[{"data":1,"prerenderedAt":229},["ShallowReactive",2],{"drug-nilotinib":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":51,"contraindications":98,"warnings":108,"renal":123,"monitoring":124,"interactions":125,"review":126,"examples":129,"atc":138,"iran":140,"usApproval":164,"links":170,"populations":186},"nilotinib",1,{"fa":7,"en":8},"نیلوتینیب","Nilotinib","antineoplastic-immunomodulating",{"fa":11,"en":12},"مهارکننده تیروزین کیناز BCR-ABL","BCR-ABL tyrosine kinase inhibitor",[14],{"name":15,"market":16},"Tasigna","US",[18,19,7],"tasigna","تاسیگنا",[21,35,43],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"cap-50","capsule","oral","50 mg capsule",{"amount":27,"unit":28,"perUnit":23,"scored":29},50,"mg",false,[16],[32],{"source":33,"section":34},"fda-tasigna","3",{"id":36,"form":23,"route":24,"label":37,"concentration":38,"markets":40,"refs":41},"cap-150","150 mg capsule",{"amount":39,"unit":28,"perUnit":23,"scored":29},150,[16],[42],{"source":33,"section":34},{"id":44,"form":23,"route":24,"label":45,"concentration":46,"markets":48,"refs":49},"cap-200","200 mg capsule",{"amount":47,"unit":28,"perUnit":23,"scored":29},200,[16],[50],{"source":33,"section":34},[52,82],{"id":53,"disease":54,"label":55,"population":58,"type":62,"unit":28,"dose":63,"refs":66,"notes":69},"new","chronic-myeloid-leukemia",{"fa":56,"en":57},"CML فاز مزمن Ph+ تازه بزرگسال — ۳۰۰ mg دو بار در روز (ناشتا)","Newly diagnosed Ph+ chronic-phase CML, adults — 300 mg twice daily (fasting)",{"minAge":59},{"value":60,"unit":61},18,"year","fixed",{"perDose":64,"dosesPerDay":65},300,2,[67],{"source":33,"section":68},"2.1",[70,76],{"text":71,"refs":74},{"fa":72,"en":73},"فقط زیر نظر متخصص انکولوژی؛ ادامه تا پیشرفت بیماری یا سمیت غیرقابل‌قبول. تنظیم دوز برای عوارض و تداخل‌ها طبق برچسب.","Only under an oncologist; continue until progression or unacceptable toxicity. Dose adjustments for toxicity and interactions per label.",[75],{"source":33,"section":68},{"text":77,"refs":80},{"fa":78,"en":79},"هر ۱۲ ساعت؛ ۲ ساعت قبل و ۱ ساعت بعد چیزی خورده نشود. کودک: ۲۳۰ mg\u002Fm² دو بار در روز گرد به نزدیک‌ترین ۵۰ mg (حداکثر ۴۰۰ mg در هر دوز).","Every 12 h; no food for 2 h before and 1 h after. Children: 230 mg\u002Fm² twice daily rounded to nearest 50 mg (max 400 mg per dose).",[81],{"source":33,"section":68},{"id":83,"disease":54,"label":84,"population":87,"type":62,"unit":28,"dose":89,"refs":91,"notes":93},"res",{"fa":85,"en":86},"CML فاز مزمن یا تسریع‌شده مقاوم یا عدم تحمل — ۴۰۰ mg دو بار در روز","Resistant or intolerant chronic- or accelerated-phase CML — 400 mg twice daily",{"minAge":88},{"value":60,"unit":61},{"perDose":90,"dosesPerDay":65},400,[92],{"source":33,"section":68},[94],{"text":95,"refs":96},{"fa":72,"en":73},[97],{"source":33,"section":68},[99],{"id":100,"severity":101,"text":102,"refs":105},"ci","block",{"fa":103,"en":104},"هیپوکالمی، هیپومنیزیمی یا سندرم QT طولانی.","Hypokalaemia, hypomagnesaemia or long QT syndrome.",[106],{"source":33,"section":107},"4",[109,116],{"text":110,"refs":113},{"fa":111,"en":112},"هشدار جعبه‌ای: طولانی شدن QT و مرگ ناگهانی — ECG پایه، ۷ روز بعد و دوره‌ای؛ اصلاح پتاسیم و منیزیم؛ پرهیز از غذا و مهارکننده‌های قوی CYP3A4.","Boxed warning: QT prolongation and sudden deaths — ECG at baseline, day 7 and periodically; correct potassium and magnesium; avoid food and strong CYP3A4 inhibitors.",[114],{"source":33,"section":115},"Boxed Warning",{"text":117,"refs":120},{"fa":118,"en":119},"سرکوب مغز استخوان؛ انسداد عروقی قلبی و شریانی؛ پانکراتیت؛ سمیت کبدی؛ خونریزی؛ احتباس