[{"data":1,"prerenderedAt":386},["ShallowReactive",2],{"drug-tocilizumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":45,"contraindications":224,"warnings":234,"renal":249,"monitoring":250,"interactions":251,"review":252,"examples":255,"atc":303,"iran":305,"usApproval":329,"links":335,"populations":352},"tocilizumab",1,{"fa":7,"en":8},"توسیلیزوماب","Tocilizumab","antineoplastic-immunomodulating",{"fa":11,"en":12},"آنتی‌بادی ضد گیرنده IL-6","Anti-IL-6 receptor antibody",[14],{"name":15,"market":16},"Actemra","US",[18,19,20,7],"actemra","roactemra","اکتمرا",[22,35],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":30,"refs":31},"vial-20","injection","iv","20 mg\u002FmL vial (80\u002F200\u002F400 mg) for IV infusion",{"amount":28,"unit":29,"perVolumeMl":5},20,"mg",[16],[32],{"source":33,"section":34},"fda-actemra","3",{"id":36,"form":24,"route":37,"label":38,"concentration":39,"markets":42,"refs":43},"pfs-162","sc","162 mg\u002F0.9 mL prefilled syringe or ACTPen",{"amount":40,"unit":29,"perVolumeMl":41},162,0.9,[16],[44],{"source":33,"section":34},[46,74,87,102,114,131,144,158,170,191,203],{"id":47,"disease":48,"label":49,"population":52,"type":56,"unit":29,"dose":57,"refs":61,"durationDays":64,"allowedFormulations":65,"notes":66},"ra-iv","rheumatoid-arthritis",{"fa":50,"en":51},"آرتریت روماتوئید بزرگسال (وریدی) — شروع ۴ mg\u002Fkg هر ۴ هفته؛ افزایش تا ۸ mg\u002Fkg","Rheumatoid arthritis, adults (IV) — start 4 mg\u002Fkg every 4 weeks; increase to 8 mg\u002Fkg",{"minAge":53},{"value":54,"unit":55},18,"year","weightBased",{"perKgPerDose":58,"perKgPerDoseMax":59,"intervalHours":60},4,8,24,[62],{"source":33,"section":63},"2.2",{"min":5,"max":5},[23],[67],{"text":68,"refs":71},{"fa":69,"en":70},"شروع نکنید اگر ANC \u003C۲۰۰۰، پلاکت \u003C۱۰۰ هزار یا ALT\u002FAST >۱٫۵ برابر حد بالا.","Do not start if ANC \u003C2000, platelets \u003C100,000 or ALT\u002FAST >1.5× ULN.",[72],{"source":33,"section":73},"2.1",{"id":75,"disease":48,"label":76,"population":79,"type":81,"unit":29,"dose":82,"refs":83,"durationDays":85,"allowedFormulations":86},"ra-sc",{"fa":77,"en":78},"آرتریت روماتوئید بزرگسال (زیرجلدی) — ۱۶۲ mg هر ۲ هفته (زیر ۱۰۰ kg؛ افزایش به هفتگی) یا هفتگی (۱۰۰ kg و بالاتر)","Rheumatoid arthritis, adults (SC) — 162 mg every other week (\u003C100 kg; may increase to weekly) or weekly (≥100 kg)",{"minAge":80},{"value":54,"unit":55},"fixed",{"perDose":40,"dosesPerDay":5},[84],{"source":33,"section":63},{"min":5,"max":5},[36],{"id":88,"disease":89,"label":90,"population":93,"type":56,"unit":29,"dose":95,"refs":97,"durationDays":100,"allowedFormulations":101},"gca-iv","giant-cell-arteritis",{"fa":91,"en":92},"آرتریت سلول غول‌آسا (وریدی) — ۶ mg\u002Fkg هر ۴ هفته همراه کاهش تدریجی گلوکوکورتیکوئید","Giant cell arteritis (IV) — 6 mg\u002Fkg every 4 weeks with tapering glucocorticoids",{"minAge":94},{"value":54,"unit":55},{"perKgPerDose":96,"intervalHours":60},6,[98],{"source":33,"section":99},"2.3",{"min":5,"max":5},[23],{"id":103,"disease":89,"label":104,"population":107,"type":81,"unit":29,"dose":109,"refs":110,"durationDays":112,"allowedFormulations":113},"gca-sc",{"fa":105,"en":106},"آرتریت