[{"data":1,"prerenderedAt":189},["ShallowReactive",2],{"drug-abiraterone":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":43,"contraindications":78,"warnings":79,"renal":87,"monitoring":88,"interactions":89,"review":90,"examples":93,"atc":100,"iran":102,"links":118,"populations":139,"usApproval":184},"abiraterone",1,{"fa":7,"en":8},"آبیراترون","Abiraterone acetate","antineoplastic-immunomodulating",{"fa":11,"en":12},"مهارکننده CYP17","CYP17 inhibitor",[14],{"name":15,"market":16},"Zytiga","US",[18,19,7],"zytiga","زایتیگا",[21,35],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"tab-500","tablet","oral","500 mg film-coated tablet",{"amount":27,"unit":28,"perUnit":23,"scored":29},500,"mg",false,[16],[32],{"source":33,"section":34},"fda-zytiga","3",{"id":36,"form":23,"route":24,"label":37,"concentration":38,"markets":40,"refs":41},"tab-250","250 mg tablet",{"amount":39,"unit":28,"perUnit":23,"scored":29},250,[16],[42],{"source":33,"section":34},[44],{"id":45,"disease":46,"label":47,"population":50,"type":54,"unit":28,"dose":55,"refs":57,"notes":60},"crpc","prostate-cancer",{"fa":48,"en":49},"سرطان پروستات متاستاتیک مقاوم به اخته — ۱۰۰۰ mg یک بار ناشتا با پردنیزون ۵ mg دو بار","Metastatic castration-resistant prostate cancer — 1000 mg once daily on an empty stomach with prednisone 5 mg twice daily",{"minAge":51},{"value":52,"unit":53},18,"year","fixed",{"perDose":56,"dosesPerDay":5},1000,[58],{"source":33,"section":59},"2.1",[61,72],{"text":62,"refs":65},{"fa":63,"en":64},"حساس به اخته پرخطر: پردنیزون ۵ mg یک بار. ۲ ساعت قبل و ۱ ساعت بعد غذا نخورد. با القاگر قوی CYP3A4 دو بار در روز.","High-risk castration-sensitive: prednisone 5 mg once daily. No food 2 h before and 1 h after. With strong CYP3A4 inducers twice daily.",[66,68,70],{"source":33,"section":67},"2.2",{"source":33,"section":69},"2",{"source":33,"section":71},"2.5",{"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":69},[],[80],{"text":81,"refs":84},{"fa":82,"en":83},"هیپوکالمی، احتباس مایع و عوارض قلبی (اضافه مینرالوکورتیکوئید)؛ نارسایی آدرنال؛ سمیت کبد (آزمایش قبل و حین)؛ شکستگی و مرگ بیشتر با رادیوم-۲۲۳؛ هیپوگلیسمی.","Hypokalaemia, fluid retention and cardiovascular events (mineralocorticoid excess); adrenal insufficiency; hepatotoxicity (tests before and during); more fractures and deaths with radium-223; hypoglycaemia.",[85],{"source":33,"section":86},"5",[],[],[],{"status":91,"reviewer":92,"date":92},"unverified",null,[94],{"regimen":45,"formulation":22,"input":95,"expect":98},{"ageYears":96,"weightKg":97},70,80,{"perDose":56,"tabletsPerDoseRounded":99},2,[101],"L02BX03",{"status":103,"forms":104,"refs":113},"registered",[105,109],{"code":106,"en":107,"fa":108},"19011","ABIRATERON 250MG TAB","قرص آبیراترون ۲۵۰ میلی‌گرم",{"code":110,"en":111,"fa":112},"52063","ABIRATERON 500MG TAB","قرص آبیراترون ۵۰۰ میلی‌گرم",[114],{"source":115,"section":116,"url":117},"darooyab-generic","G-4866\u002FAbiraterone","https:\u002F\u002Fwww.darooyab.ir\u002FG-4866\u002FAbiraterone",[119,123,127,131,134,137],{"kind":120,"url":121,"label":122},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=202379","NDA202379",{"kind":124,"url":125,"label":126},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=4e338e89-3cf2-48eb-b6e2-a06c608c6513","FDA Zytiga",{"kind":128,"url":129,"label":130},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa611046.html","Abiraterone",{"kind":128,"url":132,"label":133},"https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa623037.html","Niraparib and Abiraterone",{"kind":135,"url":136,"label":101},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L02BX03",{"kind":138,"url":117,"label":130},"darooyab",{"pregnancy":140,"lactation":149,"pediatric":158,"geriatric":167,"reproductive":176},{"level":141,"text":142,"quote":145,"refs":146},"avoid",{"fa":143,"en":144},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","Based on findings from animal studies and the mechanism of action, ZYTIGA can cause fetal harm and potential loss of pregnancy.",[147],{"source":33,"section":148},"8.1",{"level":150,"text":151,"quote":154,"refs":155},"caution",{"fa":152,"en":153},"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 ZYTIGA have not been established in females.",[156],{"source":33,"section":157},"8.2",{"level":159,"text":160,"quote":163,"refs":164},"not-established",{"fa":161,"en":162},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","Safety and effectiveness of ZYTIGA in pediatric patients have not been established.",[165],{"source":33,"section":166},"8.4",{"level":168,"text":169,"quote":172,"refs":173},"ok",{"fa":170,"en":171},"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 elderly patients and younger patients.",[174],{"source":33,"section":175},"8.5",{"level":150,"text":177,"quote":180,"refs":181},{"fa":178,"en":179},"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 and its mechanism of action, advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 weeks after the final dose of ZYTIGA [see Use in Specific Populations (8.1) ] .",[182],{"source":33,"section":183},"8.3",{"kind":185,"refs":186,"id":122},"NDA",[187],{"source":33,"section":188},"SPL approval \u002F marketing category",1792444374838]