[{"data":1,"prerenderedAt":223},["ShallowReactive",2],{"drug-emicizumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":42,"contraindications":97,"warnings":98,"renal":108,"monitoring":109,"interactions":110,"review":111,"examples":114,"atc":132,"iran":134,"usApproval":158,"links":164,"populations":181},"emicizumab",1,{"fa":7,"en":8},"امیسیزوماب","Emicizumab","blood",{"fa":11,"en":12},"آنتی‌بادی دوویژه (جایگزین عملکرد فاکتور VIII)","Bispecific antibody (factor VIII mimetic)",[14],{"name":15,"market":16},"Hemlibra","US",[18,19,7],"hemlibra","هملیبرا",[21,34],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":29,"refs":30},"vial-30","injection","sc","30 mg\u002FmL vial",{"amount":27,"unit":28,"perVolumeMl":5},30,"mg",[16],[31],{"source":32,"section":33},"fda-hemlibra","3",{"id":35,"form":23,"route":24,"label":36,"concentration":37,"markets":39,"refs":40},"vial-150","150 mg\u002FmL vial (60 mg\u002F0.4, 105 mg\u002F0.7, 150 mg\u002F1, 300 mg\u002F2 mL)",{"amount":38,"unit":28,"perVolumeMl":5},150,[16],[41],{"source":32,"section":33},[43,65,76,86],{"id":44,"disease":45,"label":46,"population":49,"type":50,"unit":28,"dose":51,"refs":54,"durationDays":57,"notes":58},"load","hemophilia-a",{"fa":47,"en":48},"پیشگیری هموفیلی A (همه سنین از نوزادی) — بارگذاری ۳ mg\u002Fkg زیرجلدی هفتگی ۴ هفته اول","Haemophilia A prophylaxis (all ages from newborn) — loading 3 mg\u002Fkg SC weekly for the first 4 weeks",{},"weightBased",{"perKgPerDose":52,"intervalHours":53},3,24,[55],{"source":32,"section":56},"2.1",{"min":5,"max":5},[59],{"text":60,"refs":63},{"fa":61,"en":62},"مصرف پیشگیرانه داروهای بای‌پس از روز قبل قطع؛ فاکتور VIII پیشگیرانه در هفته اول قابل ادامه.","Stop prophylactic bypassing agents the day before starting; prophylactic factor VIII may continue in week 1.",[64],{"source":32,"section":56},{"id":66,"disease":45,"label":67,"population":70,"type":50,"unit":28,"dose":71,"refs":73,"durationDays":75},"w1",{"fa":68,"en":69},"نگهدارنده — ۱٫۵ mg\u002Fkg هفتگی","Maintenance — 1.5 mg\u002Fkg once weekly",{},{"perKgPerDose":72,"intervalHours":53},1.5,[74],{"source":32,"section":56},{"min":5,"max":5},{"id":77,"disease":45,"label":78,"population":81,"type":50,"unit":28,"dose":82,"refs":83,"durationDays":85},"w2",{"fa":79,"en":80},"نگهدارنده — ۳ mg\u002Fkg هر ۲ هفته","Maintenance — 3 mg\u002Fkg every 2 weeks",{},{"perKgPerDose":52,"intervalHours":53},[84],{"source":32,"section":56},{"min":5,"max":5},{"id":87,"disease":45,"label":88,"population":91,"type":50,"unit":28,"dose":92,"refs":94,"durationDays":96},"w4",{"fa":89,"en":90},"نگهدارنده — ۶ mg\u002Fkg هر ۴ هفته","Maintenance — 6 mg\u002Fkg every 4 weeks",{},{"perKgPerDose":93,"intervalHours":53},6,[95],{"source":32,"section":56},{"min":5,"max":5},[],[99],{"text":100,"refs":103},{"fa":101,"en":102},"هشدار جعبه‌ای: میکروآنژیوپاتی ترومبوتیک و ترومبوز با aPCC (بیش از ۱۰۰ U\u002Fkg\u002F۲۴ ساعت به مدت ۲۴ ساعت یا بیشتر). تداخل با آزمایش‌های انعقادی (aPTT).","Boxed warning: thrombotic microangiopathy and thromboembolism with aPCC (>100 U\u002Fkg\u002F24 h for ≥24 h). Interferes with coagulation tests (aPTT).",[104,106],{"source":32,"section":105},"Boxed