[{"data":1,"prerenderedAt":287},["ShallowReactive",2],{"drug-imatinib":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":44,"contraindications":156,"warnings":157,"renal":165,"monitoring":166,"interactions":167,"review":168,"examples":171,"atc":192,"iran":194,"usApproval":222,"links":228,"populations":244},"imatinib",1,{"fa":7,"en":8},"ایماتینیب","Imatinib","antineoplastic-immunomodulating",{"fa":11,"en":12},"مهارکننده تیروزین کیناز BCR-ABL","BCR-ABL tyrosine kinase inhibitor",[14],{"name":15,"market":16},"Gleevec","US",[18,19,20,7],"gleevec","glivec","گلیوک",[22,36],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":31,"refs":32},"tab-100","tablet","oral","100 mg tablet (scored)",{"amount":28,"unit":29,"perUnit":24,"scored":30},100,"mg",true,[16],[33],{"source":34,"section":35},"fda-imatinib","3",{"id":37,"form":24,"route":25,"label":38,"concentration":39,"markets":41,"refs":42},"tab-400","400 mg tablet (scored)",{"amount":40,"unit":29,"perUnit":24,"scored":30},400,[16],[43],{"source":34,"section":35},[45,77,98,126],{"id":46,"disease":47,"label":48,"population":51,"type":55,"unit":29,"dose":56,"refs":57,"notes":60},"cml-cp","cml",{"fa":49,"en":50},"CML فاز مزمن — بزرگسال ۴۰۰ mg یک بار در روز","CML chronic phase — adult 400 mg once daily",{"minAge":52},{"value":53,"unit":54},18,"year","fixed",{"perDose":40,"dosesPerDay":5},[58],{"source":34,"section":59},"2.2",[61,68],{"text":62,"refs":65},{"fa":63,"en":64},"فقط زیر نظر متخصص انکولوژی؛ دوز بر اساس پاسخ و عوارض تنظیم می‌شود.","Only under an oncologist; dose is adjusted by response and toxicity.",[66],{"source":34,"section":67},"2",{"text":69,"refs":72},{"fa":70,"en":71},"با غذا و یک لیوان پر آب. ۴۰۰ و ۶۰۰ mg یک بار؛ ۸۰۰ mg به‌صورت ۴۰۰ mg دو بار. با القاگر قوی CYP3A4 دست‌کم ۵۰٪ افزایش.","With a meal and a large glass of water. 400 and 600 mg once daily; 800 mg as 400 mg twice daily. With strong CYP3A4 inducers increase by at least 50%.",[73,75],{"source":34,"section":74},"2.1",{"source":34,"section":76},"2.12",{"id":78,"disease":47,"label":79,"population":82,"type":55,"unit":29,"dose":84,"refs":86,"notes":88},"cml-ap",{"fa":80,"en":81},"CML فاز تسریع یا بلاستی — بزرگسال ۶۰۰ mg یک بار در روز","CML accelerated phase or blast crisis — adult 600 mg once daily",{"minAge":83},{"value":53,"unit":54},{"perDose":85,"dosesPerDay":5},600,[87],{"source":34,"section":59},[89,93],{"text":90,"refs":91},{"fa":63,"en":64},[92],{"source":34,"section":67},{"text":94,"refs":95},{"fa":70,"en":71},[96,97],{"source":34,"section":74},{"source":34,"section":76},{"id":99,"disease":47,"label":100,"population":103,"type":106,"unit":29,"dose":107,"refs":109,"limits":112,"notes":115},"cml-child",{"fa":101,"en":102},"CML کودک (۱ سال به بالا) — ۳۴۰ mg\u002Fm²\u002Fروز (حداکثر ۶۰۰ mg)","Pediatric CML (≥1 y) — 340 mg\u002Fm²\u002Fday (max 600 mg)",{"minAge":104,"maxAge":105},{"value":5,"unit":54},{"value":53,"unit":54},"bsa",{"perM2PerDay":108,"dividedDoses":5},340,[110],{"source":34,"section":111},"2.3",{"maxPerDay":85,"refs":113},[114],{"source":34,"section":111},[116,120],{"text":117,"refs":118},{"fa":63,"en":64},[119],{"source":34,"section":67},{"text":121,"refs":124},{"fa":122,"en":123},"یک بار یا تقسیم در دو نوبت صبح و عصر.","Once daily or split into morning and evening doses.",[125],{"source":34,"section":111},{"id":127,"disease":47,"label":128,"population":131,"type":55,"unit":29,"dose":133,"refs":134,"notes":139},"gist",{"fa":129,"en":130},"GIST متاستاتیک یا کمکی — بزرگسال ۴۰۰ mg یک بار در روز","Metastatic or adjuvant GIST — adult 400 mg once daily",{"minAge":132},{"value":53,"unit":54},{"perDose":40,"dosesPerDay":5},[135,137],{"source":34,"section":136},"2.10",{"source":34,"section":138},"2.11",[140,144,149],{"text":141,"refs":142},{"fa":63,"en":64},[143],{"source":34,"section":67},{"text":145,"refs":146},{"fa":70,"en":71},[147,148],{"source":34,"section":74},{"source":34,"section":76},{"text":150,"refs":153},{"fa":151,"en":152},"کمکی: ۳ سال. پیشرفت در GIST متاستاتیک: تا ۸۰۰ mg (۴۰۰ دو بار).","Adjuvant: 3 years. Progression in metastatic GIST: up to 800 mg (400 twice daily).",[154,155],{"source":34,"section":136},{"source":34,"section":138},[],[158],{"text":159,"refs":162},{"fa":160,"en":161},"احتباس