[{"data":1,"prerenderedAt":138},["ShallowReactive",2],{"drug-inclisiran":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":35,"contraindications":54,"warnings":64,"renal":65,"monitoring":66,"interactions":67,"review":68,"examples":71,"atc":72,"iran":74,"usApproval":81,"links":87,"populations":102},"inclisiran",1,{"fa":7,"en":8},"اینکلیسیران","Inclisiran","cardiovascular",{"fa":11,"en":12},"siRNA مهارکننده PCSK9","PCSK9-directed siRNA",[14],{"name":15,"market":16},"Leqvio","US",[18,19,7],"leqvio","لکویو",[21],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"syr-284","injection","sc","284 mg\u002F1.5 mL prefilled syringe",{"amount":27,"unit":28,"perVolumeMl":29},284,"mg",1.5,[16],[32],{"source":33,"section":34},"fda-leqvio","3",[36],{"id":37,"disease":38,"label":39,"population":42,"type":46,"unit":28,"dose":47,"refs":51},"ldl","hyperlipidemia",{"fa":40,"en":41},"کاهش LDL (۱۲ سال به بالا) — ۲۸۴ mg، دوباره در ماه ۳، سپس هر ۶ ماه","LDL lowering (≥12 y) — 284 mg, again at 3 months, then every 6 months",{"minAge":43},{"value":44,"unit":45},12,"year","notCalculated",{"reason":48},{"fa":49,"en":50},"تزریق زیرجلدی توسط کادر درمان: شروع، ماه ۳، سپس هر ۶ ماه. دوز فراموش‌شده کمتر از ۳ ماه: تزریق و ادامه برنامه؛ بیش از ۳ ماه: شروع برنامه جدید.","SC by a healthcare professional: initially, at 3 months, then every 6 months. Missed by \u003C3 months: give and keep the schedule; >3 months: restart the schedule.",[52],{"source":33,"section":53},"2.1",[55],{"id":56,"severity":57,"text":58,"refs":61},"hyper","block",{"fa":59,"en":60},"سابقه حساسیت جدی به اینکلیسیران (آنافیلاکسی، آنژیوادم).","Prior serious hypersensitivity to inclisiran (anaphylaxis, angioedema).",[62],{"source":33,"section":63},"4",[],[],[],[],{"status":69,"reviewer":70,"date":70},"unverified",null,[],[73],"C10AX16",{"status":75,"refs":76},"not-found",[77],{"source":78,"section":79,"url":80},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Inclisiran",{"kind":82,"refs":83,"id":86},"NDA",[84],{"source":33,"section":85},"SPL approval \u002F marketing category","NDA214012",[88,91,95,99],{"kind":89,"url":90,"label":86},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=214012",{"kind":92,"url":93,"label":94},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=6fc0afca-4513-4c35-b594-6544aee29a44","FDA Leqvio",{"kind":96,"url":97,"label":98},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa622009.html","Inclisiran injection",{"kind":100,"url":101,"label":73},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=C10AX16",{"pregnancy":103,"lactation":112,"pediatric":121,"geriatric":129},{"level":104,"text":105,"quote":108,"refs":109},"avoid",{"fa":106,"en":107},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","… us decreasing cholesterol and possibly other biologically active substances derived from cholesterol; therefore, LEQVIO may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1)] .",[110],{"source":33,"section":111},"8.1",{"level":113,"text":114,"quote":117,"refs":118},"caution",{"fa":115,"en":116},"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 on the presence of inclisiran in human milk, the effects on the breastfed infant, or the effects on milk production.",[119],{"source":33,"section":120},"8.2",{"level":113,"text":122,"quote":125,"refs":126},{"fa":123,"en":124},"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 LEQVIO as an adjunct to diet and other LDL-C-lowering therapies for the treatment of HeFH have been established in pediatric patients aged 12 years and older.",[127],{"source":33,"section":128},"8.4",{"level":130,"text":131,"quote":134,"refs":135},"ok",{"fa":132,"en":133},"برچسب: در سالمندان تفاوت یا تنظیم دوز خاصی ذکر نشده.","Label: no specific difference or dose adjustment stated for older adults.","No overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger adult patients.",[136],{"source":33,"section":137},"8.5",1792156182132]