[{"data":1,"prerenderedAt":200},["ShallowReactive",2],{"drug-erlotinib":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":51,"contraindications":91,"warnings":92,"renal":100,"monitoring":101,"interactions":102,"review":103,"examples":106,"atc":115,"iran":117,"usApproval":133,"links":139,"populations":155},"erlotinib",1,{"fa":7,"en":8},"ارلوتینیب","Erlotinib","antineoplastic-immunomodulating",{"fa":11,"en":12},"مهارکننده EGFR","EGFR inhibitor",[14],{"name":15,"market":16},"Tarceva","US",[18,19,7],"tarceva","تارسوا",[21,35,43],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"tab-25","tablet","oral","25 mg tablet",{"amount":27,"unit":28,"perUnit":23,"scored":29},25,"mg",false,[16],[32],{"source":33,"section":34},"fda-erlotinib","3",{"id":36,"form":23,"route":24,"label":37,"concentration":38,"markets":40,"refs":41},"tab-100","100 mg tablet",{"amount":39,"unit":28,"perUnit":23,"scored":29},100,[16],[42],{"source":33,"section":34},{"id":44,"form":23,"route":24,"label":45,"concentration":46,"markets":48,"refs":49},"tab-150","150 mg tablet",{"amount":47,"unit":28,"perUnit":23,"scored":29},150,[16],[50],{"source":33,"section":34},[52,74],{"id":53,"disease":54,"label":55,"population":58,"type":62,"unit":28,"dose":63,"refs":64,"notes":67},"nsclc","lung-cancer",{"fa":56,"en":57},"NSCLC متاستاتیک با جهش EGFR — ۱۵۰ mg ناشتا یک بار در روز","Metastatic EGFR-mutated NSCLC — 150 mg on an empty stomach once daily",{"minAge":59},{"value":60,"unit":61},18,"year","fixed",{"perDose":47,"dosesPerDay":5},[65],{"source":33,"section":66},"2.2",[68],{"text":69,"refs":72},{"fa":70,"en":71},"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.",[73],{"source":33,"section":66},{"id":75,"disease":76,"label":77,"population":80,"type":62,"unit":28,"dose":82,"refs":83,"notes":86},"pancreas","pancreatic-cancer",{"fa":78,"en":79},"سرطان پانکراس (با جمسیتابین) — ۱۰۰ mg ناشتا یک بار در روز","Pancreatic cancer (with gemcitabine) — 100 mg on an empty stomach once daily",{"minAge":81},{"value":60,"unit":61},{"perDose":39,"dosesPerDay":5},[84],{"source":33,"section":85},"2.3",[87],{"text":88,"refs":89},{"fa":70,"en":71},[90],{"source":33,"section":85},[],[93],{"text":94,"refs":97},{"fa":95,"en":96},"بیماری بینابینی ریه؛ نارسایی کلیه؛ سمیت کبدی؛ سوراخ شدن گوارش؛ واکنش پوستی تاولی؛ سکته مغزی؛ کم‌خونی همولیتیک میکروآنژیوپاتیک؛ اختلال چشمی؛ خونریزی با وارفارین؛ سمیت جنینی.","Interstitial lung disease; renal failure; hepatotoxicity; GI perforation; bullous skin disorders; stroke; microangiopathic haemolytic anaemia; ocular disorders; bleeding with warfarin; embryo-fetal toxicity.",[98],{"source":33,"section":99},"5",[],[],[],{"status":104,"reviewer":105,"date":105},"unverified",null,[107,112],{"regimen":53,"formulation":44,"input":108,"expect":111},{"ageYears":109,"weightKg":110},55,70,{"perDose":47,"tabletsPerDoseRounded":5},{"regimen":75,"formulation":36,"input":113,"expect":114},{"ageYears":109,"weightKg":110},{"perDose":39,"tabletsPerDoseRounded":5},[116],"L01EB02",{"status":118,"forms":119,"refs":128},"registered",[120,124],{"code":121,"en":122,"fa":123},"14887","ERLOTINIB 100MG TAB","قرص ارلوتینیب ۱۰۰ میلی‌گرم",{"code":125,"en":126,"fa":127},"06154","ERLOTINIB 150MG TAB","قرص ارلوتینیب ۱۵۰ میلی‌گرم",[129],{"source":130,"section":131,"url":132},"darooyab-generic","G-4743\u002FErlotinib","https:\u002F\u002Fwww.darooyab.ir\u002FG-4743\u002FErlotinib",{"kind":134,"refs":135,"id":138},"ANDA",[136],{"source":33,"section":137},"SPL approval \u002F marketing category","ANDA091059",[140,143,147,150,153],{"kind":141,"url":142,"label":138},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=091059",{"kind":144,"url":145,"label":146},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=5d97f401-4853-4a9a-907d-21e8a4d16088","FDA Erlotinib",{"kind":148,"url":149,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa605008.html",{"kind":151,"url":152,"label":116},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L01EB02",{"kind":154,"url":132,"label":8},"darooyab",{"pregnancy":156,"lactation":165,"pediatric":173,"geriatric":182,"reproductive":191},{"level":157,"text":158,"quote":161,"refs":162},"avoid",{"fa":159,"en":160},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","Risk Summary Based on animal data and its mechanism of action, erlotinib can cause fetal harm when administered to a pregnant woman.",[163],{"source":33,"section":164},"8.1",{"level":157,"text":166,"quote":169,"refs":170},{"fa":167,"en":168},"برچسب: شیردهی توصیه نمی‌شود یا باید بین دارو و شیردهی یکی انتخاب شود.","Label: breastfeeding not recommended, or choose between the drug and breastfeeding.","Advise a lactating woman not to breastfeed during treatment with erlotinib tablets and for 2 weeks after the final dose.",[171],{"source":33,"section":172},"8.2",{"level":174,"text":175,"quote":178,"refs":179},"not-established",{"fa":176,"en":177},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","The safety and effectiveness of erlotinib in pediatric patients have not been established.",[180],{"source":33,"section":181},"8.4",{"level":183,"text":184,"quote":187,"refs":188},"ok",{"fa":185,"en":186},"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 or efficacy were observed between subjects 65 years and older and those younger than 65.",[189],{"source":33,"section":190},"8.5",{"level":192,"text":193,"quote":196,"refs":197},"caution",{"fa":194,"en":195},"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 Females Erlotinib can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )] .",[198],{"source":33,"section":199},"8.3",1792444396847]