[{"data":1,"prerenderedAt":167},["ShallowReactive",2],{"drug-denosumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":35,"contraindications":58,"warnings":68,"renal":76,"monitoring":77,"interactions":78,"review":79,"examples":82,"atc":83,"iran":85,"usApproval":101,"links":107,"populations":125},"denosumab",1,{"fa":7,"en":8},"دنوزوماب (پرولیا)","Denosumab (Prolia)","musculoskeletal",{"fa":11,"en":12},"آنتی‌بادی ضد RANKL","Anti-RANKL antibody",[14],{"name":15,"market":16},"Prolia","US",[18,19,20],"prolia","پرولیا","دنوزوماب",[22],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":30,"refs":31},"syr-60","injection","sc","60 mg\u002FmL prefilled syringe",{"amount":28,"unit":29,"perVolumeMl":5},60,"mg",[16],[32],{"source":33,"section":34},"fda-prolia","3",[36],{"id":37,"disease":38,"label":39,"population":42,"type":46,"unit":29,"dose":47,"refs":51},"pmo","osteoporosis",{"fa":40,"en":41},"پوکی استخوان — ۶۰ mg زیرجلدی هر ۶ ماه","Osteoporosis — 60 mg SC every 6 months",{"minAge":43},{"value":44,"unit":45},18,"year","notCalculated",{"reason":48},{"fa":49,"en":50},"۶۰ mg زیرجلدی یک بار هر ۶ ماه توسط کادر درمان. کلسیم ۱۰۰۰ mg و ویتامین D دست‌کم ۴۰۰ واحد روزانه. پیش از شروع تست بارداری؛ در eGFR زیر ۳۰ ابتدا CKD-MBD بررسی شود.","60 mg SC once every 6 months by a healthcare provider. Calcium 1,000 mg and vitamin D ≥400 IU daily. Pregnancy test before starting; with eGFR \u003C30 evaluate CKD-MBD first.",[52,54,56],{"source":33,"section":53},"2.3",{"source":33,"section":55},"2.1",{"source":33,"section":57},"2.2",[59],{"id":60,"severity":61,"text":62,"refs":65},"ci","block",{"fa":63,"en":64},"هیپوکلسمی (پیش از شروع اصلاح شود)؛ بارداری؛ حساسیت سیستمیک.","Hypocalcaemia (correct before starting); pregnancy; systemic hypersensitivity.",[66],{"source":33,"section":67},"4",[69],{"text":70,"refs":73},{"fa":71,"en":72},"هشدار جعبه‌ای: هیپوکلسمی شدید در بیماری پیشرفته کلیه (eGFR زیر ۳۰ یا دیالیز).","Boxed warning: severe hypocalcaemia in advanced CKD (eGFR \u003C30 or dialysis).",[74],{"source":33,"section":75},"Boxed Warning",[],[],[],{"status":80,"reviewer":81,"date":81},"unverified",null,[],[84],"M05BX04",{"status":86,"forms":87,"refs":96},"registered",[88,92],{"code":89,"en":90,"fa":91},"22018","DENOSUMAB 120MG VIAL","ویال دنوسومب ۱۲۰ میلی‌گرم",{"code":93,"en":94,"fa":95},"18084","DENOSUMAB 60MG  INGECTION","دنوسومب ۶۰ میلی‌گرم اینجکشن",[97],{"source":98,"section":99,"url":100},"darooyab-generic","G-4718\u002FDenosumab","https:\u002F\u002Fwww.darooyab.ir\u002FG-4718\u002FDenosumab",{"kind":102,"refs":103,"id":106},"BLA",[104],{"source":33,"section":105},"SPL approval \u002F marketing category","BLA125320",[108,111,115,119,122],{"kind":109,"url":110,"label":106},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=125320",{"kind":112,"url":113,"label":114},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=49e5afe9-a0c7-40c4-af9f-f287a80c5c88","FDA Prolia",{"kind":116,"url":117,"label":118},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa610023.html","Denosumab Injection",{"kind":120,"url":121,"label":84},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=M05BX04",{"kind":123,"url":100,"label":124},"darooyab","Denosumab",{"pregnancy":126,"lactation":134,"pediatric":143,"geriatric":151,"reproductive":159},{"level":127,"text":128,"quote":131,"refs":132},"contraindicated",{"fa":129,"en":130},"برچسب: در بارداری منع مصرف دارد.","Label: contraindicated in pregnancy.","Pregnant women: Prolia may cause fetal harm when administered to a pregnant woman.",[133],{"source":33,"section":67},{"level":135,"text":136,"quote":139,"refs":140},"caution",{"fa":137,"en":138},"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 denosumab in human milk, the effects on the breastfed infant, or the effects on milk production.",[141],{"source":33,"section":142},"8.2",{"level":135,"text":144,"quote":147,"refs":148},{"fa":145,"en":146},"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 Prolia have not been established in pediatric patients.",[149],{"source":33,"section":150},"8.4",{"level":135,"text":152,"quote":155,"refs":156},{"fa":153,"en":154},"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 total number of patients in clinical studies of Prolia, 9943 patients (76%) were ≥ 65 years old, while 3576 (27%) were ≥ 75 years old.",[157],{"source":33,"section":158},"8.5",{"level":135,"text":160,"quote":163,"refs":164},{"fa":161,"en":162},"برچسب نکته‌ای درباره بارداری، پیشگیری یا باروری زنان و مردان دارد.","Label has advice on pregnancy testing, contraception or fertility for females and males.","Contraception Females Advise females of reproductive potential to use effective contraception during therapy, and for at least 5 months after the last dose of Prolia.",[165],{"source":33,"section":166},"8.3",1792111450787]