[{"data":1,"prerenderedAt":183},["ShallowReactive",2],{"drug-durvalumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":34,"contraindications":80,"warnings":81,"renal":89,"monitoring":90,"interactions":91,"review":92,"examples":95,"atc":107,"iran":109,"usApproval":116,"links":122,"populations":139},"durvalumab",1,{"fa":7,"en":8},"دوروالوماب","Durvalumab","antineoplastic-immunomodulating",{"fa":11,"en":12},"مهارکننده PD-L1","PD-L1 blocking antibody",[14],{"name":15,"market":16},"Imfinzi","US",[18,19,7],"imfinzi","ایمفینزی",[21],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":29,"refs":30},"inj-50","injection","iv","50 mg\u002FmL (120 mg\u002F2.4 mL, 500 mg\u002F10 mL)",{"amount":27,"unit":28,"perVolumeMl":5},50,"mg",[16],[31],{"source":32,"section":33},"fda-imfinzi","3",[35,60],{"id":36,"disease":37,"label":38,"population":41,"type":36,"unit":28,"dose":46,"refs":48,"durationDays":51,"notes":52},"fixed","lung-cancer",{"fa":39,"en":40},"NSCLC، SCLC، سرطان مجاری صفراوی، کبد و سایر — وزن ۳۰ kg به بالا: ۱۵۰۰ mg وریدی هر ۳ یا ۴ هفته طبق رژیم","NSCLC, SCLC, biliary tract, liver and other cancers — weight ≥30 kg: 1500 mg IV every 3 or 4 weeks by regimen",{"minAge":42,"minWeightKg":45},{"value":43,"unit":44},18,"year",30,{"perDose":47,"dosesPerDay":5},1500,[49],{"source":32,"section":50},"2.2, Table 1",{"min":5,"max":5},[53],{"text":54,"refs":57},{"fa":55,"en":56},"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.",[58],{"source":32,"section":59},"2.2",{"id":61,"disease":37,"label":62,"population":65,"type":68,"unit":28,"dose":69,"refs":72,"durationDays":74,"notes":75},"light",{"fa":63,"en":64},"وزن زیر ۳۰ kg — ۲۰ mg\u002Fkg وریدی هر ۳ یا ۴ هفته","Weight under 30 kg — 20 mg\u002Fkg IV every 3 or 4 weeks",{"minAge":66,"maxWeightKg":67},{"value":43,"unit":44},29.99,"weightBased",{"perKgPerDose":70,"intervalHours":71},20,24,[73],{"source":32,"section":50},{"min":5,"max":5},[76],{"text":77,"refs":78},{"fa":55,"en":56},[79],{"source":32,"section":59},[],[82],{"text":83,"refs":86},{"fa":84,"en":85},"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.",[87],{"source":32,"section":88},"5",[],[],[],{"status":93,"reviewer":94,"date":94},"unverified",null,[96,101],{"regimen":36,"formulation":22,"input":97,"expect":100},{"ageYears":98,"weightKg":99},60,70,{"perDose":47,"mlPerDose":45},{"regimen":61,"formulation":22,"input":102,"expect":104},{"ageYears":99,"weightKg":103},28,{"perDose":105,"mlPerDose":106},560,11.2,[108],"L01FF03",{"status":110,"refs":111},"not-found",[112],{"source":113,"section":114,"url":115},"darooyab-generic","G-5560\u002FDurvalumab","https:\u002F\u002Fwww.darooyab.ir\u002FG-5560\u002FDurvalumab",{"kind":117,"refs":118,"id":121},"BLA",[119],{"source":32,"section":120},"SPL approval \u002F marketing category","BLA761069",[123,126,130,134,137],{"kind":124,"url":125,"label":121},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=761069",{"kind":127,"url":128,"label":129},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=8baba4ea-2855-42fa-9bd9-5a7548d4cec3","FDA Imfinzi",{"kind":131,"url":132,"label":133},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa617030.html","Durvalumab Injection",{"kind":135,"url":136,"label":108},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L01FF03",{"kind":138,"url":115,"label":8},"darooyab",{"pregnancy":140,"lactation":149,"pediatric":157,"geriatric":166,"reproductive":175},{"level":141,"text":142,"quote":145,"refs":146},"avoid",{"fa":143,"en":144},"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, IMFINZI can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] .",[147],{"source":32,"section":148},"8.1",{"level":141,"text":150,"quote":153,"refs":154},{"fa":151,"en":152},"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 adverse reactions in a breastfed child, advise women not to breastfeed during treatment with IMFINZI and for 3 months after the last dose.",[155],{"source":32,"section":156},"8.2",{"level":158,"text":159,"quote":162,"refs":163},"caution",{"fa":160,"en":161},"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 IMFINZI have not been established in pediatric patients.",[164],{"source":32,"section":165},"8.4",{"level":167,"text":168,"quote":171,"refs":172},"ok",{"fa":169,"en":170},"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.",[173],{"source":32,"section":174},"8.5",{"level":158,"text":176,"quote":179,"refs":180},{"fa":177,"en":178},"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 IMFINZI can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] .",[181],{"source":32,"section":182},"8.3",1792444709816]