[{"data":1,"prerenderedAt":230},["ShallowReactive",2],{"drug-pegfilgrastim":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":23,"regimens":37,"contraindications":117,"warnings":127,"renal":135,"monitoring":136,"interactions":137,"review":138,"examples":141,"atc":165,"iran":167,"usApproval":174,"links":180,"populations":195},"pegfilgrastim",1,{"fa":7,"en":8},"پگ‌فیلگراستیم","Pegfilgrastim","antineoplastic-immunomodulating",{"fa":11,"en":12},"فاکتور محرک کلونی گرانولوسیت طولانی‌اثر","Long-acting granulocyte colony-stimulating factor",[14],{"name":15,"market":16},"Neulasta","US",[18,19,20,21,22],"neulasta","pegagen","پگاژن","نولاستا","پگ فیلگراستیم",[24],{"id":25,"form":26,"route":27,"label":28,"concentration":29,"markets":32,"refs":33},"pfs-6","injection","sc","6 mg\u002F0.6 mL prefilled syringe (10 mg\u002FmL)",{"amount":30,"unit":31,"perVolumeMl":5},10,"mg",[16],[34],{"source":35,"section":36},"fda-neulasta","3",[38,67,98],{"id":39,"disease":40,"label":41,"population":44,"type":46,"unit":31,"dose":47,"refs":49,"durationDays":52,"notes":53},"adult","febrile-neutropenia",{"fa":42,"en":43},"کاهش نوتروپنی تب‌دار در شیمی‌درمانی سرکوب‌کننده مغز استخوان — بزرگسال و کودک ۴۵ kg به بالا: ۶ mg زیرجلدی","Reduce febrile neutropenia with myelosuppressive chemotherapy — adults and children ≥45 kg: 6 mg SC",{"minWeightKg":45},45,"fixed",{"perDose":48,"dosesPerDay":5},6,[50],{"source":35,"section":51},"2.1",{"min":5,"max":5},[54,60],{"text":55,"refs":58},{"fa":56,"en":57},"یک بار در هر دوره شیمی‌درمانی؛ نه در فاصله ۱۴ روز قبل تا ۲۴ ساعت بعد از شیمی‌درمانی.","Once per chemotherapy cycle; not between 14 days before and 24 hours after chemotherapy.",[59],{"source":35,"section":51},{"text":61,"refs":64},{"fa":62,"en":63},"سندرم حاد پرتوی (زیرگروه خونی): دو دوز ۶ mg به فاصله یک هفته.","Haematopoietic acute radiation syndrome: two 6 mg doses one week apart.",[65],{"source":35,"section":66},"2.2",{"id":68,"disease":40,"label":69,"population":72,"type":77,"unit":31,"dose":78,"refs":89,"durationDays":92,"notes":93},"child",{"fa":70,"en":71},"کودک ۱۰ تا \u003C۴۵ kg — ۱۰ تا ۲۰ kg: ۱٫۵ mg؛ ۲۱ تا ۳۰: ۲٫۵ mg؛ ۳۱ تا ۴۴: ۴ mg زیرجلدی","Children 10 to \u003C45 kg — 10–20 kg: 1.5 mg; 21–30: 2.5 mg; 31–44: 4 mg SC",{"maxAge":73,"minWeightKg":30,"maxWeightKg":76},{"value":74,"unit":75},18,"year",44.99,"weightBand",{"weightBands":79},[80,84,87],{"minWeightKg":81,"maxWeightKg":82,"perDose":83,"dosesPerDay":5},9.99,20.99,1.5,{"minWeightKg":82,"maxWeightKg":85,"perDose":86,"dosesPerDay":5},30.99,2.5,{"minWeightKg":85,"maxWeightKg":76,"perDose":88,"dosesPerDay":5},4,[90],{"source":35,"section":91},"2.1, Table 1",{"min":5,"max":5},[94],{"text":95,"refs":96},{"fa":56,"en":57},[97],{"source":35,"section":51},{"id":99,"disease":40,"label":100,"population":103,"type":105,"unit":31,"dose":106,"refs":109,"durationDays":111,"notes":112},"infant",{"fa":101,"en":102},"کودک زیر ۱۰ kg — ۰٫۱ mg\u002Fkg (۰٫۰۱ mL\u002Fkg) زیرجلدی","Children under 10 kg — 0.1 mg\u002Fkg (0.01 mL\u002Fkg) SC",{"maxAge":104,"maxWeightKg":81},{"value":74,"unit":75},"weightBased",{"perKgPerDose":107,"intervalHours":108},0.1,24,[110],{"source":35,"section":91},{"min":5,"max":5},[113],{"text":114,"refs":115},{"fa":56,"en":57},[116],{"source":35,"section":51},[118],{"id":119,"severity":120,"text":121,"refs":124},"hyper","block",{"fa":122,"en":123},"سابقه