[{"data":1,"prerenderedAt":208},["ShallowReactive",2],{"drug-sunitinib":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":59,"contraindications":91,"warnings":92,"renal":107,"monitoring":108,"interactions":109,"review":110,"examples":113,"atc":119,"iran":121,"usApproval":141,"links":147,"populations":163},"sunitinib",1,{"fa":7,"en":8},"سونیتینیب","Sunitinib","antineoplastic-immunomodulating",{"fa":11,"en":12},"مهارکننده چندکینازی","Multikinase inhibitor",[14],{"name":15,"market":16},"Sutent","US",[18,19,7],"sutent","سوتنت",[21,35,43,51],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"cap-12-5","capsule","oral","12.5 mg capsule",{"amount":27,"unit":28,"perUnit":23,"scored":29},12.5,"mg",false,[16],[32],{"source":33,"section":34},"fda-sutent","3",{"id":36,"form":23,"route":24,"label":37,"concentration":38,"markets":40,"refs":41},"cap-25","25 mg capsule",{"amount":39,"unit":28,"perUnit":23,"scored":29},25,[16],[42],{"source":33,"section":34},{"id":44,"form":23,"route":24,"label":45,"concentration":46,"markets":48,"refs":49},"cap-37-5","37.5 mg capsule",{"amount":47,"unit":28,"perUnit":23,"scored":29},37.5,[16],[50],{"source":33,"section":34},{"id":52,"form":23,"route":24,"label":53,"concentration":54,"markets":56,"refs":57},"cap-50","50 mg capsule",{"amount":55,"unit":28,"perUnit":23,"scored":29},50,[16],[58],{"source":33,"section":34},[60],{"id":61,"disease":62,"label":63,"population":66,"type":70,"unit":28,"dose":71,"refs":72,"notes":75},"rcc","renal-cell-carcinoma",{"fa":64,"en":65},"RCC پیشرفته و GIST — ۵۰ mg یک بار در روز، ۴ هفته مصرف و ۲ هفته استراحت","Advanced RCC and GIST — 50 mg once daily, 4 weeks on and 2 weeks off",{"minAge":67},{"value":68,"unit":69},18,"year","fixed",{"perDose":55,"dosesPerDay":5},[73],{"source":33,"section":74},"2.1",[76,82],{"text":77,"refs":80},{"fa":78,"en":79},"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.",[81],{"source":33,"section":74},{"text":83,"refs":86},{"fa":84,"en":85},"درمان کمکی RCC: همین برنامه، حداکثر ۹ دوره. pNET: ۳۷٫۵ mg مداوم.","Adjuvant RCC: same schedule for up to 9 cycles. pNET: 37.5 mg continuously.",[87,89],{"source":33,"section":88},"2.2",{"source":33,"section":90},"2",[],[93,100],{"text":94,"refs":97},{"fa":95,"en":96},"هشدار جعبه‌ای: سمیت کبدی شدید و گاه کشنده.","Boxed warning: severe, sometimes fatal hepatotoxicity.",[98],{"source":33,"section":99},"Boxed Warning",{"text":101,"refs":104},{"fa":102,"en":103},"عوارض قلبی‌عروقی؛ QT طولانی؛ فشار خون؛ خونریزی؛ لیز تومور؛ TMA؛ پروتئینوری؛ واکنش پوستی؛ اختلال تیروئید؛ هیپوگلیسمی؛ استئونکروز فک.","Cardiovascular events; QT prolongation; hypertension; haemorrhage; tumour lysis; TMA; proteinuria; skin reactions; thyroid dysfunction; hypoglycaemia; osteonecrosis of the jaw.",[105],{"source":33,"section":106},"5",[],[],[],{"status":111,"reviewer":112,"date":112},"unverified",null,[114],{"regimen":61,"formulation":52,"input":115,"expect":118},{"ageYears":116,"weightKg":117},55,70,{"perDose":55,"tabletsPerDoseRounded":5},[120],"L01EX01",{"status":122,"forms":123,"refs":136},"registered",[124,128,132],{"code":125,"en":126,"fa":127},"09988","SUNITINIB MALATE 12.5MG CAP","کپسول سونیتینیب مالات ۱۲٫۵ میلی‌گرم",{"code":129,"en":130,"fa":131},"09753","SUNITINIB MALATE 25MG CAP","کپسول سونیتینیب مالات ۲۵ میلی‌گرم",{"code":133,"en":134,"fa":135},"07804","SUNITINIB MALATE 50MG CAP","کپسول سونیتینیب مالات ۵۰ میلی‌گرم",[137],{"source":138,"section":139,"url":140},"darooyab-generic","G-4691\u002FSunitinib","https:\u002F\u002Fwww.darooyab.ir\u002FG-4691\u002FSunitinib",{"kind":142,"refs":143,"id":146},"NDA",[144],{"source":33,"section":145},"SPL approval \u002F marketing category","NDA021938",[148,151,155,158,161],{"kind":149,"url":150,"label":146},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=021938",{"kind":152,"url":153,"label":154},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c","FDA Sutent",{"kind":156,"url":157,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa607052.html",{"kind":159,"url":160,"label":120},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L01EX01",{"kind":162,"url":140,"label":8},"darooyab",{"pregnancy":164,"lactation":173,"pediatric":181,"geriatric":190,"reproductive":199},{"level":165,"text":166,"quote":169,"refs":170},"avoid",{"fa":167,"en":168},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","Risk Summary Based on animal reproduction studies and its mechanism of action, SUTENT can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] .",[171],{"source":33,"section":172},"8.1",{"level":165,"text":174,"quote":177,"refs":178},{"fa":175,"en":176},"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, advise women not to breastfeed during treatment with SUTENT and for at least 4 weeks after the last dose.",[179],{"source":33,"section":180},"8.2",{"level":182,"text":183,"quote":186,"refs":187},"not-established",{"fa":184,"en":185},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","The safety and effectiveness of SUTENT in pediatric patients have not been established.",[188],{"source":33,"section":189},"8.4",{"level":191,"text":192,"quote":195,"refs":196},"ok",{"fa":193,"en":194},"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 these patients and younger patients.",[197],{"source":33,"section":198},"8.5",{"level":200,"text":201,"quote":204,"refs":205},"caution",{"fa":202,"en":203},"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 SUTENT and for at least 4 weeks after the last dose.",[206],{"source":33,"section":207},"8.3",1792444424369]