[{"data":1,"prerenderedAt":220},["ShallowReactive",2],{"drug-ibrutinib":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":67,"contraindications":96,"warnings":97,"renal":105,"monitoring":106,"interactions":107,"review":108,"examples":111,"atc":120,"iran":122,"usApproval":154,"links":160,"populations":176},"ibrutinib",1,{"fa":7,"en":8},"ایبروتینیب","Ibrutinib","antineoplastic-immunomodulating",{"fa":11,"en":12},"مهارکننده BTK","BTK inhibitor",[14],{"name":15,"market":16},"Imbruvica","US",[18,19,7],"imbruvica","ایمبرویکا",[21,35,43,51,59],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"cap-70","capsule","oral","70 mg capsule",{"amount":27,"unit":28,"perUnit":23,"scored":29},70,"mg",false,[16],[32],{"source":33,"section":34},"fda-imbruvica","3",{"id":36,"form":23,"route":24,"label":37,"concentration":38,"markets":40,"refs":41},"cap-140","140 mg capsule",{"amount":39,"unit":28,"perUnit":23,"scored":29},140,[16],[42],{"source":33,"section":34},{"id":44,"form":45,"route":24,"label":46,"concentration":47,"markets":48,"refs":49},"tab-140","tablet","140 mg tablet",{"amount":39,"unit":28,"perUnit":45,"scored":29},[16],[50],{"source":33,"section":34},{"id":52,"form":45,"route":24,"label":53,"concentration":54,"markets":56,"refs":57},"tab-280","280 mg tablet",{"amount":55,"unit":28,"perUnit":45,"scored":29},280,[16],[58],{"source":33,"section":34},{"id":60,"form":45,"route":24,"label":61,"concentration":62,"markets":64,"refs":65},"tab-420","420 mg tablet",{"amount":63,"unit":28,"perUnit":45,"scored":29},420,[16],[66],{"source":33,"section":34},[68],{"id":69,"disease":70,"label":71,"population":74,"type":78,"unit":28,"dose":79,"refs":80,"notes":83},"cll","chronic-lymphocytic-leukemia",{"fa":72,"en":73},"CLL\u002FSLL و ماکروگلوبولینمی والدنشتروم — ۴۲۰ mg یک بار در روز","CLL\u002FSLL and Waldenström macroglobulinaemia — 420 mg once daily",{"minAge":75},{"value":76,"unit":77},18,"year","fixed",{"perDose":63,"dosesPerDay":5},[81],{"source":33,"section":82},"2.1",[84,90],{"text":85,"refs":88},{"fa":86,"en":87},"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.",[89],{"source":33,"section":82},{"text":91,"refs":94},{"fa":92,"en":93},"GVHD مزمن: ۱۲ سال به بالا ۴۲۰ mg؛ ۱ تا \u003C۱۲ سال ۲۴۰ mg\u002Fm² (حداکثر ۴۲۰). قرص یا کپسول کامل با آب بلعیده شود.","Chronic GVHD: ≥12 years 420 mg; 1–\u003C12 years 240 mg\u002Fm² (max 420). Swallow tablets or capsules whole with water.",[95],{"source":33,"section":82},[],[98],{"text":99,"refs":102},{"fa":100,"en":101},"خونریزی؛ عفونت؛ آریتمی، نارسایی قلب و مرگ ناگهانی؛ فشار خون؛ سیتوپنی؛ بدخیمی دوم؛ سمیت کبدی؛ سمیت جنینی.","Haemorrhage; infections; arrhythmias, cardiac failure and sudden death; hypertension; cytopenias; second primary malignancies; hepatotoxicity; embryo-fetal toxicity.",[103],{"source":33,"section":104},"5",[],[],[],{"status":109,"reviewer":110,"date":110},"unverified",null,[112,117],{"regimen":69,"formulation":36,"input":113,"expect":115},{"ageYears":114,"weightKg":27},65,{"perDose":63,"tabletsPerDoseRounded":116},3,{"regimen":69,"formulation":60,"input":118,"expect":119},{"ageYears":114,"weightKg":27},{"perDose":63,"tabletsPerDoseRounded":5},[121],"L01EL01",{"status":123,"forms":124,"refs":149},"registered",[125,129,133,137,141,145],{"code":126,"en":127,"fa":128},"50769","IBRUTINIB CAPSULE ORAL 140 mg","کپسول ایبروتینیب ۱۴۰ میلی‌گرم",{"code":130,"en":131,"fa":132},"52760","IBRUTINIB CAPSULE ORAL 70 mg","کپسول ایبروتینیب ۷۰ میلی‌گرم",{"code":134,"en":135,"fa":136},"52992","IBRUTINIB CAPSULE ORAL 420 mg","کپسول ایبروتینیب ۴۲۰ میلی‌گرم",{"code":138,"en":139,"fa":140},"52700","IBRUTINIB TABLET ORAL 140 mg","قرص ایبروتینیب ۱۴۰ میلی‌گرم",{"code":142,"en":143,"fa":144},"52993","IBRUTINIB TABLET ORAL 560 mg","قرص ایبروتینیب ۵۶۰ میلی‌گرم",{"code":146,"en":147,"fa":148},"52991","IBRUTINIB TABLET ORAL 280 mg","قرص ایبروتینیب ۲۸۰ میلی‌گرم",[150],{"source":151,"section":152,"url":153},"darooyab-generic","G-3748\u002FIbrutinib","https:\u002F\u002Fwww.darooyab.ir\u002FG-3748\u002FIbrutinib",{"kind":155,"refs":156,"id":159},"NDA",[157],{"source":33,"section":158},"SPL approval \u002F marketing category","NDA205552",[161,164,168,171,174],{"kind":162,"url":163,"label":159},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=205552",{"kind":165,"url":166,"label":167},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=0dfd0279-ff17-4ea9-89be-9803c71bab44","FDA Imbruvica",{"kind":169,"url":170,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa614007.html",{"kind":172,"url":173,"label":121},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L01EL01",{"kind":175,"url":153,"label":8},"darooyab",{"pregnancy":177,"lactation":186,"pediatric":194,"geriatric":203,"reproductive":212},{"level":178,"text":179,"quote":182,"refs":183},"avoid",{"fa":180,"en":181},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","Risk Summary IMBRUVICA can cause fetal harm based on findings from animal studies.",[184],{"source":33,"section":185},"8.1",{"level":178,"text":187,"quote":190,"refs":191},{"fa":188,"en":189},"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 the breastfed child, advise women not to breastfeed during treatment with IMBRUVICA and for 1 week after the last dose.",[192],{"source":33,"section":193},"8.2",{"level":195,"text":196,"quote":199,"refs":200},"caution",{"fa":197,"en":198},"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.","Chronic GVHD The safety and effectiveness of IMBRUVICA have been established for treatment of cGVHD after failure of one or more lines of systemic therapy in pediatric patients 1 year of age and older.",[201],{"source":33,"section":202},"8.4",{"level":204,"text":205,"quote":208,"refs":209},"ok",{"fa":206,"en":207},"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 effectiveness were observed between younger and older patients.",[210],{"source":33,"section":211},"8.5",{"level":195,"text":213,"quote":216,"refs":217},{"fa":214,"en":215},"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 IMBRUVICA and for 1 month after the last dose.",[218],{"source":33,"section":219},"8.3",1792444402869]