[{"data":1,"prerenderedAt":153},["ShallowReactive",2],{"drug-cabenuva":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":34,"contraindications":58,"warnings":68,"renal":76,"monitoring":77,"interactions":78,"review":79,"examples":82,"atc":83,"iran":86,"usApproval":93,"links":99,"populations":119},"cabenuva",1,{"fa":7,"en":8},"کابنوا (کابوتگراویر + ریلپیویرین تزریقی)","Cabotegravir\u002Frilpivirine long-acting injection","anti-infectives",{"fa":11,"en":12},"رژیم تزریقی طولانی‌اثر HIV","Long-acting injectable HIV regimen",[14],{"name":15,"market":16},"Cabenuva","US",[4,18,19,20],"کابنوا","cabotegravir","کابوتگراویر",[22],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":29,"refs":30},"kit","injection","im","Kit: cabotegravir 600 mg\u002F3 mL + rilpivirine 900 mg\u002F3 mL (or 400\u002F600 mg)",{"amount":5,"unit":28,"perUnit":28},"application",[16],[31],{"source":32,"section":33},"fda-cabenuva","3",[35],{"id":36,"disease":36,"label":37,"population":40,"type":45,"unit":46,"dose":47,"refs":51},"hiv",{"fa":38,"en":39},"HIV-1 سرکوب‌شده (≥۱۲ سال، ≥۳۵ kg) — تزریق گلوتئال ماهانه یا هر ۲ ماه توسط کادر درمان","Virologically suppressed HIV-1 (≥12 y, ≥35 kg) — gluteal IM injections monthly or every 2 months by a healthcare provider",{"minAge":41,"minWeightKg":44},{"value":42,"unit":43},12,"year",35,"notCalculated","mg",{"reason":48},{"fa":49,"en":50},"شروع: کابوتگراویر ۶۰۰ mg + ریلپیویرین ۹۰۰ mg. ماهانه: سپس ۴۰۰\u002F۶۰۰ mg هر ماه. هر ۲ ماه: ۶۰۰\u002F۹۰۰ mg ماه ۱ و ۲، سپس هر ۲ ماه. دو تزریق جداگانه در دو طرف باسن. شروع خوراکی اختیاری.","Initiation: cabotegravir 600 mg + rilpivirine 900 mg. Monthly: then 400\u002F600 mg every month. Every 2 months: 600\u002F900 mg at months 1 and 2, then every 2 months. Two separate gluteal injections. Optional oral lead-in.",[52,54,56],{"source":32,"section":53},"2.4",{"source":32,"section":55},"2.5",{"source":32,"section":57},"2.3",[59],{"id":60,"severity":61,"text":62,"refs":65},"ci","block",{"fa":63,"en":64},"حساسیت قبلی به کابوتگراویر یا ریلپیویرین؛ القاگرهای UGT1A1 یا CYP3A (کاربامازپین، اکس‌کاربازپین، فنوباربیتال، فنی‌توئین، ریفابوتین، ریفامپین، ریفاپنتین، دگزامتازون، گل راعی).","Prior hypersensitivity to cabotegravir or rilpivirine; UGT1A1\u002FCYP3A inducers (carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, dexamethasone, St John’s wort).",[66],{"source":32,"section":67},"4",[69],{"text":70,"refs":73},{"fa":71,"en":72},"واکنش پس از تزریق (مشابه مسمومیت ریلپیویرین)؛ واکنش حساسیتی؛ سمیت کبد؛ افسردگی؛ اثر طولانی تا ۱۲ ماه پس از قطع.","Post-injection reactions (rilpivirine-like toxicity); hypersensitivity; hepatotoxicity; depression; long-acting exposure up to 12 months after stopping.",[74],{"source":32,"section":75},"5",[],[],[],{"status":80,"reviewer":81,"date":81},"unverified",null,[],[84,85],"J05AJ04","J05AG05",{"status":87,"refs":88},"not-found",[89],{"source":90,"section":91,"url":92},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Cabotegravir\u002Frilpivirine%20long-acting%20injection",{"kind":94,"refs":95,"id":98},"NDA",[96],{"source":32,"section":97},"SPL approval \u002F marketing category","NDA212888",[100,103,107,111,114,117],{"kind":101,"url":102,"label":98},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=212888",{"kind":104,"url":105,"label":106},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=1698baf3-f895-4c42-a1b1-e9ee3f20da36","FDA Cabenuva",{"kind":108,"url":109,"label":110},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa621010.html","Cabotegravir",{"kind":108,"url":112,"label":113},"https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa621009.html","Cabotegravir and Rilpivirine Injection",{"kind":115,"url":116,"label":84},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=J05AJ04",{"kind":115,"url":118,"label":85},"https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=J05AG05",{"pregnancy":120,"lactation":129,"pediatric":137,"geriatric":145},{"level":121,"text":122,"quote":125,"refs":126},"caution",{"fa":123,"en":124},"برچسب: داده انسانی کافی نیست؛ سود و خطر با فرد بارور یا باردار بحث شود (دارو تا ۱۲ ماه در گردش خون می‌ماند).","Label: insufficient human data; discuss benefit-risk with people who could become or are pregnant (drug persists up to 12 months).","There are insufficient human data on the use of CABENUVA during pregnancy to adequately assess a drug-associated risk of birth defects and miscarriage. Discuss the benefit-risk of using CABENUVA with individuals of childbearing potential or during pregnancy.",[127],{"source":32,"section":128},"8.1",{"level":121,"text":130,"quote":133,"refs":134},{"fa":131,"en":132},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary Based on limited data after oral administration, rilpivirine is present in human breast milk.",[135],{"source":32,"section":136},"8.2",{"level":121,"text":138,"quote":141,"refs":142},{"fa":139,"en":140},"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 CABENUVA have been established in adolescents aged 12 to younger than 18 years and weighing at least 35 kg, which is supported by the following: • Trials in adults [see Clinical Studies ( 14.1 )] • MOCHA (NCT03497676) trial in adolescents, in which virologically suppressed adolescents …",[143],{"source":32,"section":144},"8.4",{"level":121,"text":146,"quote":149,"refs":150},{"fa":147,"en":148},"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.","In general, caution should be exercised in administration of CABENUVA in elderly patients, reflecting greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy [see Clinical Pharmacology ( 12.3 )] .",[151],{"source":32,"section":152},"8.5",1792191530353]