[{"data":1,"prerenderedAt":190},["ShallowReactive",2],{"drug-natalizumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":35,"contraindications":74,"warnings":84,"renal":99,"monitoring":100,"interactions":101,"review":102,"examples":105,"atc":114,"iran":116,"usApproval":132,"links":138,"populations":155},"natalizumab",1,{"fa":7,"en":8},"ناتالیزوماب","Natalizumab","antineoplastic-immunomodulating",{"fa":11,"en":12},"آنتی‌بادی ضد اینتگرین α4","Anti-α4 integrin antibody",[14],{"name":15,"market":16},"Tysabri","US",[18,19,7],"tysabri","تیزابری",[21],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"vial-300","injection","iv","300 mg\u002F15 mL (20 mg\u002FmL) vial for IV infusion",{"amount":27,"unit":28,"perVolumeMl":29},300,"mg",15,[16],[32],{"source":33,"section":34},"fda-tysabri","3",[36,61],{"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 — ۳۰۰ mg انفوزیون وریدی ۱ ساعته هر ۴ هفته","Relapsing MS, adults — 300 mg IV infusion over 1 h every 4 weeks",{"minAge":43},{"value":44,"unit":45},18,"year","fixed",{"perDose":27,"dosesPerDay":5},[49],{"source":33,"section":50},"2.1",{"min":5,"max":5},[53],{"text":54,"refs":57},{"fa":55,"en":56},"فقط در برنامه TOUCH؛ بولوس نه؛ تا ۴۸ ساعت پس از تهیه. ۱۲ انفوزیون اول یک ساعت پس از آن پایش.","TOUCH program only; never IV push; use within 48 h of preparation. Observe 1 h after each of the first 12 infusions.",[58,59],{"source":33,"section":50},{"source":33,"section":60},"2",{"id":62,"disease":63,"label":64,"population":67,"type":46,"unit":28,"dose":69,"refs":70,"durationDays":73},"cd","crohns",{"fa":65,"en":66},"کرون متوسط تا شدید بزرگسال — ۳۰۰ mg وریدی هر ۴ هفته (بدون سرکوب‌کننده ایمنی یا ضد TNF همزمان)","Moderate–severe Crohn disease, adults — 300 mg IV every 4 weeks (no concomitant immunosuppressants or TNF inhibitors)",{"minAge":68},{"value":44,"unit":45},{"perDose":27,"dosesPerDay":5},[71],{"source":33,"section":72},"2.2",{"min":5,"max":5},[75],{"id":76,"severity":77,"text":78,"refs":81},"ci","block",{"fa":79,"en":80},"PML فعلی یا قبلی؛ حساسیت به ناتالیزوماب.","Current or past PML; hypersensitivity to natalizumab.",[82],{"source":33,"section":83},"4",[85,92],{"text":86,"refs":89},{"fa":87,"en":88},"هشدار جعبه‌ای: لکوآنسفالوپاتی چندکانونی پیشرونده (PML) — خطر با آنتی‌بادی JCV، مدت درمان و سرکوب ایمنی قبلی بیشتر.","Boxed warning: progressive multifocal leukoencephalopathy (PML) — risk rises with anti-JCV antibodies, treatment duration and prior immunosuppressants.",[90],{"source":33,"section":91},"Boxed Warning",{"text":93,"refs":96},{"fa":94,"en":95},"عفونت هرپسی (آنسفالیت، رتینیت)؛ سمیت کبد؛ حساسیت.","Herpes infections (encephalitis, retinitis); hepatotoxicity; hypersensitivity.",[97],{"source":33,"section":98},"5",[],[],[],{"status":103,"reviewer":104,"date":104},"unverified",null,[106,111],{"regimen":37,"formulation":22,"input":107,"expect":110},{"ageYears":108,"weightKg":109},35,65,{"perDose":27,"mlPerDose":29},{"regimen":62,"formulation":22,"input":112,"expect":113},{"ageYears":108,"weightKg":109},{"perDose":27,"mlPerDose":29},[115],"L04AG03",{"status":117,"forms":118,"refs":127},"registered",[119,123],{"code":120,"en":121,"fa":122},"12534","NATALIZUMAB 20MG\u002FML  VIAL","ویال ناتالیزومب ۲۰ میلی‌گرم \u002F میلی‌لیتر",{"code":124,"en":125,"fa":126},"11759","NATALIZUMAB 300 AMP","آمپول ناتالیزومب ۳۰۰",[128],{"source":129,"section":130,"url":131},"darooyab-generic","G-4040\u002FNatalizumab","https:\u002F\u002Fwww.darooyab.ir\u002FG-4040\u002FNatalizumab",{"kind":133,"refs":134,"id":137},"BLA",[135],{"source":33,"section":136},"SPL approval \u002F marketing category","BLA125104",[139,142,146,150,153],{"kind":140,"url":141,"label":137},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=125104",{"kind":143,"url":144,"label":145},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=c5fdde91-1989-4dd2-9129-4f3323ea2962","FDA Tysabri",{"kind":147,"url":148,"label":149},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa605006.html","Natalizumab Injection",{"kind":151,"url":152,"label":115},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L04AG03",{"kind":154,"url":131,"label":8},"darooyab",{"pregnancy":156,"lactation":165,"pediatric":173,"geriatric":182},{"level":157,"text":158,"quote":161,"refs":162},"caution",{"fa":159,"en":160},"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 risk of major birth defects, miscarriage, or other adverse maternal outcomes associated with the use of TYSABRI in pregnant women.",[163],{"source":33,"section":164},"8.1",{"level":157,"text":166,"quote":169,"refs":170},{"fa":167,"en":168},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary Natalizumab has been detected in human milk.",[171],{"source":33,"section":172},"8.2",{"level":174,"text":175,"quote":178,"refs":179},"not-established",{"fa":176,"en":177},"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 with multiple sclerosis or Crohn's disease below the age of 18 years have not been established.",[180],{"source":33,"section":181},"8.4",{"level":157,"text":183,"quote":186,"refs":187},{"fa":184,"en":185},"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 TYSABRI did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients.",[188],{"source":33,"section":189},"8.5",1792191556880]