[{"data":1,"prerenderedAt":198},["ShallowReactive",2],{"drug-ledipasvir-sofosbuvir":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":23,"regimens":45,"contraindications":88,"warnings":98,"renal":113,"monitoring":114,"interactions":115,"review":116,"examples":119,"atc":129,"iran":131,"usApproval":138,"links":144,"populations":155},"ledipasvir-sofosbuvir",1,{"fa":7,"en":8},"لدیپاسویر\u002Fسوفوسبوویر","Ledipasvir\u002Fsofosbuvir","anti-infectives",{"fa":11,"en":12},"ضد ویروس مستقیم HCV","HCV direct-acting antiviral",[14],{"name":15,"market":16},"Harvoni","US",[18,19,20,21,22],"harvoni","هاروونی","ledipasvir","لدیپاسویر","sovodak",[24,37],{"id":25,"form":26,"route":27,"label":28,"concentration":29,"markets":32,"refs":33},"tab-90","tablet","oral","90 mg ledipasvir \u002F 400 mg sofosbuvir tablet",{"amount":30,"unit":31,"perUnit":26},90,"mg",[16],[34],{"source":35,"section":36},"fda-harvoni","3",{"id":38,"form":26,"route":27,"label":39,"concentration":40,"markets":42,"refs":43},"tab-45","45 mg \u002F 200 mg tablet",{"amount":41,"unit":31,"perUnit":26},45,[16],[44],{"source":35,"section":36},[46,75],{"id":47,"disease":48,"label":49,"population":52,"type":57,"unit":31,"dose":58,"refs":59,"doseComponent":20,"notes":64},"hcv","hepatitis-c",{"fa":50,"en":51},"هپاتیت C ژنوتیپ ۱، ۴، ۵، ۶ — یک قرص ۹۰\u002F۴۰۰ mg یک بار (معمولاً ۱۲ هفته)","Hepatitis C genotype 1, 4, 5, 6 — one 90\u002F400 mg tablet once daily (usually 12 weeks)",{"minAge":53,"minWeightKg":56},{"value":54,"unit":55},3,"year",35,"fixed",{"perDose":30,"dosesPerDay":5},[60,62],{"source":35,"section":61},"2.3",{"source":35,"section":63},"2.4, Table 2",[65],{"text":66,"refs":69},{"fa":67,"en":68},"مدت طبق جدول ۱ (۸ تا ۲۴ هفته؛ با یا بدون ریباویرین). کودک ۱۷ تا \u003C۳۵ kg: ۴۵\u002F۲۰۰ mg؛ زیر ۱۷ kg: پلت ۳۳٫۷۵\u002F۱۵۰ mg. نارسایی کلیه تنظیم ندارد.","Duration per Table 1 (8–24 weeks; with or without ribavirin). Children 17–\u003C35 kg: 45\u002F200 mg; \u003C17 kg: 33.75\u002F150 mg pellets. No renal adjustment.",[70,72,73],{"source":35,"section":71},"2.2",{"source":35,"section":63},{"source":35,"section":74},"2.6",{"id":76,"disease":48,"label":77,"population":80,"type":57,"unit":31,"dose":84,"refs":85,"doseComponent":20,"allowedFormulations":87},"child",{"fa":78,"en":79},"کودک ۳ سال به بالا، ۱۷ تا \u003C۳۵ kg — ۴۵\u002F۲۰۰ mg یک بار","Children ≥3 y, 17–\u003C35 kg — 45\u002F200 mg once daily",{"minAge":81,"minWeightKg":82,"maxWeightKg":83},{"value":54,"unit":55},17,34.99,{"perDose":41,"dosesPerDay":5},[86],{"source":35,"section":63},[38],[89],{"id":90,"severity":91,"text":92,"refs":95},"ci","block",{"fa":93,"en":94},"در صورت مصرف همراه ریباویرین، منع مصرف‌های ریباویرین هم صدق می‌کند.","When given with ribavirin, ribavirin contraindications also apply.",[96],{"source":35,"section":97},"4",[99,106],{"text":100,"refs":103},{"fa":101,"en":102},"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.",[104],{"source":35,"section":105},"Boxed Warning",{"text":107,"refs":110},{"fa":108,"en":109},"برادیکاردی شدید علامت‌دار با آمیودارون (همزمان توصیه نمی‌شود)؛ کاهش اثر با القاگرهای P-gp (ریفامپین، گل راعی).","Serious symptomatic bradycardia with amiodarone (not recommended together); reduced effect with P-gp inducers (rifampin, St John’s wort).",[111],{"source":35,"section":112},"5",[],[],[],{"status":117,"reviewer":118,"date":118},"unverified",null,[120,124],{"regimen":47,"formulation":25,"input":121,"expect":123},{"ageYears":41,"weightKg":122},70,{"perDose":30,"tabletsPerDoseRounded":5},{"regimen":76,"formulation":38,"input":125,"expect":128},{"ageYears":126,"weightKg":127},7,25,{"perDose":41,"tabletsPerDoseRounded":5},[130],"J05AP51",{"status":132,"refs":133},"not-found",[134],{"source":135,"section":136,"url":137},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Ledipasvir\u002Fsofosbuvir",{"kind":139,"refs":140,"id":143},"NDA",[141],{"source":35,"section":142},"SPL approval \u002F marketing category","NDA205834",[145,148,152],{"kind":146,"url":147,"label":143},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=205834",{"kind":149,"url":150,"label":151},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=f4ec77e4-bae8-4db0-b3d5-bde09c5fa075","FDA Harvoni",{"kind":153,"url":154,"label":130},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=J05AP51",{"pregnancy":156,"lactation":165,"pediatric":173,"geriatric":181,"reproductive":190},{"level":157,"text":158,"quote":161,"refs":162},"caution",{"fa":159,"en":160},"برچسب: داده انسانی کافی نیست؛ در مطالعات حیوانی عارضه‌ای دیده نشد. همراه ریباویرین در بارداری منع مصرف است.","Label: no adequate human data; no adverse developmental outcomes in animals. With ribavirin the combination is contraindicated in pregnancy.","No adequate human data are available to establish whether or not HARVONI poses a risk to pregnancy outcomes. In animal reproduction studies, no evidence of adverse developmental outcomes was observed with the components of HARVONI.",[163],{"source":35,"section":164},"8.1",{"level":157,"text":166,"quote":169,"refs":170},{"fa":167,"en":168},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","When administered to lactating rats, ledipasvir was detected in the plasma of nursing pups likely due to the presence of ledipasvir in milk, without clear effects on nursing pups [see Data ].",[171],{"source":35,"section":172},"8.2",{"level":157,"text":174,"quote":177,"refs":178},{"fa":175,"en":176},"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, pharmacokinetics, and efficacy of HARVONI for treatment of HCV genotype 1 and 4 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 (Study 1116, …",[179],{"source":35,"section":180},"8.4",{"level":182,"text":183,"quote":186,"refs":187},"ok",{"fa":184,"en":185},"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 HARVONI is warranted in geriatric patients [see Clinical Pharmacology (12.3) ] .",[188],{"source":35,"section":189},"8.5",{"level":157,"text":191,"quote":194,"refs":195},{"fa":192,"en":193},"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 HARVONI is administered with ribavirin, the information for ribavirin with regard to pregnancy testing, contraception, and infertility also applies to this combination regimen.",[196],{"source":35,"section":197},"8.3",1792444406590]