[{"data":1,"prerenderedAt":193},["ShallowReactive",2],{"drug-romiplostim":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":52,"contraindications":92,"warnings":93,"renal":101,"monitoring":102,"interactions":103,"review":104,"examples":107,"atc":117,"iran":119,"usApproval":135,"links":141,"populations":158},"romiplostim",1,{"fa":7,"en":8},"رومی‌پلوستیم","Romiplostim","blood",{"fa":11,"en":12},"آگونیست گیرنده ترومبوپویتین","Thrombopoietin receptor agonist",[14],{"name":15,"market":16},"Nplate","US",[18,19,20],"nplate","ان‌پلیت","رومیپلوستیم",[22,36,44],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":31,"refs":32},"vial-250","powder-for-injection","sc","250 mcg vial",{"amount":28,"unit":29,"perUnit":30},250,"mcg","vial",[16],[33],{"source":34,"section":35},"fda-nplate","3",{"id":37,"form":24,"route":25,"label":38,"concentration":39,"markets":41,"refs":42},"vial-125","125 mcg vial",{"amount":40,"unit":29,"perUnit":30},125,[16],[43],{"source":34,"section":35},{"id":45,"form":24,"route":25,"label":46,"concentration":47,"markets":49,"refs":50},"vial-500","500 mcg vial",{"amount":48,"unit":29,"perUnit":30},500,[16],[51],{"source":34,"section":35},[53,79],{"id":54,"disease":55,"label":56,"population":59,"type":63,"unit":29,"dose":64,"refs":66,"durationDays":69,"notes":70},"itp","immune-thrombocytopenia",{"fa":57,"en":58},"ITP بزرگسال — شروع ۱ mcg\u002Fkg زیرجلدی هفتگی","Adult ITP — start 1 mcg\u002Fkg SC once weekly",{"minAge":60},{"value":61,"unit":62},18,"year","weightBased",{"perKgPerDose":5,"intervalHours":65},24,[67],{"source":34,"section":68},"2.1",{"min":5,"max":5},[71],{"text":72,"refs":75},{"fa":73,"en":74},"هفتگی ۱ mcg\u002Fkg افزایش تا پلاکت ≥۵۰ هزار؛ حداکثر ۱۰ mcg\u002Fkg\u002Fهفته؛ وزن واقعی شروع. سرنگ با درجه ۰٫۰۱ mL. اگر پس از ۴ هفته با حداکثر دوز پاسخ نبود قطع.","Increase weekly by 1 mcg\u002Fkg until platelets ≥50×10⁹\u002FL; max 10 mcg\u002Fkg\u002Fweek; use actual body weight at initiation. Syringe with 0.01 mL graduations. Stop if no response after 4 weeks at max dose.",[76,77],{"source":34,"section":68},{"source":34,"section":78},"2.3",{"id":80,"disease":81,"label":82,"population":85,"type":63,"unit":29,"dose":86,"refs":88,"durationDays":91},"ars","acute-radiation-syndrome",{"fa":83,"en":84},"پرتوگیری حاد با دوز سرکوب‌کننده مغز استخوان — ۱۰ mcg\u002Fkg زیرجلدی یک بار، هرچه زودتر","Acute exposure to myelosuppressive radiation — 10 mcg\u002Fkg SC once, as soon as possible",{},{"perKgPerDose":87,"intervalHours":65},10,[89],{"source":34,"section":90},"2.2",{"min":5,"max":5},[],[94],{"text":95,"refs":98},{"fa":96,"en":97},"پیشرفت سندرم میلودیسپلاستیک به AML؛ ترومبوز؛ از دست رفتن پاسخ.","Progression of myelodysplastic syndromes to AML; thrombotic events; loss of response.",[99],{"source":34,"section":100},"5",[],[],[],{"status":105,"reviewer":106,"date":106},"unverified",null,[108,113],{"regimen":54,"formulation":23,"input":109,"expect":112},{"ageYears":110,"weightKg":111},40,70,{"perDose":111},{"regimen":80,"formulation":45,"input":114,"expect":115},{"ageYears":110,"weightKg":111},{"perDose":116},700,[118],"B02BX04",{"status":120,"forms":121,"refs":130},"registered",[122,126],{"code":123,"en":124,"fa":125},"17038","ROMIPLOSTIM 250MCG VIAL","ویال رومیپلوستیم ۲۵۰ میکروگرم",{"code":127,"en":128,"fa":129},"17074","ROMIPLOSTIM 500MCG VIAL","ویال رومیپلوستیم ۵۰۰ میکروگرم",[131],{"source":132,"section":133,"url":134},"darooyab-generic","G-4799\u002FRomiplostim","https:\u002F\u002Fwww.darooyab.ir\u002FG-4799\u002FRomiplostim",{"kind":136,"refs":137,"id":140},"BLA",[138],{"source":34,"section":139},"SPL approval \u002F marketing category","BLA125268",[142,145,149,153,156],{"kind":143,"url":144,"label":140},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=125268",{"kind":146,"url":147,"label":148},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=c45f9a58-37c1-4f76-8e36-97d38c577037","FDA Nplate",{"kind":150,"url":151,"label":152},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa609008.html","Romiplostim Injection",{"kind":154,"url":155,"label":118},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=B02BX04",{"kind":157,"url":134,"label":8},"darooyab",{"pregnancy":159,"lactation":168,"pediatric":176,"geriatric":185},{"level":160,"text":161,"quote":164,"refs":165},"avoid",{"fa":162,"en":163},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","Risk Summary Based on findings from animal reproduction studies, Nplate may cause fetal harm when administered to a pregnant woman.",[166],{"source":34,"section":167},"8.1",{"level":160,"text":169,"quote":172,"refs":173},{"fa":170,"en":171},"برچسب: شیردهی توصیه نمی‌شود یا باید بین دارو و شیردهی یکی انتخاب شود.","Label: breastfeeding not recommended, or choose between the drug and breastfeeding.","Due to the potential for serious adverse reactions in a breastfed child from Nplate, advise women not to breastfeed during treatment with Nplate.",[174],{"source":34,"section":175},"8.2",{"level":177,"text":178,"quote":181,"refs":182},"caution",{"fa":179,"en":180},"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 Nplate have been established in pediatric patients age 1 year and older with ITP for at least 6 months evaluated in two randomized, placebo-controlled studies.",[183],{"source":34,"section":184},"8.4",{"level":177,"text":186,"quote":189,"refs":190},{"fa":187,"en":188},"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 general, dose adjustment for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.",[191],{"source":34,"section":192},"8.5",1792191565149]