[{"data":1,"prerenderedAt":198},["ShallowReactive",2],{"drug-nivolumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":34,"contraindications":85,"warnings":86,"renal":94,"monitoring":95,"interactions":96,"review":97,"examples":100,"atc":113,"iran":115,"usApproval":131,"links":137,"populations":154},"nivolumab",1,{"fa":7,"en":8},"نیولوماب","Nivolumab","antineoplastic-immunomodulating",{"fa":11,"en":12},"مهارکننده PD-1","PD-1 blocking antibody",[14],{"name":15,"market":16},"Opdivo","US",[18,19,7],"opdivo","اپدیوو",[21],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":29,"refs":30},"vial-10","injection","iv","10 mg\u002FmL (40\u002F100\u002F120\u002F240 mg)",{"amount":27,"unit":28,"perVolumeMl":5},10,"mg",[16],[31],{"source":32,"section":33},"fda-opdivo","3",[35,67],{"id":36,"disease":37,"label":38,"population":41,"type":43,"unit":28,"dose":44,"refs":46,"durationDays":49,"notes":50},"adult","lung-cancer",{"fa":39,"en":40},"تک‌دارو (NSCLC، ملانوم، کلیه، هوچکین و سایر) — ۲۴۰ mg هر ۲ هفته یا ۴۸۰ mg هر ۴ هفته (≥۴۰ kg)","Single agent (NSCLC, melanoma, RCC, Hodgkin and others) — 240 mg every 2 weeks or 480 mg every 4 weeks (≥40 kg)",{"minWeightKg":42},40,"fixed",{"perDose":45,"dosesPerDay":5},240,[47],{"source":32,"section":48},"2.2, Table 1",{"min":5,"max":5},[51,60],{"text":52,"refs":55},{"fa":53,"en":54},"انفوزیون ۳۰ دقیقه. ترکیب با ایپیلیموماب یا شیمی‌درمانی دوز متفاوت (جدول برچسب). کاهش دوز ندارد.","30-min infusion. Combinations with ipilimumab or chemotherapy use different doses (label tables). No dose reductions.",[56,58],{"source":32,"section":57},"2.2",{"source":32,"section":59},"2.3",{"text":61,"refs":64},{"fa":62,"en":63},"فقط زیر نظر پزشک متخصص انکولوژی؛ پروتکل، فاصله دوره‌ها و تنظیم با تیم درمان.","Only under an oncologist; protocol, cycle interval and adjustment rest with the treating team.",[65],{"source":32,"section":66},"2",{"id":68,"disease":69,"label":70,"population":73,"type":78,"unit":28,"dose":79,"refs":82,"durationDays":84},"child","melanoma",{"fa":71,"en":72},"ملانوم کودک زیر ۴۰ kg — ۳ mg\u002Fkg هر ۲ هفته (یا ۶ mg\u002Fkg هر ۴ هفته)","Melanoma, children \u003C40 kg — 3 mg\u002Fkg every 2 weeks (or 6 mg\u002Fkg every 4 weeks)",{"maxAge":74,"maxWeightKg":77},{"value":75,"unit":76},18,"year",39.99,"weightBased",{"perKgPerDose":80,"intervalHours":81},3,24,[83],{"source":32,"section":57},{"min":5,"max":5},[],[87],{"text":88,"refs":91},{"fa":89,"en":90},"واکنش‌های ایمنی شدید و کشنده (پنومونیت، کولیت، هپاتیت، اندوکرینوپاتی، نفریت، پوستی)؛ واکنش انفوزیون؛ عوارض پیوند آلوژن؛ سمیت جنینی.","Severe and fatal immune-mediated reactions (pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, skin); infusion reactions; allogeneic HSCT complications; embryo-fetal toxicity.",[92],{"source":32,"section":93},"5",[],[],[],{"status":98,"reviewer":99,"date":99},"unverified",null,[101,106],{"regimen":36,"formulation":22,"input":102,"expect":105},{"ageYears":103,"weightKg":104},60,70,{"perDose":45,"mlPerDose":81},{"regimen":68,"formulation":22,"input":107,"expect":110},{"ageYears":108,"weightKg":109},12,30,{"perDose":111,"mlPerDose":112},90,9,[114],"L01FF01",{"status":116,"forms":117,"refs":126},"registered",[118,122],{"code":119,"en":120,"fa":121},"50884","NIVOLUMAB 10 MG\u002FML INJECTION","فرآورده تزریقی نیوولومب ۱۰ میلی‌گرم \u002F میلی‌لیتر",{"code":123,"en":124,"fa":125},"52363","NIVOLUMAB 40 MG\u002F4ML INJECTION","فرآورده تزریقی نیوولومب ۴۰ میلی‌گرم \u002F ۴ میلی‌لیتر",[127],{"source":128,"section":129,"url":130},"darooyab-generic","G-5421\u002FNivolumab","https:\u002F\u002Fwww.darooyab.ir\u002FG-5421\u002FNivolumab",{"kind":132,"refs":133,"id":136},"BLA",[134],{"source":32,"section":135},"SPL approval \u002F marketing category","BLA125554",[138,141,145,149,152],{"kind":139,"url":140,"label":136},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=125554",{"kind":142,"url":143,"label":144},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394","FDA Opdivo",{"kind":146,"url":147,"label":148},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa614056.html","Nivolumab Injection",{"kind":150,"url":151,"label":114},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L01FF01",{"kind":153,"url":130,"label":8},"darooyab",{"pregnancy":155,"lactation":164,"pediatric":172,"geriatric":181,"reproductive":190},{"level":156,"text":157,"quote":160,"refs":161},"avoid",{"fa":158,"en":159},"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) ] , OPDIVO can cause fetal harm when administered to a pregnant woman.",[162],{"source":32,"section":163},"8.1",{"level":156,"text":165,"quote":168,"refs":169},{"fa":166,"en":167},"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 the breastfed child, advise women not to breastfeed during treatment and for 5 months after the last dose of OPDIVO.",[170],{"source":32,"section":171},"8.2",{"level":173,"text":174,"quote":177,"refs":178},"caution",{"fa":175,"en":176},"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 OPDIVO have been established in pediatric patients aged 12 years and older for the following indications: as a single agent and in combination with ipilimumab for the treatment of unresectable or metastatic melanoma, as a single agent for the adjuvant treatment of completely resected …",[179],{"source":32,"section":180},"8.4",{"level":182,"text":183,"quote":186,"refs":187},"ok",{"fa":184,"en":185},"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 elderly patients and younger patients [see Clinical Studies (14.1 , 14.2 , 14.5 , 14.7 , 14.10 , 14.13 , 14.14) ].",[188],{"source":32,"section":189},"8.5",{"level":173,"text":191,"quote":194,"refs":195},{"fa":192,"en":193},"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 OPDIVO can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] .",[196],{"source":32,"section":197},"8.3",1792444413935]