[{"data":1,"prerenderedAt":142},["ShallowReactive",2],{"drug-biktarvy":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":34,"contraindications":57,"warnings":67,"renal":75,"monitoring":76,"interactions":77,"review":78,"examples":81,"atc":82,"iran":84,"usApproval":91,"links":97,"populations":108},"biktarvy",1,{"fa":7,"en":8},"بیکتاروی (بیکتگراویر\u002Fامتریسیتابین\u002FTAF)","Bictegravir\u002Femtricitabine\u002Ftenofovir alafenamide","anti-infectives",{"fa":11,"en":12},"رژیم کامل تک‌قرص HIV","Complete single-tablet HIV regimen",[14],{"name":15,"market":16},"Biktarvy","US",[4,18,19,20],"بیکتاروی","bictegravir","بیکتگراویر",[22],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":29,"refs":30},"tab","tablet","oral","50\u002F200\u002F25 mg tablet (30\u002F120\u002F15 mg for 14–\u003C25 kg)",{"amount":5,"unit":28,"perUnit":24},"application",[16],[31],{"source":32,"section":33},"fda-biktarvy","3",[35],{"id":36,"disease":36,"label":37,"population":40,"type":42,"unit":43,"dose":44,"refs":48},"hiv",{"fa":38,"en":39},"HIV-1 (رژیم کامل) — ≥۲۵ kg: یک قرص ۵۰\u002F۲۰۰\u002F۲۵ mg روزانه؛ ۱۴ تا \u003C۲۵ kg: یک قرص ۳۰\u002F۱۲۰\u002F۱۵ mg","HIV-1 (complete regimen) — ≥25 kg: one 50\u002F200\u002F25 mg tablet daily; 14–\u003C25 kg: one 30\u002F120\u002F15 mg tablet",{"minWeightKg":41},14,"notCalculated","mg",{"reason":45},{"fa":46,"en":47},"یک قرص یک بار در روز با یا بدون غذا؛ ClCr ۳۰ و بالاتر. ClCr ۱۵ تا \u003C۳۰ یا ESRD بدون دیالیز مزمن و نارسایی شدید کبد توصیه نمی‌شود.","One tablet once daily with or without food; CrCl ≥30. Not recommended at CrCl 15–\u003C30, ESRD not on chronic haemodialysis, or severe hepatic impairment.",[49,51,53,55],{"source":32,"section":50},"2.2",{"source":32,"section":52},"2.3",{"source":32,"section":54},"2.5",{"source":32,"section":56},"2.6",[58],{"id":59,"severity":60,"text":61,"refs":64},"ci","block",{"fa":62,"en":63},"دوفتیلید یا ریفامپین همزمان.","Concomitant dofetilide or rifampin.",[65],{"source":32,"section":66},"4",[68],{"text":69,"refs":72},{"fa":70,"en":71},"هشدار جعبه‌ای: تشدید شدید هپاتیت B پس از قطع در عفونت همزمان HBV — پایش کبد چند ماه.","Boxed warning: severe acute exacerbation of hepatitis B after discontinuation in HBV co-infection — monitor the liver for several months.",[73],{"source":32,"section":74},"Boxed Warning",[],[],[],{"status":79,"reviewer":80,"date":80},"unverified",null,[],[83],"J05AR20",{"status":85,"refs":86},"not-found",[87],{"source":88,"section":89,"url":90},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Bictegravir\u002Femtricitabine\u002Ftenofovir%20alafenamide",{"kind":92,"refs":93,"id":96},"NDA",[94],{"source":32,"section":95},"SPL approval \u002F marketing category","NDA210251",[98,101,105],{"kind":99,"url":100,"label":96},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=210251",{"kind":102,"url":103,"label":104},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=664cb8f0-1f65-441b-b0d9-ba3d798be309","FDA Biktarvy",{"kind":106,"url":107,"label":83},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=J05AR20",{"pregnancy":109,"lactation":118,"pediatric":126,"geriatric":134},{"level":110,"text":111,"quote":114,"refs":115},"caution",{"fa":112,"en":113},"برچسب: داده‌های مشاهده‌ای و رجیستری خطر دارویی نقص مادرزادی بزرگ، سقط یا پیامد بد را ثابت نکرده‌اند.","Label: observational and registry data have not established a drug-associated risk of major birth defects, miscarriage or adverse outcomes.","Available data from observational studies and the APR with BIC, FTC and TAF use during pregnancy have not established a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.",[116],{"source":32,"section":117},"8.1",{"level":110,"text":119,"quote":122,"refs":123},{"fa":120,"en":121},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary Data from the published literature report the presence of BIC, FTC, TAF, and tenofovir in human milk.",[124],{"source":32,"section":125},"8.2",{"level":110,"text":127,"quote":130,"refs":131},{"fa":128,"en":129},"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 BIKTARVY have been established as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in pediatric patients weighing at least 14 kg: who have no antiretroviral treatment history, or with an antiretroviral treatment history and not virologically …",[132],{"source":32,"section":133},"8.4",{"level":110,"text":135,"quote":138,"refs":139},{"fa":136,"en":137},"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.","Clinical trials in virologically-suppressed participants (Trials 4449, 1844, and 1878) included 111 participants aged 65 years and over who received BIKTARVY, including 86 patients from an open-label, single-arm trial of participants aged 65 years and over who were switched from their previous antiretroviral regimen …",[140],{"source":32,"section":141},"8.5",1792191528780]