[{"data":1,"prerenderedAt":244},["ShallowReactive",2],{"drug-upadacitinib":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":51,"contraindications":120,"warnings":130,"renal":138,"monitoring":139,"interactions":140,"review":141,"examples":144,"atc":161,"iran":163,"usApproval":179,"links":185,"populations":201},"upadacitinib",1,{"fa":7,"en":8},"اوپاداسیتینیب","Upadacitinib","antineoplastic-immunomodulating",{"fa":11,"en":12},"مهارکننده JAK","JAK inhibitor",[14],{"name":15,"market":16},"Rinvoq","US",[18,19,7],"rinvoq","رینووک",[21,35,43],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"er-15","tablet","oral","15 mg extended-release tablet",{"amount":27,"unit":28,"perUnit":23,"scored":29},15,"mg",false,[16],[32],{"source":33,"section":34},"fda-rinvoq","3",{"id":36,"form":23,"route":24,"label":37,"concentration":38,"markets":40,"refs":41},"er-30","30 mg extended-release tablet",{"amount":39,"unit":28,"perUnit":23,"scored":29},30,[16],[42],{"source":33,"section":34},{"id":44,"form":23,"route":24,"label":45,"concentration":46,"markets":48,"refs":49},"er-45","45 mg extended-release tablet",{"amount":47,"unit":28,"perUnit":23,"scored":29},45,[16],[50],{"source":33,"section":34},[52,67,92,106],{"id":53,"disease":54,"label":55,"population":58,"type":62,"unit":28,"dose":63,"refs":64},"ra","rheumatoid-arthritis",{"fa":56,"en":57},"آرتریت روماتوئید — ۱۵ mg یک بار در روز","Rheumatoid arthritis — 15 mg once daily",{"minAge":59},{"value":60,"unit":61},18,"year","fixed",{"perDose":27,"dosesPerDay":5},[65],{"source":33,"section":66},"2.3",{"id":68,"disease":69,"label":70,"population":73,"type":62,"unit":28,"dose":79,"refs":80,"notes":83},"ad","atopic-dermatitis",{"fa":71,"en":72},"درماتیت آتوپیک (۱۲ سال و ≥۴۰ kg، زیر ۶۵ سال) — ۱۵ mg، در صورت پاسخ ناکافی ۳۰ mg","Atopic dermatitis (≥12 y and ≥40 kg, \u003C65 y) — 15 mg, 30 mg if inadequate response",{"minAge":74,"maxAge":76,"minWeightKg":78},{"value":75,"unit":61},12,{"value":77,"unit":61},65,40,{"perDose":27,"perDoseMax":39,"dosesPerDay":5},[81],{"source":33,"section":82},"2.5",[84],{"text":85,"refs":88},{"fa":86,"en":87},"۶۵ سال به بالا: ۱۵ mg. نارسایی شدید کلیه: ۱۵ mg.","≥65 y: 15 mg. Severe renal impairment: 15 mg.",[89,90],{"source":33,"section":82},{"source":33,"section":91},"2.12",{"id":93,"disease":94,"label":95,"population":98,"type":62,"unit":28,"dose":100,"refs":101,"durationDays":104},"uc","ulcerative-colitis",{"fa":96,"en":97},"کولیت اولسروز — القا ۴۵ mg روزانه ۸ هفته، نگهدارنده ۱۵ mg (تا ۳۰)","Ulcerative colitis — induction 45 mg daily for 8 weeks, maintenance 15 mg (up to 30)",{"minAge":99},{"value":60,"unit":61},{"perDose":47,"dosesPerDay":5},[102],{"source":33,"section":103},"2.6",{"min":105,"max":105},56,{"id":107,"disease":108,"label":109,"population":112,"type":62,"unit":28,"dose":114,"refs":115,"durationDays":118},"cd","crohns",{"fa":110,"en":111},"کرون — القا ۴۵ mg روزانه ۱۲ هفته، نگهدارنده ۱۵ mg (تا ۳۰)","Crohn’s — induction 45 mg daily for 12 weeks, maintenance 15 mg (up to 30)",{"minAge":113},{"value":60,"unit":61},{"perDose":47,"dosesPerDay":5},[116],{"source":33,"section":117},"2.7",{"min":119,"max":119},84,[121],{"id":122,"severity":123,"text":124,"refs":127},"hyper","block",{"fa":125,"en":126},"حساسیت به اوپاداسیتینیب.","Hypersensitivity to upadacitinib.",[128],{"source":33,"section":129},"4",[131],{"text":132,"refs":135},{"fa":133,"en":134},"هشدار جعبه‌ای (مهارکننده JAK): عفونت جدی، مرگ، بدخیمی، حوادث قلبی‌عروقی بزرگ و ترومبوز. تست سل پیش از شروع.","Boxed warning (JAK inhibitors): serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis. TB test before starting.",[136],{"source":33,"section":137},"Boxed