[{"data":1,"prerenderedAt":211},["ShallowReactive",2],{"drug-ustekinumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":45,"contraindications":115,"warnings":125,"renal":133,"monitoring":134,"interactions":135,"review":136,"examples":138,"atc":145,"iran":147,"usApproval":154,"links":160,"populations":177},"ustekinumab",1,{"fa":7,"en":8},"اوستکینومب","Ustekinumab","antineoplastic-immunomodulating",{"fa":11,"en":12},"مهارکننده IL-12\u002F23","IL-12\u002F23 inhibitor",[14],{"name":15,"market":16},"Stelara","US",[18,19,20],"stelara","استلارا","اوستکینوماب",[22,35],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":30,"refs":31},"iv-130","injection","iv","130 mg\u002F26 mL (5 mg\u002FmL) IV vial",{"amount":28,"unit":29,"perVolumeMl":5},5,"mg",[16],[32],{"source":33,"section":34},"fda-stelara","3",{"id":36,"form":24,"route":37,"label":38,"concentration":39,"markets":42,"refs":43},"sc-45","sc","45 mg\u002F0.5 mL prefilled syringe (also 90 mg\u002FmL)",{"amount":40,"unit":29,"perVolumeMl":41},45,0.5,[16],[44],{"source":33,"section":34},[46,84,100],{"id":47,"disease":48,"label":49,"population":52,"type":56,"unit":29,"dose":57,"refs":69,"durationDays":74,"allowedFormulations":75,"notes":76},"cd-iv","crohns",{"fa":50,"en":51},"کرون و کولیت اولسروز — القای وریدی یک‌باره بر اساس وزن: ≤۵۵ kg ۲۶۰، ۵۵ تا ۸۵ ← ۳۹۰، >۸۵ ← ۵۲۰ mg","Crohn’s \u002F UC — single IV induction by weight: ≤55 kg 260, 55–85 → 390, >85 kg → 520 mg",{"minAge":53},{"value":54,"unit":55},18,"year","weightBand",{"weightBands":58},[59,63,66],{"minWeightKg":60,"maxWeightKg":61,"perDose":62,"dosesPerDay":5},0,55,260,{"minWeightKg":61,"maxWeightKg":64,"perDose":65,"dosesPerDay":5},85,390,{"minWeightKg":64,"maxWeightKg":67,"perDose":68,"dosesPerDay":5},null,520,[70,72],{"source":33,"section":71},"2.3, Table 4",{"source":33,"section":73},"2.5",{"min":5,"max":5},[23],[77],{"text":78,"refs":81},{"fa":79,"en":80},"یک انفوزیون (دست‌کم ۱ ساعت)؛ سپس ۹۰ mg زیرجلدی ۸ هفته بعد و هر ۸ هفته.","One infusion (≥1 h); then 90 mg SC 8 weeks later and every 8 weeks.",[82],{"source":33,"section":83},"2.3",{"id":85,"disease":86,"label":87,"population":90,"type":92,"unit":29,"dose":93,"refs":97},"pso","psoriasis",{"fa":88,"en":89},"پسوریازیس پلاک بزرگسال — ≤۱۰۰ kg: ۴۵ mg؛ >۱۰۰ kg: ۹۰ mg (هفته ۰ و ۴، سپس هر ۱۲ هفته)","Adult plaque psoriasis — ≤100 kg: 45 mg; >100 kg: 90 mg (weeks 0 and 4, then every 12 weeks)",{"minAge":91},{"value":54,"unit":55},"notCalculated",{"reason":94},{"fa":95,"en":96},"زیرجلدی در هفته ۰ و ۴، سپس هر ۱۲ هفته؛ دوز بر اساس وزن ۱۰۰ kg.","SC at weeks 0 and 4, then every 12 weeks; dose by the 100 kg cut-off.",[98],{"source":33,"section":99},"2.1",{"id":101,"disease":102,"label":103,"population":106,"type":92,"unit":29,"dose":108,"refs":112},"psa","psoriatic-arthritis",{"fa":104,"en":105},"آرتریت پسوریاتیک — ۴۵ mg هفته ۰ و ۴، سپس هر ۱۲ هفته","Psoriatic arthritis — 45 mg at weeks 0 and 4, then every 12 weeks",{"minAge":107},{"value":54,"unit":55},{"reason":109},{"fa":110,"en":111},"همراه پسوریازیس متوسط تا شدید و وزن >۱۰۰ kg: ۹۰ mg.","With moderate–severe psoriasis and weight >100 kg: 90 