[{"data":1,"prerenderedAt":180},["ShallowReactive",2],{"drug-ozanimod":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":34,"contraindications":73,"warnings":83,"renal":91,"monitoring":92,"interactions":93,"review":94,"examples":97,"atc":106,"iran":108,"usApproval":115,"links":121,"populations":137},"ozanimod",1,{"fa":7,"en":8},"اوزانیمود","Ozanimod","antineoplastic-immunomodulating",{"fa":11,"en":12},"تعدیل‌کننده گیرنده S1P","S1P receptor modulator",[14],{"name":15,"market":16},"Zeposia","US",[18,19,7],"zeposia","زپوسیا",[21],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":29,"refs":30},"cap-0-92","capsule","oral","0.92 mg capsule",{"amount":27,"unit":28,"perUnit":23},0.92,"mg",[16],[31],{"source":32,"section":33},"fda-zeposia","3",[35,62],{"id":36,"disease":37,"label":38,"population":41,"type":45,"unit":28,"dose":46,"refs":47,"notes":50},"ms","multiple-sclerosis",{"fa":39,"en":40},"ام‌اس عودکننده بزرگسال — ۰٫۹۲ mg یک بار از روز ۸ پس از تیتراسیون ۷ روزه","Relapsing MS, adults — 0.92 mg once daily from day 8 after a 7-day titration",{"minAge":42},{"value":43,"unit":44},18,"year","fixed",{"perDose":27,"dosesPerDay":5},[48],{"source":32,"section":49},"2.2",[51],{"text":52,"refs":55},{"fa":53,"en":54},"روز ۱–۴: ۰٫۲۳ mg؛ روز ۵–۷: ۰٫۴۶ mg. نارسایی خفیف\u002Fمتوسط کبد: ۰٫۹۲ mg یک روز در میان. فراموشی دوز در ۲ هفته اول: تیتراسیون از نو.","Days 1–4: 0.23 mg; days 5–7: 0.46 mg. Mild\u002Fmoderate hepatic impairment: 0.92 mg every other day. Missed dose in the first 2 weeks: restart titration.",[56,58,60],{"source":32,"section":57},"2.2, Table 1",{"source":32,"section":59},"2.3",{"source":32,"section":61},"2.4",{"id":63,"disease":64,"label":65,"population":68,"type":45,"unit":28,"dose":70,"refs":71},"uc","ulcerative-colitis",{"fa":66,"en":67},"کولیت اولسراتیو متوسط تا شدید بزرگسال — ۰٫۹۲ mg یک بار از روز ۸ پس از تیتراسیون","Moderate–severe ulcerative colitis, adults — 0.92 mg once daily from day 8 after titration",{"minAge":69},{"value":43,"unit":44},{"perDose":27,"dosesPerDay":5},[72],{"source":32,"section":49},[74],{"id":75,"severity":76,"text":77,"refs":80},"ci","block",{"fa":78,"en":79},"در ۶ ماه اخیر: MI، آنژین ناپایدار، سکته، TIA، نارسایی قلب جبران‌نشده یا کلاس III\u002FIV؛ بلوک AV موبیتز II یا درجه ۳ یا سندرم سینوس بیمار بدون پیس‌میکر؛ آپنه خواب شدید درمان‌نشده؛ مهارکننده MAO همزمان.","Within 6 months: MI, unstable angina, stroke, TIA, decompensated or class III\u002FIV heart failure; Mobitz II or third-degree AV block or sick sinus syndrome without a pacemaker; severe untreated sleep apnoea; concomitant MAO inhibitors.",[81],{"source":32,"section":82},"4",[84],{"text":85,"refs":88},{"fa":86,"en":87},"عفونت و PML؛ ادم ماکولا؛ برادی‌آریتمی در شروع؛ اثر تنفسی؛ آسیب کبد؛ سرطان پوست؛ افزایش فشار خون؛ خطر جنینی؛ تشدید شدید ناتوانی پس از قطع.","Infections and PML; macular oedema; bradyarrhythmia at initiation; respiratory effects; liver injury; skin cancer; raised blood pressure; fetal risk; severe disability increase after stopping.",[89],{"source":32,"section":90},"5",[],[],[],{"status":95,"reviewer":96,"date":96},"unverified",null,[98,103],{"regimen":36,"formulation":22,"input":99,"expect":102},{"ageYears":100,"weightKg":101},40,65,{"perDose":27,"tabletsPerDoseRounded":5},{"regimen":63,"formulation":22,"input":104,"expect":105},{"ageYears":100,"weightKg":101},{"perDose":27,"tabletsPerDoseRounded":5},[107],"L04AE02",{"status":109,"refs":110},"registered",[111],{"source":112,"section":113,"url":114},"darooyab-generic","G-5538\u002FOzanimod","https:\u002F\u002Fwww.darooyab.ir\u002FG-5538\u002FOzanimod",{"kind":116,"refs":117,"id":120},"NDA",[118],{"source":32,"section":119},"SPL approval \u002F marketing category","NDA209899",[122,125,129,132,135],{"kind":123,"url":124,"label":120},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=209899",{"kind":126,"url":127,"label":128},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=93ce2fab-edfb-4804-8074-963071de51e4","FDA Zeposia",{"kind":130,"url":131,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa620029.html",{"kind":133,"url":134,"label":107},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L04AE02",{"kind":136,"url":114,"label":8},"darooyab",{"pregnancy":138,"lactation":147,"pediatric":155,"geriatric":164,"reproductive":172},{"level":139,"text":140,"quote":143,"refs":144},"caution",{"fa":141,"en":142},"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 There are no adequate data on the developmental risk associated with the use of ZEPOSIA in pregnant women .",[145],{"source":32,"section":146},"8.1",{"level":139,"text":148,"quote":151,"refs":152},{"fa":149,"en":150},"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 ozanimod in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.",[153],{"source":32,"section":154},"8.2",{"level":156,"text":157,"quote":160,"refs":161},"not-established",{"fa":158,"en":159},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","Safety and effectiveness in pediatric patients have not been established.",[162],{"source":32,"section":163},"8.4",{"level":139,"text":165,"quote":168,"refs":169},{"fa":166,"en":167},"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.","Monitor elderly patients for cardiac and hepatic adverse reactions, because of the greater frequency of reduced cardiac and hepatic function in the elderly population.",[170],{"source":32,"section":171},"8.5",{"level":139,"text":173,"quote":176,"refs":177},{"fa":174,"en":175},"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 Before initiation of ZEPOSIA treatment, women of childbearing potential should be counseled on the potential for a serious risk to the fetus and the need for contraception during treatment with ZEPOSIA [see Use in Specific Populations (8.1) ] .",[178],{"source":32,"section":179},"8.3",1792191558979]