مایع و ادم؛ سرکوب مغز استخوان (CBC هفتگی ماه اول)؛ سمیت کبد؛ نارسایی قلب؛ آسیب جنینی.","Fluid retention and oedema; myelosuppression (weekly CBC in month 1); hepatotoxicity; heart failure; embryo-fetal toxicity.",[163],{"source":34,"section":164},"5",[],[],[],{"status":169,"reviewer":170,"date":170},"unverified",null,[172,177,181,187],{"regimen":46,"formulation":37,"input":173,"expect":176},{"ageYears":174,"weightKg":175},50,70,{"perDose":40,"tabletsPerDoseRounded":5},{"regimen":78,"formulation":23,"input":178,"expect":179},{"ageYears":174,"weightKg":175},{"perDose":85,"tabletsPerDoseRounded":180},6,{"regimen":99,"formulation":23,"input":182,"expect":185},{"ageYears":183,"weightKg":184,"heightCm":28},10,36,{"perDose":108,"tabletsPerDoseRounded":186},3.5,{"regimen":127,"formulation":37,"input":188,"expect":191},{"ageYears":189,"weightKg":190},60,75,{"perDose":40,"tabletsPerDoseRounded":5},[193],"L01EA01",{"status":195,"forms":196,"refs":217},"registered",[197,201,205,209,213],{"code":198,"en":199,"fa":200},"02289","IMATINIB MESYLATE 100MG CAP","کپسول ایماتینیب مزیلات ۱۰۰ میلی‌گرم",{"code":202,"en":203,"fa":204},"04840","IMATINIB MESYLATE 100MG TAB","قرص ایماتینیب مزیلات ۱۰۰ میلی‌گرم",{"code":206,"en":207,"fa":208},"02288","IMATINIB MESYLATE 50MG CAP","کپسول ایماتینیب مزیلات ۵۰ میلی‌گرم",{"code":210,"en":211,"fa":212},"23155","IMATINIB TABLET 400 mg","قرص ایماتینیب ۴۰۰ میلی‌گرم",{"code":214,"en":215,"fa":216},"51979","IMATINIB MESYLATE 400MG CAP","کپسول ایماتینیب مزیلات ۴۰۰ میلی‌گرم",[218],{"source":219,"section":220,"url":221},"darooyab-generic","G-1016\u002FImatinib","https:\u002F\u002Fwww.darooyab.ir\u002FG-1016\u002FImatinib",{"kind":223,"refs":224,"id":227},"ANDA",[225],{"source":34,"section":226},"SPL approval \u002F marketing category","ANDA212773",[229,232,236,239,242],{"kind":230,"url":231,"label":227},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=212773",{"kind":233,"url":234,"label":235},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=c0611fc0-b217-4988-acd4-b8c629ce489b","FDA Imatinib",{"kind":237,"url":238,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa606018.html",{"kind":240,"url":241,"label":193},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L01EA01",{"kind":243,"url":221,"label":8},"darooyab",{"pregnancy":245,"lactation":254,"pediatric":262,"geriatric":271,"reproductive":279},{"level":246,"text":247,"quote":250,"refs":251},"avoid",{"fa":248,"en":249},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","Risk Summary Imatinib mesylate can cause fetal harm when administered to a pregnant woman based on human and animal data.",[252],{"source":34,"section":253},"8.1",{"level":246,"text":255,"quote":258,"refs":259},{"fa":256,"en":257},"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 breastfed infants from imatinib mesylate, advise a lactating woman not to breastfeed during treatment and for 1 month after the last dose.",[260],{"source":34,"section":261},"8.2",{"level":263,"text":264,"quote":267,"refs":268},"caution",{"fa":265,"en":266},"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 imatinib mesylate have been demonstrated in pediatric patients with newly diagnosed Ph+ chronic phase CML and Ph+ ALL [see Clinical Studies ( 14.2 , 14.4 ) ] .",[269],{"source":34,"section":270},"8.4",{"level":263,"text":272,"quote":275,"refs":276},{"fa":273,"en":274},"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.","The frequency of edema was higher in patients older than 65 years as compared to younger patients; no other difference in the safety profile was observed [see Warnings and Precautions ( 5.1 )] .",[277],{"source":34,"section":278},"8.5",{"level":263,"text":280,"quote":283,"refs":284},{"fa":281,"en":282},"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 female patients of reproductive potential to use effective contraception (methods that result in less than 1% pregnancy rates) when using imatinib mesylate during treatment and for fourteen days after stopping treatment with imatinib mesylate [see Specific Populations ( 8 )] .",[285],{"source":34,"section":286},"8.3",1792156181958]