mg.",[113],{"source":33,"section":114},"2.2",[116],{"id":117,"severity":118,"text":119,"refs":122},"hyper","block",{"fa":120,"en":121},"حساسیت قابل‌توجه به اوستکینومب یا اجزای آن.","Clinically significant hypersensitivity to ustekinumab or excipients.",[123],{"source":33,"section":124},"4",[126],{"text":127,"refs":130},{"fa":128,"en":129},"عفونت جدی و سل (تست قبل)؛ بدخیمی؛ سندرم انسفالوپاتی برگشت‌پذیر خلفی؛ واکسن زنده نه.","Serious infections and TB (test first); malignancy; posterior reversible encephalopathy; no live vaccines.",[131],{"source":33,"section":132},"5",[],[],[],{"status":137,"reviewer":67,"date":67},"unverified",[139],{"regimen":47,"formulation":23,"input":140,"expect":143},{"ageYears":141,"weightKg":142},35,70,{"perDose":65,"mlPerDose":144},78,[146],"L04AC05",{"status":148,"refs":149},"registered",[150],{"source":151,"section":152,"url":153},"darooyab-generic","G-5322\u002FUstekinumab","https:\u002F\u002Fwww.darooyab.ir\u002FG-5322\u002FUstekinumab",{"kind":155,"refs":156,"id":159},"BLA",[157],{"source":33,"section":158},"SPL approval \u002F marketing category","BLA125261",[161,164,168,172,175],{"kind":162,"url":163,"label":159},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=125261",{"kind":165,"url":166,"label":167},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b","FDA Stelara",{"kind":169,"url":170,"label":171},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa611013.html","Ustekinumab Injection",{"kind":173,"url":174,"label":146},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L04AC05",{"kind":176,"url":153,"label":8},"darooyab",{"pregnancy":178,"lactation":187,"pediatric":195,"geriatric":203},{"level":179,"text":180,"quote":183,"refs":184},"caution",{"fa":181,"en":182},"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 Available data from the Organization of Teratology Information Specialists (OTIS)\u002FMotherToBaby STELARA Pregnancy Registry, published literature and pharmacovigilance in pregnant women have not identified a STELARA-associated risk of major birth defects, miscarriage or other adverse maternal or fetal …",[185],{"source":33,"section":186},"8.1",{"level":179,"text":188,"quote":191,"refs":192},{"fa":189,"en":190},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary Limited data from published literature suggests that ustekinumab is present in human breast milk.",[193],{"source":33,"section":194},"8.2",{"level":179,"text":196,"quote":199,"refs":200},{"fa":197,"en":198},"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.","Plaque Psoriasis The safety and effectiveness of STELARA have been established for the treatment of moderate to severe plaque psoriasis in pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy.",[201],{"source":33,"section":202},"8.4",{"level":179,"text":204,"quote":207,"refs":208},{"fa":205,"en":206},"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.","Of the 6709 subjects exposed to STELARA, a total of 340 were 65 years of age or older (183 subjects with plaque psoriasis, 65 subjects with psoriatic arthritis, 58 subjects with Crohn's disease, and 34 subjects with ulcerative colitis), and 40 subjects were 75 years of age or older.",[209],{"source":33,"section":210},"8.5",1792156198895]