[{"data":1,"prerenderedAt":161},["ShallowReactive",2],{"drug-fezolinetant":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":35,"contraindications":60,"warnings":70,"renal":77,"monitoring":78,"interactions":79,"review":87,"examples":90,"atc":96,"iran":98,"links":105,"populations":122,"usApproval":156},"fezolinetant",1,{"fa":7,"en":8},"فزولینتانت","Fezolinetant","genitourinary-sex-hormones",{"fa":11,"en":12},"آنتاگونیست گیرنده نوروکینین ۳ (گرگرفتگی یائسگی)","Neurokinin-3 receptor antagonist (menopausal hot flushes)",[14],{"name":15,"market":16},"Veozah","US",[18,7,19],"veozah","گرگرفتگی",[21],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"tab-45","tablet","oral","45 mg tablet",{"amount":27,"unit":28,"perUnit":23,"scored":29},45,"mg",false,[16],[32],{"source":33,"section":34},"fda-veozah","3",[36],{"id":37,"disease":38,"label":39,"population":42,"type":46,"unit":28,"dose":47,"refs":48,"notes":51},"vms","menopause-symptoms",{"fa":40,"en":41},"گرگرفتگی متوسط تا شدید یائسگی — ۴۵ mg یک بار در روز","Moderate–severe menopausal hot flushes — 45 mg once daily",{"minAge":43},{"value":44,"unit":45},18,"year","fixed",{"perDose":27,"dosesPerDay":5},[49],{"source":33,"section":50},"2.1",[52],{"text":53,"refs":56},{"fa":54,"en":55},"پیش از شروع آزمایش کبد؛ اگر ALT یا AST ≥ ۲ برابر حد بالا یا بیلی‌روبین ≥ ۲ برابر، شروع نشود. پایش ماهانه در ۳ ماه اول و سپس ماه ۶ و ۹. قرص کامل بلعیده شود.","Liver tests before starting; do not start if ALT or AST ≥2× ULN or bilirubin ≥2× ULN. Monitor monthly for 3 months, then at 6 and 9 months. Swallow whole.",[57,58],{"source":33,"section":50},{"source":33,"section":59},"Boxed Warning",[61],{"id":62,"severity":63,"text":64,"refs":67},"ci","block",{"fa":65,"en":66},"سیروز؛ نارسایی شدید کلیه یا ESRD؛ مصرف همزمان مهارکننده‌های CYP1A2.","Cirrhosis; severe renal impairment or ESRD; concomitant CYP1A2 inhibitors.",[68],{"source":33,"section":69},"4",[71],{"text":72,"refs":75},{"fa":73,"en":74},"هشدار جعبه‌ای: سمیت کبدی؛ با علائم آسیب کبد فوراً قطع شود.","Boxed warning: hepatotoxicity; stop immediately with signs of liver injury.",[76],{"source":33,"section":59},[],[],[80],{"with":81,"text":82,"refs":85},"cyp1a2",{"fa":83,"en":84},"مهارکننده‌های CYP1A2 (مثل فلووکسامین، سیپروفلوکساسین) — ممنوع.","CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) — contraindicated.",[86],{"source":33,"section":69},{"status":88,"reviewer":89,"date":89},"unverified",null,[91],{"regimen":37,"formulation":22,"input":92,"expect":95},{"ageYears":93,"weightKg":94},52,70,{"perDose":27,"tabletsPerDoseRounded":5},[97],"G02CX06",{"status":99,"refs":100},"registered",[101],{"source":102,"section":103,"url":104},"darooyab-generic","G-5576\u002FFezolinetant","https:\u002F\u002Fwww.darooyab.ir\u002FG-5576\u002FFezolinetant",[106,110,114,117,120],{"kind":107,"url":108,"label":109},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=216578","NDA216578",{"kind":111,"url":112,"label":113},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=cae9f798-24f9-4580-a4fc-e6c710cbda3c","FDA Veozah",{"kind":115,"url":116,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa623051.html",{"kind":118,"url":119,"label":97},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=G02CX06",{"kind":121,"url":104,"label":8},"darooyab",{"pregnancy":123,"lactation":132,"pediatric":140,"geriatric":148},{"level":124,"text":125,"quote":128,"refs":129},"caution",{"fa":126,"en":127},"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 data on VEOZAH use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.",[130],{"source":33,"section":131},"8.1",{"level":124,"text":133,"quote":136,"refs":137},{"fa":134,"en":135},"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 fezolinetant in human milk, the effects on the breastfed child, or the effects on milk production.",[138],{"source":33,"section":139},"8.2",{"level":124,"text":141,"quote":144,"refs":145},{"fa":142,"en":143},"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 efficacy and safety of VEOZAH in individuals less than 18 years of age have not been established.",[146],{"source":33,"section":147},"8.4",{"level":124,"text":149,"quote":152,"refs":153},{"fa":150,"en":151},"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.","There have not been sufficient numbers of geriatric women involved in clinical trials utilizing VEOZAH to determine whether those over 65 years of age differ from younger women in their response to VEOZAH.",[154],{"source":33,"section":155},"8.5",{"kind":157,"refs":158,"id":109},"NDA",[159],{"source":33,"section":160},"SPL approval \u002F marketing category",1792111454138]