[{"data":1,"prerenderedAt":176},["ShallowReactive",2],{"drug-dupilumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":36,"contraindications":84,"warnings":94,"renal":102,"monitoring":103,"interactions":104,"review":105,"examples":108,"atc":109,"iran":111,"usApproval":118,"links":124,"populations":141},"dupilumab",1,{"fa":7,"en":8},"دوپیلومب","Dupilumab","dermatology",{"fa":11,"en":12},"آنتی‌بادی ضد گیرنده IL-4α","Anti-IL-4Rα antibody",[14],{"name":15,"market":16},"Dupixent","US",[18,19,20],"dupixent","دوپیکسنت","دوپیلوماب",[22],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":31,"refs":32},"syr-300","injection","sc","300 mg\u002F2 mL (and 200 mg\u002F1.14 mL) pen or syringe",{"amount":28,"unit":29,"perVolumeMl":30},300,"mg",2,[16],[33],{"source":34,"section":35},"fda-dupixent","3",[37,55,70],{"id":38,"disease":39,"label":40,"population":43,"type":47,"unit":29,"dose":48,"refs":52},"ad","atopic-dermatitis",{"fa":41,"en":42},"درماتیت آتوپیک بزرگسال — ۶۰۰ mg سپس ۳۰۰ mg هر ۲ هفته","Adult atopic dermatitis — 600 mg, then 300 mg every 2 weeks",{"minAge":44},{"value":45,"unit":46},18,"year","notCalculated",{"reason":49},{"fa":50,"en":51},"دوز اول ۶۰۰ mg (دو تزریق ۳۰۰)، سپس ۳۰۰ mg هر ۲ هفته زیرجلدی (نه روزانه). کودک ۶ ماه به بالا: بر اساس جدول وزن برچسب.","Initial 600 mg (two 300 mg injections), then 300 mg SC every 2 weeks (not daily). Children ≥6 months: per label weight table.",[53],{"source":34,"section":54},"2.3",{"id":56,"disease":56,"label":57,"population":60,"type":47,"unit":29,"dose":63,"refs":67},"asthma",{"fa":58,"en":59},"آسم ائوزینوفیلیک یا وابسته به کورتون — ۴۰۰ یا ۶۰۰ mg، سپس ۲۰۰ یا ۳۰۰ mg هر ۲ هفته","Eosinophilic or steroid-dependent asthma — 400 or 600 mg, then 200 or 300 mg every 2 weeks",{"minAge":61},{"value":62,"unit":46},6,{"reason":64},{"fa":65,"en":66},"نگهدارنده هر ۲ هفته طبق برچسب؛ کودک ۶ تا ۱۱ سال بر اساس وزن. برای حمله حاد آسم نیست.","Maintenance every 2 weeks per label; children 6–11 y by weight. Not for acute asthma attacks.",[68],{"source":34,"section":69},"2",{"id":71,"disease":71,"label":72,"population":75,"type":47,"unit":29,"dose":77,"refs":81},"copd",{"fa":73,"en":74},"COPD با ائوزینوفیلی — بزرگسال ۳۰۰ mg هر ۲ هفته","COPD with eosinophilia — adult 300 mg every 2 weeks",{"minAge":76},{"value":45,"unit":46},{"reason":78},{"fa":79,"en":80},"۳۰۰ mg زیرجلدی هر ۲ هفته.","300 mg SC every 2 weeks.",[82],{"source":34,"section":83},"2.8",[85],{"id":86,"severity":87,"text":88,"refs":91},"hyper","block",{"fa":89,"en":90},"حساسیت به دوپیلومب یا اجزای فرآورده.","Hypersensitivity to dupilumab or its excipients.",[92],{"source":34,"section":93},"4",[95],{"text":96,"refs":99},{"fa":97,"en":98},"ورم ملتحمه و کراتیت؛ ائوزینوفیلی؛ کورتون را ناگهانی قطع نکنید؛ واکسن زنده نه.","Conjunctivitis and keratitis; eosinophilic conditions; do not stop steroids abruptly; no live vaccines.",[100],{"source":34,"section":101},"5",[],[],[],{"status":106,"reviewer":107,"date":107},"unverified",null,[],[110],"D11AH05",{"status":112,"refs":113},"registered",[114],{"source":115,"section":116,"url":117},"darooyab-generic","G-5363\u002FDupilumab","https:\u002F\u002Fwww.darooyab.ir\u002FG-5363\u002FDupilumab",{"kind":119,"refs":120,"id":123},"BLA",[121],{"source":34,"section":122},"SPL approval \u002F marketing category","BLA761055",[125,128,132,136,139],{"kind":126,"url":127,"label":123},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=761055",{"kind":129,"url":130,"label":131},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=595f437d-2729-40bb-9c62-c8ece1f82780","FDA Dupixent",{"kind":133,"url":134,"label":135},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa617021.html","Dupilumab Injection",{"kind":137,"url":138,"label":110},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=D11AH05",{"kind":140,"url":117,"label":8},"darooyab",{"pregnancy":142,"lactation":151,"pediatric":159,"geriatric":167},{"level":143,"text":144,"quote":147,"refs":148},"caution",{"fa":145,"en":146},"برچسب خطر مشخصی برای بارداری ذکر نکرده یا داده کافی ندارد؛ فقط در صورت لزوم و با نظر پزشک.","Label states no clear risk or has limited data; use only if needed, under medical advice.","Risk Summary Available data from case reports and case series with DUPIXENT use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.",[149],{"source":34,"section":150},"8.1",{"level":143,"text":152,"quote":155,"refs":156},{"fa":153,"en":154},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary There are no data on the presence of dupilumab in human milk, the effects on the breastfed infant, or the effects on milk production.",[157],{"source":34,"section":158},"8.2",{"level":143,"text":160,"quote":163,"refs":164},{"fa":161,"en":162},"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.","Atopic Dermatitis The safety and effectiveness of DUPIXENT have been established in pediatric patients 6 months of age and older with moderate-to-severe AD, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.",[165],{"source":34,"section":166},"8.4",{"level":168,"text":169,"quote":172,"refs":173},"ok",{"fa":170,"en":171},"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 of DUPIXENT have been observed between subjects 65 years of age and older and younger adult subjects.",[174],{"source":34,"section":175},"8.5",1792156176160]