[{"data":1,"prerenderedAt":255},["ShallowReactive",2],{"drug-mepolizumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":43,"contraindications":127,"warnings":137,"renal":152,"monitoring":153,"interactions":154,"review":155,"examples":158,"atc":183,"iran":185,"usApproval":197,"links":203,"populations":220},"mepolizumab",1,{"fa":7,"en":8},"مپولیزوماب","Mepolizumab","respiratory",{"fa":11,"en":12},"آنتی‌بادی ضد IL-5","Anti-IL-5 antibody",[14],{"name":15,"market":16},"Nucala","US",[18,19,7],"nucala","نوکالا",[21,34],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":29,"refs":30},"pfs-100","injection","sc","100 mg\u002FmL prefilled syringe or autoinjector",{"amount":27,"unit":28,"perVolumeMl":5},100,"mg",[16],[31],{"source":32,"section":33},"fda-nucala","3",{"id":35,"form":23,"route":24,"label":36,"concentration":37,"markets":40,"refs":41},"pfs-40","40 mg\u002F0.4 mL prefilled syringe",{"amount":38,"unit":28,"perVolumeMl":39},40,0.4,[16],[42],{"source":32,"section":33},[44,60,74,89,101,114],{"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) — ۱۰۰ mg زیرجلدی هر ۴ هفته","Severe eosinophilic asthma (≥12 y) — 100 mg SC every 4 weeks",{"minAge":50},{"value":51,"unit":52},12,"year","fixed",{"perDose":27,"dosesPerDay":5},[56],{"source":32,"section":57},"2.1, Table 1",{"min":5,"max":5},[22],{"id":61,"disease":45,"label":62,"population":65,"type":53,"unit":28,"dose":69,"refs":70,"durationDays":72,"allowedFormulations":73},"asthma-child",{"fa":63,"en":64},"آسم شدید ائوزینوفیلیک کودک ۶ تا ۱۱ سال — ۴۰ mg هر ۴ هفته","Severe eosinophilic asthma, children 6–11 y — 40 mg every 4 weeks",{"minAge":66,"maxAge":68},{"value":67,"unit":52},6,{"value":51,"unit":52},{"perDose":38,"dosesPerDay":5},[71],{"source":32,"section":57},{"min":5,"max":5},[35],{"id":75,"disease":76,"label":77,"population":80,"type":53,"unit":28,"dose":83,"refs":84,"durationDays":87,"allowedFormulations":88},"crswnp","nasal-polyps",{"fa":78,"en":79},"رینوسینوزیت مزمن با پولیپ بینی بزرگسال — ۱۰۰ mg هر ۴ هفته","CRSwNP, adults — 100 mg every 4 weeks",{"minAge":81},{"value":82,"unit":52},18,{"perDose":27,"dosesPerDay":5},[85],{"source":32,"section":86},"2.1",{"min":5,"max":5},[22],{"id":90,"disease":90,"label":91,"population":94,"type":53,"unit":28,"dose":96,"refs":97,"durationDays":99,"allowedFormulations":100},"copd",{"fa":92,"en":93},"COPD با فنوتیپ ائوزینوفیلیک (افزودنی) بزرگسال — ۱۰۰ mg هر ۴ هفته","COPD with eosinophilic phenotype (add-on), adults — 100 mg every 4 weeks",{"minAge":95},{"value":82,"unit":52},{"perDose":27,"dosesPerDay":5},[98],{"source":32,"section":86},{"min":5,"max":5},[22],{"id":102,"disease":102,"label":103,"population":106,"type":53,"unit":28,"dose":108,"refs":110,"durationDays":112,"allowedFormulations":113},"egpa",{"fa":104,"en":105},"EGPA بزرگسال — ۳۰۰ mg هر ۴ هفته (سه تزریق ۱۰۰ mg با ۵ cm فاصله)","EGPA, adults — 300 mg every 4 weeks (three 100 mg injections ≥5 cm apart)",{"minAge":107},{"value":82,"unit":52},{"perDose":109,"dosesPerDay":5},300,[111],{"source":32,"section":57},{"min":5,"max":5},[22],{"id":115,"disease":116,"label":117,"population":120,"type":53,"unit":28,"dose":122,"refs":123,"durationDays":125,"allowedFormulations":126},"hes","hypereosinophilic-syndrome",{"fa":118,"en":119},"سندرم هیپرائوزینوفیلیک (۱۲ سال به بالا) — ۳۰۰ mg هر ۴ هفته","Hypereosinophilic syndrome (≥12 y) — 300 mg every 4 weeks",{"minAge":121},{"value":51,"unit":52},{"perDose":109,"dosesPerDay":5},[124],{"source":32,"section":86},{"min":5,"max":5},[22],[128],{"id":129,"severity":130,"text":131,"refs":134},"hyper","block",{"fa":132,"en":133},"سابقه