[{"data":1,"prerenderedAt":185},["ShallowReactive",2],{"drug-omalizumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":35,"contraindications":76,"warnings":86,"renal":94,"monitoring":95,"interactions":96,"review":97,"examples":100,"atc":106,"iran":108,"usApproval":128,"links":134,"populations":151},"omalizumab",1,{"fa":7,"en":8},"اومالیزومب","Omalizumab","respiratory",{"fa":11,"en":12},"آنتی‌بادی ضد IgE","Anti-IgE antibody",[14],{"name":15,"market":16},"Xolair","US",[18,19,20],"xolair","زولر","اومالیزوماب",[22],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":30,"refs":31},"syr-150","injection","sc","150 mg\u002FmL prefilled syringe (also 75 mg\u002F0.5 mL, 300 mg\u002F2 mL)",{"amount":28,"unit":29,"perVolumeMl":5},150,"mg",[16],[32],{"source":33,"section":34},"fda-xolair","3",[36,60],{"id":37,"disease":38,"label":39,"population":42,"type":46,"unit":29,"dose":47,"refs":49,"durationDays":52,"notes":53},"csu","chronic-urticaria",{"fa":40,"en":41},"کهیر مزمن خودبه‌خودی (۱۲ سال به بالا) — ۱۵۰ یا ۳۰۰ mg هر ۴ هفته","Chronic spontaneous urticaria (≥12 y) — 150 or 300 mg every 4 weeks",{"minAge":43},{"value":44,"unit":45},12,"year","fixed",{"perDose":28,"perDoseMax":48,"dosesPerDay":5},300,[50],{"source":33,"section":51},"2.5",{"min":5,"max":5},[54],{"text":55,"refs":58},{"fa":56,"en":57},"یک دوز هر ۴ هفته (نه روزانه)؛ مستقل از IgE و وزن.","One dose every 4 WEEKS (not daily); independent of IgE and weight.",[59],{"source":33,"section":51},{"id":61,"disease":61,"label":62,"population":65,"type":68,"unit":29,"dose":69,"refs":73},"asthma",{"fa":63,"en":64},"آسم آلرژیک متوسط تا شدید (۶ سال به بالا) — ۷۵ تا ۳۷۵ mg هر ۲ یا ۴ هفته بر اساس IgE و وزن","Moderate–severe allergic asthma (≥6 y) — 75–375 mg every 2 or 4 weeks by IgE and weight",{"minAge":66},{"value":67,"unit":45},6,"notCalculated",{"reason":70},{"fa":71,"en":72},"دوز و فاصله از جدول برچسب بر اساس IgE تام سرم پیش از درمان و وزن.","Dose and interval from the label tables by pre-treatment total serum IgE and body weight.",[74],{"source":33,"section":75},"2.2",[77],{"id":78,"severity":79,"text":80,"refs":83},"hyper","block",{"fa":81,"en":82},"واکنش حساسیتی شدید به اومالیزومب.","Severe hypersensitivity reaction to omalizumab.",[84],{"source":33,"section":85},"4",[87],{"text":88,"refs":91},{"fa":89,"en":90},"هشدار جعبه‌ای: آنافیلاکسی (حتی پس از یک سال)؛ شروع در مرکز درمانی با مشاهده پس از تزریق.","Boxed warning: anaphylaxis (even after a year); start in a healthcare setting with observation after injection.",[92],{"source":33,"section":93},"Boxed Warning",[],[],[],{"status":98,"reviewer":99,"date":99},"unverified",null,[101],{"regimen":37,"formulation":23,"input":102,"expect":105},{"ageYears":103,"weightKg":104},30,70,{"perDose":28,"mlPerDose":5,"upperPerDose":48},[107],"R03DX05",{"status":109,"forms":110,"refs":123},"registered",[111,115,119],{"code":112,"en":113,"fa":114},"07525","OMALIZUMAB 150MG INJ","فرآورده تزریقی امالیزومب ۱۵۰ میلی‌گرم",{"code":116,"en":117,"fa":118},"18947","OMALIZUMAB 75MG VIAL","ویال امالیزومب ۷۵ میلی‌گرم",{"code":120,"en":121,"fa":122},"53096","OMALIZUMAB INJECTION, SOLUTION PARENTERAL 150 mg\u002F1mL 1 mL","محلول تزریقی امالیزومب ۱۵۰ میلی‌گرم \u002F ۱ میلی‌لیتر ۱ میلی‌لیتر",[124],{"source":125,"section":126,"url":127},"darooyab-generic","G-1476\u002FOmalizumab","https:\u002F\u002Fwww.darooyab.ir\u002FG-1476\u002FOmalizumab",{"kind":129,"refs":130,"id":133},"BLA",[131],{"source":33,"section":132},"SPL approval \u002F marketing category","BLA103976",[135,138,142,146,149],{"kind":136,"url":137,"label":133},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=103976",{"kind":139,"url":140,"label":141},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=7f6a2191-adfb-48b9-9bfa-0d9920479f0d","FDA Xolair",{"kind":143,"url":144,"label":145},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa603031.html","Omalizumab Injection",{"kind":147,"url":148,"label":107},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=R03DX05",{"kind":150,"url":127,"label":8},"darooyab",{"pregnancy":152,"lactation":161,"pediatric":169,"geriatric":177},{"level":153,"text":154,"quote":157,"refs":158},"caution",{"fa":155,"en":156},"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 A registry study of XOLAIR exposure during pregnancy showed no increase in the rate of major birth defects or miscarriage.",[159],{"source":33,"section":160},"8.1",{"level":153,"text":162,"quote":165,"refs":166},{"fa":163,"en":164},"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 omalizumab in human milk, or the effects on milk production.",[167],{"source":33,"section":168},"8.2",{"level":153,"text":170,"quote":173,"refs":174},{"fa":171,"en":172},"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 Safety and effectiveness of XOLAIR for moderate to severe persistent asthma who had a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids, have been established in pediatric patients aged 6 years and older.",[175],{"source":33,"section":176},"8.4",{"level":153,"text":178,"quote":181,"refs":182},{"fa":179,"en":180},"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.","In clinical studies, 134 asthma patients, 20 CRSwNP patients, 37 CSU patients and no IgE-mediated food allergy patients 65 years of age or older were treated with XOLAIR.",[183],{"source":33,"section":184},"8.5",1792156189548]