[{"data":1,"prerenderedAt":226},["ShallowReactive",2],{"drug-sofosbuvir-velpatasvir":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":22,"regimens":58,"contraindications":98,"warnings":108,"renal":123,"monitoring":124,"interactions":125,"review":133,"examples":135,"atc":146,"iran":148,"links":160,"populations":178,"usApproval":221},"sofosbuvir-velpatasvir",1,{"fa":7,"en":8},"سوفوسبوویر + ولپاتاسویر","Sofosbuvir + velpatasvir","anti-infectives",{"fa":11,"en":12},"ضد HCV (همه ژنوتیپ‌ها)","Pangenotypic anti-HCV",[14],{"name":15,"market":16},"Epclusa","US",[18,19,20,21],"epclusa","اپکلوسا","سوفوسبوویر","ولپاتاسویر",[23,44],{"id":24,"form":25,"route":26,"label":27,"concentration":28,"markets":31,"refs":32,"components":36},"tab-400-100","tablet","oral","Sofosbuvir 400 mg + velpatasvir 100 mg tablet",{"amount":29,"unit":30,"perUnit":25},400,"mg",[16],[33],{"source":34,"section":35},"fda-epclusa","3",{"sofosbuvir":37,"velpatasvir":40},{"name":38,"amount":29,"unit":30},{"fa":20,"en":39},"Sofosbuvir",{"name":41,"amount":43,"unit":30},{"fa":21,"en":42},"Velpatasvir",100,{"id":45,"form":25,"route":26,"label":46,"concentration":47,"markets":49,"refs":50,"components":52},"tab-200-50","Sofosbuvir 200 mg + velpatasvir 50 mg tablet",{"amount":48,"unit":30,"perUnit":25},200,[16],[51],{"source":34,"section":35},{"sofosbuvir":53,"velpatasvir":55},{"name":54,"amount":48,"unit":30},{"fa":20,"en":39},{"name":56,"amount":57,"unit":30},{"fa":21,"en":42},50,[59],{"id":60,"disease":61,"label":62,"population":65,"type":70,"unit":30,"dose":71,"refs":78,"doseComponent":83,"durationDays":84,"notes":86},"hcv","hepatitis-c",{"fa":63,"en":64},"هپاتیت C — یک بار در روز، ۱۲ هفته (۳ سال به بالا، قرص از ۱۷ kg)","Hepatitis C — once daily for 12 weeks (≥3 y; tablets from 17 kg)",{"minAge":66,"minWeightKg":69},{"value":67,"unit":68},3,"year",17,"weightBand",{"weightBands":72},[73,76],{"minWeightKg":74,"maxWeightKg":75,"perDose":48,"dosesPerDay":5},16.99,29.99,{"minWeightKg":75,"maxWeightKg":77,"perDose":29,"dosesPerDay":5},null,[79,81],{"source":34,"section":80},"2.3",{"source":34,"section":82},"2.4, Table 2","sofosbuvir",{"min":85,"max":85},84,[87],{"text":88,"refs":91},{"fa":89,"en":90},"دوز به‌صورت جزء سوفوسبوویر. زیر ۱۷ kg: پلت خوراکی ۱۵۰\u002F۳۷٫۵ mg. سیروز جبران‌نشده: همراه ریباویرین. پیش از شروع HBsAg و anti-HBc.","Shown as the sofosbuvir component. Under 17 kg: 150\u002F37.5 mg oral pellets. Decompensated cirrhosis: add ribavirin. Test HBsAg and anti-HBc before starting.",[92,94,96],{"source":34,"section":93},"2.2",{"source":34,"section":95},"2.4",{"source":34,"section":97},"2.1",[99],{"id":100,"severity":101,"text":102,"refs":105},"rbv","block",{"fa":103,"en":104},"ترکیب با ریباویرین در مواردی که ریباویرین ممنوع است.","Combination with ribavirin where ribavirin is contraindicated.",[106],{"source":34,"section":107},"4",[109,116],{"text":110,"refs":113},{"fa":111,"en":112},"هشدار جعبه‌ای: فعال شدن مجدد HBV در عفونت همزمان HCV\u002FHBV.","Boxed warning: HBV reactivation in HCV\u002FHBV co-infection.",[114],{"source":34,"section":115},"Boxed Warning",{"text":117,"refs":120},{"fa":118,"en":119},"برادی‌کاردی علامت‌دار شدید با آمیودارون.","Serious symptomatic bradycardia with amiodarone.",[121],{"source":34,"section":122},"5.2",[],[],[126],{"with":127,"text":128,"refs":131},"amiodarone",{"fa":129,"en":130},"آمیودارون: برادی‌کاردی شدید و نیاز به پیس‌میکر؛ یک مورد ایست قلبی کشنده با رژیم‌های سوفوسبوویر.","Amiodarone: severe bradycardia needing pacing; a fatal cardiac arrest with a sofosbuvir