سلول غول‌آسا (زیرجلدی) — ۱۶۲ mg هفتگی همراه کاهش گلوکوکورتیکوئید","Giant cell arteritis (SC) — 162 mg weekly with tapering glucocorticoids",{"minAge":108},{"value":54,"unit":55},{"perDose":40,"dosesPerDay":5},[111],{"source":33,"section":99},{"min":5,"max":5},[36],{"id":115,"disease":116,"label":117,"population":120,"type":56,"unit":29,"dose":124,"refs":126,"durationDays":129,"allowedFormulations":130},"pjia-s","juvenile-arthritis",{"fa":118,"en":119},"JIA پلی‌آرتیکولار (وریدی) — زیر ۳۰ kg: ۱۰ mg\u002Fkg هر ۴ هفته","Polyarticular JIA (IV) — \u003C30 kg: 10 mg\u002Fkg every 4 weeks",{"minAge":121,"maxWeightKg":123},{"value":122,"unit":55},2,29.99,{"perKgPerDose":125,"intervalHours":60},10,[127],{"source":33,"section":128},"2.5",{"min":5,"max":5},[23],{"id":132,"disease":116,"label":133,"population":136,"type":56,"unit":29,"dose":139,"refs":140,"durationDays":142,"allowedFormulations":143},"pjia-l",{"fa":134,"en":135},"JIA پلی‌آرتیکولار (وریدی) — ۳۰ kg و بالاتر: ۸ mg\u002Fkg هر ۴ هفته","Polyarticular JIA (IV) — ≥30 kg: 8 mg\u002Fkg every 4 weeks",{"minAge":137,"minWeightKg":138},{"value":122,"unit":55},30,{"perKgPerDose":59,"intervalHours":60},[141],{"source":33,"section":128},{"min":5,"max":5},[23],{"id":145,"disease":116,"label":146,"population":149,"type":56,"unit":29,"dose":151,"refs":153,"durationDays":156,"allowedFormulations":157},"sjia-s",{"fa":147,"en":148},"JIA سیستمیک (وریدی) — زیر ۳۰ kg: ۱۲ mg\u002Fkg هر ۲ هفته","Systemic JIA (IV) — \u003C30 kg: 12 mg\u002Fkg every 2 weeks",{"minAge":150,"maxWeightKg":123},{"value":122,"unit":55},{"perKgPerDose":152,"intervalHours":60},12,[154],{"source":33,"section":155},"2.6",{"min":5,"max":5},[23],{"id":159,"disease":116,"label":160,"population":163,"type":56,"unit":29,"dose":165,"refs":166,"durationDays":168,"allowedFormulations":169},"sjia-l",{"fa":161,"en":162},"JIA سیستمیک (وریدی) — ۳۰ kg و بالاتر: ۸ mg\u002Fkg هر ۲ هفته","Systemic JIA (IV) — ≥30 kg: 8 mg\u002Fkg every 2 weeks",{"minAge":164,"minWeightKg":138},{"value":122,"unit":55},{"perKgPerDose":59,"intervalHours":60},[167],{"source":33,"section":155},{"min":5,"max":5},[23],{"id":171,"disease":172,"label":173,"population":176,"type":56,"unit":29,"dose":178,"refs":179,"durationDays":182,"allowedFormulations":183,"notes":184},"crs-s","cytokine-release-syndrome",{"fa":174,"en":175},"سندرم آزادسازی سیتوکین (۲ سال به بالا) — زیر ۳۰ kg: ۱۲ mg\u002Fkg انفوزیون ۶۰ دقیقه","Cytokine release syndrome (≥2 y) — \u003C30 kg: 12 mg\u002Fkg over 60 min",{"minAge":177,"maxWeightKg":123},{"value":122,"unit":55},{"perKgPerDose":152,"intervalHours":60},[180],{"source":33,"section":181},"2.7",{"min":5,"max":5},[23],[185],{"text":186,"refs":189},{"fa":187,"en":188},"اگر بهبود نیافت تا ۳ دوز دیگر با فاصله دست‌کم ۸ ساعت. فقط وریدی.","If no improvement, up to 3 more doses at least 8 h apart. IV only.",[190],{"source":33,"section":181},{"id":192,"disease":172,"label":193,"population":196,"type":56,"unit":29,"dose":198,"refs":199,"durationDays":201,"allowedFormulations":202},"crs-l",{"fa":194,"en":195},"سندرم