Warning",[],[],[],{"status":142,"reviewer":143,"date":143},"unverified",null,[145,150,154,158],{"regimen":53,"formulation":22,"input":146,"expect":149},{"ageYears":147,"weightKg":148},50,70,{"perDose":27,"tabletsPerDoseRounded":5},{"regimen":68,"formulation":22,"input":151,"expect":153},{"ageYears":152,"weightKg":77},25,{"perDose":27,"tabletsPerDoseRounded":5,"upperPerDose":39},{"regimen":93,"formulation":44,"input":155,"expect":157},{"ageYears":156,"weightKg":148},35,{"perDose":47,"tabletsPerDoseRounded":5},{"regimen":107,"formulation":44,"input":159,"expect":160},{"ageYears":156,"weightKg":148},{"perDose":47,"tabletsPerDoseRounded":5},[162],"L04AF03",{"status":164,"forms":165,"refs":174},"registered",[166,170],{"code":167,"en":168,"fa":169},"53370","UPADACITINIB 15 mg E.R Tablet","قرص آهسته‌رهش اوپاداسیتینیب ۱۵ میلی‌گرم",{"code":171,"en":172,"fa":173},"53371","UPADACITINIB 30 mg E.R Tablet","قرص آهسته‌رهش اوپاداسیتینیب ۳۰ میلی‌گرم",[175],{"source":176,"section":177,"url":178},"darooyab-generic","G-5556\u002FUpadacitinib","https:\u002F\u002Fwww.darooyab.ir\u002FG-5556\u002FUpadacitinib",{"kind":180,"refs":181,"id":184},"NDA",[182],{"source":33,"section":183},"SPL approval \u002F marketing category","NDA211675",[186,189,193,196,199],{"kind":187,"url":188,"label":184},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=211675",{"kind":190,"url":191,"label":192},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=2966aec7-2ef0-923c-d8ff-fe1a957bf095","FDA Rinvoq",{"kind":194,"url":195,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa619051.html",{"kind":197,"url":198,"label":162},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L04AF03",{"kind":200,"url":178,"label":8},"darooyab",{"pregnancy":202,"lactation":211,"pediatric":220,"geriatric":228,"reproductive":236},{"level":203,"text":204,"quote":207,"refs":208},"caution",{"fa":205,"en":206},"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 pharmacovigilance safety database and postmarketing case reports on use of RINVOQ in pregnant women are not sufficient to evaluate a drug-associated risk for major birth defects or miscarriage.",[209],{"source":33,"section":210},"8.1",{"level":212,"text":213,"quote":216,"refs":217},"avoid",{"fa":214,"en":215},"برچسب: شیردهی توصیه نمی‌شود یا باید بین دارو و شیردهی یکی انتخاب شود.","Label: breastfeeding not recommended, or choose between the drug and breastfeeding.","Because of the potential for serious adverse reactions in the breastfed infant, advise patients that breastfeeding is not recommended during treatment with RINVOQ\u002FRINVOQ LQ, and for 6 days (approximately 10 half-lives) after the last dose.",[218],{"source":33,"section":219},"8.2",{"level":203,"text":221,"quote":224,"refs":225},{"fa":222,"en":223},"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.","Polyarticular Juvenile Idiopathic Arthritis and Psoriatic Arthritis The safety and effectiveness of RINVOQ\u002FRINVOQ LQ in pediatric patients 2 to less than 18 years of age with pJIA and psoriatic arthritis have been established.",[226],{"source":33,"section":227},"8.4",{"level":203,"text":229,"quote":232,"refs":233},{"fa":230,"en":231},"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.","Rheumatoid Arthritis and Psoriatic Arthritis Of the 4381 patients treated in the five clinical trials, a total of 906 rheumatoid arthritis patients were 65 years of age or older, including 146 patients 75 years and older.",[234],{"source":33,"section":235},"8.5",{"level":203,"text":237,"quote":240,"refs":241},{"fa":238,"en":239},"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 Based on animal studies, upadacitinib may cause embryo-fetal harm when administered to pregnant women [see Use in Specific Populations ( 8.1 )] .",[242],{"source":33,"section":243},"8.3",1792156198795]