[{"data":1,"prerenderedAt":218},["ShallowReactive",2],{"drug-benralizumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":43,"contraindications":109,"warnings":119,"renal":127,"monitoring":128,"interactions":129,"review":130,"examples":132,"atc":154,"iran":156,"usApproval":163,"links":169,"populations":184},"benralizumab",1,{"fa":7,"en":8},"بنرالیزوماب","Benralizumab","respiratory",{"fa":11,"en":12},"آنتی‌بادی ضد گیرنده IL-5","Anti-IL-5 receptor antibody",[14],{"name":15,"market":16},"Fasenra","US",[18,19,7],"fasenra","فاسنرا",[21,34],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":29,"refs":30},"pfs-30","injection","sc","30 mg\u002FmL prefilled syringe or pen",{"amount":27,"unit":28,"perVolumeMl":5},30,"mg",[16],[31],{"source":32,"section":33},"fda-fasenra","3",{"id":35,"form":23,"route":24,"label":36,"concentration":37,"markets":40,"refs":41},"pfs-10","10 mg\u002F0.5 mL prefilled syringe",{"amount":38,"unit":28,"perVolumeMl":39},10,0.5,[16],[42],{"source":32,"section":33},[44,60,81,95],{"id":45,"disease":45,"label":46,"population":49,"type":53,"unit":28,"dose":54,"refs":55,"durationDays":58,"allowedFormulations":59},"asthma",{"fa":47,"en":48},"آسم شدید ائوزینوفیلیک (۱۲ سال به بالا) — ۳۰ mg زیرجلدی هر ۴ هفته برای ۳ دوز، سپس هر ۸ هفته","Severe eosinophilic asthma (≥12 y) — 30 mg SC every 4 weeks for 3 doses, then every 8 weeks",{"minAge":50},{"value":51,"unit":52},12,"year","fixed",{"perDose":27,"dosesPerDay":5},[56],{"source":32,"section":57},"2.1",{"min":5,"max":5},[22],{"id":61,"disease":45,"label":62,"population":65,"type":69,"unit":28,"dose":70,"refs":77,"durationDays":80},"asthma-child",{"fa":63,"en":64},"آسم شدید کودک ۶ تا ۱۱ سال — زیر ۳۵ kg: ۱۰ mg؛ ۳۵ kg و بالاتر: ۳۰ mg (هر ۴ هفته ×۳، سپس هر ۸ هفته)","Severe asthma, children 6–11 y — \u003C35 kg: 10 mg; ≥35 kg: 30 mg (every 4 weeks ×3, then every 8 weeks)",{"minAge":66,"maxAge":68},{"value":67,"unit":52},6,{"value":51,"unit":52},"weightBand",{"weightBands":71},[72,75],{"minWeightKg":73,"maxWeightKg":74,"perDose":38,"dosesPerDay":5},0,34.99,{"minWeightKg":74,"maxWeightKg":76,"perDose":27,"dosesPerDay":5},null,[78],{"source":32,"section":79},"2.1, Table 1",{"min":5,"max":5},{"id":82,"disease":82,"label":83,"population":86,"type":53,"unit":28,"dose":89,"refs":90,"durationDays":93,"allowedFormulations":94},"egpa",{"fa":84,"en":85},"EGPA بزرگسال — ۳۰ mg هر ۴ هفته","EGPA, adults — 30 mg every 4 weeks",{"minAge":87},{"value":88,"unit":52},18,{"perDose":27,"dosesPerDay":5},[91],{"source":32,"section":92},"2.2",{"min":5,"max":5},[22],{"id":96,"disease":97,"label":98,"population":101,"type":53,"unit":28,"dose":103,"refs":104,"durationDays":107,"allowedFormulations":108},"hes","hypereosinophilic-syndrome",{"fa":99,"en":100},"سندرم هیپرائوزینوفیلیک — ۳۰ mg هر ۴ هفته","Hypereosinophilic syndrome — 30 mg every 4 weeks",{"minAge":102},{"value":51,"unit":52},{"perDose":27,"dosesPerDay":5},[105],{"source":32,"section":106},"2.3",{"min":5,"max":5},[22],[110],{"id":111,"severity":112,"text":113,"refs":116},"hyper","block",{"fa":114,"en":115},"حساسیت به بنرالیزوماب.","Hypersensitivity to benralizumab.",[117],{"source":32,"section":118},"4",[120],{"text":121,"refs":124},{"fa":122,"en":123},"واکنش حساسیتی؛ برای حمله حاد آسم نیست؛ کورتیکواستروئید را ناگهانی قطع نکنید؛ عفونت کرمی پیش از شروع درمان شود.","Hypersensitivity; not for acute asthma; do not stop corticosteroids abruptly; treat helminth infection before starting.",[125],{"source":32,"section":126},"5",[],[],[],{"status":131,"reviewer":76,"date":76},"unverified",[133,138,143,147,151],{"regimen":45,"formulation":22,"input":134,"expect":137},{"ageYears":135,"weightKg":136},40,70,{"perDose":27,"mlPerDose":5},{"regimen":61,"formulation":35,"input":139,"expect":142},{"ageYears":140,"weightKg":141},8,25,{"perDose":38,"mlPerDose":39},{"regimen":61,"formulation":22,"input":144,"expect":146},{"ageYears":145,"weightKg":135},11,{"perDose":27,"mlPerDose":5},{"regimen":82,"formulation":22,"input":148,"expect":150},{"ageYears":149,"weightKg":136},50,{"perDose":27,"mlPerDose":5},{"regimen":96,"formulation":22,"input":152,"expect":153},{"ageYears":135,"weightKg":136},{"perDose":27,"mlPerDose":5},[155],"R03DX10",{"status":157,"refs":158},"not-found",[159],{"source":160,"section":161,"url":162},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Benralizumab",{"kind":164,"refs":165,"id":168},"BLA",[166],{"source":32,"section":167},"SPL approval \u002F marketing category","BLA761070",[170,173,177,181],{"kind":171,"url":172,"label":168},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=761070",{"kind":174,"url":175,"label":176},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=da6aca1a-19ed-44a4-abb7-696c7d58b784","FDA Fasenra",{"kind":178,"url":179,"label":180},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa618002.html","Benralizumab Injection",{"kind":182,"url":183,"label":155},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=R03DX10",{"pregnancy":185,"lactation":194,"pediatric":202,"geriatric":210},{"level":186,"text":187,"quote":190,"refs":191},"caution",{"fa":188,"en":189},"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 The data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk.",[192],{"source":32,"section":193},"8.1",{"level":186,"text":195,"quote":198,"refs":199},{"fa":196,"en":197},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary There is no information regarding the presence of benralizumab in human or animal milk, and the effects of benralizumab on the breast fed infant and on milk production are not known.",[200],{"source":32,"section":201},"8.2",{"level":186,"text":203,"quote":206,"refs":207},{"fa":204,"en":205},"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.","Asthma The safety and effectiveness of FASENRA for add-on maintenance treatment of patients with severe asthma and with an eosinophilic phenotype have been established in pediatric patients 6 years and older.",[208],{"source":32,"section":209},"8.4",{"level":186,"text":211,"quote":214,"refs":215},{"fa":212,"en":213},"برچسب: در سالمندان با احتیاط و معمولاً از دوز پایین شروع شود.","Label: use with caution in older adults, usually starting at the low end of the dose range.","Asthma Of the total number of patients in asthma clinical trials of benralizumab, 13% (n=320) were 65 and over, while 0.4% (n=9) were 75 and over.",[216],{"source":32,"section":217},"8.5",1792191528234]