آزادسازی سیتوکین — ۳۰ kg و بالاتر: ۸ mg\u002Fkg انفوزیون ۶۰ دقیقه","Cytokine release syndrome — ≥30 kg: 8 mg\u002Fkg over 60 min",{"minAge":197,"minWeightKg":138},{"value":122,"unit":55},{"perKgPerDose":59,"intervalHours":60},[200],{"source":33,"section":181},{"min":5,"max":5},[23],{"id":204,"disease":205,"label":206,"population":209,"type":56,"unit":29,"dose":211,"refs":212,"durationDays":215,"allowedFormulations":216,"notes":217},"covid","covid-19",{"fa":207,"en":208},"COVID-19 بستری با کورتیکواستروئید و اکسیژن — ۳۰ kg و بالاتر: ۸ mg\u002Fkg یک انفوزیون ۶۰ دقیقه","Hospitalised COVID-19 on corticosteroids and oxygen — ≥30 kg: 8 mg\u002Fkg single 60-min infusion",{"minAge":210,"minWeightKg":138},{"value":122,"unit":55},{"perKgPerDose":59,"intervalHours":60},[213],{"source":33,"section":214},"2.8",{"min":5,"max":5},[23],[218],{"text":219,"refs":222},{"fa":220,"en":221},"زیر ۳۰ kg: ۱۲ mg\u002Fkg. اگر بدتر شد یک انفوزیون دیگر دست‌کم ۸ ساعت بعد.","\u003C30 kg: 12 mg\u002Fkg. If worse or no improvement, one more infusion at least 8 h later.",[223],{"source":33,"section":214},[225],{"id":226,"severity":227,"text":228,"refs":231},"hyper","block",{"fa":229,"en":230},"حساسیت شناخته‌شده به توسیلیزوماب.","Known hypersensitivity to tocilizumab.",[232],{"source":33,"section":233},"4",[235,242],{"text":236,"refs":239},{"fa":237,"en":238},"هشدار جعبه‌ای: عفونت‌های جدی (سل، قارچی، فرصت‌طلب) — در عفونت جدی قطع.","Boxed warning: serious infections (TB, fungal, opportunistic) — interrupt for serious infection.",[240],{"source":33,"section":241},"Boxed Warning",{"text":243,"refs":246},{"fa":244,"en":245},"سوراخ‌شدگی گوارشی؛ سمیت کبدی؛ نوتروپنی، ترومبوسیتوپنی و افزایش چربی خون؛ بیماری دمیلینه‌کننده.","GI perforation; hepatotoxicity; neutropenia, thrombocytopenia and lipid elevation; demyelinating disorders.",[247],{"source":33,"section":248},"5",[],[],[],{"status":253,"reviewer":254,"date":254},"unverified",null,[256,264,267,272,275,279,285,289,292,295,299],{"regimen":47,"formulation":23,"input":257,"expect":260},{"ageYears":258,"weightKg":259},50,70,{"perDose":261,"mlPerDose":262,"upperPerDose":263},280,14,560,{"regimen":75,"formulation":36,"input":265,"expect":266},{"ageYears":258,"weightKg":259},{"perDose":40,"mlPerDose":41},{"regimen":88,"formulation":23,"input":268,"expect":269},{"ageYears":259,"weightKg":259},{"perDose":270,"mlPerDose":271},420,21,{"regimen":103,"formulation":36,"input":273,"expect":274},{"ageYears":259,"weightKg":259},{"perDose":40,"mlPerDose":41},{"regimen":115,"formulation":23,"input":276,"expect":277},{"ageYears":96,"weightKg":28},{"perDose":278,"mlPerDose":125},200,{"regimen":132,"formulation":23,"input":280,"expect":282},{"ageYears":152,"weightKg":281},40,{"perDose":283,"mlPerDose":284},320,16,{"regimen":145,"formulation":23,"input":286,"expect":287},{"ageYears":96,"weightKg":28},{"perDose":288,"mlPerDose":152},240,{"regimen":159,"formulation":23,"input":290,"expect":291},{"ageYears":152,"weightKg":281},{"perDose":283,"mlPerDose":284},{"regimen":171