Warning",{"source":32,"section":107},"5.4",[],[],[],{"status":112,"reviewer":113,"date":113},"unverified",null,[115,121,124,127],{"regimen":44,"formulation":35,"input":116,"expect":118},{"ageYears":93,"weightKg":117},20,{"perDose":119,"mlPerDose":120},60,0.4,{"regimen":66,"formulation":22,"input":122,"expect":123},{"ageYears":93,"weightKg":117},{"perDose":27,"mlPerDose":5},{"regimen":77,"formulation":35,"input":125,"expect":126},{"ageYears":93,"weightKg":117},{"perDose":119,"mlPerDose":120},{"regimen":87,"formulation":35,"input":128,"expect":129},{"ageYears":93,"weightKg":117},{"perDose":130,"mlPerDose":131},120,0.8,[133],"B02BX06",{"status":135,"forms":136,"refs":153},"registered",[137,141,145,149],{"code":138,"en":139,"fa":140},"52947","EMICIZUMAB 30 mg\u002F1mL INJECTION","فرآورده تزریقی امیسیزومب ۳۰ میلی‌گرم \u002F ۱ میلی‌لیتر",{"code":142,"en":143,"fa":144},"52950","EMICIZUMAB 150 mg\u002F1mL 1 ML INJECTION","فرآورده تزریقی امیسیزومب ۱۵۰ میلی‌گرم \u002F ۱ میلی‌لیتر ۱ میلی‌لیتر",{"code":146,"en":147,"fa":148},"52949","EMICIZUMAB 150 mg\u002F1mL 0.7 ML INJECTION","فرآورده تزریقی امیسیزومب ۱۵۰ میلی‌گرم \u002F ۱ میلی‌لیتر ۰٫۷ میلی‌لیتر",{"code":150,"en":151,"fa":152},"52948","EMICIZUMAB 150 mg\u002F1mL 0.4 ML INJECTION","فرآورده تزریقی امیسیزومب ۱۵۰ میلی‌گرم \u002F ۱ میلی‌لیتر ۰٫۴ میلی‌لیتر",[154],{"source":155,"section":156,"url":157},"darooyab-generic","G-5488\u002FEmicizumab","https:\u002F\u002Fwww.darooyab.ir\u002FG-5488\u002FEmicizumab",{"kind":159,"refs":160,"id":163},"BLA",[161],{"source":32,"section":162},"SPL approval \u002F marketing category","BLA761083",[165,168,172,176,179],{"kind":166,"url":167,"label":163},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=761083",{"kind":169,"url":170,"label":171},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=2483adba-fab6-4d1b-96c5-c195577ed071","FDA Hemlibra",{"kind":173,"url":174,"label":175},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa622046.html","Emicizumab-kxwh Injection",{"kind":177,"url":178,"label":133},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=B02BX06",{"kind":180,"url":157,"label":8},"darooyab",{"pregnancy":182,"lactation":191,"pediatric":199,"geriatric":207,"reproductive":215},{"level":183,"text":184,"quote":187,"refs":188},"caution",{"fa":185,"en":186},"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 There are no available data on HEMLIBRA use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage.",[189],{"source":32,"section":190},"8.1",{"level":183,"text":192,"quote":195,"refs":196},{"fa":193,"en":194},"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 emicizumab-kxwh in human milk, the effects on the breastfed child, or the effects on milk production.",[197],{"source":32,"section":198},"8.2",{"level":183,"text":200,"quote":203,"refs":204},{"fa":201,"en":202},"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 efficacy of HEMLIBRA have been established in pediatric patients.",[205],{"source":32,"section":206},"8.4",{"level":183,"text":208,"quote":211,"refs":212},{"fa":209,"en":210},"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.","Clinical studies of HEMLIBRA did not include a sufficient number of patients aged 65 and over to determine whether they respond differently from younger patients.",[213],{"source":32,"section":214},"8.5",{"level":183,"text":216,"quote":219,"refs":220},{"fa":217,"en":218},"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 Women of childbearing potential should use contraception while receiving HEMLIBRA.",[221],{"source":32,"section":222},"8.3",1792191541054]