[{"data":1,"prerenderedAt":169},["ShallowReactive",2],{"drug-sorafenib":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":35,"contraindications":60,"warnings":70,"renal":78,"monitoring":79,"interactions":80,"review":81,"examples":84,"atc":90,"iran":92,"usApproval":104,"links":110,"populations":126},"sorafenib",1,{"fa":7,"en":8},"سورافنیب","Sorafenib","antineoplastic-immunomodulating",{"fa":11,"en":12},"مهارکننده چندکینازی","Multikinase inhibitor",[14],{"name":15,"market":16},"Nexavar","US",[18,19,7],"nexavar","نکساوار",[21],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"tab-200","tablet","oral","200 mg tablet",{"amount":27,"unit":28,"perUnit":23,"scored":29},200,"mg",false,[16],[32],{"source":33,"section":34},"fda-nexavar","3",[36],{"id":37,"disease":38,"label":39,"population":42,"type":46,"unit":28,"dose":47,"refs":50,"notes":53},"hcc","hepatocellular-carcinoma",{"fa":40,"en":41},"کارسینوم هپاتوسلولار غیرقابل‌جراحی، RCC پیشرفته و سرطان تمایزیافته تیروئید مقاوم به ید — ۴۰۰ mg دو بار در روز بدون غذا","Unresectable HCC, advanced RCC and RAI-refractory differentiated thyroid cancer — 400 mg twice daily without food",{"minAge":43},{"value":44,"unit":45},18,"year","fixed",{"perDose":48,"dosesPerDay":49},400,2,[51],{"source":33,"section":52},"2.1",[54],{"text":55,"refs":58},{"fa":56,"en":57},"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.",[59],{"source":33,"section":52},[61],{"id":62,"severity":63,"text":64,"refs":67},"ci","block",{"fa":65,"en":66},"حساسیت شدید به سورافنیب؛ همراه کربوپلاتین و پاکلی‌تاکسل در سرطان سلول سنگفرشی ریه.","Severe hypersensitivity to sorafenib; with carboplatin and paclitaxel in squamous cell lung cancer.",[68],{"source":33,"section":69},"4",[71],{"text":72,"refs":75},{"fa":73,"en":74},"ایسکمی قلب؛ خونریزی؛ فشار خون؛ واکنش پوستی (دست و پا)؛ سوراخ شدن گوارش؛ اختلال ترمیم زخم؛ طولانی شدن QT؛ آسیب کبدی؛ سمیت جنینی.","Cardiac ischaemia; haemorrhage; hypertension; skin toxicity (hand-foot); GI perforation; impaired wound healing; QT prolongation; liver injury; embryo-fetal toxicity.",[76],{"source":33,"section":77},"5",[],[],[],{"status":82,"reviewer":83,"date":83},"unverified",null,[85],{"regimen":37,"formulation":22,"input":86,"expect":89},{"ageYears":87,"weightKg":88},55,70,{"perDose":48,"tabletsPerDoseRounded":49},[91],"L01EX02",{"status":93,"forms":94,"refs":99},"registered",[95],{"code":96,"en":97,"fa":98},"08448","SORAFENIB 200MG TAB","قرص سورافنیب ۲۰۰ میلی‌گرم",[100],{"source":101,"section":102,"url":103},"darooyab-generic","G-4808\u002FSorafenib","https:\u002F\u002Fwww.darooyab.ir\u002FG-4808\u002FSorafenib",{"kind":105,"refs":106,"id":109},"NDA",[107],{"source":33,"section":108},"SPL approval \u002F marketing category","NDA021923",[111,114,118,121,124],{"kind":112,"url":113,"label":109},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=021923",{"kind":115,"url":116,"label":117},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=b50667e4-5ebc-4968-a646-d605058dbef0","FDA Nexavar",{"kind":119,"url":120,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa607051.html",{"kind":122,"url":123,"label":91},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L01EX02",{"kind":125,"url":103,"label":8},"darooyab",{"pregnancy":127,"lactation":136,"pediatric":144,"geriatric":153,"reproductive":161},{"level":128,"text":129,"quote":132,"refs":133},"avoid",{"fa":130,"en":131},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology ( 12.1 )] , NEXAVAR may cause fetal harm when administered to a pregnant woman.",[134],{"source":33,"section":135},"8.1",{"level":128,"text":137,"quote":140,"refs":141},{"fa":138,"en":139},"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 a breastfed child from NEXAVAR, advise women not to breastfeed during treatment with NEXAVAR and for 2 weeks after the last dose.",[142],{"source":33,"section":143},"8.2",{"level":145,"text":146,"quote":149,"refs":150},"caution",{"fa":147,"en":148},"برچسب برای کودکان شرط، محدودیت سنی یا نکته دارد؛ جمله برچسب در زیر آمده است.","The label has conditions, age limits or notes for children; the label sentence is quoted below.","The safety and effectiveness of NEXAVAR have not been established in pediatric patients.",[151],{"source":33,"section":152},"8.4",{"level":145,"text":154,"quote":157,"refs":158},{"fa":155,"en":156},"برچسب: در سالمندان با احتیاط و معمولاً از دوز پایین شروع شود.","Label: use with caution in older adults, usually starting at the low end of the dose range.","In total, 59% of HCC patients treated with NEXAVAR were age 65 years or older and 19% were 75 and older.",[159],{"source":33,"section":160},"8.5",{"level":145,"text":162,"quote":165,"refs":166},{"fa":163,"en":164},"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 and for 6 months following the last dose of NEXAVAR.",[167],{"source":33,"section":168},"8.3",1792444423554]