,"formulation":23,"input":293,"expect":294},{"ageYears":96,"weightKg":28},{"perDose":288,"mlPerDose":152},{"regimen":192,"formulation":23,"input":296,"expect":297},{"ageYears":281,"weightKg":259},{"perDose":263,"mlPerDose":298},28,{"regimen":204,"formulation":23,"input":300,"expect":302},{"ageYears":301,"weightKg":259},60,{"perDose":263,"mlPerDose":298},[304],"L04AC07",{"status":306,"forms":307,"refs":324},"registered",[308,312,316,320],{"code":309,"en":310,"fa":311},"15157","TOCILIZUMAB 400MG\u002F20ML VIAL","ویال توسیلیزومب ۴۰۰ میلی‌گرم \u002F ۲۰ میلی‌لیتر",{"code":313,"en":314,"fa":315},"16254","TOCILIZUMAB 80MG\u002F4ML VIAL","ویال توسیلیزومب ۸۰ میلی‌گرم \u002F ۴ میلی‌لیتر",{"code":317,"en":318,"fa":319},"50908","TOCILIZUMAB 200MG\u002F10ML VIAL","ویال توسیلیزومب ۲۰۰ میلی‌گرم \u002F ۱۰ میلی‌لیتر",{"code":321,"en":322,"fa":323},"52706","TOCILIZUMAB 162MG\u002F0.9ML VIAL","ویال توسیلیزومب ۱۶۲ میلی‌گرم \u002F ۰٫۹ میلی‌لیتر",[325],{"source":326,"section":327,"url":328},"darooyab-generic","G-4308\u002FTocilizumab","https:\u002F\u002Fwww.darooyab.ir\u002FG-4308\u002FTocilizumab",{"kind":330,"refs":331,"id":334},"BLA",[332],{"source":33,"section":333},"SPL approval \u002F marketing category","BLA125276",[336,339,343,347,350],{"kind":337,"url":338,"label":334},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=125276",{"kind":340,"url":341,"label":342},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13","FDA Actemra",{"kind":344,"url":345,"label":346},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa611004.html","Tocilizumab Injection",{"kind":348,"url":349,"label":304},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L04AC07",{"kind":351,"url":328,"label":8},"darooyab",{"pregnancy":353,"lactation":362,"pediatric":370,"geriatric":378},{"level":354,"text":355,"quote":358,"refs":359},"caution",{"fa":356,"en":357},"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 The available data with ACTEMRA from a pregnancy exposure registry, retrospective cohort study, pharmacovigilance, and published literature are insufficient to draw conclusions about a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.",[360],{"source":33,"section":361},"8.1",{"level":354,"text":363,"quote":366,"refs":367},{"fa":364,"en":365},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary No information is available on the presence of tocilizumab in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production.",[368],{"source":33,"section":369},"8.2",{"level":354,"text":371,"quote":374,"refs":375},{"fa":372,"en":373},"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.","COVID-19 – Intravenous Use The safety and effectiveness of ACTEMRA have been established for the treatment of pediatric patients aged 2 years and older with COVID-19.",[376],{"source":33,"section":377},"8.4",{"level":354,"text":379,"quote":382,"refs":383},{"fa":380,"en":381},"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.","As there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly.",[384],{"source":33,"section":385},"8.5",1792191569802]