[{"data":1,"prerenderedAt":146},["ShallowReactive",2],{"drug-tildrakizumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":34,"contraindications":51,"warnings":61,"renal":69,"monitoring":70,"interactions":71,"review":72,"examples":75,"atc":81,"iran":83,"usApproval":90,"links":96,"populations":111},"tildrakizumab",1,{"fa":7,"en":8},"تیلدراکیزوماب","Tildrakizumab","antineoplastic-immunomodulating",{"fa":11,"en":12},"آنتی‌بادی ضد IL-23","Anti-IL-23 antibody",[14],{"name":15,"market":16},"Ilumya","US",[18,19,7],"ilumya","ایلومیا",[21],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":29,"refs":30},"pfs-100","injection","sc","100 mg\u002FmL prefilled syringe",{"amount":27,"unit":28,"perVolumeMl":5},100,"mg",[16],[31],{"source":32,"section":33},"fda-ilumya","3",[35],{"id":36,"disease":37,"label":38,"population":41,"type":45,"unit":28,"dose":46,"refs":47,"durationDays":50},"pso","psoriasis",{"fa":39,"en":40},"پسوریازیس پلاک متوسط تا شدید بزرگسال — ۱۰۰ mg هفته ۰، ۴ و سپس هر ۱۲ هفته","Moderate–severe plaque psoriasis, adults — 100 mg at weeks 0, 4, then every 12 weeks",{"minAge":42},{"value":43,"unit":44},18,"year","fixed",{"perDose":27,"dosesPerDay":5},[48],{"source":32,"section":49},"2.2",{"min":5,"max":5},[52],{"id":53,"severity":54,"text":55,"refs":58},"hyper","block",{"fa":56,"en":57},"حساسیت جدی به تیلدراکیزوماب.","Serious hypersensitivity to tildrakizumab.",[59],{"source":32,"section":60},"4",[62],{"text":63,"refs":66},{"fa":64,"en":65},"حساسیت؛ عفونت؛ سل (پیش از شروع بررسی)؛ واکسن زنده نه.","Hypersensitivity; infections; tuberculosis (screen first); no live vaccines.",[67],{"source":32,"section":68},"5",[],[],[],{"status":73,"reviewer":74,"date":74},"unverified",null,[76],{"regimen":36,"formulation":22,"input":77,"expect":80},{"ageYears":78,"weightKg":79},40,80,{"perDose":27,"mlPerDose":5},[82],"L04AC17",{"status":84,"refs":85},"not-found",[86],{"source":87,"section":88,"url":89},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Tildrakizumab",{"kind":91,"refs":92,"id":95},"BLA",[93],{"source":32,"section":94},"SPL approval \u002F marketing category","BLA761067",[97,100,104,108],{"kind":98,"url":99,"label":95},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=761067",{"kind":101,"url":102,"label":103},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=c6a322bb-51b9-4f0e-8642-62a9682ffcde","FDA Ilumya",{"kind":105,"url":106,"label":107},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa618026.html","Tildrakizumab-asmn injection",{"kind":109,"url":110,"label":82},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L04AC17",{"pregnancy":112,"lactation":121,"pediatric":129,"geriatric":138},{"level":113,"text":114,"quote":117,"refs":118},"caution",{"fa":115,"en":116},"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 clinical trials, published literature, and pharmacovigilance with ILUMYA use in pregnant women are insufficient to inform a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.",[119],{"source":32,"section":120},"8.1",{"level":113,"text":122,"quote":125,"refs":126},{"fa":123,"en":124},"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 tildrakizumab in human milk, the effects on the breastfed infant, or the effects on milk production.",[127],{"source":32,"section":128},"8.2",{"level":130,"text":131,"quote":134,"refs":135},"not-established",{"fa":132,"en":133},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","Safety and effectiveness of ILUMYA in pediatric patients (\u003C18 years of age) have not been established.",[136],{"source":32,"section":137},"8.4",{"level":113,"text":139,"quote":142,"refs":143},{"fa":140,"en":141},"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.","A total of 1083 subjects were exposed to ILUMYA 100 mg during Phase 2 and 3 trials.",[144],{"source":32,"section":145},"8.5",1792191569401]