حساسیت به مپولیزوماب.","History of hypersensitivity to mepolizumab.",[135],{"source":32,"section":136},"4",[138,145],{"text":139,"refs":142},{"fa":140,"en":141},"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.",[143],{"source":32,"section":144},"5",{"text":146,"refs":149},{"fa":147,"en":148},"هرپس زوستر (واکسن پیش از شروع در نظر گرفته شود).","Herpes zoster (consider vaccination before starting).",[150],{"source":32,"section":151},"5.3",[],[],[],{"status":156,"reviewer":157,"date":157},"unverified",null,[159,163,168,171,175,180],{"regimen":45,"formulation":22,"input":160,"expect":162},{"ageYears":38,"weightKg":161},70,{"perDose":27,"mlPerDose":5},{"regimen":61,"formulation":35,"input":164,"expect":167},{"ageYears":165,"weightKg":166},8,25,{"perDose":38,"mlPerDose":39},{"regimen":75,"formulation":22,"input":169,"expect":170},{"ageYears":38,"weightKg":161},{"perDose":27,"mlPerDose":5},{"regimen":90,"formulation":22,"input":172,"expect":174},{"ageYears":173,"weightKg":161},65,{"perDose":27,"mlPerDose":5},{"regimen":102,"formulation":22,"input":176,"expect":178},{"ageYears":177,"weightKg":161},50,{"perDose":109,"mlPerDose":179},3,{"regimen":115,"formulation":22,"input":181,"expect":182},{"ageYears":38,"weightKg":161},{"perDose":109,"mlPerDose":179},[184],"R03DX09",{"status":186,"forms":187,"refs":192},"registered",[188],{"code":189,"en":190,"fa":191},"50765","MEPOLIZOMAB INJECTION, POWDER, FOR SOLUTION PARENTERAL 100 mg","پودر برای تهیه محلول تزریقی مپولیزومب ۱۰۰ میلی‌گرم",[193],{"source":194,"section":195,"url":196},"darooyab-generic","G-5503\u002FMepolizumab","https:\u002F\u002Fwww.darooyab.ir\u002FG-5503\u002FMepolizumab",{"kind":198,"refs":199,"id":202},"BLA",[200],{"source":32,"section":201},"SPL approval \u002F marketing category","BLA125526",[204,207,211,215,218],{"kind":205,"url":206,"label":202},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=125526",{"kind":208,"url":209,"label":210},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=fefb887c-e4ac-431e-8893-e9d1a5a63fea","FDA Nucala",{"kind":212,"url":213,"label":214},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa615058.html","Mepolizumab Injection",{"kind":216,"url":217,"label":184},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=R03DX09",{"kind":219,"url":196,"label":8},"darooyab",{"pregnancy":221,"lactation":230,"pediatric":238,"geriatric":246},{"level":222,"text":223,"quote":226,"refs":227},"caution",{"fa":224,"en":225},"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 are insufficient to inform on drug-associated risk.",[228],{"source":32,"section":229},"8.1",{"level":222,"text":231,"quote":234,"refs":235},{"fa":232,"en":233},"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 mepolizumab in human milk, the effects on the breastfed infant, or the effects on milk production.",[236],{"source":32,"section":237},"8.2",{"level":222,"text":239,"quote":242,"refs":243},{"fa":240,"en":241},"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.","Severe Asthma The safety and effectiveness of NUCALA for severe asthma, and with an eosinophilic phenotype, have been established in pediatric patients aged 6 years and older.",[244],{"source":32,"section":245},"8.4",{"level":247,"text":248,"quote":251,"refs":252},"ok",{"fa":249,"en":250},"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 and effectiveness were observed between these patients and younger patients.",[253],{"source":32,"section":254},"8.5",1792191554249]