[{"data":1,"prerenderedAt":204},["ShallowReactive",2],{"drug-vedolizumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":46,"contraindications":95,"warnings":105,"renal":113,"monitoring":114,"interactions":115,"review":116,"examples":119,"atc":131,"iran":133,"usApproval":145,"links":151,"populations":168},"vedolizumab",1,{"fa":7,"en":8},"ودولیزوماب","Vedolizumab","antineoplastic-immunomodulating",{"fa":11,"en":12},"آنتی‌بادی ضد اینتگرین α4β7","Anti-α4β7 integrin antibody",[14],{"name":15,"market":16},"Entyvio","US",[18,19,7],"entyvio","انتیویو",[21,35],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"vial-300","powder-for-injection","iv","300 mg vial",{"amount":27,"unit":28,"perUnit":29},300,"mg","vial",[16],[32],{"source":33,"section":34},"fda-entyvio","3",{"id":36,"form":37,"route":38,"label":39,"concentration":40,"markets":43,"refs":44},"pfs-108","injection","sc","108 mg\u002F0.68 mL prefilled syringe or pen",{"amount":41,"unit":28,"perVolumeMl":42},108,0.68,[16],[45],{"source":33,"section":34},[47,71,84],{"id":48,"disease":49,"label":50,"population":53,"type":57,"unit":28,"dose":58,"refs":59,"durationDays":62,"allowedFormulations":63,"notes":64},"uc","ulcerative-colitis",{"fa":51,"en":52},"کولیت اولسراتیو متوسط تا شدید بزرگسال — ۳۰۰ mg وریدی هفته ۰، ۲ و ۶، سپس هر ۸ هفته","Moderate–severe ulcerative colitis, adults — 300 mg IV at weeks 0, 2 and 6, then every 8 weeks",{"minAge":54},{"value":55,"unit":56},18,"year","fixed",{"perDose":27,"dosesPerDay":5},[60],{"source":33,"section":61},"2",{"min":5,"max":5},[22],[65],{"text":66,"refs":69},{"fa":67,"en":68},"انفوزیون حدود ۳۰ دقیقه. پس از ۲ دوز وریدی می‌توان به زیرجلدی ۱۰۸ mg هر ۲ هفته تغییر داد. اگر تا هفته ۱۴ سودی نبود قطع.","Infuse over about 30 min. After two IV doses, may switch to 108 mg SC every 2 weeks. Stop if no benefit by week 14.",[70],{"source":33,"section":61},{"id":72,"disease":73,"label":74,"population":77,"type":57,"unit":28,"dose":79,"refs":80,"durationDays":82,"allowedFormulations":83},"cd","crohns",{"fa":75,"en":76},"کرون متوسط تا شدید بزرگسال — ۳۰۰ mg وریدی هفته ۰، ۲ و ۶، سپس هر ۸ هفته","Moderate–severe Crohn disease, adults — 300 mg IV at weeks 0, 2 and 6, then every 8 weeks",{"minAge":78},{"value":55,"unit":56},{"perDose":27,"dosesPerDay":5},[81],{"source":33,"section":61},{"min":5,"max":5},[22],{"id":38,"disease":49,"label":85,"population":88,"type":57,"unit":28,"dose":90,"refs":91,"durationDays":93,"allowedFormulations":94},{"fa":86,"en":87},"نگهدارنده زیرجلدی (کولیت یا کرون) — ۱۰۸ mg هر ۲ هفته","Subcutaneous maintenance (UC or Crohn) — 108 mg every 2 weeks",{"minAge":89},{"value":55,"unit":56},{"perDose":41,"dosesPerDay":5},[92],{"source":33,"section":61},{"min":5,"max":5},[36],[96],{"id":97,"severity":98,"text":99,"refs":102},"hyper","block",{"fa":100,"en":101},"حساسیت جدی قبلی به ودولیزوماب.","Prior serious hypersensitivity to vedolizumab.",[103],{"source":33,"section":104},"4",[106],{"text":107,"refs":110},{"fa":108,"en":109},"واکنش انفوزیون و حساسیت؛ عفونت؛ لکوآنسفالوپاتی چندکانونی پیشرونده (PML)؛ آسیب کبدی؛ واکسن‌ها پیش از شروع کامل شود.","Infusion and hypersensitivity reactions; infections; progressive multifocal leukoencephalopathy (PML); liver injury; complete immunisations before starting.",[111],{"source":33,"section":112},"5",[],[],[],{"status":117,"reviewer":118,"date":118},"unverified",null,[120,125,128],{"regimen":48,"formulation":22,"input":121,"expect":124},{"ageYears":122,"weightKg":123},35,70,{"perDose":27},{"regimen":72,"formulation":22,"input":126,"expect":127},{"ageYears":122,"weightKg":123},{"perDose":27},{"regimen":38,"formulation":36,"input":129,"expect":130},{"ageYears":122,"weightKg":123},{"perDose":41,"mlPerDose":42},[132],"L04AG05",{"status":134,"forms":135,"refs":140},"registered",[136],{"code":137,"en":138,"fa":139},"52954","VEDOLIZUMAB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PARENTERAL 300 mg","محلول تزریقی ودولیزومب ۳۰۰ میلی‌گرم",[141],{"source":142,"section":143,"url":144},"darooyab-generic","G-4574\u002FVedolizumab","https:\u002F\u002Fwww.darooyab.ir\u002FG-4574\u002FVedolizumab",{"kind":146,"refs":147,"id":150},"BLA",[148],{"source":33,"section":149},"SPL approval \u002F marketing category","BLA125476",[152,155,159,163,166],{"kind":153,"url":154,"label":150},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=125476",{"kind":156,"url":157,"label":158},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=6e94621c-1a95-4af9-98d1-52b9e6f1949c","FDA Entyvio",{"kind":160,"url":161,"label":162},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa614034.html","Vedolizumab Injection",{"kind":164,"url":165,"label":132},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L04AG05",{"kind":167,"url":144,"label":8},"darooyab",{"pregnancy":169,"lactation":178,"pediatric":186,"geriatric":195},{"level":170,"text":171,"quote":174,"refs":175},"caution",{"fa":172,"en":173},"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 Available data from the Organization of Teratology Information Specialists (OTIS)\u002FMotherToBaby ENTYVIO Pregnancy Registry, published literature and pharmacovigilance in pregnant women have not reliably identified an ENTYVIO-associated risk of major birth defects, miscarriage or adverse maternal or fetal …",[176],{"source":33,"section":177},"8.1",{"level":170,"text":179,"quote":182,"refs":183},{"fa":180,"en":181},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary Data from a clinical lactation study show the presence of vedolizumab in human milk.",[184],{"source":33,"section":185},"8.2",{"level":187,"text":188,"quote":191,"refs":192},"not-established",{"fa":189,"en":190},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","Safety and effectiveness of ENTYVIO in pediatric patients have not been established.",[193],{"source":33,"section":194},"8.4",{"level":196,"text":197,"quote":200,"refs":201},"ok",{"fa":198,"en":199},"برچسب: در سالمندان تفاوت یا تنظیم دوز خاصی ذکر نشده.","Label: no specific difference or dose adjustment stated for older adults.","However, no overall differences in safety or effectiveness were observed between these patients and younger adult patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients.",[202],{"source":33,"section":203},"8.5",1792191572268]