regimen.",[132],{"source":34,"section":122},{"status":134,"reviewer":77,"date":77},"unverified",[136,141],{"regimen":60,"formulation":24,"input":137,"expect":140},{"ageYears":138,"weightKg":139},40,70,{"perDose":29,"tabletsPerDoseRounded":5},{"regimen":60,"formulation":45,"input":142,"expect":145},{"ageYears":143,"weightKg":144},7,22,{"perDose":48,"tabletsPerDoseRounded":5},[147],"J05AP55",{"status":149,"forms":150,"refs":155},"registered",[151],{"code":152,"en":153,"fa":154},"51994","SOFOSBUVIR \u002F VELPATASVIR TABLET ORAL 400 mg\u002F100 mg","قرص سوفوسبوویر \u002F ولپاتاسویر ۴۰۰ میلی‌گرم \u002F ۱۰۰ میلی‌گرم",[156],{"source":157,"section":158,"url":159},"darooyab-generic","G-5387\u002FSofosbuvir-Velpatasvir","https:\u002F\u002Fwww.darooyab.ir\u002FG-5387\u002FSofosbuvir-Velpatasvir",[161,165,169,172,175],{"kind":162,"url":163,"label":164},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=208341","NDA208341",{"kind":166,"url":167,"label":168},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=7f30631a-ee3b-4cfe-866b-964df3f0a44f","FDA Epclusa",{"kind":170,"url":171,"label":39},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa614014.html",{"kind":173,"url":174,"label":147},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=J05AP55",{"kind":176,"url":159,"label":177},"darooyab","Sofosbuvir-Velpatasvir",{"pregnancy":179,"lactation":188,"pediatric":196,"geriatric":204,"reproductive":213},{"level":180,"text":181,"quote":184,"refs":185},"caution",{"fa":182,"en":183},"برچسب: منع مصرف فقط برای ترکیب با ریباویرین (در زن باردار و مردی که همسرش باردار است)؛ برای اپکلوسا به‌تنهایی داده کافی نیست.","Label: contraindicated only in combination with ribavirin (pregnant women and men whose partners are pregnant); limited data for Epclusa alone.","Risk Summary If EPCLUSA is administered with ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant.",[186],{"source":34,"section":187},"8.1",{"level":180,"text":189,"quote":192,"refs":193},{"fa":190,"en":191},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","The predominant circulating metabolite of sofosbuvir (GS-331007) was the primary component observed in the milk of lactating rats administered sofosbuvir, without effect on nursing pups.",[194],{"source":34,"section":195},"8.2",{"level":180,"text":197,"quote":200,"refs":201},{"fa":198,"en":199},"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 pharmacokinetics, safety, and effectiveness of EPCLUSA for treatment of HCV genotype 1, 2, 3, 4, or 6 infection in treatment-naïve and treatment-experienced pediatric patients 3 years of age and older without cirrhosis or with compensated cirrhosis have been established in an open-label, multicenter clinical trial …",[202],{"source":34,"section":203},"8.4",{"level":205,"text":206,"quote":209,"refs":210},"ok",{"fa":207,"en":208},"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 EPCLUSA is warranted in geriatric patients [see Clinical Pharmacology (12.3) ] .",[211],{"source":34,"section":212},"8.5",{"level":180,"text":214,"quote":217,"refs":218},{"fa":215,"en":216},"برچسب نکته‌ای درباره بارداری، پیشگیری یا باروری زنان و مردان دارد.","Label has advice on pregnancy testing, contraception or fertility for females and males.","If EPCLUSA is administered with ribavirin, the information for ribavirin with regard to pregnancy testing, contraception, and infertility also applies to this combination regimen.",[219],{"source":34,"section":220},"8.3",{"kind":222,"refs":223,"id":164},"NDA",[224],{"source":34,"section":225},"SPL approval \u002F marketing category",1792108437511]