[{"data":1,"prerenderedAt":157},["ShallowReactive",2],{"drug-romosozumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":36,"contraindications":63,"warnings":73,"renal":81,"monitoring":82,"interactions":83,"review":84,"examples":87,"atc":94,"iran":96,"usApproval":103,"links":109,"populations":124},"romosozumab",1,{"fa":7,"en":8},"رموزوزومب","Romosozumab","musculoskeletal",{"fa":11,"en":12},"مهارکننده اسکلروستین","Sclerostin inhibitor",[14],{"name":15,"market":16},"Evenity","US",[18,19,20],"evenity","اونیتی","رموزوزوماب",[22],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":31,"refs":32},"syr-105","injection","sc","105 mg\u002F1.17 mL syringe (dose = 2 syringes)",{"amount":28,"unit":29,"perVolumeMl":30},105,"mg",1.17,[16],[33],{"source":34,"section":35},"fda-evenity","3",[37],{"id":38,"disease":39,"label":40,"population":43,"type":47,"unit":29,"dose":48,"refs":50,"durationDays":53,"notes":54},"op","osteoporosis",{"fa":41,"en":42},"پوکی استخوان پرخطر پس از یائسگی — ۲۱۰ mg ماهی یک بار، ۱۲ دوز","High-risk postmenopausal osteoporosis — 210 mg once MONTHLY, 12 doses",{"minAge":44},{"value":45,"unit":46},18,"year","fixed",{"perDose":49,"dosesPerDay":5},210,[51],{"source":34,"section":52},"2.2",{"min":5,"max":5},[55],{"text":56,"refs":59},{"fa":57,"en":58},"یک دوز در ماه (نه روزانه) = دو سرنگ ۱۰۵ mg پشت سر هم توسط کادر درمان؛ ۱۲ ماه. کلسیم و ویتامین D کافی.","One dose per MONTH (not daily) = two 105 mg syringes one after the other by a healthcare provider; 12 months. Adequate calcium and vitamin D.",[60,62],{"source":34,"section":61},"2.1",{"source":34,"section":52},[64],{"id":65,"severity":66,"text":67,"refs":70},"ci","block",{"fa":68,"en":69},"هیپوکلسمی (پیش از شروع اصلاح شود)؛ حساسیت سیستمیک به رموزوزومب.","Hypocalcaemia (correct before starting); systemic hypersensitivity to romosozumab.",[71],{"source":34,"section":72},"4",[74],{"text":75,"refs":78},{"fa":76,"en":77},"هشدار جعبه‌ای: احتمال افزایش MI، سکته و مرگ قلبی — در MI یا سکته طی سال گذشته شروع نشود.","Boxed warning: possible increase in MI, stroke and cardiovascular death — do not start within a year of MI or stroke.",[79],{"source":34,"section":80},"Boxed Warning",[],[],[],{"status":85,"reviewer":86,"date":86},"unverified",null,[88],{"regimen":38,"formulation":23,"input":89,"expect":92},{"ageYears":90,"weightKg":91},70,60,{"perDose":49,"mlPerDose":93},2.34,[95],"M05BX06",{"status":97,"refs":98},"not-found",[99],{"source":100,"section":101,"url":102},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Romosozumab",{"kind":104,"refs":105,"id":108},"BLA",[106],{"source":34,"section":107},"SPL approval \u002F marketing category","BLA761062",[110,113,117,121],{"kind":111,"url":112,"label":108},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=761062",{"kind":114,"url":115,"label":116},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=471baba2-7154-4488-9891-0db2f46791e7","FDA Evenity",{"kind":118,"url":119,"label":120},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa619026.html","Romosozumab-aqqg Injection",{"kind":122,"url":123,"label":95},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=M05BX06",{"pregnancy":125,"lactation":134,"pediatric":141,"geriatric":149},{"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 EVENITY is not indicated for use in women of reproductive potential.",[132],{"source":34,"section":133},"8.1",{"level":126,"text":135,"quote":130,"refs":138},{"fa":136,"en":137},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.",[139],{"source":34,"section":140},"8.2",{"level":126,"text":142,"quote":145,"refs":146},{"fa":143,"en":144},"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.","Safety and effectiveness of EVENITY have not been established in pediatric patients.",[147],{"source":34,"section":148},"8.4",{"level":126,"text":150,"quote":153,"refs":154},{"fa":151,"en":152},"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 6544 postmenopausal women with osteoporosis in the clinical studies of EVENITY, 5234 (80%) were age 65 years and over and 2390 (37%) were age 75 years and over.",[155],{"source":34,"section":156},"8.5",1792156194466]