[{"data":1,"prerenderedAt":165},["ShallowReactive",2],{"drug-pegloticase":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":34,"contraindications":61,"warnings":71,"renal":85,"monitoring":86,"interactions":87,"review":88,"examples":91,"atc":97,"iran":99,"links":106,"populations":124,"usApproval":160},"pegloticase",1,{"fa":7,"en":8},"پگلوتیکاز","Pegloticase","musculoskeletal",{"fa":11,"en":12},"اوریکاز پگیله","PEGylated uricase",[14],{"name":15,"market":16},"Krystexxa","US",[18,19,7],"krystexxa","کریستکسا",[21],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":29,"refs":30},"vial-8","injection","iv","8 mg\u002FmL vial (to be diluted)",{"amount":27,"unit":28,"perVolumeMl":5},8,"mg",[16],[31],{"source":32,"section":33},"fda-krystexxa","3",[35],{"id":36,"disease":36,"label":37,"population":40,"type":44,"unit":28,"dose":45,"refs":46,"durationDays":49,"notes":50},"gout",{"fa":38,"en":39},"نقرس مزمن مقاوم بزرگسال — ۸ mg انفوزیون وریدی هر ۲ هفته همراه متوترکسات ۱۵ mg هفتگی","Refractory chronic gout, adults — 8 mg IV infusion every 2 weeks with methotrexate 15 mg weekly",{"minAge":41},{"value":42,"unit":43},18,"year","fixed",{"perDose":27,"dosesPerDay":5},[47],{"source":32,"section":48},"2.2",{"min":5,"max":5},[51],{"text":52,"refs":55},{"fa":53,"en":54},"متوترکسات و اسید فولیک دست‌کم ۴ هفته پیش از شروع. داروهای خوراکی کاهنده اسید اوریک قطع شود. پیش‌دارو آنتی‌هیستامین و کورتیکواستروئید. اسید اوریک پیش از هر انفوزیون (دو بار پیاپی بالای ۶ mg\u002FdL: قطع).","Methotrexate and folic acid at least 4 weeks before. Stop oral urate-lowering drugs. Premedicate with antihistamine and corticosteroid. Check uric acid before each infusion (two consecutive >6 mg\u002FdL: stop).",[56,57,59],{"source":32,"section":48},{"source":32,"section":58},"2",{"source":32,"section":60},"Boxed Warning",[62],{"id":63,"severity":64,"text":65,"refs":68},"ci","block",{"fa":66,"en":67},"کمبود G6PD؛ سابقه حساسیت جدی به پگلوتیکاز.","G6PD deficiency; prior serious hypersensitivity to pegloticase.",[69],{"source":32,"section":70},"4",[72,78],{"text":73,"refs":76},{"fa":74,"en":75},"هشدار جعبه‌ای: آنافیلاکسی و واکنش انفوزیون (فقط در مرکز درمانی)؛ همولیز و مت‌هموگلوبینمی در کمبود G6PD — پیش از شروع تست G6PD.","Boxed warning: anaphylaxis and infusion reactions (healthcare setting only); haemolysis and methaemoglobinaemia in G6PD deficiency — screen for G6PD first.",[77],{"source":32,"section":60},{"text":79,"refs":82},{"fa":80,"en":81},"حمله نقرس در شروع؛ نارسایی قلب.","Gout flares at initiation; congestive heart failure.",[83],{"source":32,"section":84},"5",[],[],[],{"status":89,"reviewer":90,"date":90},"unverified",null,[92],{"regimen":36,"formulation":22,"input":93,"expect":96},{"ageYears":94,"weightKg":95},55,85,{"perDose":27,"mlPerDose":5},[98],"M04AX02",{"status":100,"refs":101},"not-found",[102],{"source":103,"section":104,"url":105},"darooyab-generic","G-4694\u002FPegloticase","https:\u002F\u002Fwww.darooyab.ir\u002FG-4694\u002FPegloticase",[107,111,115,119,122],{"kind":108,"url":109,"label":110},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=125293","BLA125293",{"kind":112,"url":113,"label":114},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=6e566303-d93a-4130-b764-25749829aa95","FDA Krystexxa",{"kind":116,"url":117,"label":118},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa611015.html","Pegloticase Injection",{"kind":120,"url":121,"label":98},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=M04AX02",{"kind":123,"url":105,"label":8},"darooyab",{"pregnancy":125,"lactation":134,"pediatric":142,"geriatric":151},{"level":126,"text":127,"quote":130,"refs":131},"caution",{"fa":128,"en":129},"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 and well-controlled studies of KRYSTEXXA in pregnant women.",[132],{"source":32,"section":133},"8.1",{"level":126,"text":135,"quote":138,"refs":139},{"fa":136,"en":137},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Therefore, KRYSTEXXA should not be used when breastfeeding unless the clear benefit to the mother can overcome the unknown risk to the newborn\u002Finfant.",[140],{"source":32,"section":141},"8.2",{"level":143,"text":144,"quote":147,"refs":148},"not-established",{"fa":145,"en":146},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","The safety and effectiveness of KRYSTEXXA in pediatric patients less than 18 years of age have not been established.",[149],{"source":32,"section":150},"8.4",{"level":152,"text":153,"quote":156,"refs":157},"ok",{"fa":154,"en":155},"برچسب: در سالمندان تفاوت یا تنظیم دوز خاصی ذکر نشده.","Label: no specific difference or dose adjustment stated for older adults.","No dose adjustment is needed for patients 65 years of age and older.",[158],{"source":32,"section":159},"8.5",{"kind":161,"refs":162,"id":110},"BLA",[163],{"source":32,"section":164},"SPL approval \u002F marketing category",1792191560037]