[{"data":1,"prerenderedAt":180},["ShallowReactive",2],{"drug-osimertinib":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":43,"contraindications":74,"warnings":75,"renal":83,"monitoring":84,"interactions":85,"review":86,"examples":89,"atc":95,"iran":97,"usApproval":113,"links":119,"populations":135},"osimertinib",1,{"fa":7,"en":8},"اوسیمرتینیب","Osimertinib","antineoplastic-immunomodulating",{"fa":11,"en":12},"مهارکننده EGFR نسل سوم","Third-generation EGFR inhibitor",[14],{"name":15,"market":16},"Tagrisso","US",[18,19,7],"tagrisso","تاگریسو",[21,35],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"tab-40","tablet","oral","40 mg tablet",{"amount":27,"unit":28,"perUnit":23,"scored":29},40,"mg",false,[16],[32],{"source":33,"section":34},"fda-tagrisso","3",{"id":36,"form":23,"route":24,"label":37,"concentration":38,"markets":40,"refs":41},"tab-80","80 mg tablet",{"amount":39,"unit":28,"perUnit":23,"scored":29},80,[16],[42],{"source":33,"section":34},[44],{"id":45,"disease":46,"label":47,"population":50,"type":54,"unit":28,"dose":55,"refs":56,"notes":59},"nsclc","lung-cancer",{"fa":48,"en":49},"NSCLC با جهش EGFR (حذف اگزون ۱۹ یا L858R) — ۸۰ mg یک بار در روز","EGFR-mutated NSCLC (exon 19 deletion or L858R) — 80 mg once daily",{"minAge":51},{"value":52,"unit":53},18,"year","fixed",{"perDose":39,"dosesPerDay":5},[57],{"source":33,"section":58},"2.3",[60,66],{"text":61,"refs":64},{"fa":62,"en":63},"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.",[65],{"source":33,"section":58},{"text":67,"refs":70},{"fa":68,"en":69},"درمان کمکی پس از جراحی: حداکثر ۳ سال. انتخاب بیمار با تست مورد تأیید FDA.","Adjuvant after resection: up to 3 years. Select patients with an FDA-approved test.",[71,72],{"source":33,"section":58},{"source":33,"section":73},"2.2",[],[76],{"text":77,"refs":80},{"fa":78,"en":79},"بیماری بینابینی ریه؛ طولانی شدن QT؛ کاردیومیوپاتی؛ کراتیت؛ SJS؛ واسکولیت پوستی؛ آنمی آپلاستیک؛ میوزیت؛ سمیت جنینی.","Interstitial lung disease; QT prolongation; cardiomyopathy; keratitis; SJS; cutaneous vasculitis; aplastic anaemia; myositis; embryo-fetal toxicity.",[81],{"source":33,"section":82},"5",[],[],[],{"status":87,"reviewer":88,"date":88},"unverified",null,[90],{"regimen":45,"formulation":36,"input":91,"expect":94},{"ageYears":92,"weightKg":93},55,70,{"perDose":39,"tabletsPerDoseRounded":5},[96],"L01EB04",{"status":98,"forms":99,"refs":108},"registered",[100,104],{"code":101,"en":102,"fa":103},"50911","OSIMERTINIB 80 mg TABLET","قرص اسیمرتینیب ۸۰ میلی‌گرم",{"code":105,"en":106,"fa":107},"50910","OSIMERTINIB 40 mg TABLET","قرص اسیمرتینیب ۴۰ میلی‌گرم",[109],{"source":110,"section":111,"url":112},"darooyab-generic","G-5379\u002FOsimertinib","https:\u002F\u002Fwww.darooyab.ir\u002FG-5379\u002FOsimertinib",{"kind":114,"refs":115,"id":118},"NDA",[116],{"source":33,"section":117},"SPL approval \u002F marketing category","NDA208065",[120,123,127,130,133],{"kind":121,"url":122,"label":118},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=208065",{"kind":124,"url":125,"label":126},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7","FDA Tagrisso",{"kind":128,"url":129,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa616005.html",{"kind":131,"url":132,"label":96},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L01EB04",{"kind":134,"url":112,"label":8},"darooyab",{"pregnancy":136,"lactation":145,"pediatric":153,"geriatric":162,"reproductive":171},{"level":137,"text":138,"quote":141,"refs":142},"avoid",{"fa":139,"en":140},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","Risk Summary Based on data from animal studies and its mechanism of action [see Clinical Pharmacology (12.1) ] , TAGRISSO can cause fetal harm when administered to a pregnant woman.",[143],{"source":33,"section":144},"8.1",{"level":137,"text":146,"quote":149,"refs":150},{"fa":147,"en":148},"برچسب: شیردهی توصیه نمی‌شود یا باید بین دارو و شیردهی یکی انتخاب شود.","Label: breastfeeding not recommended, or choose between the drug and breastfeeding.","Because of the potential for serious adverse reactions in breastfed infants from osimertinib, advise women not to breastfeed during treatment with TAGRISSO and for 2 weeks after the last dose.",[151],{"source":33,"section":152},"8.2",{"level":154,"text":155,"quote":158,"refs":159},"not-established",{"fa":156,"en":157},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","The safety and effectiveness of TAGRISSO in pediatric patients have not been established.",[160],{"source":33,"section":161},"8.4",{"level":163,"text":164,"quote":167,"refs":168},"ok",{"fa":165,"en":166},"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 effectiveness were observed between patients 65 years or older and younger patients.",[169],{"source":33,"section":170},"8.5",{"level":172,"text":173,"quote":176,"refs":177},"caution",{"fa":174,"en":175},"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 Advise females of reproductive potential to use effective contraception during treatment with TAGRISSO and for 6 weeks after the last dose [see Use in Specific Populations (8.1) ] .",[178],{"source":33,"section":179},"8.3",1792444415175]