[{"data":1,"prerenderedAt":143},["ShallowReactive",2],{"drug-evolocumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":35,"contraindications":54,"warnings":64,"renal":65,"monitoring":66,"interactions":67,"review":68,"examples":71,"atc":72,"iran":74,"usApproval":86,"links":92,"populations":109},"evolocumab",1,{"fa":7,"en":8},"اوولوکومب","Evolocumab","cardiovascular",{"fa":11,"en":12},"مهارکننده PCSK9","PCSK9 inhibitor",[14],{"name":15,"market":16},"Repatha","US",[18,19,20],"repatha","رپاتا","اوولوکوماب",[22],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":30,"refs":31},"pen-140","injection","sc","140 mg\u002FmL pen, autoinjector or syringe",{"amount":28,"unit":29,"perVolumeMl":5},140,"mg",[16],[32],{"source":33,"section":34},"fda-repatha","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 یا خطر بالای قلبی — ۱۴۰ mg هر ۲ هفته یا ۴۲۰ mg ماهانه","Hypercholesterolaemia or high CV risk — 140 mg every 2 weeks or 420 mg monthly",{"minAge":43},{"value":44,"unit":45},10,"year","notCalculated",{"reason":48},{"fa":49,"en":50},"زیرجلدی ۱۴۰ mg هر ۲ هفته یا ۴۲۰ mg یک بار در ماه (نه روزانه). HeFH از ۱۰ سالگی هم همین دوز. هنگام تعویض رژیم، اولین دوز جدید در تاریخ بعدی رژیم قبلی.","140 mg SC every 2 weeks or 420 mg once monthly (not daily). HeFH from 10 y: same dosage. When switching, give the first new dose on the next scheduled date.",[52],{"source":33,"section":53},"2.1",[55],{"id":56,"severity":57,"text":58,"refs":61},"hyper","block",{"fa":59,"en":60},"سابقه واکنش حساسیتی جدی به دارو (از جمله آنژیوادم).","History of serious hypersensitivity to the drug (including angioedema).",[62],{"source":33,"section":63},"4",[],[],[],[],{"status":69,"reviewer":70,"date":70},"unverified",null,[],[73],"C10AX13",{"status":75,"forms":76,"refs":81},"registered",[77],{"code":78,"en":79,"fa":80},"50701","EVOLOCUMAB INJECTION PARENTERAL 140 mg\u002F1mL","فرآورده تزریقی اوولوکومب ۱۴۰ میلی‌گرم \u002F ۱ میلی‌لیتر",[82],{"source":83,"section":84,"url":85},"darooyab-generic","G-5367\u002FEvolocumab","https:\u002F\u002Fwww.darooyab.ir\u002FG-5367\u002FEvolocumab",{"kind":87,"refs":88,"id":91},"BLA",[89],{"source":33,"section":90},"SPL approval \u002F marketing category","BLA125522",[93,96,100,104,107],{"kind":94,"url":95,"label":91},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=125522",{"kind":97,"url":98,"label":99},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e","FDA Repatha",{"kind":101,"url":102,"label":103},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa615043.html","Evolocumab Injection",{"kind":105,"url":106,"label":73},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=C10AX13",{"kind":108,"url":85,"label":8},"darooyab",{"pregnancy":110,"lactation":119,"pediatric":127,"geriatric":135},{"level":111,"text":112,"quote":115,"refs":116},"caution",{"fa":113,"en":114},"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 REPATHA 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.",[117],{"source":33,"section":118},"8.1",{"level":111,"text":120,"quote":123,"refs":124},{"fa":121,"en":122},"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 evolocumab in human milk, the effects on the breastfed infant, or the effects on milk production.",[125],{"source":33,"section":126},"8.2",{"level":111,"text":128,"quote":131,"refs":132},{"fa":129,"en":130},"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 REPATHA in combination with diet and other LDL-C-lowering therapies for the treatment of HoFH have been established in pediatric patients aged 10 years and older.",[133],{"source":33,"section":134},"8.4",{"level":111,"text":136,"quote":139,"refs":140},{"fa":137,"en":138},"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, 7656 (41%) patients treated with REPATHA were ≥ 65 years old and 1500 (8%) were ≥ 75 years old.",[141],{"source":33,"section":142},"8.5",1792156177953]