[{"data":1,"prerenderedAt":179},["ShallowReactive",2],{"drug-ofatumumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":35,"contraindications":60,"warnings":70,"renal":84,"monitoring":85,"interactions":86,"review":87,"examples":90,"atc":96,"iran":98,"usApproval":110,"links":116,"populations":136},"ofatumumab",1,{"fa":7,"en":8},"اوفاتوموماب","Ofatumumab","antineoplastic-immunomodulating",{"fa":11,"en":12},"آنتی‌بادی ضد CD20 (زیرجلدی)","Anti-CD20 antibody (SC)",[14],{"name":15,"market":16},"Kesimpta","US",[18,19,7],"kesimpta","کسیمپتا",[21],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"pen-20","injection","sc","20 mg\u002F0.4 mL Sensoready pen or syringe",{"amount":27,"unit":28,"perVolumeMl":29},20,"mg",0.4,[16],[32],{"source":33,"section":34},"fda-kesimpta","3",[36],{"id":37,"disease":38,"label":39,"population":42,"type":46,"unit":28,"dose":47,"refs":48,"durationDays":51,"notes":52},"ms","multiple-sclerosis",{"fa":40,"en":41},"ام‌اس عودکننده بزرگسال — ۲۰ mg زیرجلدی هفته ۰، ۱ و ۲، سپس ماهانه از هفته ۴","Relapsing MS, adults — 20 mg SC at weeks 0, 1 and 2, then monthly from week 4",{"minAge":43},{"value":44,"unit":45},18,"year","fixed",{"perDose":27,"dosesPerDay":5},[49],{"source":33,"section":50},"2.2",{"min":5,"max":5},[53],{"text":54,"refs":57},{"fa":55,"en":56},"پیش از شروع HBV، ایمونوگلوبولین و آنزیم کبد.","Screen HBV, immunoglobulins and liver tests before starting.",[58],{"source":33,"section":59},"2.1",[61],{"id":62,"severity":63,"text":64,"refs":67},"ci","block",{"fa":65,"en":66},"عفونت فعال HBV؛ سابقه حساسیت یا واکنش تزریقی تهدیدکننده حیات.","Active HBV infection; prior hypersensitivity or life-threatening injection reaction.",[68],{"source":33,"section":69},"4",[71,78],{"text":72,"refs":75},{"fa":73,"en":74},"عفونت (HBV پیش از شروع)؛ PML؛ کاهش ایمونوگلوبولین‌ها؛ آسیب کبد.","Infections (screen HBV first); PML; reduced immunoglobulins; liver injury.",[76],{"source":33,"section":77},"5",{"text":79,"refs":82},{"fa":80,"en":81},"واکنش تزریقی؛ خطر جنینی (پیشگیری تا ۶ ماه).","Injection-related reactions; fetal risk (contraception for 6 months).",[83],{"source":33,"section":77},[],[],[],{"status":88,"reviewer":89,"date":89},"unverified",null,[91],{"regimen":37,"formulation":22,"input":92,"expect":95},{"ageYears":93,"weightKg":94},35,65,{"perDose":27,"mlPerDose":29},[97],"L04AG12",{"status":99,"forms":100,"refs":105},"registered",[101],{"code":102,"en":103,"fa":104},"51632","OFATUMUMAB INJECTION, SOLUTION, CONCENTRATE PARENTERAL 20 mg\u002F1mL 5 mL","کنسانتره محلول تزریقی افاتومومب ۲۰ میلی‌گرم \u002F ۱ میلی‌لیتر ۵ میلی‌لیتر",[106],{"source":107,"section":108,"url":109},"darooyab-generic","G-5290\u002FOfatumumab","https:\u002F\u002Fwww.darooyab.ir\u002FG-5290\u002FOfatumumab",{"kind":111,"refs":112,"id":115},"BLA",[113],{"source":33,"section":114},"SPL approval \u002F marketing category","BLA125326",[117,120,124,128,131,134],{"kind":118,"url":119,"label":115},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=125326",{"kind":121,"url":122,"label":123},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=6a8a3f53-2062-48ff-9dbe-b939df133ca3","FDA Kesimpta",{"kind":125,"url":126,"label":127},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa610009.html","Ofatumumab Injection (Chronic Lymphocytic Leukemia)",{"kind":125,"url":129,"label":130},"https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa621050.html","Ofatumumab Injection (Multiple Sclerosis)",{"kind":132,"url":133,"label":97},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L04AG12",{"kind":135,"url":109,"label":8},"darooyab",{"pregnancy":137,"lactation":146,"pediatric":154,"geriatric":163,"reproductive":171},{"level":138,"text":139,"quote":142,"refs":143},"caution",{"fa":140,"en":141},"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 There are no adequate data on the developmental risk associated with the use of KESIMPTA in pregnant women.",[144],{"source":33,"section":145},"8.1",{"level":138,"text":147,"quote":150,"refs":151},{"fa":148,"en":149},"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 ofatumumab in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.",[152],{"source":33,"section":153},"8.2",{"level":155,"text":156,"quote":159,"refs":160},"not-established",{"fa":157,"en":158},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","Safety and effectiveness in pediatric patients have not been established.",[161],{"source":33,"section":162},"8.4",{"level":138,"text":164,"quote":167,"refs":168},{"fa":165,"en":166},"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.","Clinical studies of KESIMPTA did not include sufficient numbers of geriatric patients to determine whether they respond differently from younger subjects.",[169],{"source":33,"section":170},"8.5",{"level":138,"text":172,"quote":175,"refs":176},{"fa":173,"en":174},"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 Females of childbearing potential should use effective contraception while receiving KESIMPTA and for 6 months after the last treatment of KESIMPTA.",[177],{"source":33,"section":178},"8.3",1792191557832]