[{"data":1,"prerenderedAt":281},["ShallowReactive",2],{"drug-certolizumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":35,"contraindications":158,"warnings":168,"renal":183,"monitoring":184,"interactions":185,"review":186,"examples":188,"atc":214,"iran":216,"links":223,"populations":242,"usApproval":276},"certolizumab",1,{"fa":7,"en":8},"سرتولیزوماب پگول","Certolizumab pegol","antineoplastic-immunomodulating",{"fa":11,"en":12},"مهارکننده TNF","TNF blocker",[14],{"name":15,"market":16},"Cimzia","US",[18,19,20],"cimzia","سیمزیا","سرتولیزوماب",[22],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":30,"refs":31},"pfs-200","injection","sc","200 mg\u002FmL prefilled syringe",{"amount":28,"unit":29,"perVolumeMl":5},200,"mg",[16],[32],{"source":33,"section":34},"fda-cimzia","3",[36,67,79,93,105,125],{"id":37,"disease":38,"label":39,"population":42,"type":46,"unit":29,"dose":47,"refs":49,"durationDays":58,"notes":59},"load","rheumatoid-arthritis",{"fa":40,"en":41},"بارگذاری (آرتریت روماتوئید، پسوریاتیک، اسپوندیلیت، کرون) — ۴۰۰ mg (دو تزریق ۲۰۰) هفته ۰، ۲ و ۴","Loading (RA, PsA, axSpA, Crohn) — 400 mg (two 200 mg injections) at weeks 0, 2 and 4",{"minAge":43},{"value":44,"unit":45},18,"year","fixed",{"perDose":48,"dosesPerDay":5},400,[50,52,54,56],{"source":33,"section":51},"2.2",{"source":33,"section":53},"2.1",{"source":33,"section":55},"2.4",{"source":33,"section":57},"2.5",{"min":5,"max":5},[60],{"text":61,"refs":64},{"fa":62,"en":63},"پیش از شروع: بررسی سل فعال و نهفته (درمان سل نهفته قبل از شروع) و واکسن‌های مناسب سن.","Before starting: screen for active and latent TB (treat latent TB first) and complete age-appropriate vaccines.",[65],{"source":33,"section":66},"2.10",{"id":68,"disease":38,"label":69,"population":72,"type":46,"unit":29,"dose":74,"refs":75,"durationDays":78},"ra",{"fa":70,"en":71},"نگهدارنده آرتریت روماتوئید یا پسوریاتیک — ۲۰۰ mg هر ۲ هفته (یا ۴۰۰ mg هر ۴ هفته)","Maintenance RA or PsA — 200 mg every 2 weeks (or 400 mg every 4 weeks)",{"minAge":73},{"value":44,"unit":45},{"perDose":28,"dosesPerDay":5},[76,77],{"source":33,"section":51},{"source":33,"section":55},{"min":5,"max":5},{"id":80,"disease":81,"label":82,"population":85,"type":46,"unit":29,"dose":87,"refs":88,"durationDays":92},"as","ankylosing-spondylitis",{"fa":83,"en":84},"نگهدارنده اسپوندیلیت آنکیلوزان یا axSpA غیررادیوگرافیک — ۲۰۰ mg هر ۲ هفته یا ۴۰۰ mg هر ۴ هفته","Maintenance AS or non-radiographic axSpA — 200 mg every 2 weeks or 400 mg every 4 weeks",{"minAge":86},{"value":44,"unit":45},{"perDose":28,"dosesPerDay":5},[89,90],{"source":33,"section":57},{"source":33,"section":91},"2.6",{"min":5,"max":5},{"id":94,"disease":95,"label":96,"population":99,"type":46,"unit":29,"dose":101,"refs":102,"durationDays":104},"cd","crohns",{"fa":97,"en":98},"نگهدارنده کرون — ۴۰۰ mg هر ۴ هفته","Maintenance Crohn disease — 400 mg every 4 weeks",{"minAge":100},{"value":44,"unit":45},{"perDose":48,"dosesPerDay":5},[103],{"source":33,"section":53},{"min":5,"max":5},{"id":106,"disease":107,"label":108,"population":111,"type":46,"unit":29,"dose":113,"refs":114,"durationDays":117,"notes":118},"pso","psoriasis",{"fa":109,"en":110},"پسوریازیس پلاک متوسط تا شدید — ۴۰۰ mg هر ۲ هفته","Moderate–severe plaque psoriasis — 400 mg every other week",{"minAge":112},{"value":44,"unit":45},{"perDose":48,"dosesPerDay":5},[115],{"source":33,"section":116},"2.7",{"min":5,"max":5},[119],{"text":120,"refs":123},{"fa":121,"en":122},"وزن ۹۰ kg یا کمتر: می‌توان ۴۰۰ mg هفته ۰، ۲، ۴ سپس ۲۰۰ mg هر ۲ هفته.","≤90 kg: may use 400 mg at weeks 0, 2, 4 then 200 mg every other week.",[124],{"source":33,"section":116},{"id":126,"disease":127,"label":128,"population":131,"type":135,"unit":29,"dose":136,"refs":147,"durationDays":150,"notes":151},"pjia","juvenile-arthritis",{"fa":129,"en":130},"JIA پلی‌آرتیکولار (۲ سال به بالا) — نگهدارنده از هفته ۶ هر ۲ هفته بر اساس وزن","Polyarticular JIA (≥2 y) — maintenance from week 6 every 2 weeks by weight",{"minAge":132,"minWeightKg":134},{"value":133,"unit":45},2,10,"weightBand",{"weightBands":137},[138,142,145],{"minWeightKg":139,"maxWeightKg":140,"perDose":141,"dosesPerDay":5},9.99,19.99,50,{"minWeightKg":140,"maxWeightKg":143,"perDose":144,"dosesPerDay":5},39.99,100,{"minWeightKg":143,"maxWeightKg":146,"perDose":28,"dosesPerDay":5},null,[148],{"source":33,"section":149},"2.3",{"min":5,"max":5},[152],{"text":153,"refs":156},{"fa":154,"en":155},"بارگذاری هفته ۰، ۲، ۴: ۱۰ تا \u003C۲۰ kg: ۱۰۰؛ ۲۰ تا \u003C۴۰: ۲۰۰؛ ≥۴۰: ۴۰۰ mg.","Loading at weeks 0, 2, 4: 10–\u003C20 kg: 100; 20–\u003C40: 200; ≥40: 400 mg.",[157],{"source":33,"section":149},[159],{"id":160,"severity":161,"text":162,"refs":165},"hyper","block",{"fa":163,"en":164},"حساسیت جدی به سرتولیزوماب (آنژیوادم، آنافیلاکسی، بیماری سرم).","Serious hypersensitivity to certolizumab (angioedema, anaphylaxis, serum sickness).",[166],{"source":33,"section":167},"4",[169,176],{"text":170,"refs":173},{"fa":171,"en":172},"هشدار جعبه‌ای: عفونت‌های جدی (سل، قارچی تهاجمی، فرصت‌طلب) و بدخیمی (لنفوم، به‌ویژه در کودکان) — پیش از شروع تست سل نهفته و HBV.","Boxed warning: serious infections (TB, invasive fungal, opportunistic) and malignancy (lymphoma, especially in children) — test for latent TB and HBV first.",[174],{"source":33,"section":175},"Boxed Warning",{"text":177,"refs":180},{"fa":178,"en":179},"نارسایی قلب؛ فعال شدن HBV؛ بیماری دمیلینه‌کننده؛ سیتوپنی؛ سندرم شبه‌لوپوس؛ همراه داروهای بیولوژیک دیگر نه.","Heart failure; HBV reactivation; demyelinating disease; cytopenias; lupus-like syndrome; not with other biologics.",[181],{"source":33,"section":182},"5",[],[],[],{"status":187,"reviewer":146,"date":146},"unverified",[189,194,197,201,204,208],{"regimen":37,"formulation":23,"input":190,"expect":193},{"ageYears":191,"weightKg":192},45,70,{"perDose":48,"mlPerDose":133},{"regimen":68,"formulation":23,"input":195,"expect":196},{"ageYears":191,"weightKg":192},{"perDose":28,"mlPerDose":5},{"regimen":80,"formulation":23,"input":198,"expect":200},{"ageYears":199,"weightKg":192},35,{"perDose":28,"mlPerDose":5},{"regimen":94,"formulation":23,"input":202,"expect":203},{"ageYears":199,"weightKg":192},{"perDose":48,"mlPerDose":133},{"regimen":106,"formulation":23,"input":205,"expect":207},{"ageYears":199,"weightKg":206},95,{"perDose":48,"mlPerDose":133},{"regimen":126,"formulation":23,"input":209,"expect":212},{"ageYears":210,"weightKg":211},8,25,{"perDose":144,"mlPerDose":213},0.5,[215],"L04AB05",{"status":217,"refs":218},"not-found",[219],{"source":220,"section":221,"url":222},"darooyab-generic","G-2927\u002FCertolizumab-Pegol","https:\u002F\u002Fwww.darooyab.ir\u002FG-2927\u002FCertolizumab-Pegol",[224,228,232,236,239],{"kind":225,"url":226,"label":227},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=125160","BLA125160",{"kind":229,"url":230,"label":231},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=b4c2c9dc-a0bb-4d64-a667-a67ebe88392d","FDA Cimzia",{"kind":233,"url":234,"label":235},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa608041.html","Certolizumab Injection",{"kind":237,"url":238,"label":215},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L04AB05",{"kind":240,"url":222,"label":241},"darooyab","Certolizumab-Pegol",{"pregnancy":243,"lactation":252,"pediatric":260,"geriatric":268},{"level":244,"text":245,"quote":248,"refs":249},"caution",{"fa":246,"en":247},"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 Limited data from an ongoing pregnancy exposure registry on use of CIMZIA in pregnant women are not sufficient to inform a risk of major birth defects or other adverse pregnancy outcomes.",[250],{"source":33,"section":251},"8.1",{"level":244,"text":253,"quote":256,"refs":257},{"fa":254,"en":255},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary In a multicenter clinical study of 17 lactating women treated with CIMZIA at 200 mg every 2 weeks or 400 mg every 4 weeks, minimal certolizumab pegol concentrations were observed in breast milk.",[258],{"source":33,"section":259},"8.2",{"level":244,"text":261,"quote":264,"refs":265},{"fa":262,"en":263},"برچسب: در JIA پلی‌آرتیکولار از ۲ سالگی ثابت شده؛ هشدار جعبه‌ای لنفوم و بدخیمی در کودکان و نوجوانان.","Label: established for polyarticular JIA from 2 y; boxed warning of lymphoma and malignancy in children and adolescents.","The safety and effectiveness of CIMZIA for active polyarticular juvenile idiopathic arthritis has been established in pediatric patients 2 years of age and older.",[266],{"source":33,"section":267},"8.4",{"level":244,"text":269,"quote":272,"refs":273},{"fa":270,"en":271},"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.","Because there is a higher incidence of infections in the elderly population in general, use caution when treating the elderly with CIMZIA [see Warnings and Precautions (5.1) ] .",[274],{"source":33,"section":275},"8.5",{"kind":277,"refs":278,"id":227},"BLA",[279],{"source":33,"section":280},"SPL approval \u002F marketing category",1792191532457]