[{"data":1,"prerenderedAt":203},["ShallowReactive",2],{"drug-golimumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":43,"contraindications":96,"warnings":97,"renal":112,"monitoring":113,"interactions":114,"review":115,"examples":117,"atc":132,"iran":134,"usApproval":146,"links":152,"populations":169},"golimumab",1,{"fa":7,"en":8},"گولیموماب","Golimumab","antineoplastic-immunomodulating",{"fa":11,"en":12},"مهارکننده TNF","TNF blocker",[14],{"name":15,"market":16},"Simponi","US",[18,19,7],"simponi","سیمپونی",[21,35],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"pfs-50","injection","sc","50 mg\u002F0.5 mL syringe or SmartJect",{"amount":27,"unit":28,"perVolumeMl":29},50,"mg",0.5,[16],[32],{"source":33,"section":34},"fda-simponi","3",{"id":36,"form":23,"route":24,"label":37,"concentration":38,"markets":40,"refs":41},"pfs-100","100 mg\u002FmL syringe or SmartJect",{"amount":39,"unit":28,"perVolumeMl":5},100,[16],[42],{"source":33,"section":34},[44,69],{"id":45,"disease":46,"label":47,"population":50,"type":54,"unit":28,"dose":55,"refs":56,"durationDays":59,"allowedFormulations":60,"notes":61},"ra","rheumatoid-arthritis",{"fa":48,"en":49},"آرتریت روماتوئید (با متوترکسات)، پسوریاتیک یا اسپوندیلیت آنکیلوزان بزرگسال — ۵۰ mg زیرجلدی ماهانه","RA (with methotrexate), PsA or AS, adults — 50 mg SC once a month",{"minAge":51},{"value":52,"unit":53},18,"year","fixed",{"perDose":27,"dosesPerDay":5},[57],{"source":33,"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":33,"section":68},"2.1",{"id":70,"disease":71,"label":72,"population":75,"type":77,"unit":28,"dose":78,"refs":85,"durationDays":88,"notes":89},"uc","ulcerative-colitis",{"fa":73,"en":74},"کولیت اولسراتیو (≥۱۵ kg) — نگهدارنده از هفته ۶ هر ۴ هفته بر اساس وزن","Ulcerative colitis (≥15 kg) — maintenance from week 6 every 4 weeks by weight",{"minWeightKg":76},15,"weightBand",{"weightBands":79},[80,83],{"minWeightKg":81,"maxWeightKg":82,"perDose":27,"dosesPerDay":5},14.99,39.99,{"minWeightKg":82,"maxWeightKg":84,"perDose":39,"dosesPerDay":5},null,[86],{"source":33,"section":87},"2.3, Table 1",{"min":5,"max":5},[90],{"text":91,"refs":94},{"fa":92,"en":93},"القا: ≥۴۰ kg: ۲۰۰ mg هفته ۰ و ۱۰۰ mg هفته ۲؛ ۱۵ تا \u003C۴۰ kg: ۱۰۰ و ۵۰ mg.","Induction: ≥40 kg: 200 mg week 0 and 100 mg week 2; 15–\u003C40 kg: 100 and 50 mg.",[95],{"source":33,"section":87},[],[98,105],{"text":99,"refs":102},{"fa":100,"en":101},"هشدار جعبه‌ای: عفونت‌های جدی (سل، قارچی تهاجمی، فرصت‌طلب) و بدخیمی (لنفوم، به‌ویژه در کودکان) — پیش از شروع تست سل نهفته و HBV.","Boxed warning: serious infections (TB, invasive fungal, opportunistic) and malignancy (lymphoma, especially in children) — test for latent TB and HBV first.",[103],{"source":33,"section":104},"Boxed Warning",{"text":106,"refs":109},{"fa":107,"en":108},"نارسایی قلب؛ دمیلینه شدن؛ فعال شدن HBV؛ سیتوپنی؛ همراه آباتاسپت یا آناکینرا نه.","Heart failure; demyelination; HBV reactivation; cytopenias; not with abatacept or anakinra.",[110],{"source":33,"section":111},"5",[],[],[],{"status":116,"reviewer":84,"date":84},"unverified",[118,123,127],{"regimen":45,"formulation":22,"input":119,"expect":122},{"ageYears":120,"weightKg":121},45,70,{"perDose":27,"mlPerDose":29},{"regimen":70,"formulation":36,"input":124,"expect":126},{"ageYears":125,"weightKg":121},35,{"perDose":39,"mlPerDose":5},{"regimen":70,"formulation":22,"input":128,"expect":131},{"ageYears":129,"weightKg":130},10,30,{"perDose":27,"mlPerDose":29},[133],"L04AB06",{"status":135,"forms":136,"refs":141},"registered",[137],{"code":138,"en":139,"fa":140},"17284","GOLIMUMAB 50MG\u002F0.5ML VIAL","ویال گولیمومب ۵۰ میلی‌گرم \u002F ۰٫۵ میلی‌لیتر",[142],{"source":143,"section":144,"url":145},"darooyab-generic","G-4758\u002FGolimumab","https:\u002F\u002Fwww.darooyab.ir\u002FG-4758\u002FGolimumab",{"kind":147,"refs":148,"id":151},"BLA",[149],{"source":33,"section":150},"SPL approval \u002F marketing category","BLA125289",[153,156,160,164,167],{"kind":154,"url":155,"label":151},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=125289",{"kind":157,"url":158,"label":159},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=f86cb4a7-c358-4136-ae57-b32bda9bba00","FDA Simponi",{"kind":161,"url":162,"label":163},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa610010.html","Golimumab Injection",{"kind":165,"url":166,"label":133},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L04AB06",{"kind":168,"url":145,"label":8},"darooyab",{"pregnancy":170,"lactation":179,"pediatric":187,"geriatric":195},{"level":171,"text":172,"quote":175,"refs":176},"caution",{"fa":173,"en":174},"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 postmarketing case reports with golimumab use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.",[177],{"source":33,"section":178},"8.1",{"level":171,"text":180,"quote":183,"refs":184},{"fa":181,"en":182},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary There is no information regarding the presence of SIMPONI in human milk, the effects on breastfed infants, or the effects on milk production.",[185],{"source":33,"section":186},"8.2",{"level":171,"text":188,"quote":191,"refs":192},{"fa":189,"en":190},"برچسب: در کولیت اولسراتیو کودکان ≥۱۵ kg ثابت شده؛ هشدار جعبه‌ای لنفوم و بدخیمی در کودکان و نوجوانان.","Label: established for ulcerative colitis in children ≥15 kg; boxed warning of lymphoma and malignancy in children and adolescents.","The safety and effectiveness of SIMPONI for the treatment of moderately to severely active ulcerative colitis have been established in pediatric patients weighing at least 15 kg.",[193],{"source":33,"section":194},"8.4",{"level":171,"text":196,"quote":199,"refs":200},{"fa":197,"en":198},"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.","Because there is a higher incidence of infections in the geriatric population in general, caution should be used in treating geriatric patients with SIMPONI [see Warnings and Precautions (5.1 , 5.5) ] .",[201],{"source":33,"section":202},"8.5",1792191547185]