[{"data":1,"prerenderedAt":145},["ShallowReactive",2],{"drug-ruxolitinib-cream":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":33,"contraindications":68,"warnings":69,"renal":77,"monitoring":78,"interactions":79,"review":80,"examples":83,"atc":84,"iran":86,"usApproval":93,"links":99,"populations":110},"ruxolitinib-cream",1,{"fa":7,"en":8},"کرم روکسولیتینیب ۱٫۵٪","Ruxolitinib cream 1.5%","dermatology",{"fa":11,"en":12},"مهارکننده JAK موضعی","Topical JAK inhibitor",[14],{"name":15,"market":16},"Opzelura","US",[18,19,20],"opzelura","اپزلورا","روکسولیتینیب",[22],{"id":23,"form":23,"route":24,"label":25,"concentration":26,"markets":28,"refs":29},"cream","topical","Ruxolitinib 1.5% cream (60 g, 100 g)",{"amount":5,"unit":27,"perUnit":27},"application",[16],[30],{"source":31,"section":32},"fda-opzelura","3",[34,52],{"id":35,"disease":35,"label":36,"population":39,"type":43,"unit":44,"dose":45,"refs":49},"vitiligo",{"fa":37,"en":38},"ویتیلیگوی غیرسگمنتال (۱۲ سال به بالا) — لایه نازک دو بار در روز تا ۱۰٪ سطح بدن","Nonsegmental vitiligo (≥12 y) — thin layer twice daily up to 10% BSA",{"minAge":40},{"value":41,"unit":42},12,"year","notCalculated","mg",{"reason":46},{"fa":47,"en":48},"لایه نازک دو بار در روز روی نواحی درگیر تا ۱۰٪ سطح بدن؛ پانسمان بسته نه؛ حداکثر یک لوله ۶۰ گرمی در هفته یا ۱۰۰ گرمی در ۲ هفته.","Thin layer twice daily to affected areas up to 10% BSA; no occlusion; max one 60 g tube per week or 100 g per 2 weeks.",[50],{"source":31,"section":51},"2.2",{"id":53,"disease":54,"label":55,"population":58,"type":43,"unit":44,"dose":61,"refs":65},"ad","atopic-dermatitis",{"fa":56,"en":57},"درماتیت آتوپیک خفیف تا متوسط — دو بار در روز تا ۲۰٪ سطح بدن","Mild–moderate atopic dermatitis — twice daily up to 20% BSA",{"minAge":59},{"value":60,"unit":42},2,{"reason":62},{"fa":63,"en":64},"لایه نازک دو بار در روز تا ۲۰٪ سطح بدن. ۱۲ سال به بالا: حداکثر ۶۰ g در هفته؛ ۲ تا ۱۱ سال: ۶۰ g در ۲ هفته.","Thin layer twice daily up to 20% BSA. ≥12 y: max 60 g per week; 2–11 y: 60 g per 2 weeks.",[66],{"source":31,"section":67},"2.1",[],[70],{"text":71,"refs":74},{"fa":72,"en":73},"هشدار جعبه‌ای (مهارکننده‌های JAK): عفونت جدی، مرگ، بدخیمی، حوادث قلبی و ترومبوز.","Boxed warning (JAK inhibitors): serious infections, mortality, malignancy, MACE and thrombosis.",[75],{"source":31,"section":76},"Boxed Warning",[],[],[],{"status":81,"reviewer":82,"date":82},"unverified",null,[],[85],"D11AH09",{"status":87,"refs":88},"not-found",[89],{"source":90,"section":91,"url":92},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Ruxolitinib%20cream%201.5%25",{"kind":94,"refs":95,"id":98},"NDA",[96],{"source":31,"section":97},"SPL approval \u002F marketing category","NDA215309",[100,103,107],{"kind":101,"url":102,"label":98},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=215309",{"kind":104,"url":105,"label":106},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=24da5509-6631-4795-9d42-273faecd08e7","FDA Opzelura",{"kind":108,"url":109,"label":85},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=D11AH09",{"pregnancy":111,"lactation":120,"pediatric":129,"geriatric":137},{"level":112,"text":113,"quote":116,"refs":117},"caution",{"fa":114,"en":115},"برچسب خطر مشخصی برای بارداری ذکر نکرده یا داده کافی ندارد؛ فقط در صورت لزوم و با نظر پزشک.","Label states no clear risk or has limited data; use only if needed, under medical advice.","Risk Summary Available data from pregnancies reported in clinical trials with OPZELURA are not sufficient to evaluate a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes.",[118],{"source":31,"section":119},"8.1",{"level":121,"text":122,"quote":125,"refs":126},"avoid",{"fa":123,"en":124},"برچسب: شیردهی توصیه نمی‌شود یا باید بین دارو و شیردهی یکی انتخاب شود.","Label: breastfeeding not recommended, or choose between the drug and breastfeeding.","Because of the serious adverse findings in adults, including risks of serious infections, thrombocytopenia, anemia, and neutropenia, advise women not to breastfeed during treatment with OPZELURA and for approximately four weeks after the last dose (approximately 5‑6 elimination half-lives).",[127],{"source":31,"section":128},"8.2",{"level":112,"text":130,"quote":133,"refs":134},{"fa":131,"en":132},"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.","Atopic Dermatitis The safety and effectiveness of OPZELURA for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis have been established in non-immunocompromised pediatric patients ages 2 years and older whose disease is not adequately controlled with topical prescription …",[135],{"source":31,"section":136},"8.4",{"level":112,"text":138,"quote":141,"refs":142},{"fa":139,"en":140},"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.","Of the 1249 total subjects with atopic dermatitis in clinical trials with OPZELURA, 115 (9%) were 65 years of age and older [see Clinical Studies ( 14.1 ) ] .",[143],{"source":31,"section":144},"8.5",1792115195063]