[{"data":1,"prerenderedAt":138},["ShallowReactive",2],{"drug-alirocumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":35,"contraindications":56,"warnings":66,"renal":67,"monitoring":68,"interactions":69,"review":70,"examples":73,"atc":74,"iran":76,"usApproval":83,"links":89,"populations":104},"alirocumab",1,{"fa":7,"en":8},"آلیروکومب","Alirocumab","cardiovascular",{"fa":11,"en":12},"مهارکننده PCSK9","PCSK9 inhibitor",[14],{"name":15,"market":16},"Praluent","US",[18,19,20],"praluent","پرالوئنت","آلیروکوماب",[22],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":30,"refs":31},"pen-75","injection","sc","75 mg\u002FmL or 150 mg\u002FmL pen",{"amount":28,"unit":29,"perVolumeMl":5},75,"mg",[16],[32],{"source":33,"section":34},"fda-praluent","3",[36],{"id":37,"disease":38,"label":39,"population":42,"type":46,"unit":29,"dose":47,"refs":51},"ldl","hyperlipidemia",{"fa":40,"en":41},"هیپرکلسترولمی بزرگسال — ۷۵ mg هر ۲ هفته یا ۳۰۰ mg هر ۴ هفته","Adult hypercholesterolaemia — 75 mg every 2 weeks or 300 mg every 4 weeks",{"minAge":43},{"value":44,"unit":45},18,"year","notCalculated",{"reason":48},{"fa":49,"en":50},"زیرجلدی (نه روزانه). پاسخ ناکافی: تا ۱۵۰ mg هر ۲ هفته. کودک ۸ سال به بالا با HeFH: زیر ۵۰ kg ← ۱۵۰ mg هر ۴ هفته؛ ≥۵۰ kg ← ۳۰۰ mg هر ۴ هفته.","SC (not daily). Inadequate response: up to 150 mg every 2 weeks. Children ≥8 y with HeFH: \u003C50 kg → 150 mg every 4 weeks; ≥50 kg → 300 mg every 4 weeks.",[52,54],{"source":33,"section":53},"2.1",{"source":33,"section":55},"2.2",[57],{"id":58,"severity":59,"text":60,"refs":63},"hyper","block",{"fa":61,"en":62},"سابقه واکنش حساسیتی جدی به دارو (از جمله آنژیوادم).","History of serious hypersensitivity to the drug (including angioedema).",[64],{"source":33,"section":65},"4",[],[],[],[],{"status":71,"reviewer":72,"date":72},"unverified",null,[],[75],"C10AX14",{"status":77,"refs":78},"not-found",[79],{"source":80,"section":81,"url":82},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Alirocumab",{"kind":84,"refs":85,"id":88},"BLA",[86],{"source":33,"section":87},"SPL approval \u002F marketing category","BLA125559",[90,93,97,101],{"kind":91,"url":92,"label":88},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=125559",{"kind":94,"url":95,"label":96},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4","FDA Praluent",{"kind":98,"url":99,"label":100},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa615035.html","Alirocumab Injection",{"kind":102,"url":103,"label":75},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=C10AX14",{"pregnancy":105,"lactation":114,"pediatric":122,"geriatric":130},{"level":106,"text":107,"quote":110,"refs":111},"caution",{"fa":108,"en":109},"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 clinical trials and postmarketing reports on PRALUENT use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.",[112],{"source":33,"section":113},"8.1",{"level":106,"text":115,"quote":118,"refs":119},{"fa":116,"en":117},"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 alirocumab in human milk, the effects on the breastfed infant, or the effects on milk production.",[120],{"source":33,"section":121},"8.2",{"level":106,"text":123,"quote":126,"refs":127},{"fa":124,"en":125},"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 effectiveness of PRALUENT as an adjunct to diet and other LDL-C-lowering therapies for the treatment of HeFH have been established in pediatric patients aged 8 years and older.",[128],{"source":33,"section":129},"8.4",{"level":106,"text":131,"quote":134,"refs":135},{"fa":132,"en":133},"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.","In controlled trials, 3663 patients treated with PRALUENT were ≥65 years of age and 734 patients treated with PRALUENT were ≥75 years of age.",[136],{"source":33,"section":137},"8.5",1792156161102]