حساسیت جدی به پگ‌فیلگراستیم یا فیلگراستیم.","History of serious hypersensitivity to pegfilgrastim or filgrastim.",[125],{"source":35,"section":126},"4",[128],{"text":129,"refs":132},{"fa":130,"en":131},"پارگی طحال؛ ARDS؛ حساسیت جدی؛ بحران داسی‌شکل؛ گلومرولونفریت؛ لکوسیتوز؛ سندرم نشت مویرگی؛ MDS\u002FAML.","Splenic rupture; ARDS; serious hypersensitivity; sickle-cell crises; glomerulonephritis; leukocytosis; capillary leak syndrome; MDS\u002FAML.",[133],{"source":35,"section":134},"5",[],[],[],{"status":139,"reviewer":140,"date":140},"unverified",null,[142,148,153,158],{"regimen":39,"formulation":25,"input":143,"expect":146},{"ageYears":144,"weightKg":145},50,70,{"perDose":48,"mlPerDose":147},0.6,{"regimen":68,"formulation":25,"input":149,"expect":151},{"ageYears":88,"weightKg":150},15,{"perDose":83,"mlPerDose":152},0.15,{"regimen":68,"formulation":25,"input":154,"expect":156},{"ageYears":30,"weightKg":155},35,{"perDose":88,"mlPerDose":157},0.4,{"regimen":99,"formulation":25,"input":159,"expect":162},{"ageYears":160,"weightKg":161},0.5,8,{"perDose":163,"mlPerDose":164},0.8,0.08,[166],"L03AA13",{"status":168,"refs":169},"not-found",[170],{"source":171,"section":172,"url":173},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Pegfilgrastim",{"kind":175,"refs":176,"id":179},"BLA",[177],{"source":35,"section":178},"SPL approval \u002F marketing category","BLA125031",[181,184,188,192],{"kind":182,"url":183,"label":179},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=125031",{"kind":185,"url":186,"label":187},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce","FDA Neulasta",{"kind":189,"url":190,"label":191},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa607058.html","Pegfilgrastim Injection",{"kind":193,"url":194,"label":166},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L03AA13",{"pregnancy":196,"lactation":205,"pediatric":213,"geriatric":221},{"level":197,"text":198,"quote":201,"refs":202},"caution",{"fa":199,"en":200},"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 Although available data with Neulasta use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to filgrastim products.",[203],{"source":35,"section":204},"8.1",{"level":197,"text":206,"quote":209,"refs":210},{"fa":207,"en":208},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary There are no data on the presence of pegfilgrastim in human milk, the effects on the breastfed child, or the effects on milk production.",[211],{"source":35,"section":212},"8.2",{"level":197,"text":214,"quote":217,"refs":218},{"fa":215,"en":216},"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 Neulasta for chemotherapy-induced neutropenia and hematopoietic subsyndrome of acute radiation syndrome have been established in pediatric patients.",[219],{"source":35,"section":220},"8.4",{"level":222,"text":223,"quote":226,"refs":227},"ok",{"fa":224,"en":225},"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 aged 65 and older and younger patients.",[228],{"source":35,"section":229},"8.5",1792444707870]