[{"data":1,"prerenderedAt":168},["ShallowReactive",2],{"drug-blinatumomab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":35,"contraindications":56,"warnings":66,"renal":81,"monitoring":82,"interactions":83,"review":84,"examples":87,"atc":88,"iran":90,"usApproval":102,"links":108,"populations":125},"blinatumomab",1,{"fa":7,"en":8},"بلیناتوموماب","Blinatumomab","antineoplastic-immunomodulating",{"fa":11,"en":12},"درگیرکننده دوگانه سلول T (CD19\u002FCD3)","Bispecific CD19\u002FCD3 T-cell engager",[14],{"name":15,"market":16},"Blincyto","US",[18,19,7],"blincyto","بلینسایتو",[21],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"vial-35","powder-for-injection","iv","35 mcg vial",{"amount":27,"unit":28,"perUnit":29},35,"mcg","vial",[16],[32],{"source":33,"section":34},"fda-blincyto","3",[36],{"id":37,"disease":38,"label":39,"population":42,"type":43,"unit":44,"dose":45,"refs":49},"all","acute-lymphoblastic-leukemia",{"fa":40,"en":41},"ALL پیش‌ساز B (MRD مثبت، عودکننده یا تثبیت) — انفوزیون وریدی مداوم ۲۸ روزه، سپس ۱۴ روز استراحت","B-cell precursor ALL (MRD-positive, relapsed\u002Frefractory or consolidation) — continuous IV infusion for 28 days, then 14 days off",{},"notCalculated","mg",{"reason":46},{"fa":47,"en":48},"دوز روزانه (mcg\u002Fروز) ثابت برای ۴۵ kg و بالاتر و بر حسب mcg\u002Fm²\u002Fروز برای زیر ۴۵ kg، و بسته به نوع درمان و دوره متفاوت است (جداول ۱ تا ۳). فقط در مرکز مجهز؛ بستری در روزهای اول دوره اول.","Daily dose (mcg\u002Fday) is fixed for ≥45 kg and mcg\u002Fm²\u002Fday for \u003C45 kg, and varies by setting and cycle (Tables 1–3). Only in an equipped centre; hospitalise for the first days of the first cycle.",[50,52,54],{"source":33,"section":51},"2.1",{"source":33,"section":53},"2.2",{"source":33,"section":55},"2.3",[57],{"id":58,"severity":59,"text":60,"refs":63},"hyper","block",{"fa":61,"en":62},"حساسیت به بلیناتوموماب یا اجزا.","Hypersensitivity to blinatumomab or components.",[64],{"source":33,"section":65},"4",[67,74],{"text":68,"refs":71},{"fa":69,"en":70},"هشدار جعبه‌ای: سندرم آزادسازی سیتوکین تهدیدکننده حیات؛ سمیت عصبی شامل ICANS.","Boxed warning: life-threatening cytokine release syndrome; neurological toxicities including ICANS.",[72],{"source":33,"section":73},"Boxed Warning",{"text":75,"refs":78},{"fa":76,"en":77},"عفونت؛ لیز تومور؛ نوتروپنی؛ افزایش آنزیم کبد؛ پانکراتیت؛ لکوانسفالوپاتی؛ خطای آماده‌سازی؛ بنزیل الکل در نوزاد.","Infections; tumour lysis; neutropenia; elevated liver enzymes; pancreatitis; leukoencephalopathy; preparation errors; benzyl alcohol toxicity in neonates.",[79],{"source":33,"section":80},"5",[],[],[],{"status":85,"reviewer":86,"date":86},"unverified",null,[],[89],"L01FX07",{"status":91,"forms":92,"refs":97},"registered",[93],{"code":94,"en":95,"fa":96},"52711","BLINATUMOMAB INJECTION, POWDER, FOR SOLUTION PARENTERAL 38.5 ug","پودر برای تهیه محلول تزریقی بلیناتومومب ۳۸٫۵ میکروگرم",[98],{"source":99,"section":100,"url":101},"darooyab-generic","G-5470\u002FBlinatumomab","https:\u002F\u002Fwww.darooyab.ir\u002FG-5470\u002FBlinatumomab",{"kind":103,"refs":104,"id":107},"BLA",[105],{"source":33,"section":106},"SPL approval \u002F marketing category","BLA125557",[109,112,116,120,123],{"kind":110,"url":111,"label":107},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=125557",{"kind":113,"url":114,"label":115},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=38b482a8-960b-4591-9857-5031ecb830aa","FDA Blincyto",{"kind":117,"url":118,"label":119},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa614061.html","Blinatumomab Injection",{"kind":121,"url":122,"label":89},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L01FX07",{"kind":124,"url":101,"label":8},"darooyab",{"pregnancy":126,"lactation":135,"pediatric":143,"geriatric":152,"reproductive":160},{"level":127,"text":128,"quote":131,"refs":132},"avoid",{"fa":129,"en":130},"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, BLINCYTO may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] .",[133],{"source":33,"section":134},"8.1",{"level":127,"text":136,"quote":139,"refs":140},{"fa":137,"en":138},"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 many drugs are excreted in human milk and because of the potential for serious adverse reactions in breastfed infants from BLINCYTO, including B-cell lymphocytopenia, advise patients not to breastfeed during treatment with BLINCYTO and for 48 hours after the last dose.",[141],{"source":33,"section":142},"8.2",{"level":144,"text":145,"quote":148,"refs":149},"caution",{"fa":146,"en":147},"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.","Relapsed or Refractory B-cell Precursor ALL The safety and efficacy of BLINCYTO have been established in pediatric patients one month and older with relapsed or refractory B-cell precursor ALL.",[150],{"source":33,"section":151},"8.4",{"level":144,"text":153,"quote":156,"refs":157},{"fa":154,"en":155},"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.","However, elderly patients experienced a higher rate of serious infections and neurological toxicities, including cognitive disorder, encephalopathy, and confusion [see Warnings and Precautions (5.2 , 5.3) ] .",[158],{"source":33,"section":159},"8.5",{"level":144,"text":161,"quote":164,"refs":165},{"fa":162,"en":163},"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 BLINCYTO and for 48 hours after the last dose.",[166],{"source":33,"section":167},"8.3",1792444707207]