67630-00-6 Tert-butoxycarbonyl-4-NO2-phenylalanine-ethyl ester

Nidanib, ndi mankhwala.Dzina la mankhwala 1 h - indole - 6 - carboxylic acid, 2, 3 - dihydro - 3 - [[[4 - (methyl [(4 - methyl - 1 - piperazine) acetyl] amino] phenyl] amino]ne heartland of methyl] - 2 - oxygen -, methyl ester, (z) - Zachipatala, mankhwalawa amagwiritsidwa ntchito pochiza idiopathic pulmonary fibrosis (IPF).
Nidanib adaphunzira odwala 1,529 omwe ali ndi idiopathic pulmonary fibrosis (IPF) m'mayesero angapo azachipatala.Deta yachitetezo yomwe yaperekedwa imachokera ku kuyerekeza kwa odwala 1061 omwe amapatsidwa nidanib 150 mg kawiri tsiku lililonse ndi placebo m'masabata awiri a 52-gawo 3, maphunziro osasinthika, osawona, akhungu awiri, olamulidwa ndi placebo (INPULSIS-1 ndi INPULSIS-2).Zochitika zovuta kwambiri zomwe zimagwirizanitsidwa ndi kugwiritsa ntchito nidanib zimaphatikizapo kutsekula m'mimba, nseru ndi kusanza, kupweteka kwa m'mimba, kusowa kwa njala, kuchepa thupi, ndi kuchuluka kwa michere ya chiwindi.Chonde onani [Zosamala] kuti muyang'anire zovuta zomwe zingachitike.Dongosolo la Systematic Organ Classification (SOC) la MedDRA limapereka chidule cha zovuta komanso kugawa pafupipafupi.
Nidanib ndi gawo lapansi la P-gp (onani Pharmacokinetics).Pakufufuza kwapadera kwa kuyanjana kwa mankhwala, kuphatikiza kaphatikizidwe ka ketoconazole, mphamvu yamphamvu ya P-gp inhibitor, kuwonjezeka kwa nidanib kwa nthawi 1.61 ndi dera lomwe lili pansi pa kupindika (AUC) ndi nthawi 1.83 ndi chiwerengero chachikulu (Cmax).
Pakafukufuku wokhudzana ndi mankhwala ndi P-gp inducer rifampicin yamphamvu, kukhudzana ndi nidanib kudatsika mpaka 50.3%, monga momwe amayezera dera lomwe lili pansi pa kupindika (AUC), litaphatikizidwa ndi rifampicin poyerekeza ndi Nidanib yokha.Pofika pachimake (Cmax), idatsika mpaka 60.3%.
Mukagwiritsidwa ntchito limodzi ndi mankhwalawa, zoletsa zamphamvu za P-gp (mwachitsanzo, ketoconazole kapena erythromycin) zimatha kuwonjezera kukhudzana ndi nidanib.Pazifukwa izi, kulolera kwa wodwala ku nidanib kuyenera kuyang'aniridwa mosamala.Kuwongolera zovuta kungafunike kusimitsidwa, kuchepetsa mlingo, kapena kusiya kumwa mankhwalawa ndi mankhwalawa (onani [Magwiritsidwe ndi Mlingo]).
P-gp potent inducers (monga rifampicin, carbamazepine, phenytoin ndi St. John's wort) amatha kuchepetsa kukhudzana ndi nidanib.Kuphatikizika kwina kopanda kapena kutsika kwa P-gp kuyenera kuganiziridwa.