[{"data":1,"prerenderedAt":202},["ShallowReactive",2],{"drug-pembrolizumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":34,"contraindications":89,"warnings":90,"renal":98,"monitoring":99,"interactions":100,"review":101,"examples":104,"atc":117,"iran":119,"usApproval":135,"links":141,"populations":158},"pembrolizumab",1,{"fa":7,"en":8},"پمبرولیزوماب","Pembrolizumab","antineoplastic-immunomodulating",{"fa":11,"en":12},"مهارکننده PD-1","PD-1 blocking antibody",[14],{"name":15,"market":16},"Keytruda","US",[18,19,7],"keytruda","کیترودا",[21],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":29,"refs":30},"vial-25","injection","iv","25 mg\u002FmL (100 mg\u002F4 mL)",{"amount":27,"unit":28,"perVolumeMl":5},25,"mg",[16],[31],{"source":32,"section":33},"fda-keytruda","3",[35,71],{"id":36,"disease":37,"label":38,"population":41,"type":45,"unit":28,"dose":46,"refs":48,"durationDays":51,"notes":52},"adult","lung-cancer",{"fa":39,"en":40},"بزرگسال (ملانوم، NSCLC، سر و گردن، اوروتلیال و سایر اندیکاسیون‌ها) — ۲۰۰ mg هر ۳ هفته یا ۴۰۰ mg هر ۶ هفته","Adults (melanoma, NSCLC, head & neck, urothelial and other indications) — 200 mg every 3 weeks or 400 mg every 6 weeks",{"minAge":42},{"value":43,"unit":44},18,"year","fixed",{"perDose":47,"dosesPerDay":5},200,[49],{"source":32,"section":50},"2.2, Table 1",{"min":5,"max":5},[53,64],{"text":54,"refs":57},{"fa":55,"en":56},"انفوزیون ۳۰ دقیقه. اندیکاسیون و انتخاب بیمار (PD-L1، MSI) طبق جدول ۱ و ۲٫۱. کاهش دوز ندارد؛ در عوارض ایمنی قطع موقت یا دائم.","30-min infusion. Indication and patient selection (PD-L1, MSI) per Table 1 and 2.1. No dose reductions; withhold or discontinue for immune-mediated reactions.",[58,60,62],{"source":32,"section":59},"2.2",{"source":32,"section":61},"2.1",{"source":32,"section":63},"2.3",{"text":65,"refs":68},{"fa":66,"en":67},"فقط زیر نظر پزشک متخصص انکولوژی؛ پروتکل، فاصله دوره‌ها و تنظیم با تیم درمان.","Only under an oncologist; protocol, cycle interval and adjustment rest with the treating team.",[69],{"source":32,"section":70},"2",{"id":72,"disease":73,"label":74,"population":77,"type":79,"unit":28,"dose":80,"refs":83,"limits":85,"durationDays":88},"child","melanoma",{"fa":75,"en":76},"کودک (ملانوم، cHL، PMBCL) — ۲ mg\u002Fkg هر ۳ هفته (حداکثر ۲۰۰ mg)","Children (melanoma, cHL, PMBCL) — 2 mg\u002Fkg every 3 weeks (max 200 mg)",{"maxAge":78},{"value":43,"unit":44},"weightBased",{"perKgPerDose":81,"intervalHours":82},2,24,[84],{"source":32,"section":59},{"maxPerDose":47,"refs":86},[87],{"source":32,"section":59},{"min":5,"max":5},[],[91],{"text":92,"refs":95},{"fa":93,"en":94},"واکنش‌های ایمنی شدید و کشنده (پنومونیت، کولیت، هپاتیت، اندوکرینوپاتی، نفریت، پوستی)؛ واکنش انفوزیون؛ عوارض پیوند آلوژن؛ سمیت جنینی.","Severe and fatal immune-mediated reactions (pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, skin); infusion reactions; allogeneic HSCT complications; embryo-fetal toxicity.",[96],{"source":32,"section":97},"5",[],[],[],{"status":102,"reviewer":103,"date":103},"unverified",null,[105,111],{"regimen":36,"formulation":22,"input":106,"expect":109},{"ageYears":107,"weightKg":108},60,70,{"perDose":47,"mlPerDose":110},8,{"regimen":72,"formulation":22,"input":112,"expect":115},{"ageYears":113,"weightKg":114},10,30,{"perDose":107,"mlPerDose":116},2.4,[118],"L01FF02",{"status":120,"forms":121,"refs":130},"registered",[122,126],{"code":123,"en":124,"fa":125},"25268","PEMBROLIZUMAB 100MG\u002F4ML VIAL","ویال پمبرولیزومب ۱۰۰ میلی‌گرم \u002F ۴ میلی‌لیتر",{"code":127,"en":128,"fa":129},"51831","PEMBROLIZUMAB 50 MG Powder For INJ","فرآورده تزریقی پمبرولیزومب ۵۰ میلی‌گرم",[131],{"source":132,"section":133,"url":134},"darooyab-generic","G-2581\u002FPembrolizumab","https:\u002F\u002Fwww.darooyab.ir\u002FG-2581\u002FPembrolizumab",{"kind":136,"refs":137,"id":140},"BLA",[138],{"source":32,"section":139},"SPL approval \u002F marketing category","BLA125514",[142,145,149,153,156],{"kind":143,"url":144,"label":140},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=125514",{"kind":146,"url":147,"label":148},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287","FDA Keytruda",{"kind":150,"url":151,"label":152},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa614048.html","Pembrolizumab Injection",{"kind":154,"url":155,"label":118},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L01FF02",{"kind":157,"url":134,"label":8},"darooyab",{"pregnancy":159,"lactation":168,"pediatric":176,"geriatric":185,"reproductive":194},{"level":160,"text":161,"quote":164,"refs":165},"avoid",{"fa":162,"en":163},"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, KEYTRUDA can cause fetal harm when administered to a pregnant woman.",[166],{"source":32,"section":167},"8.1",{"level":160,"text":169,"quote":172,"refs":173},{"fa":170,"en":171},"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 children, advise women not to breastfeed during treatment with KEYTRUDA and for 4 months after the last dose.",[174],{"source":32,"section":175},"8.2",{"level":177,"text":178,"quote":181,"refs":182},"caution",{"fa":179,"en":180},"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 KEYTRUDA as a single agent have been established in pediatric patients with melanoma, cHL, PMBCL, MCC, MSI-H or dMMR cancer, and TMB-H cancer.",[183],{"source":32,"section":184},"8.4",{"level":186,"text":187,"quote":190,"refs":191},"ok",{"fa":188,"en":189},"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 safety or effectiveness were observed between elderly patients and younger patients.",[192],{"source":32,"section":193},"8.5",{"level":177,"text":195,"quote":198,"refs":199},{"fa":196,"en":197},"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 KEYTRUDA can cause fetal harm when administered to a pregnant woman [see Warnings and Precautions (5.5) , Use in Specific Populations (8.1) ].",[200],{"source":32,"section":201},"8.3",1792444707646]