[{"data":1,"prerenderedAt":192},["ShallowReactive",2],{"drug-enzalutamide":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":44,"contraindications":78,"warnings":79,"renal":87,"monitoring":88,"interactions":89,"review":90,"examples":93,"atc":103,"iran":105,"usApproval":125,"links":131,"populations":147},"enzalutamide",1,{"fa":7,"en":8},"انزالوتامید","Enzalutamide","antineoplastic-immunomodulating",{"fa":11,"en":12},"مهارکننده گیرنده آندروژن","Androgen receptor inhibitor",[14],{"name":15,"market":16},"Xtandi","US",[18,19,7],"xtandi","اکستاندی",[21,35],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"cap-40","capsule","oral","40 mg capsule",{"amount":27,"unit":28,"perUnit":23,"scored":29},40,"mg",false,[16],[32],{"source":33,"section":34},"fda-xtandi","3",{"id":36,"form":37,"route":24,"label":38,"concentration":39,"markets":41,"refs":42},"tab-80","tablet","80 mg tablet",{"amount":40,"unit":28,"perUnit":37,"scored":29},80,[16],[43],{"source":33,"section":34},[45],{"id":46,"disease":47,"label":48,"population":51,"type":55,"unit":28,"dose":56,"refs":58,"notes":61},"pc","prostate-cancer",{"fa":49,"en":50},"سرطان پروستات (مقاوم به اخته یا متاستاتیک حساس) — ۱۶۰ mg یک بار","Prostate cancer (castration-resistant or metastatic castration-sensitive) — 160 mg once daily",{"minAge":52},{"value":53,"unit":54},18,"year","fixed",{"perDose":57,"dosesPerDay":5},160,[59],{"source":33,"section":60},"2.1",[62,72],{"text":63,"refs":66},{"fa":64,"en":65},"کامل بلعیده شود. عارضه درجه ۳: یک هفته قطع، سپس همان یا ۱۲۰\u002F۸۰ mg. مهارکننده قوی CYP2C8: ۸۰ mg.","Swallow whole. Grade ≥3 reaction: hold one week, then same or 120\u002F80 mg. Strong CYP2C8 inhibitors: 80 mg.",[67,68,70],{"source":33,"section":60},{"source":33,"section":69},"2.2",{"source":33,"section":71},"2.3",{"text":73,"refs":76},{"fa":74,"en":75},"همراه آنالوگ GnRH یا پس از اورکیکتومی دوطرفه.","With a GnRH analogue or after bilateral orchiectomy.",[77],{"source":33,"section":60},[],[80],{"text":81,"refs":84},{"fa":82,"en":83},"تشنج؛ PRES؛ حساسیت؛ بیماری ایسکمیک قلب؛ زمین خوردن و شکستگی؛ سمیت جنینی؛ اختلال بلع.","Seizure; PRES; hypersensitivity; ischaemic heart disease; falls and fractures; embryo-fetal toxicity; dysphagia\u002Fchoking.",[85],{"source":33,"section":86},"5",[],[],[],{"status":91,"reviewer":92,"date":92},"unverified",null,[94,99],{"regimen":46,"formulation":22,"input":95,"expect":97},{"ageYears":96,"weightKg":40},70,{"perDose":57,"tabletsPerDoseRounded":98},4,{"regimen":46,"formulation":36,"input":100,"expect":101},{"ageYears":96,"weightKg":40},{"perDose":57,"tabletsPerDoseRounded":102},2,[104],"L02BB04",{"status":106,"forms":107,"refs":120},"registered",[108,112,116],{"code":109,"en":110,"fa":111},"53117","ENZALUTAMIDE 40MG TABLET","قرص انزالوتامید ۴۰ میلی‌گرم",{"code":113,"en":114,"fa":115},"53118","ENZALUTAMIDE 80MG TABLET","قرص انزالوتامید ۸۰ میلی‌گرم",{"code":117,"en":118,"fa":119},"22558","ENZALUTAMIDE 40MG SOFTGEL","ژل انزالوتامید ۴۰ میلی‌گرم",[121],{"source":122,"section":123,"url":124},"darooyab-generic","G-5392\u002FEnzalutamide","https:\u002F\u002Fwww.darooyab.ir\u002FG-5392\u002FEnzalutamide",{"kind":126,"refs":127,"id":130},"NDA",[128],{"source":33,"section":129},"SPL approval \u002F marketing category","NDA203415",[132,135,139,142,145],{"kind":133,"url":134,"label":130},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=203415",{"kind":136,"url":137,"label":138},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf","FDA Xtandi",{"kind":140,"url":141,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa612033.html",{"kind":143,"url":144,"label":104},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L02BB04",{"kind":146,"url":124,"label":8},"darooyab",{"pregnancy":148,"lactation":157,"pediatric":166,"geriatric":175,"reproductive":184},{"level":149,"text":150,"quote":153,"refs":154},"avoid",{"fa":151,"en":152},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","Based on animal reproductive studies and mechanism of action, XTANDI can cause fetal harm and loss of pregnancy.",[155],{"source":33,"section":156},"8.1",{"level":158,"text":159,"quote":162,"refs":163},"caution",{"fa":160,"en":161},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary The safety and efficacy of XTANDI have not been established in females.",[164],{"source":33,"section":165},"8.2",{"level":167,"text":168,"quote":171,"refs":172},"not-established",{"fa":169,"en":170},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","Safety and effectiveness of XTANDI in pediatric patients have not been established.",[173],{"source":33,"section":174},"8.4",{"level":176,"text":177,"quote":180,"refs":181},"ok",{"fa":178,"en":179},"برچسب: در سالمندان تفاوت یا تنظیم دوز خاصی ذکر نشده.","Label: no specific difference or dose adjustment stated for older adults.","No overall differences in safety or effectiveness were observed between these patients and younger patients.",[182],{"source":33,"section":183},"8.5",{"level":158,"text":185,"quote":188,"refs":189},{"fa":186,"en":187},"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 Males Based on findings in animal reproduction studies, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of XTANDI [see Use in Specific Populations ( 8.1 )] .",[190],{"source":33,"section":191},"8.3",1792444710221]