[{"data":1,"prerenderedAt":199},["ShallowReactive",2],{"drug-cetuximab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":34,"contraindications":79,"warnings":80,"renal":95,"monitoring":96,"interactions":97,"review":98,"examples":101,"atc":113,"iran":115,"usApproval":131,"links":137,"populations":154},"cetuximab",1,{"fa":7,"en":8},"ستوکسیماب","Cetuximab","antineoplastic-immunomodulating",{"fa":11,"en":12},"آنتی‌بادی ضد EGFR","EGFR antagonist antibody",[14],{"name":15,"market":16},"Erbitux","US",[18,19,7],"erbitux","اربیتوکس",[21],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":29,"refs":30},"inj-2","injection","iv","2 mg\u002FmL (100 mg\u002F50 mL, 200 mg\u002F100 mL)",{"amount":27,"unit":28,"perVolumeMl":5},2,"mg",[16],[31],{"source":32,"section":33},"fda-erbitux","3",[35,61],{"id":36,"disease":37,"label":38,"population":41,"type":45,"unit":28,"dose":46,"refs":48,"durationDays":53,"notes":54},"load","colorectal-cancer",{"fa":39,"en":40},"سرطان کولورکتال RAS وحشی و سر و گردن — دوز اول ۴۰۰ mg\u002Fm² وریدی ۱۲۰ دقیقه","RAS wild-type colorectal and head-and-neck cancer — initial dose 400 mg\u002Fm² IV over 120 min",{"minAge":42},{"value":43,"unit":44},18,"year","bsa",{"perM2PerDay":47,"dividedDoses":5},400,[49,51],{"source":32,"section":50},"2.2",{"source":32,"section":52},"2.3",{"min":5,"max":5},[55],{"text":56,"refs":59},{"fa":57,"en":58},"فقط زیر نظر متخصص انکولوژی؛ ادامه تا پیشرفت بیماری یا سمیت غیرقابل‌قبول. تنظیم دوز برای عوارض و تداخل‌ها طبق برچسب.","Only under an oncologist; continue until progression or unacceptable toxicity. Dose adjustments for toxicity and interactions per label.",[60],{"source":32,"section":52},{"id":62,"disease":37,"label":63,"population":66,"type":45,"unit":28,"dose":68,"refs":70,"durationDays":73,"notes":74},"weekly",{"fa":64,"en":65},"ادامه هفتگی — ۲۵۰ mg\u002Fm² وریدی ۶۰ دقیقه هر هفته (یا ۵۰۰ mg\u002Fm² هر ۲ هفته)","Weekly continuation — 250 mg\u002Fm² IV over 60 min every week (or 500 mg\u002Fm² every 2 weeks)",{"minAge":67},{"value":43,"unit":44},{"perM2PerDay":69,"dividedDoses":5},250,[71,72],{"source":32,"section":50},{"source":32,"section":52},{"min":5,"max":5},[75],{"text":76,"refs":77},{"fa":57,"en":58},[78],{"source":32,"section":52},[],[81,88],{"text":82,"refs":85},{"fa":83,"en":84},"هشدار جعبه‌ای: واکنش انفوزیون جدی و کشنده؛ ایست قلبی‌ریوی یا مرگ ناگهانی (پایش الکترولیت‌ها).","Boxed warning: serious and fatal infusion reactions; cardiopulmonary arrest or sudden death (monitor electrolytes).",[86],{"source":32,"section":87},"Boxed Warning",{"text":89,"refs":92},{"fa":90,"en":91},"سمیت ریوی؛ سمیت پوستی؛ هیپومنیزیمی؛ پیشرفت تومور و مرگ بیشتر در RAS جهش‌یافته؛ سمیت جنینی.","Pulmonary toxicity; dermatologic toxicity; hypomagnesaemia; increased progression and mortality in RAS-mutant disease; embryo-fetal toxicity.",[93],{"source":32,"section":94},"5",[],[],[],{"status":99,"reviewer":100,"date":100},"unverified",null,[102,109],{"regimen":36,"formulation":22,"input":103,"expect":107},{"ageYears":104,"weightKg":105,"heightCm":106},55,80,180,{"perDose":108,"mlPerDose":47},800,{"regimen":62,"formulation":22,"input":110,"expect":111},{"ageYears":104,"weightKg":105,"heightCm":106},{"perDose":112,"mlPerDose":69},500,[114],"L01FE01",{"status":116,"forms":117,"refs":126},"registered",[118,122],{"code":119,"en":120,"fa":121},"04258","CETUXIMAB 100MG\u002F50ML VIAL","ویال ستوکسیمب ۱۰۰ میلی‌گرم \u002F ۵۰ میلی‌لیتر",{"code":123,"en":124,"fa":125},"15691","CETUXIMAB 5MG\u002FML 20ML VIAL","ویال ستوکسیمب ۵ میلی‌گرم \u002F میلی‌لیتر ۲۰ میلی‌لیتر",[127],{"source":128,"section":129,"url":130},"darooyab-generic","G-966\u002FCetuximab","https:\u002F\u002Fwww.darooyab.ir\u002FG-966\u002FCetuximab",{"kind":132,"refs":133,"id":136},"BLA",[134],{"source":32,"section":135},"SPL approval \u002F marketing category","BLA125084",[138,141,145,149,152],{"kind":139,"url":140,"label":136},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=125084",{"kind":142,"url":143,"label":144},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=8bc6397e-4bd8-4d37-a007-a327e4da34d9","FDA Erbitux",{"kind":146,"url":147,"label":148},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa607041.html","Cetuximab Injection",{"kind":150,"url":151,"label":114},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L01FE01",{"kind":153,"url":130,"label":8},"darooyab",{"pregnancy":155,"lactation":164,"pediatric":172,"geriatric":181,"reproductive":190},{"level":156,"text":157,"quote":160,"refs":161},"avoid",{"fa":158,"en":159},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology ( 12.1 )] , ERBITUX can cause fetal harm when administered to a pregnant woman.",[162],{"source":32,"section":163},"8.1",{"level":156,"text":165,"quote":168,"refs":169},{"fa":166,"en":167},"برچسب: شیردهی توصیه نمی‌شود یا باید بین دارو و شیردهی یکی انتخاب شود.","Label: breastfeeding not recommended, or choose between the drug and breastfeeding.","Due to the potential for serious adverse reactions in breastfed infants from ERBITUX, advise women not to breastfeed during treatment with ERBITUX and for 2 months after the last dose of ERBITUX.",[170],{"source":32,"section":171},"8.2",{"level":173,"text":174,"quote":177,"refs":178},"not-established",{"fa":175,"en":176},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","The safety and effectiveness of ERBITUX in pediatric patients have not been established.",[179],{"source":32,"section":180},"8.4",{"level":182,"text":183,"quote":186,"refs":187},"ok",{"fa":184,"en":185},"برچسب: در سالمندان تفاوت یا تنظیم دوز خاصی ذکر نشده.","Label: no specific difference or dose adjustment stated for older adults.","No overall differences in safety or efficacy were observed between these patients and younger patients.",[188],{"source":32,"section":189},"8.5",{"level":191,"text":192,"quote":195,"refs":196},"caution",{"fa":193,"en":194},"برچسب نکته‌ای درباره بارداری، پیشگیری یا باروری زنان و مردان دارد.","Label has advice on pregnancy testing, contraception or fertility for females and males.","Contraception Based on its mechanism of action, ERBITUX can cause harm to the fetus when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )] .",[197],{"source":32,"section":198},"8.3",1792444387688]