[{"data":1,"prerenderedAt":197},["ShallowReactive",2],{"drug-azacitidine":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":35,"contraindications":71,"warnings":89,"renal":97,"monitoring":98,"interactions":99,"review":100,"examples":103,"atc":111,"iran":113,"links":129,"populations":149,"usApproval":192},"azacitidine",1,{"fa":7,"en":8},"آزاسیتیدین","Azacitidine","antineoplastic-immunomodulating",{"fa":11,"en":12},"عامل هیپومتیله‌کننده","Hypomethylating agent",[14],{"name":15,"market":16},"Vidaza","US",[18,19,7],"vidaza","ویدازا",[21],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"vial-100","powder-for-injection","sc","100 mg vial (25 mg\u002FmL after reconstitution for SC)",{"amount":27,"unit":28,"perUnit":29},100,"mg","vial",[16],[32],{"source":33,"section":34},"fda-vidaza","3",[36],{"id":37,"disease":38,"label":39,"population":42,"type":46,"unit":28,"dose":47,"refs":49,"durationDays":54,"notes":56},"mds","myelodysplastic-syndrome",{"fa":40,"en":41},"سندرم میلودیسپلاستیک بزرگسال — ۷۵ mg\u002Fm² زیرجلدی یا وریدی روزانه ۷ روز، هر ۴ هفته","Myelodysplastic syndromes, adults — 75 mg\u002Fm² SC or IV daily for 7 days every 4 weeks",{"minAge":43},{"value":44,"unit":45},18,"year","bsa",{"perM2PerDay":48,"dividedDoses":5},75,[50,52],{"source":33,"section":51},"2.2",{"source":33,"section":53},"2.3",{"min":55,"max":55},7,[57,63],{"text":58,"refs":61},{"fa":59,"en":60},"فقط زیر نظر پزشک متخصص شیمی‌درمانی و در مرکز مجهز. عدد ماشین‌حساب = mg\u002Fm² برچسب × سطح بدن (Mosteller)؛ پروتکل، فاصله دوره‌ها، تنظیم بر اساس CBC و عملکرد کلیه\u002Fکبد با تیم انکولوژی.","Only under an oncologist in an equipped centre. Calculator = label mg\u002Fm² × BSA (Mosteller); protocol, cycle interval and adjustment for CBC and renal\u002Fhepatic function rest with the oncology team.",[62],{"source":33,"section":51},{"text":64,"refs":67},{"fa":65,"en":66},"پس از ۲ دوره بدون پاسخ و بدون سمیت (جز تهوع) تا ۱۰۰ mg\u002Fm². حداقل ۴ تا ۶ دوره. با آزاسیتیدین خوراکی جایگزین نشود.","May increase to 100 mg\u002Fm² after 2 cycles without benefit or toxicity (other than nausea). At least 4–6 cycles. Not interchangeable with oral azacitidine.",[68,69],{"source":33,"section":53},{"source":33,"section":70},"2.1",[72,81],{"id":73,"severity":74,"text":75,"refs":78},"liver","block",{"fa":76,"en":77},"تومورهای بدخیم پیشرفته کبد.","Advanced malignant hepatic tumours.",[79],{"source":33,"section":80},"4.1",{"id":82,"severity":74,"text":83,"refs":86},"hyper",{"fa":84,"en":85},"حساسیت به آزاسیتیدین یا مانیتول.","Hypersensitivity to azacitidine or mannitol.",[87],{"source":33,"section":88},"4.2",[90],{"text":91,"refs":94},{"fa":92,"en":93},"کم‌خونی، نوتروپنی و ترومبوسیتوپنی؛ سمیت کبدی در نارسایی شدید کبد؛ سمیت کلیه؛ سندرم لیز تومور؛ سمیت جنینی.","Anaemia, neutropenia and thrombocytopenia; hepatotoxicity with severe hepatic impairment; renal toxicity; tumour lysis syndrome; embryo-fetal toxicity.",[95],{"source":33,"section":96},"5",[],[],[],{"status":101,"reviewer":102,"date":102},"unverified",null,[104],{"regimen":37,"formulation":22,"input":105,"expect":109},{"ageYears":106,"weightKg":107,"heightCm":108},70,80,180,{"perDose":110},150,[112],"L01BC07",{"status":114,"forms":115,"refs":124},"registered",[116,120],{"code":117,"en":118,"fa":119},"09486","AZACITIDINE 100MG AMP","آمپول آزاسیتیدین ۱۰۰ میلی‌گرم",{"code":121,"en":122,"fa":123},"15946","AZACITIDINE 25MG AMP","آمپول آزاسیتیدین ۲۵ میلی‌گرم",[125],{"source":126,"section":127,"url":128},"darooyab-generic","G-949\u002FAzacitidine","https:\u002F\u002Fwww.darooyab.ir\u002FG-949\u002FAzacitidine",[130,134,138,141,144,147],{"kind":131,"url":132,"label":133},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=050794","NDA050794",{"kind":135,"url":136,"label":137},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=3495a71a-cc04-4776-851f-f185956f32af","FDA Vidaza",{"kind":139,"url":140,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa620060.html",{"kind":139,"url":142,"label":143},"https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa607068.html","Azacitidine Injection",{"kind":145,"url":146,"label":112},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L01BC07",{"kind":148,"url":128,"label":8},"darooyab",{"pregnancy":150,"lactation":159,"pediatric":167,"geriatric":176,"reproductive":184},{"level":151,"text":152,"quote":155,"refs":156},"avoid",{"fa":153,"en":154},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","Risk Summary Based on its mechanism of action and findings in animals, VIDAZA can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )].",[157],{"source":33,"section":158},"8.1",{"level":151,"text":160,"quote":163,"refs":164},{"fa":161,"en":162},"برچسب: شیردهی توصیه نمی‌شود یا باید بین دارو و شیردهی یکی انتخاب شود.","Label: breastfeeding not recommended, or choose between the drug and breastfeeding.","… s [see Nonclinical Toxicology ( 13.1 )] and the potential for serious adverse reactions in nursing infants from VIDAZA, advise patients not to breastfeed during treatment with VIDAZA and for 1 week after the last dose.",[165],{"source":33,"section":166},"8.2",{"level":168,"text":169,"quote":172,"refs":173},"caution",{"fa":170,"en":171},"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 safety and effectiveness of VIDAZA have been established in pediatric patients with newly diagnosed JMML aged 1 month and older and the information on this use is discussed throughout the labeling.",[174],{"source":33,"section":175},"8.4",{"level":168,"text":177,"quote":180,"refs":181},{"fa":178,"en":179},"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 renal function in these patients [see Dosage and Administration ( 2.7 ) and Warnings and Precautions ( 5.4 )].",[182],{"source":33,"section":183},"8.5",{"level":168,"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 Females Advise pregnant women of the potential risk to a fetus.",[190],{"source":33,"section":191},"8.3",{"kind":193,"refs":194,"id":133},"NDA",[195],{"source":33,"section":196},"SPL approval \u002F marketing category",1792444379654]