[{"data":1,"prerenderedAt":237},["ShallowReactive",2],{"drug-ixekizumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":43,"contraindications":128,"warnings":138,"renal":146,"monitoring":147,"interactions":148,"review":149,"examples":151,"atc":173,"iran":175,"usApproval":182,"links":188,"populations":203},"ixekizumab",1,{"fa":7,"en":8},"ایکسکیزوماب","Ixekizumab","antineoplastic-immunomodulating",{"fa":11,"en":12},"آنتی‌بادی ضد IL-17A","Anti-IL-17A antibody",[14],{"name":15,"market":16},"Taltz","US",[18,19,7],"taltz","تالتز",[21,34],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":29,"refs":30},"ai-80","injection","sc","80 mg\u002FmL autoinjector or syringe",{"amount":27,"unit":28,"perVolumeMl":5},80,"mg",[16],[31],{"source":32,"section":33},"fda-taltz","3",{"id":35,"form":23,"route":24,"label":36,"concentration":37,"markets":40,"refs":41},"pfs-40","40 mg\u002F0.5 mL syringe",{"amount":38,"unit":28,"perVolumeMl":39},40,0.5,[16],[42],{"source":32,"section":33},[44,69,98,112],{"id":45,"disease":46,"label":47,"population":50,"type":54,"unit":28,"dose":55,"refs":56,"durationDays":59,"allowedFormulations":60,"notes":61},"pso","psoriasis",{"fa":48,"en":49},"پسوریازیس پلاک بزرگسال — ۱۶۰ mg هفته ۰، سپس ۸۰ mg هفته ۲ تا ۱۲ هر ۲ هفته، سپس ۸۰ mg هر ۴ هفته","Plaque psoriasis, adults — 160 mg at week 0, then 80 mg every 2 weeks to week 12, then 80 mg every 4 weeks",{"minAge":51},{"value":52,"unit":53},18,"year","fixed",{"perDose":27,"dosesPerDay":5},[57],{"source":32,"section":58},"2.2",{"min":5,"max":5},[22],[62],{"text":63,"refs":66},{"fa":64,"en":65},"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.",[67],{"source":32,"section":68},"2.1",{"id":70,"disease":46,"label":71,"population":74,"type":79,"unit":28,"dose":80,"refs":87,"durationDays":90,"notes":91},"pso-child",{"fa":72,"en":73},"پسوریازیس پلاک کودک ۶ سال به بالا — هر ۴ هفته: ۲۵ تا ۵۰ kg: ۴۰ mg؛ بالای ۵۰ kg: ۸۰ mg","Plaque psoriasis, children ≥6 y — every 4 weeks: 25–50 kg: 40 mg; >50 kg: 80 mg",{"minAge":75,"maxAge":77,"minWeightKg":78},{"value":76,"unit":53},6,{"value":52,"unit":53},25,"weightBand",{"weightBands":81},[82,85],{"minWeightKg":83,"maxWeightKg":84,"perDose":38,"dosesPerDay":5},24.99,50,{"minWeightKg":84,"maxWeightKg":86,"perDose":27,"dosesPerDay":5},null,[88],{"source":32,"section":89},"2.3, Table 1",{"min":5,"max":5},[92],{"text":93,"refs":96},{"fa":94,"en":95},"دوز شروع (هفته ۰): ۲۵ تا ۵۰ kg: ۸۰ mg؛ بالای ۵۰ kg: ۱۶۰ mg.","Starting dose (week 0): 25–50 kg: 80 mg; >50 kg: 160 mg.",[97],{"source":32,"section":89},{"id":99,"disease":100,"label":101,"population":104,"type":54,"unit":28,"dose":106,"refs":107,"durationDays":110,"allowedFormulations":111},"psa","psoriatic-arthritis",{"fa":102,"en":103},"آرتریت پسوریاتیک — ۱۶۰ mg هفته ۰، سپس ۸۰ mg هر ۴ هفته","Psoriatic arthritis — 160 mg at week 0, then 80 mg every 4 weeks",{"minAge":105},{"value":52,"unit":53},{"perDose":27,"dosesPerDay":5},[108],{"source":32,"section":109},"2.4",{"min":5,"max":5},[22],{"id":113,"disease":114,"label":115,"population":118,"type":54,"unit":28,"dose":120,"refs":121,"durationDays":126,"allowedFormulations":127},"as","ankylosing-spondylitis",{"fa":116,"en":117},"اسپوندیلیت آنکیلوزان — ۱۶۰ mg هفته ۰، سپس ۸۰ mg هر ۴ هفته (nr-axSpA: ۸۰ mg هر ۴ هفته)","Ankylosing spondylitis — 160 mg at week 0, then 80 mg every 4 weeks (nr-axSpA: 80 mg every 4 