[{"data":1,"prerenderedAt":165},["ShallowReactive",2],{"drug-glecaprevir-pibrentasvir":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":23,"regimens":37,"contraindications":68,"warnings":78,"renal":93,"monitoring":94,"interactions":95,"review":96,"examples":99,"atc":104,"iran":106,"usApproval":113,"links":119,"populations":130},"glecaprevir-pibrentasvir",1,{"fa":7,"en":8},"گلکاپرویر\u002Fپیبرنتاسویر","Glecaprevir\u002Fpibrentasvir","anti-infectives",{"fa":11,"en":12},"ضد ویروس مستقیم HCV (پان‌ژنوتیپ)","Pangenotypic HCV direct-acting antiviral",[14],{"name":15,"market":16},"Mavyret","US",[18,19,20,21,22],"mavyret","maviret","ماویرت","glecaprevir","گلکاپرویر",[24],{"id":25,"form":26,"route":27,"label":28,"concentration":29,"markets":32,"refs":33},"tab-100","tablet","oral","100 mg glecaprevir \u002F 40 mg pibrentasvir tablet",{"amount":30,"unit":31,"perUnit":26},100,"mg",[16],[34],{"source":35,"section":36},"fda-mavyret","3",[38],{"id":39,"disease":40,"label":41,"population":44,"type":49,"unit":31,"dose":50,"refs":52,"doseComponent":21,"notes":57},"hcv","hepatitis-c",{"fa":42,"en":43},"هپاتیت C همه ژنوتیپ‌ها (بزرگسال و ≥۱۲ سال یا ≥۴۵ kg) — ۳ قرص با هم یک بار با غذا؛ درمان‌نشده ۸ هفته","Hepatitis C, all genotypes (adults and ≥12 y or ≥45 kg) — 3 tablets together once daily with food; treatment-naive 8 weeks",{"minAge":45,"minWeightKg":48},{"value":46,"unit":47},3,"year",45,"fixed",{"perDose":51,"dosesPerDay":5},300,[53,55],{"source":35,"section":54},"2.3",{"source":35,"section":56},"2.4",[58],{"text":59,"refs":62},{"fa":60,"en":61},"مدت طبق جداول ۱ و ۲ (درمان‌شده قبلی یا پیوند ۱۲ تا ۱۶ هفته). ۳ تا \u003C۱۲ سال و زیر ۴۵ kg: پلت بر اساس وزن. هر درجه نارسایی کلیه تنظیم ندارد.","Duration per Tables 1–2 (experienced or transplant 12–16 weeks). 3–\u003C12 y and \u003C45 kg: weight-based pellets. No adjustment for any renal impairment.",[63,65,67],{"source":35,"section":64},"2.2",{"source":35,"section":66},"2.6",{"source":35,"section":56},[69],{"id":70,"severity":71,"text":72,"refs":75},"ci","block",{"fa":73,"en":74},"نارسایی متوسط یا شدید کبد (Child-Pugh B\u002FC) یا سابقه جبران‌نشدن کبد؛ آتازاناویر یا ریفامپین همزمان.","Moderate or severe hepatic impairment (Child-Pugh B\u002FC) or prior hepatic decompensation; concomitant atazanavir or rifampin.",[76],{"source":35,"section":77},"4",[79,86],{"text":80,"refs":83},{"fa":81,"en":82},"هشدار جعبه‌ای: فعال شدن مجدد HBV در عفونت همزمان (گاه نارسایی کبد و مرگ) — پیش از شروع HBsAg و anti-HBc.","Boxed warning: HBV reactivation in HCV\u002FHBV co-infection (sometimes fulminant hepatitis and death) — test HBsAg and anti-HBc first.",[84],{"source":35,"section":85},"Boxed Warning",{"text":87,"refs":90},{"fa":88,"en":89},"جبران‌نشدن یا نارسایی کبد در سیروز پیشرفته.","Hepatic decompensation\u002Ffailure in advanced cirrhosis.",[91],{"source":35,"section":92},"5.2",[],[],[],{"status":97,"reviewer":98,"date":98},"unverified",null,[100],{"regimen":39,"formulation":25,"input":101,"expect":103},{"ageYears":48,"weightKg":102},70,{"perDose":51,"tabletsPerDoseRounded":46},[105],"J05AP57",{"status":107,"refs":108},"not-found",[109],{"source":110,"section":111,"url":112},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Glecaprevir\u002Fpibrentasvir",{"kind":114,"refs":115,"id":118},"NDA",[116],{"source":35,"section":117},"SPL approval \u002F marketing category","NDA209394",[120,123,127],{"kind":121,"url":122,"label":118},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=209394",{"kind":124,"url":125,"label":126},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=7bf99777-0401-9095-8645-16c6e907fcc0","FDA Mavyret",{"kind":128,"url":129,"label":105},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=J05AP57",{"pregnancy":131,"lactation":140,"pediatric":148,"geriatric":156},{"level":132,"text":133,"quote":136,"refs":137},"caution",{"fa":134,"en":135},"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 No adequate human data are available to establish whether or not MAVYRET poses a risk to pregnancy outcomes.",[138],{"source":35,"section":139},"8.1",{"level":132,"text":141,"quote":144,"refs":145},{"fa":142,"en":143},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","When administered to lactating rodents, the components of MAVYRET were present in milk, without effect on growth and development observed in the nursing pups (see Data ) .",[146],{"source":35,"section":147},"8.2",{"level":132,"text":149,"quote":152,"refs":153},{"fa":150,"en":151},"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.","No dosage adjustment of MAVYRET is required in pediatric patients 12 years and older or weighing at least 45 kg.",[154],{"source":35,"section":155},"8.4",{"level":157,"text":158,"quote":161,"refs":162},"ok",{"fa":159,"en":160},"برچسب: در سالمندان تفاوت یا تنظیم دوز خاصی ذکر نشده.","Label: no specific difference or dose adjustment stated for older adults.","No dosage adjustment of MAVYRET is warranted in geriatric patients [see Clinical Pharmacology ( 12.3 ) ] .",[163],{"source":35,"section":164},"8.5",1792444401192]