Nidanib, ọ bụ kemịkalụ.Aha kemịkal 1 h - indole - 6 - carboxylic acid, 2, 3 - dihydro - 3 - [[4 - (methyl [(4 - methyl - 1 - piperazine) acetyl] amino] phenyl] amino] benzene heartland nke methyl] - 2 - oxygen -, methyl ester, (z) - Clinically, ngwaahịa a na-eji na-emeso idiopathic pulmonary fibrosis (IPF).
Nidanib amụla ndị ọrịa 1,529 nwere idiopathic pulmonary fibrosis (IPF) n'ọtụtụ ule ụlọ ọgwụ.Ihe nchekwa data ewepụtara dabere na ntụnyere ndị ọrịa 1061 nyere nidanib 150 mg ugboro abụọ kwa ụbọchị yana placebo n'ime usoro 52-izu abụọ nke 3, randomized, kpuru ìsì abụọ, ebe a na-achịkwa placebo (INPULSIS-1 na INPULSIS-2).Ihe omume ọjọọ kachasị ejikọta na iji nidanib gụnyere afọ ọsịsa, ọgbụgbọ na ọgbụgbọ, afọ mgbu, ọnwụ nke agụụ, ọnwụ dị arọ, na enzymes imeju dị elu.Biko rụtụ aka na [akpachara anya] maka njikwa mmeghachi omume ọjọọ kwekọrọ.Usoro nhazi akụkụ (SOC) nke MedDRA na-enye nchịkọta nke mmeghachi omume ọjọọ yana nhazi oge.
Nidanib bụ mkpụrụ maka P-gp (lee Pharmacokinetics).N'ime nyocha a kapịrị ọnụ nke mmekọrịta ọgwụ ọjọọ, njikwa mkpokọta ketoconazole, onye na-egbochi P-gp dị ike, na-abawanye ikpughe na nidanib ugboro 1.61 site na mpaghara n'okpuru usoro (AUC) na ugboro 1.83 site na ntinye uche kacha elu (Cmax).
N'ime ọmụmụ mmekọrịta ọgwụ na P-gp inducer rifampicin dị ike, ikpughe na nidanib gbadara ruo 50.3%, dịka atụpụtara site na mpaghara n'okpuru usoro (AUC), mgbe ejikọtara ya na rifampicin ma e jiri ya tụnyere Nidanib naanị.Site na ntinye uche kacha elu (Cmax), ọ gbadara ruo 60.3%.
Mgbe ejiri ya na ngwaahịa a, ndị na-egbochi P-gp siri ike (dịka, ketoconazole ma ọ bụ erythromycin) nwere ike ịbawanye ikpughe na nidanib.N'okwu ndị a, a ga-enyocha nnabata nke onye ọrịa na nidanib.Ijikwa mmeghachi omume ọjọọ nwere ike ịchọ nkwụsị, mbelata dose, ma ọ bụ ịkwụsị ọgwụgwọ na ngwaahịa a (lee [Ojiji na usoro onunu ogwu]).
P-gp nwere ike inducers (dịka, rifampicin, carbamazepine, phenytoin na St. John's wort) nwere ike ibelata ikpughe na nidanib.Nchikota ọzọ na enweghị ma ọ bụ ntakiri ntinye P-gp kwesịrị ịtụle.