[{"data":1,"prerenderedAt":187},["ShallowReactive",2],{"drug-daratumumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":34,"contraindications":69,"warnings":79,"renal":87,"monitoring":88,"interactions":89,"review":90,"examples":93,"atc":101,"iran":103,"usApproval":119,"links":125,"populations":142},"daratumumab",1,{"fa":7,"en":8},"داراتوموماب","Daratumumab","antineoplastic-immunomodulating",{"fa":11,"en":12},"آنتی‌بادی ضد CD38","CD38-directed antibody",[14],{"name":15,"market":16},"Darzalex","US",[18,19,7],"darzalex","دارزالکس",[21],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":29,"refs":30},"inj-20","injection","iv","20 mg\u002FmL (100 mg\u002F5 mL, 400 mg\u002F20 mL) — IV",{"amount":27,"unit":28,"perVolumeMl":5},20,"mg",[16],[31],{"source":32,"section":33},"fda-darzalex","3",[35],{"id":36,"disease":37,"label":38,"population":41,"type":45,"unit":28,"dose":46,"refs":49,"durationDays":52,"notes":53},"mm","multiple-myeloma",{"fa":39,"en":40},"مولتیپل میلوما — ۱۶ mg\u002Fkg وزن واقعی، انفوزیون وریدی؛ برنامه طبق رژیم ترکیبی","Multiple myeloma — 16 mg\u002Fkg actual body weight IV infusion; schedule by combination regimen",{"minAge":42},{"value":43,"unit":44},18,"year","weightBased",{"perKgPerDose":47,"intervalHours":48},16,24,[50],{"source":32,"section":51},"2.2",{"min":5,"max":5},[54,60],{"text":55,"refs":58},{"fa":56,"en":57},"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.",[59],{"source":32,"section":51},{"text":61,"refs":64},{"fa":62,"en":63},"پیش‌دارو: کورتیکواستروئید، ضدتب و آنتی‌هیستامین؛ داروهای پس از انفوزیون. پیش از شروع گروه خون و غربالگری آنتی‌بادی (تداخل با کراس‌مچ).","Premedicate with corticosteroid, antipyretic and antihistamine; post-infusion medicines. Type and screen before starting (cross-match interference).",[65,67],{"source":32,"section":66},"2.3",{"source":32,"section":68},"5.2",[70],{"id":71,"severity":72,"text":73,"refs":76},"hyper","block",{"fa":74,"en":75},"سابقه حساسیت شدید (آنافیلاکسی) به داراتوموماب یا اجزا.","History of severe hypersensitivity (anaphylaxis) to daratumumab or components.",[77],{"source":32,"section":78},"4",[80],{"text":81,"refs":84},{"fa":82,"en":83},"واکنش انفوزیون؛ تداخل با آزمایش سرولوژی و تعیین پاسخ؛ عفونت؛ نوتروپنی؛ ترومبوسیتوپنی؛ سمیت جنینی.","Infusion reactions; interference with serological testing and response assessment; infections; neutropenia; thrombocytopenia; embryo-fetal toxicity.",[85],{"source":32,"section":86},"5",[],[],[],{"status":91,"reviewer":92,"date":92},"unverified",null,[94],{"regimen":36,"formulation":22,"input":95,"expect":98},{"ageYears":96,"weightKg":97},65,70,{"perDose":99,"mlPerDose":100},1120,56,[102],"L01FC01",{"status":104,"forms":105,"refs":114},"registered",[106,110],{"code":107,"en":108,"fa":109},"52628","DARATUMUMAB INJECTION, SOLUTION, CONCENTRATE PARENTERAL 20 mg\u002F1mL 20 mL","کنسانتره محلول تزریقی داراتومومب ۲۰ میلی‌گرم \u002F ۱ میلی‌لیتر ۲۰ میلی‌لیتر",{"code":111,"en":112,"fa":113},"52627","DARATUMUMAB INJECTION, SOLUTION, CONCENTRATE PARENTERAL 20 mg\u002F1mL 5 mL","کنسانتره محلول تزریقی داراتومومب ۲۰ میلی‌گرم \u002F ۱ میلی‌لیتر ۵ میلی‌لیتر",[115],{"source":116,"section":117,"url":118},"darooyab-generic","G-5483\u002FDaratumumab","https:\u002F\u002Fwww.darooyab.ir\u002FG-5483\u002FDaratumumab",{"kind":120,"refs":121,"id":124},"BLA",[122],{"source":32,"section":123},"SPL approval \u002F marketing category","BLA761036",[126,129,133,137,140],{"kind":127,"url":128,"label":124},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=761036",{"kind":130,"url":131,"label":132},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=a4d0efe9-5e54-467e-9eb4-56fa7d53b60b","FDA Darzalex",{"kind":134,"url":135,"label":136},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa616002.html","Daratumumab Injection",{"kind":138,"url":139,"label":102},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L01FC01",{"kind":141,"url":118,"label":8},"darooyab",{"pregnancy":143,"lactation":152,"pediatric":160,"geriatric":169,"reproductive":178},{"level":144,"text":145,"quote":148,"refs":149},"avoid",{"fa":146,"en":147},"برچسب: ترکیب با لنالیدومید، پومالیدومید یا تالیدومید در بارداری منع مصرف است.","Label: combination with lenalidomide, pomalidomide or thalidomide is contraindicated in pregnancy.","The combination of DARZALEX and lenalidomide, pomalidomide, or thalidomide is contraindicated in pregnant women, because lenalidomide, pomalidomide, and thalidomide may cause birth defects and death of the unborn child.",[150],{"source":32,"section":151},"8.1",{"level":144,"text":153,"quote":156,"refs":157},{"fa":154,"en":155},"برچسب: شیردهی توصیه نمی‌شود یا باید بین دارو و شیردهی یکی انتخاب شود.","Label: breastfeeding not recommended, or choose between the drug and breastfeeding.","Because of the potential for serious adverse reactions in the breastfed child when DARZALEX is administered with lenalidomide, pomalidomide, or thalidomide, advise women not to breastfeed during treatment with DARZALEX.",[158],{"source":32,"section":159},"8.2",{"level":161,"text":162,"quote":165,"refs":166},"not-established",{"fa":163,"en":164},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","Safety and effectiveness of DARZALEX in pediatric patients have not been established.",[167],{"source":32,"section":168},"8.4",{"level":170,"text":171,"quote":174,"refs":175},"ok",{"fa":172,"en":173},"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 effectiveness were observed between these patients and younger patients.",[176],{"source":32,"section":177},"8.5",{"level":179,"text":180,"quote":183,"refs":184},"caution",{"fa":181,"en":182},"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 Advise females of reproductive potential to use effective contraception during treatment with DARZALEX and for 3 months after the last dose.",[185],{"source":32,"section":186},"8.3",1792444391810]