[{"data":1,"prerenderedAt":175},["ShallowReactive",2],{"drug-ipilimumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":34,"contraindications":67,"warnings":68,"renal":76,"monitoring":77,"interactions":78,"review":79,"examples":82,"atc":90,"iran":92,"usApproval":108,"links":114,"populations":131},"ipilimumab",1,{"fa":7,"en":8},"ایپیلیموماب","Ipilimumab","antineoplastic-immunomodulating",{"fa":11,"en":12},"مهارکننده CTLA-4","CTLA-4 blocking antibody",[14],{"name":15,"market":16},"Yervoy","US",[18,19,7],"yervoy","یروی",[21],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":29,"refs":30},"inj-5","injection","iv","5 mg\u002FmL (50 mg\u002F10 mL, 200 mg\u002F40 mL)",{"amount":27,"unit":28,"perVolumeMl":5},5,"mg",[16],[31],{"source":32,"section":33},"fda-yervoy","3",[35],{"id":36,"disease":37,"label":38,"population":41,"type":45,"unit":28,"dose":46,"refs":49,"durationDays":52,"notes":53},"mel","melanoma",{"fa":39,"en":40},"ملانوم غیرقابل‌جراحی یا متاستاتیک (۱۲ سال به بالا) — ۳ mg\u002Fkg وریدی هر ۳ هفته، حداکثر ۴ دوز","Unresectable or metastatic melanoma (≥12 years) — 3 mg\u002Fkg IV every 3 weeks, max 4 doses",{"minAge":42},{"value":43,"unit":44},12,"year","weightBased",{"perKgPerDose":47,"intervalHours":48},3,24,[50],{"source":32,"section":51},"2.2",{"min":5,"max":5},[54,60],{"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":32,"section":51},{"text":61,"refs":64},{"fa":62,"en":63},"ترکیب با نیوولوماب و سایر اندیکاسیون‌ها (کلیه، کولورکتال، کبد، ریه، مزوتلیوما): دوز و فاصله متفاوت طبق بخش ۲.","Combinations with nivolumab and other indications (renal, colorectal, liver, lung, mesothelioma): different dose and interval per section 2.",[65],{"source":32,"section":66},"2",[],[69],{"text":70,"refs":73},{"fa":71,"en":72},"واکنش‌های ایمنی شدید و کشنده (پنومونیت، کولیت، هپاتیت، اندوکرینوپاتی، نفریت، پوستی)؛ واکنش انفوزیون؛ عوارض پیوند آلوژن مغز استخوان؛ سمیت جنینی.","Severe and fatal immune-mediated reactions (pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, skin); infusion reactions; complications of allogeneic HSCT; embryo-fetal toxicity.",[74],{"source":32,"section":75},"5",[],[],[],{"status":80,"reviewer":81,"date":81},"unverified",null,[83],{"regimen":36,"formulation":22,"input":84,"expect":87},{"ageYears":85,"weightKg":86},50,70,{"perDose":88,"mlPerDose":89},210,42,[91],"L01FX04",{"status":93,"forms":94,"refs":103},"registered",[95,99],{"code":96,"en":97,"fa":98},"21572","IPILIMUMAB 200MG\u002F40ML VIAL","ویال ایپیلیمومب ۲۰۰ میلی‌گرم \u002F ۴۰ میلی‌لیتر",{"code":100,"en":101,"fa":102},"23984","IPILIMUMAB INJECTION, SOLUTION, CONCENTRATE PARENTERAL 5 mg\u002F1mL 10 mL","کنسانتره محلول تزریقی ایپیلیمومب ۵ میلی‌گرم \u002F ۱ میلی‌لیتر ۱۰ میلی‌لیتر",[104],{"source":105,"section":106,"url":107},"darooyab-generic","G-4764\u002FIpilimumab","https:\u002F\u002Fwww.darooyab.ir\u002FG-4764\u002FIpilimumab",{"kind":109,"refs":110,"id":113},"BLA",[111],{"source":32,"section":112},"SPL approval \u002F marketing category","BLA125377",[115,118,122,126,129],{"kind":116,"url":117,"label":113},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=125377",{"kind":119,"url":120,"label":121},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=2265ef30-253e-11df-8a39-0800200c9a66","FDA Yervoy",{"kind":123,"url":124,"label":125},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa611023.html","Ipilimumab Injection",{"kind":127,"url":128,"label":91},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L01FX04",{"kind":130,"url":107,"label":8},"darooyab",{"pregnancy":132,"lactation":141,"pediatric":149,"geriatric":158,"reproductive":167},{"level":133,"text":134,"quote":137,"refs":138},"avoid",{"fa":135,"en":136},"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) ] , YERVOY can cause fetal harm when administered to a pregnant woman.",[139],{"source":32,"section":140},"8.1",{"level":133,"text":142,"quote":145,"refs":146},{"fa":143,"en":144},"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 children, advise women not to breastfeed during treatment with YERVOY and for 3 months following the last dose.",[147],{"source":32,"section":148},"8.2",{"level":150,"text":151,"quote":154,"refs":155},"caution",{"fa":152,"en":153},"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 YERVOY have been established in pediatric patients aged 12 years and older for the following indications: as a single agent and in combination with nivolumab for unresectable or metastatic melanoma, in combination with nivolumab for the treatment of MSI-H or dMMR unresectable and …",[156],{"source":32,"section":157},"8.4",{"level":159,"text":160,"quote":163,"refs":164},"ok",{"fa":161,"en":162},"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.",[165],{"source":32,"section":166},"8.5",{"level":150,"text":168,"quote":171,"refs":172},{"fa":169,"en":170},"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 YERVOY can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] .",[173],{"source":32,"section":174},"8.3",1792444404547]