[{"data":1,"prerenderedAt":168},["ShallowReactive",2],{"drug-lecanemab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":34,"contraindications":64,"warnings":74,"renal":88,"monitoring":89,"interactions":90,"review":91,"examples":94,"atc":102,"iran":104,"usApproval":111,"links":117,"populations":132},"lecanemab",1,{"fa":7,"en":8},"لکانماب","Lecanemab","nervous-system",{"fa":11,"en":12},"آنتی‌بادی ضدآمیلوئید بتا","Anti-amyloid-beta antibody",[14],{"name":15,"market":16},"Leqembi","US",[18,19,7],"leqembi","لکمبی",[21],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":29,"refs":30},"vial-100","injection","iv","100 mg\u002FmL vial (500 mg\u002F5 mL, 200 mg\u002F2 mL)",{"amount":27,"unit":28,"perVolumeMl":5},100,"mg",[16],[31],{"source":32,"section":33},"fda-leqembi","3",[35],{"id":24,"disease":36,"label":37,"population":40,"type":44,"unit":28,"dose":45,"refs":48,"durationDays":51,"notes":52},"alzheimers",{"fa":38,"en":39},"آلزایمر زودرس (MCI یا دمانس خفیف) با آمیلوئید تأییدشده — ۱۰ mg\u002Fkg وریدی هر ۲ هفته طی حدود ۱ ساعت","Early Alzheimer disease (MCI or mild dementia) with confirmed amyloid — 10 mg\u002Fkg IV every 2 weeks over about 1 hour",{"minAge":41},{"value":42,"unit":43},18,"year","weightBased",{"perKgPerDose":46,"intervalHours":47},10,24,[49],{"source":32,"section":50},"2.2, Table 1",{"min":5,"max":5},[53],{"text":54,"refs":57},{"fa":55,"en":56},"پس از ۱۸ ماه: ادامه یا نگهدارنده ۱۰ mg\u002Fkg هر ۴ هفته. زیرجلدی: شروع ۵۰۰ mg هفتگی، نگهدارنده ۳۶۰ mg هفتگی. پیش از شروع ژنوتیپ ApoE ε4 و MRI پایه؛ MRI در ماه ۱، ۲، ۳ و ۶.","After 18 months: continue, or maintenance 10 mg\u002Fkg every 4 weeks. Subcutaneous: start 500 mg weekly, maintenance 360 mg weekly. Before starting: ApoE ε4 testing and baseline MRI; MRI at months 1, 2, 3 and 6.",[58,60,62],{"source":32,"section":59},"2.2",{"source":32,"section":61},"2.4",{"source":32,"section":63},"Boxed Warning",[65],{"id":66,"severity":67,"text":68,"refs":71},"hyper","block",{"fa":69,"en":70},"حساسیت جدی به لکانماب (آنژیوادم، آنافیلاکسی).","Serious hypersensitivity to lecanemab (angioedema, anaphylaxis).",[72],{"source":32,"section":73},"4",[75,81],{"text":76,"refs":79},{"fa":77,"en":78},"هشدار جعبه‌ای: ناهنجاری تصویربرداری مرتبط با آمیلوئید (ARIA: ادم و هموسیدرین)، گاه کشنده؛ خونریزی مغزی بیش از ۱ cm؛ در هموزیگوت ApoE ε4 شایع‌تر؛ احتیاط با ضدانعقاد و ترومبولیتیک.","Boxed warning: amyloid-related imaging abnormalities (ARIA-E\u002FARIA-H), sometimes fatal; intracerebral haemorrhage >1 cm; more frequent in ApoE ε4 homozygotes; caution with anticoagulants and thrombolytics.",[80],{"source":32,"section":63},{"text":82,"refs":85},{"fa":83,"en":84},"واکنش انفوزیون و حساسیت.","Infusion-related and hypersensitivity reactions.",[86],{"source":32,"section":87},"5",[],[],[],{"status":92,"reviewer":93,"date":93},"unverified",null,[95],{"regimen":24,"formulation":22,"input":96,"expect":99},{"ageYears":97,"weightKg":98},72,70,{"perDose":100,"mlPerDose":101},700,7,[103],"N06DX04",{"status":105,"refs":106},"not-found",[107],{"source":108,"section":109,"url":110},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Lecanemab",{"kind":112,"refs":113,"id":116},"BLA",[114],{"source":32,"section":115},"SPL approval \u002F marketing category","BLA761269",[118,121,125,129],{"kind":119,"url":120,"label":116},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=761269",{"kind":122,"url":123,"label":124},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=9d1ff786-e577-410a-a273-c4d7d0e4e975","FDA Leqembi",{"kind":126,"url":127,"label":128},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa623004.html","Lecanemab-irmb Injection",{"kind":130,"url":131,"label":103},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=N06DX04",{"pregnancy":133,"lactation":142,"pediatric":150,"geriatric":159},{"level":134,"text":135,"quote":138,"refs":139},"caution",{"fa":136,"en":137},"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 adequate data on LEQEMBI use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.",[140],{"source":32,"section":141},"8.1",{"level":134,"text":143,"quote":146,"refs":147},{"fa":144,"en":145},"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 lecanemab-irmb in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.",[148],{"source":32,"section":149},"8.2",{"level":151,"text":152,"quote":155,"refs":156},"not-established",{"fa":153,"en":154},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","Safety and effectiveness of LEQEMBI in pediatric patients have not been established.",[157],{"source":32,"section":158},"8.4",{"level":160,"text":161,"quote":164,"refs":165},"ok",{"fa":162,"en":163},"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 LEQEMBI have been observed between patients 65 years of age and older and younger adult patients.",[166],{"source":32,"section":167},"8.5",1792191551645]