[{"data":1,"prerenderedAt":222},["ShallowReactive",2],{"drug-isavuconazonium":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":22,"regimens":56,"contraindications":111,"warnings":121,"renal":129,"monitoring":130,"interactions":131,"review":132,"examples":135,"atc":145,"iran":147,"usApproval":154,"links":160,"populations":178},"isavuconazonium",1,{"fa":7,"en":8},"ایزاووکونازونیوم (کرسمبا)","Isavuconazonium (isavuconazole)","anti-infectives",{"fa":11,"en":12},"ضدقارچ آزولی","Azole antifungal",[14],{"name":15,"market":16},"Cresemba","US",[18,19,20,21],"cresemba","کرسمبا","isavuconazole","ایزاووکونازول",[23,37,45],{"id":24,"form":25,"route":26,"label":27,"concentration":28,"markets":32,"refs":33},"cap-186","capsule","oral","186 mg capsule (= 100 mg isavuconazole)",{"amount":29,"unit":30,"perUnit":25,"scored":31},186,"mg",false,[16],[34],{"source":35,"section":36},"fda-cresemba","3",{"id":38,"form":25,"route":26,"label":39,"concentration":40,"markets":42,"refs":43},"cap-74","74.5 mg capsule (= 40 mg isavuconazole)",{"amount":41,"unit":30,"perUnit":25,"scored":31},74.5,[16],[44],{"source":35,"section":36},{"id":46,"form":47,"route":48,"label":49,"concentration":50,"markets":53,"refs":54},"vial-372","powder-for-injection","iv","372 mg vial (= 200 mg isavuconazole)",{"amount":51,"unit":30,"perUnit":52},372,"vial",[16],[55],{"source":35,"section":36},[57,79,95],{"id":58,"disease":59,"label":60,"population":63,"type":67,"unit":30,"dose":68,"refs":69,"notes":72},"mucor","mucormycosis",{"fa":61,"en":62},"موکورمایکوزیس تهاجمی — بزرگسال: نگهدارنده ۳۷۲ mg یک بار در روز (پس از بارگذاری)","Invasive mucormycosis — adult: maintenance 372 mg once daily (after loading)",{"minAge":64},{"value":65,"unit":66},18,"year","fixed",{"perDose":51,"dosesPerDay":5},[70],{"source":35,"section":71},"2.2, Table 1",[73],{"text":74,"refs":77},{"fa":75,"en":76},"بارگذاری: ۳۷۲ mg هر ۸ ساعت برای ۶ دوز (۴۸ ساعت)، سپس نگهدارنده یک بار در روز ۱۲ تا ۲۴ ساعت پس از آخرین دوز بارگذاری. ۳۷۲ mg ایزاووکونازونیوم = ۲۰۰ mg ایزاووکونازول.","Loading: 372 mg every 8 h for 6 doses (48 h), then once daily maintenance starting 12–24 h after the last loading dose. 372 mg isavuconazonium = 200 mg isavuconazole.",[78],{"source":35,"section":71},{"id":80,"disease":81,"label":82,"population":85,"type":67,"unit":30,"dose":87,"refs":88,"notes":90},"asperg","invasive-fungal",{"fa":83,"en":84},"آسپرژیلوز تهاجمی — بزرگسال: نگهدارنده ۳۷۲ mg یک بار در روز (پس از بارگذاری)","Invasive aspergillosis — adult: maintenance 372 mg once daily (after loading)",{"minAge":86},{"value":65,"unit":66},{"perDose":51,"dosesPerDay":5},[89],{"source":35,"section":71},[91],{"text":92,"refs":93},{"fa":75,"en":76},[94],{"source":35,"section":71},{"id":96,"disease":59,"label":97,"population":100,"type":103,"unit":30,"dose":104,"refs":108},"child",{"fa":98,"en":99},"کودک (تزریقی از ۱ سال، کپسول از ۶ سال و ۱۶ kg) — دوز بر اساس جدول وزن برچسب","Children (IV from 1 y, capsules from 6 y and 16 kg) — dose per label weight table",{"minAge":101,"maxAge":102},{"value":5,"unit":66},{"value":65,"unit":66},"notCalculated",{"reason":105},{"fa":106,"en":107},"دوز کودک طبق جدول ۲ برچسب بر اساس سن و وزن؛ هیچ دوز بارگذاری یا نگهدارنده از ۳۷۲ mg بیشتر نشود.","Pediatric dose per label Table 2 by age and weight; no loading or maintenance dose may exceed 372 mg.",[109],{"source":35,"section":110},"2.3",[112],{"id":113,"severity":114,"text":115,"refs":118},"ci","block",{"fa":116,"en":117},"حساسیت به ایزاووکونازول؛ مهارکننده قوی CYP3A4 (کتوکونازول، ریتوناویر دوز بالا)؛ القاگر قوی CYP3A4 (ریفامپین، کاربامازپین، گل راعی، باربیتورات طولانی‌اثر)؛ سندرم QT کوتاه خانوادگی.","Hypersensitivity to isavuconazole; strong CYP3A4 inhibitors (ketoconazole, high-dose ritonavir); strong CYP3A4 inducers (rifampin, carbamazepine, St John’s wort, long-acting barbiturates); familial short QT syndrome.",[119],{"source":35,"section":120},"4",[122],{"text":123,"refs":126},{"fa":124,"en":125},"آسیب کبدی جدی (آزمایش کبد در شروع و حین درمان)؛ واکنش انفوزیون؛ آنافیلاکسی.","Serious hepatic reactions (check liver tests at start and during therapy); infusion reactions; anaphylaxis.",[127],{"source":35,"section":128},"5",[],[],[],{"status":133,"reviewer":134,"date":134},"unverified",null,[136,142],{"regimen":58,"formulation":24,"input":137,"expect":140},{"ageYears":138,"weightKg":139},55,75,{"perDose":51,"tabletsPerDoseRounded":141},2,{"regimen":80,"formulation":46,"input":143,"expect":144},{"ageYears":138,"weightKg":139},{"perDose":51},[146],"J02AC05",{"status":148,"refs":149},"not-found",[150],{"source":151,"section":152,"url":153},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Isavuconazonium",{"kind":155,"refs":156,"id":159},"NDA",[157],{"source":35,"section":158},"SPL approval \u002F marketing category","NDA207500",[161,164,168,172,175],{"kind":162,"url":163,"label":159},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=207500",{"kind":165,"url":166,"label":167},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=8f7f73b8-586a-4df0-935f-fecd4696c16c","FDA Cresemba",{"kind":169,"url":170,"label":171},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa615031.html","Isavuconazonium",{"kind":169,"url":173,"label":174},"https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa615030.html","Isavuconazonium Injection",{"kind":176,"url":177,"label":146},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=J02AC05",{"pregnancy":179,"lactation":188,"pediatric":197,"geriatric":205,"reproductive":214},{"level":180,"text":181,"quote":184,"refs":185},"avoid",{"fa":182,"en":183},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","Risk Summary Based on findings from animal studies, CRESEMBA may cause fetal harm when administered to a pregnant woman.",[186],{"source":35,"section":187},"8.1",{"level":189,"text":190,"quote":193,"refs":194},"caution",{"fa":191,"en":192},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary There are no data on the presence of isavuconazole in human milk, the effects on the breastfed infant or the effects on milk production.",[195],{"source":35,"section":196},"8.2",{"level":189,"text":198,"quote":201,"refs":202},{"fa":199,"en":200},"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.","Invasive Aspergillosis The safety and effectiveness of CRESEMBA for injection for the treatment of invasive aspergillosis have been established in pediatric patients 1 year of age and older.",[203],{"source":35,"section":204},"8.4",{"level":206,"text":207,"quote":210,"refs":211},"ok",{"fa":208,"en":209},"برچسب: در سالمندان تفاوت یا تنظیم دوز خاصی ذکر نشده.","Label: no specific difference or dose adjustment stated for older adults.","No dose adjustment of CRESEMBA is needed in elderly patients.",[212],{"source":35,"section":213},"8.5",{"level":189,"text":215,"quote":218,"refs":219},{"fa":216,"en":217},"برچسب نکته‌ای درباره بارداری، پیشگیری یا باروری زنان و مردان دارد.","Label has advice on pregnancy testing, contraception or fertility for females and males.","Contraception CRESEMBA may cause embryo-fetal harm when administered to pregnant women [see Warnings and Precautions ( 5.4 ) and Use in Specific Populations ( 8.1 )].",[220],{"source":35,"section":221},"8.3",1792156183022]