مایع.","Myelosuppression; cardiac and arterial vascular occlusive events; pancreatitis; hepatotoxicity; haemorrhage; fluid retention.",[121],{"source":33,"section":122},"5",[],[],[],{"status":127,"reviewer":128,"date":128},"unverified",null,[130,135],{"regimen":53,"formulation":36,"input":131,"expect":134},{"ageYears":132,"weightKg":133},55,70,{"perDose":64,"tabletsPerDoseRounded":65},{"regimen":83,"formulation":44,"input":136,"expect":137},{"ageYears":132,"weightKg":133},{"perDose":90,"tabletsPerDoseRounded":65},[139],"L01EA03",{"status":141,"forms":142,"refs":159},"registered",[143,147,151,155],{"code":144,"en":145,"fa":146},"12273","NILOTINIB 200MG CAP","کپسول نیلوتینیب ۲۰۰ میلی‌گرم",{"code":148,"en":149,"fa":150},"13251","NILOTINIB 200MG TAB","قرص نیلوتینیب ۲۰۰ میلی‌گرم",{"code":152,"en":153,"fa":154},"11467","NILOTINIB 400MG TAB","قرص نیلوتینیب ۴۰۰ میلی‌گرم",{"code":156,"en":157,"fa":158},"51798","NILOTINIB 150MG CAP","کپسول نیلوتینیب ۱۵۰ میلی‌گرم",[160],{"source":161,"section":162,"url":163},"darooyab-generic","G-4782\u002FNilotinib","https:\u002F\u002Fwww.darooyab.ir\u002FG-4782\u002FNilotinib",{"kind":165,"refs":166,"id":169},"NDA",[167],{"source":33,"section":168},"SPL approval \u002F marketing category","NDA022068",[171,174,178,181,184],{"kind":172,"url":173,"label":169},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=022068",{"kind":175,"url":176,"label":177},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=6093952a-5248-45cb-ad17-33716a411146","FDA Tasigna",{"kind":179,"url":180,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa608002.html",{"kind":182,"url":183,"label":139},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L01EA03",{"kind":185,"url":163,"label":8},"darooyab",{"pregnancy":187,"lactation":196,"pediatric":204,"geriatric":213,"reproductive":221},{"level":188,"text":189,"quote":192,"refs":193},"avoid",{"fa":190,"en":191},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","Risk Summary Based on findings from animal studies and the mechanism of action, Tasigna can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] .",[194],{"source":33,"section":195},"8.1",{"level":188,"text":197,"quote":200,"refs":201},{"fa":198,"en":199},"برچسب: شیردهی توصیه نمی‌شود یا باید بین دارو و شیردهی یکی انتخاب شود.","Label: breastfeeding not recommended, or choose between the drug and breastfeeding.","Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with Tasigna and for 14 days after the last dose.",[202],{"source":33,"section":203},"8.2",{"level":205,"text":206,"quote":209,"refs":210},"caution",{"fa":207,"en":208},"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 Tasigna have been established in pediatric patients greater than or equal to 1 year of age with newly diagnosed and resistant or intolerant Ph+ CML in chronic phase [see Clinical Studies (14.5)] .",[211],{"source":33,"section":212},"8.4",{"level":205,"text":214,"quote":217,"refs":218},{"fa":215,"en":216},"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.","In the clinical trials of Tasigna (patients with newly diagnosed Ph+ CML-CP and resistant or intolerant Ph+ CML-CP and CML-AP), approximately 12% and 30% of patients were 65 years or over, respectively.",[219],{"source":33,"section":220},"8.5",{"level":205,"text":222,"quote":225,"refs":226},{"fa":223,"en":224},"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 females of reproductive potential to use effective contraception during treatment with Tasigna and for 14 days after the last dose.",[227],{"source":33,"section":228},"8.3",1792444413536]