[{"data":1,"prerenderedAt":161},["ShallowReactive",2],{"drug-gefitinib":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":36,"contraindications":59,"warnings":60,"renal":68,"monitoring":69,"interactions":70,"review":71,"examples":74,"atc":80,"iran":82,"usApproval":94,"links":100,"populations":116},"gefitinib",1,{"fa":7,"en":8},"جفیتینیب","Gefitinib","antineoplastic-immunomodulating",{"fa":11,"en":12},"مهارکننده EGFR","EGFR inhibitor",[14],{"name":15,"market":16},"Iressa","US",[18,19,7,20],"iressa","ایرسا","ژفیتینیب",[22],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":31,"refs":32},"tab-250","tablet","oral","250 mg tablet",{"amount":28,"unit":29,"perUnit":24,"scored":30},250,"mg",false,[16],[33],{"source":34,"section":35},"fda-iressa","3",[37],{"id":38,"disease":39,"label":40,"population":43,"type":47,"unit":29,"dose":48,"refs":49,"notes":52},"nsclc","lung-cancer",{"fa":41,"en":42},"NSCLC متاستاتیک با حذف اگزون ۱۹ یا L858R (خط اول) — ۲۵۰ mg یک بار در روز","First-line metastatic NSCLC with exon 19 deletion or L858R — 250 mg once daily",{"minAge":44},{"value":45,"unit":46},18,"year","fixed",{"perDose":28,"dosesPerDay":5},[50],{"source":34,"section":51},"2.2",[53],{"text":54,"refs":57},{"fa":55,"en":56},"فقط زیر نظر متخصص انکولوژی؛ ادامه تا پیشرفت بیماری یا سمیت غیرقابل‌قبول. تنظیم دوز برای عوارض و تداخل‌ها طبق برچسب.","Only under an oncologist; continue until progression or unacceptable toxicity. Dose adjustments for toxicity and interactions per label.",[58],{"source":34,"section":51},[],[61],{"text":62,"refs":65},{"fa":63,"en":64},"بیماری بینابینی ریه؛ سمیت کبدی؛ سوراخ شدن گوارش؛ اسهال شدید؛ کراتیت؛ واکنش پوستی تاولی؛ سمیت جنینی.","Interstitial lung disease; hepatotoxicity; GI perforation; severe diarrhoea; keratitis; bullous skin disorders; embryo-fetal toxicity.",[66],{"source":34,"section":67},"5",[],[],[],{"status":72,"reviewer":73,"date":73},"unverified",null,[75],{"regimen":38,"formulation":23,"input":76,"expect":79},{"ageYears":77,"weightKg":78},55,70,{"perDose":28,"tabletsPerDoseRounded":5},[81],"L01EB01",{"status":83,"forms":84,"refs":89},"registered",[85],{"code":86,"en":87,"fa":88},"08108","GEFITINIB 250MG TAB","قرص جفیتینیب ۲۵۰ میلی‌گرم",[90],{"source":91,"section":92,"url":93},"darooyab-generic","G-1008\u002FGefitinib","https:\u002F\u002Fwww.darooyab.ir\u002FG-1008\u002FGefitinib",{"kind":95,"refs":96,"id":99},"NDA",[97],{"source":34,"section":98},"SPL approval \u002F marketing category","NDA206995",[101,104,108,111,114],{"kind":102,"url":103,"label":99},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=206995",{"kind":105,"url":106,"label":107},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=827d60e8-7e07-41b7-c28b-49ef1c4a5a41","FDA Iressa",{"kind":109,"url":110,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa607002.html",{"kind":112,"url":113,"label":81},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L01EB01",{"kind":115,"url":93,"label":8},"darooyab",{"pregnancy":117,"lactation":126,"pediatric":135,"geriatric":144,"reproductive":153},{"level":118,"text":119,"quote":122,"refs":123},"avoid",{"fa":120,"en":121},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","Risk Summary Based on its mechanism of action and animal data, IRESSA can cause fetal harm when administered to a pregnant woman.",[124],{"source":34,"section":125},"8.1",{"level":127,"text":128,"quote":131,"refs":132},"caution",{"fa":129,"en":130},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Animal studies indicate the gefitinib and its metabolites are present in rat milk at a concentration higher than those in maternal plasma.",[133],{"source":34,"section":134},"8.2",{"level":136,"text":137,"quote":140,"refs":141},"not-established",{"fa":138,"en":139},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","The safety and effectiveness of IRESSA in pediatric patients have not been established.",[142],{"source":34,"section":143},"8.4",{"level":145,"text":146,"quote":149,"refs":150},"ok",{"fa":147,"en":148},"برچسب: در سالمندان تفاوت یا تنظیم دوز خاصی ذکر نشده.","Label: no specific difference or dose adjustment stated for older adults.","No overall differences in safety were observed between patients 65 years and older and those younger than 65 years.",[151],{"source":34,"section":152},"8.5",{"level":127,"text":154,"quote":157,"refs":158},{"fa":155,"en":156},"برچسب نکته‌ای درباره بارداری، پیشگیری یا باروری زنان و مردان دارد.","Label has advice on pregnancy testing, contraception or fertility for females and males.","Contraception Based on its mechanism of action and animal data, IRESSA can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] .",[159],{"source":34,"section":160},"8.3",1792444707408]