weeks)",{"minAge":119},{"value":52,"unit":53},{"perDose":27,"dosesPerDay":5},[122,124],{"source":32,"section":123},"2.5",{"source":32,"section":125},"2.6",{"min":5,"max":5},[22],[129],{"id":130,"severity":131,"text":132,"refs":135},"hyper","block",{"fa":133,"en":134},"حساسیت جدی به ایکسکیزوماب.","Serious hypersensitivity to ixekizumab.",[136],{"source":32,"section":137},"4",[139],{"text":140,"refs":143},{"fa":141,"en":142},"عفونت؛ سل (پیش از شروع بررسی)؛ حساسیت؛ ضایعات اگزمایی؛ بیماری التهابی روده (شروع یا تشدید)؛ واکسن زنده نه.","Infections; TB (screen first); hypersensitivity; eczematous eruptions; inflammatory bowel disease (new or worse); no live vaccines.",[144],{"source":32,"section":145},"5",[],[],[],{"status":150,"reviewer":86,"date":86},"unverified",[152,155,160,165,169],{"regimen":45,"formulation":22,"input":153,"expect":154},{"ageYears":38,"weightKg":27},{"perDose":27,"mlPerDose":5},{"regimen":70,"formulation":35,"input":156,"expect":159},{"ageYears":157,"weightKg":158},10,35,{"perDose":38,"mlPerDose":39},{"regimen":70,"formulation":22,"input":161,"expect":164},{"ageYears":162,"weightKg":163},15,60,{"perDose":27,"mlPerDose":5},{"regimen":99,"formulation":22,"input":166,"expect":168},{"ageYears":167,"weightKg":27},45,{"perDose":27,"mlPerDose":5},{"regimen":113,"formulation":22,"input":170,"expect":172},{"ageYears":158,"weightKg":171},75,{"perDose":27,"mlPerDose":5},[174],"L04AC13",{"status":176,"refs":177},"not-found",[178],{"source":179,"section":180,"url":181},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Ixekizumab",{"kind":183,"refs":184,"id":187},"BLA",[185],{"source":32,"section":186},"SPL approval \u002F marketing category","BLA125521",[189,192,196,200],{"kind":190,"url":191,"label":187},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=125521",{"kind":193,"url":194,"label":195},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=ac96658a-d7dc-4c7c-8928-2adcdf4318b2","FDA Taltz",{"kind":197,"url":198,"label":199},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa616025.html","Ixekizumab Injection",{"kind":201,"url":202,"label":174},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L04AC13",{"pregnancy":204,"lactation":213,"pediatric":221,"geriatric":229},{"level":205,"text":206,"quote":209,"refs":210},"caution",{"fa":207,"en":208},"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 published literature and the pharmacovigilance database with TALTZ use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.",[211],{"source":32,"section":212},"8.1",{"level":205,"text":214,"quote":217,"refs":218},{"fa":215,"en":216},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary There are no available data on the presence of ixekizumab in human milk, the effects on the breastfed infant, or the effects on milk production.",[219],{"source":32,"section":220},"8.2",{"level":205,"text":222,"quote":225,"refs":226},{"fa":223,"en":224},"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 TALTZ have been established in pediatric subjects aged 6 years to less than 18 years with moderate-to-severe plaque psoriasis.",[227],{"source":32,"section":228},"8.4",{"level":205,"text":230,"quote":233,"refs":234},{"fa":231,"en":232},"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 4204 adult psoriasis subjects exposed to TALTZ, a total of 301 were 65 years or older, and 36 subjects were 75 years or older.",[235],{"source":32,"section":236},"8.5",1792191550683]