[{"data":1,"prerenderedAt":209},["ShallowReactive",2],{"drug-ocrelizumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":36,"contraindications":85,"warnings":95,"renal":109,"monitoring":110,"interactions":111,"review":112,"examples":114,"atc":130,"iran":132,"usApproval":144,"links":150,"populations":167},"ocrelizumab",1,{"fa":7,"en":8},"اوکرلیزوماب","Ocrelizumab","antineoplastic-immunomodulating",{"fa":11,"en":12},"آنتی‌بادی ضد CD20","Anti-CD20 antibody",[14],{"name":15,"market":16},"Ocrevus","US",[18,19,20],"ocrevus","اوکرووس","اکرلیزوماب",[22],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":31,"refs":32},"vial-300","injection","iv","300 mg\u002F10 mL (30 mg\u002FmL) vial",{"amount":28,"unit":29,"perVolumeMl":30},300,"mg",10,[16],[33],{"source":34,"section":35},"fda-ocrevus","3",[37,70],{"id":38,"disease":39,"label":40,"population":43,"type":47,"unit":29,"dose":48,"refs":56,"durationDays":59,"notes":60},"start","multiple-sclerosis",{"fa":41,"en":42},"ام‌اس عودکننده یا پیشرونده اولیه — شروع: دو انفوزیون با ۲ هفته فاصله؛ ≥۳۵ kg: ۳۰۰ mg هر بار؛ کودک ۱۰ سال، ۲۵ تا \u003C۳۵ kg: ۱۵۰ mg","Relapsing or primary progressive MS — start: two infusions 2 weeks apart; ≥35 kg: 300 mg each; children ≥10 y, 25–\u003C35 kg: 150 mg",{"minAge":44,"minWeightKg":46},{"value":30,"unit":45},"year",25,"weightBand",{"weightBands":49},[50,54],{"minWeightKg":51,"maxWeightKg":52,"perDose":53,"dosesPerDay":5},24.99,34.99,150,{"minWeightKg":52,"maxWeightKg":55,"perDose":28,"dosesPerDay":5},null,[57],{"source":34,"section":58},"2.3",{"min":5,"max":5},[61],{"text":62,"refs":65},{"fa":63,"en":64},"پیش‌دارو متیل‌پردنیزولون و آنتی‌هیستامین پیش از هر انفوزیون؛ پایش تا ۱ ساعت بعد. پیش از شروع HBV، ایمونوگلوبولین و آنزیم کبد.","Premedicate with methylprednisolone and an antihistamine before each infusion; observe for 1 h after. Screen HBV, immunoglobulins and liver tests first.",[66,68],{"source":34,"section":67},"2.2",{"source":34,"section":69},"2.1",{"id":71,"disease":39,"label":72,"population":75,"type":47,"unit":29,"dose":77,"refs":82,"durationDays":84},"maint",{"fa":73,"en":74},"نگهدارنده هر ۶ ماه — ≥۳۵ kg: ۶۰۰ mg؛ ۲۵ تا \u003C۳۵ kg: ۳۰۰ mg","Maintenance every 6 months — ≥35 kg: 600 mg; 25–\u003C35 kg: 300 mg",{"minAge":76,"minWeightKg":46},{"value":30,"unit":45},{"weightBands":78},[79,80],{"minWeightKg":51,"maxWeightKg":52,"perDose":28,"dosesPerDay":5},{"minWeightKg":52,"maxWeightKg":55,"perDose":81,"dosesPerDay":5},600,[83],{"source":34,"section":58},{"min":5,"max":5},[86],{"id":87,"severity":88,"text":89,"refs":92},"ci","block",{"fa":90,"en":91},"عفونت فعال HBV؛ سابقه واکنش انفوزیون تهدیدکننده حیات به اوکرلیزوماب.","Active HBV infection; history of life-threatening infusion reaction to ocrelizumab.",[93],{"source":34,"section":94},"4",[96,103],{"text":97,"refs":100},{"fa":98,"en":99},"عفونت (HBV پیش از شروع)؛ PML؛ کاهش ایمونوگلوبولین‌ها؛ آسیب کبد.","Infections (screen HBV first); PML; reduced immunoglobulins; liver injury.",[101],{"source":34,"section":102},"5",{"text":104,"refs":107},{"fa":105,"en":106},"واکنش انفوزیون؛ بدخیمی (پستان)؛ کولیت ایمنی.","Infusion reactions; malignancies (breast); immune-mediated colitis.",[108],{"source":34,"section":102},[],[],[],{"status":113,"reviewer":55,"date":55},"unverified",[115,120,126],{"regimen":38,"formulation":23,"input":116,"expect":119},{"ageYears":117,"weightKg":118},35,65,{"perDose":28,"mlPerDose":30},{"regimen":38,"formulation":23,"input":121,"expect":124},{"ageYears":122,"weightKg":123},11,30,{"perDose":53,"mlPerDose":125},5,{"regimen":71,"formulation":23,"input":127,"expect":128},{"ageYears":117,"weightKg":118},{"perDose":81,"mlPerDose":129},20,[131],"L04AG08",{"status":133,"forms":134,"refs":139},"registered",[135],{"code":136,"en":137,"fa":138},"52172","OCRELIZUMAB 300 MG\u002F10 ML INJECTION","فرآورده تزریقی اکرلیزومب ۳۰۰ میلی‌گرم \u002F ۱۰ میلی‌لیتر",[140],{"source":141,"section":142,"url":143},"darooyab-generic","G-1720\u002FOcrelizumab","https:\u002F\u002Fwww.darooyab.ir\u002FG-1720\u002FOcrelizumab",{"kind":145,"refs":146,"id":149},"BLA",[147],{"source":34,"section":148},"SPL approval \u002F marketing category","BLA761053",[151,154,158,162,165],{"kind":152,"url":153,"label":149},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=761053",{"kind":155,"url":156,"label":157},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=9da42362-3bb5-4b83-b4bb-b59fd4e55f0d","FDA Ocrevus",{"kind":159,"url":160,"label":161},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa617026.html","Ocrelizumab Injection",{"kind":163,"url":164,"label":131},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L04AG08",{"kind":166,"url":143,"label":8},"darooyab",{"pregnancy":168,"lactation":177,"pediatric":185,"geriatric":193,"reproductive":201},{"level":169,"text":170,"quote":173,"refs":174},"caution",{"fa":171,"en":172},"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 OCREVUS is a humanized monoclonal antibody of an immunoglobulin G1 subtype and immunoglobulins are known to cross the placental barrier.",[175],{"source":34,"section":176},"8.1",{"level":169,"text":178,"quote":181,"refs":182},{"fa":179,"en":180},"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 ocrelizumab in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.",[183],{"source":34,"section":184},"8.2",{"level":169,"text":186,"quote":189,"refs":190},{"fa":187,"en":188},"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 effectiveness of OCREVUS for the treatment of relapsing-remitting MS have been established in pediatric patients 10 years of age and older who weigh 25 kg or more.",[191],{"source":34,"section":192},"8.4",{"level":169,"text":194,"quote":197,"refs":198},{"fa":195,"en":196},"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 OCREVUS did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.",[199],{"source":34,"section":200},"8.5",{"level":169,"text":202,"quote":205,"refs":206},{"fa":203,"en":204},"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 Females of reproductive potential should use effective contraception while receiving OCREVUS and for 6 months after the last infusion of OCREVUS [see Clinical Pharmacology (12.3) ] .",[207],{"source":34,"section":208},"8.3",1792191557725]