barwaye fibrosis idasanzwe (IPF) mu bigeragezo byinshi by’amavuriro.Amakuru yumutekano yatanzwe ashingiye ku kugereranya abarwayi 1061 bahawe nidanib 150 mg kabiri kumunsi na placebo mubyiciro bibiri byicyumweru 52 icyiciro cya 3, batabishaka, impumyi ebyiri, ubushakashatsi bugenzurwa na placebo (INPULSIS-1 na INPULSIS-2).Ibintu bibi byakunze kugaragara bifitanye isano no gukoresha nidanib harimo impiswi, isesemi no kuruka, kubabara mu nda, kubura ubushake bwo kurya, guta ibiro, hamwe na enzymes zumwijima.Nyamuneka reba kuri [Precautions] kugirango ucunge ibisubizo bibi.Itondekanya rya Organisation Itunganijwe (SOC) ya MedDRA itanga incamake yimyitwarire mibi no gutondekanya inshuro.
Nidanib ni substrate ya P-gp (reba Pharmacokinetics).Mu bushakashatsi bwihariye bwerekeye imikoranire yibiyobyabwenge, hamwe hamwe nubuyobozi bwa ketoconazole, imbaraga za P-gp inhibitor, byongereye guhura nidanib inshuro 1.61 kubice biri munsi yumurongo (AUC) ninshuro 1.83 hamwe nubushakashatsi bwimbitse (Cmax).
Mu bushakashatsi bwakozwe ku biyobyabwenge hamwe na P-gp inducer rifampicin ikomeye, guhura na nidanib byagabanutse kugera kuri 50.3%, nkuko byapimwe n'akarere kari munsi y'umurongo (AUC), iyo bihujwe na rifampicine ugereranije na Nidanib wenyine.Kwibanda cyane (Cmax), byagabanutse kugera kuri 60.3%.
Iyo bikozwe hamwe nibicuruzwa, imbaraga za P-gp inhibitor (urugero, ketoconazole cyangwa erythromycine) irashobora kongera guhura na nidanib.Muri ibi bihe, kwihanganira umurwayi kuri nidanib bigomba gukurikiranirwa hafi.Imicungire yimyitwarire mibi irashobora gusaba guhagarika, kugabanya imiti, cyangwa guhagarika imiti hamwe niki gicuruzwa (reba [Ikoreshwa na dosiye]).
P-gp inducers zikomeye (urugero, rifampicin, karbamazepine, phenytoin na wort ya Mutagatifu Yohani) irashobora kugabanya guhura na nidanib.Ubundi buryo bwo guhuza hamwe nta na P-gp induction igomba kwitabwaho.