[{"data":1,"prerenderedAt":131},["ShallowReactive",2],{"drug-andexanet":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":36,"contraindications":55,"warnings":56,"renal":64,"monitoring":65,"interactions":66,"review":67,"examples":70,"atc":71,"iran":73,"usApproval":80,"links":86,"populations":97},"andexanet",1,{"fa":7,"en":8},"آندگزانت آلفا","Andexanet alfa","various",{"fa":11,"en":12},"آنتی‌دوت مهارکننده فاکتور Xa","Factor Xa inhibitor reversal agent",[14],{"name":15,"market":16},"Andexxa","US",[18,19,20],"andexxa","آندکسا","آنتی دوت ریواروکسابان",[22],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":31,"refs":32},"vial-200","powder-for-injection","iv","200 mg vial (10 mg\u002FmL after reconstitution)",{"amount":28,"unit":29,"perUnit":30},200,"mg","vial",[16],[33],{"source":34,"section":35},"fda-andexxa","3",[37],{"id":38,"disease":39,"label":40,"population":43,"type":47,"unit":29,"dose":48,"refs":52},"rev","anticoagulant-reversal",{"fa":41,"en":42},"خونریزی تهدیدکننده با ریواروکسابان یا آپیکسابان — دوز کم یا زیاد بر اساس دارو، دوز و زمان آخرین دوز","Life-threatening bleeding on rivaroxaban or apixaban — low or high dose by drug, dose and time since last dose",{"minAge":44},{"value":45,"unit":46},18,"year","notCalculated",{"reason":49},{"fa":50,"en":51},"دوز کم: بولوس ۴۰۰ mg (۳۰ mg\u002Fدقیقه) سپس ۴ mg\u002Fدقیقه ۱۲۰ دقیقه. دوز زیاد: ۸۰۰ mg سپس ۸ mg\u002Fدقیقه ۱۲۰ دقیقه. انتخاب طبق جدول برچسب. بیش از یک دوز بررسی نشده.","Low dose: 400 mg bolus (30 mg\u002Fmin) then 4 mg\u002Fmin for 120 min. High dose: 800 mg then 8 mg\u002Fmin for 120 min. Choice per label table. More than one dose not studied.",[53],{"source":34,"section":54},"2.1",[],[57],{"text":58,"refs":61},{"fa":59,"en":60},"هشدار جعبه‌ای: ترومبوآمبولی، ایسکمی، ایست قلبی و مرگ ناگهانی.","Boxed warning: thromboembolic and ischaemic events, cardiac arrest and sudden death.",[62],{"source":34,"section":63},"Boxed Warning",[],[],[],{"status":68,"reviewer":69,"date":69},"unverified",null,[],[72],"V03AB38",{"status":74,"refs":75},"not-found",[76],{"source":77,"section":78,"url":79},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Andexanet%20alfa",{"kind":81,"refs":82,"id":85},"BLA",[83],{"source":34,"section":84},"SPL approval \u002F marketing category","BLA125586",[87,90,94],{"kind":88,"url":89,"label":85},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=125586",{"kind":91,"url":92,"label":93},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=2d9d90a6-63e6-46ef-96ff-dd6519ae7b6c","FDA Andexxa",{"kind":95,"url":96,"label":72},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=V03AB38",{"pregnancy":98,"lactation":107,"pediatric":115,"geriatric":123},{"level":99,"text":100,"quote":103,"refs":104},"caution",{"fa":101,"en":102},"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 ANDEXXA in pregnant women to inform patients of associated risks.",[105],{"source":34,"section":106},"8.1",{"level":99,"text":108,"quote":111,"refs":112},{"fa":109,"en":110},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary There is no information regarding the presence of ANDEXXA in human milk, the effects on the breastfed child, or the effects on milk production.",[113],{"source":34,"section":114},"8.2",{"level":99,"text":116,"quote":119,"refs":120},{"fa":117,"en":118},"برچسب برای کودکان شرط، محدودیت سنی یا نکته دارد؛ جمله برچسب در زیر آمده است.","The label has conditions, age limits or notes for children; the label sentence is quoted below.","The safety and efficacy of ANDEXXA in the pediatric population have not been studied.",[121],{"source":34,"section":122},"8.4",{"level":99,"text":124,"quote":127,"refs":128},{"fa":125,"en":126},"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.","Of the 419 patients in the ANNEXA-4 study of ANDEXXA, 381 (91%) were 65 years of age or older, and 278 (66%) were older than 75 years of age.",[129],{"source":34,"section":130},"8.5",1792191526060]