[{"data":1,"prerenderedAt":212},["ShallowReactive",2],{"drug-guselkumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":44,"contraindications":101,"warnings":111,"renal":126,"monitoring":127,"interactions":128,"review":129,"examples":132,"atc":146,"iran":148,"usApproval":155,"links":161,"populations":178},"guselkumab",1,{"fa":7,"en":8},"گوسلکوماب","Guselkumab","antineoplastic-immunomodulating",{"fa":11,"en":12},"آنتی‌بادی ضد IL-23","Anti-IL-23 antibody",[14],{"name":15,"market":16},"Tremfya","US",[18,19,7],"tremfya","ترمفیا",[21,34],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":29,"refs":30},"pfs-100","injection","sc","100 mg\u002FmL syringe, pen or One-Press",{"amount":27,"unit":28,"perVolumeMl":5},100,"mg",[16],[31],{"source":32,"section":33},"fda-tremfya","3",{"id":35,"form":23,"route":36,"label":37,"concentration":38,"markets":41,"refs":42},"vial-200","iv","200 mg\u002F20 mL (10 mg\u002FmL) vial for IV infusion",{"amount":39,"unit":28,"perVolumeMl":40},200,20,[16],[43],{"source":32,"section":33},[45,63,77],{"id":46,"disease":47,"label":48,"population":51,"type":56,"unit":28,"dose":57,"refs":58,"durationDays":61,"allowedFormulations":62},"pso","psoriasis",{"fa":49,"en":50},"پسوریازیس پلاک متوسط تا شدید (بزرگسال و کودک ۶ سال و ≥۴۰ kg) — ۱۰۰ mg هفته ۰، ۴ و سپس هر ۸ هفته","Moderate–severe plaque psoriasis (adults and children ≥6 y and ≥40 kg) — 100 mg at weeks 0, 4, then every 8 weeks",{"minAge":52,"minWeightKg":55},{"value":53,"unit":54},6,"year",40,"fixed",{"perDose":27,"dosesPerDay":5},[59],{"source":32,"section":60},"2.2",{"min":5,"max":5},[22],{"id":64,"disease":65,"label":66,"population":69,"type":56,"unit":28,"dose":71,"refs":72,"durationDays":75,"allowedFormulations":76},"psa","psoriatic-arthritis",{"fa":67,"en":68},"آرتریت پسوریاتیک (بزرگسال و کودک ۶ سال و ≥۴۰ kg) — ۱۰۰ mg هفته ۰، ۴ و سپس هر ۸ هفته","Psoriatic arthritis (adults and children ≥6 y and ≥40 kg) — 100 mg at weeks 0, 4, then every 8 weeks",{"minAge":70,"minWeightKg":55},{"value":53,"unit":54},{"perDose":27,"dosesPerDay":5},[73],{"source":32,"section":74},"2.3",{"min":5,"max":5},[22],{"id":78,"disease":79,"label":80,"population":83,"type":56,"unit":28,"dose":86,"refs":87,"durationDays":90,"allowedFormulations":91,"notes":92},"uc-ind","ulcerative-colitis",{"fa":81,"en":82},"کولیت اولسراتیو بزرگسال — القا ۲۰۰ mg وریدی (دست‌کم ۱ ساعت) هفته ۰، ۴ و ۸","Ulcerative colitis, adults — induction 200 mg IV (over ≥1 h) at weeks 0, 4 and 8",{"minAge":84},{"value":85,"unit":54},18,{"perDose":39,"dosesPerDay":5},[88],{"source":32,"section":89},"2.4",{"min":5,"max":5},[35],[93],{"text":94,"refs":97},{"fa":95,"en":96},"یا ۴۰۰ mg زیرجلدی (دو تزریق ۲۰۰) همان هفته‌ها. نگهدارنده: ۱۰۰ mg زیرجلدی هفته ۱۶ و سپس هر ۸ هفته. پیش از شروع آنزیم کبد و بیلی‌روبین.","Or 400 mg SC (two 200 mg injections) at the same weeks. Maintenance: 100 mg SC at week 16 then every 8 weeks. Check liver enzymes and bilirubin first.",[98,99],{"source":32,"section":89},{"source":32,"section":100},"2",[102],{"id":103,"severity":104,"text":105,"refs":108},"hyper","block",{"fa":106,"en":107},"سابقه حساسیت جدی به گوسلکوماب.","History of serious hypersensitivity to guselkumab.",[109],{"source":32,"section":110},"4",[112,119],{"text":113,"refs":116},{"fa":114,"en":115},"حساسیت؛ عفونت؛ سل (پیش از شروع بررسی)؛ واکسن زنده نه.","Hypersensitivity; infections; tuberculosis (screen first); no live vaccines.",[117],{"source":32,"section":118},"5",{"text":120,"refs":123},{"fa":121,"en":122},"سمیت کبدی (به‌ویژه دوزهای القای IBD).","Hepatotoxicity (especially IBD induction doses).",[124],{"source":32,"section":125},"5.4",[],[],[],{"status":130,"reviewer":131,"date":131},"unverified",null,[133,137,141],{"regimen":46,"formulation":22,"input":134,"expect":136},{"ageYears":55,"weightKg":135},80,{"perDose":27,"mlPerDose":5},{"regimen":64,"formulation":22,"input":138,"expect":140},{"ageYears":139,"weightKg":135},45,{"perDose":27,"mlPerDose":5},{"regimen":78,"formulation":35,"input":142,"expect":145},{"ageYears":143,"weightKg":144},35,70,{"perDose":39,"mlPerDose":40},[147],"L04AC16",{"status":149,"refs":150},"registered",[151],{"source":152,"section":153,"url":154},"darooyab-generic","G-5574\u002FGuselkumab","https:\u002F\u002Fwww.darooyab.ir\u002FG-5574\u002FGuselkumab",{"kind":156,"refs":157,"id":160},"BLA",[158],{"source":32,"section":159},"SPL approval \u002F marketing category","BLA761061",[162,165,169,173,176],{"kind":163,"url":164,"label":160},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=761061",{"kind":166,"url":167,"label":168},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56","FDA Tremfya",{"kind":170,"url":171,"label":172},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa617036.html","Guselkumab Injection",{"kind":174,"url":175,"label":147},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L04AC16",{"kind":177,"url":154,"label":8},"darooyab",{"pregnancy":179,"lactation":188,"pediatric":196,"geriatric":204},{"level":180,"text":181,"quote":184,"refs":185},"caution",{"fa":182,"en":183},"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 literature, post-marketing reports, and ongoing pregnancy registry with TREMFYA use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.",[186],{"source":32,"section":187},"8.1",{"level":180,"text":189,"quote":192,"refs":193},{"fa":190,"en":191},"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 guselkumab in human milk, the effects on the breastfed infant, or the effects on milk production.",[194],{"source":32,"section":195},"8.2",{"level":180,"text":197,"quote":200,"refs":201},{"fa":198,"en":199},"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 TREMFYA for the treatment of moderate-to-severe plaque psoriasis have been established in pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy [see Adverse Reactions (6.1) and Clinical Studies (14.1) ] .",[202],{"source":32,"section":203},"8.4",{"level":180,"text":205,"quote":208,"refs":209},{"fa":206,"en":207},"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 6418 subjects with plaque psoriasis, psoriatic arthritis, ulcerative colitis, or Crohn's disease exposed to TREMFYA, a total of 489 subjects were 65 years or older, and 55 subjects were 75 years or older.",[210],{"source":32,"section":211},"8.5",1792191547530]