[{"data":1,"prerenderedAt":195},["ShallowReactive",2],{"drug-pertuzumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":34,"contraindications":80,"warnings":90,"renal":98,"monitoring":99,"interactions":100,"review":101,"examples":104,"atc":115,"iran":117,"usApproval":129,"links":135,"populations":152},"pertuzumab",1,{"fa":7,"en":8},"پرتوزوماب","Pertuzumab","antineoplastic-immunomodulating",{"fa":11,"en":12},"آنتی‌بادی ضد HER2","HER2-directed antibody",[14],{"name":15,"market":16},"Perjeta","US",[18,19,7],"perjeta","پرجتا",[21],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":29,"refs":30},"inj-30","injection","iv","30 mg\u002FmL, 420 mg\u002F14 mL vial",{"amount":27,"unit":28,"perVolumeMl":5},30,"mg",[16],[31],{"source":32,"section":33},"fda-perjeta","3",[35,59],{"id":36,"disease":37,"label":38,"population":41,"type":45,"unit":28,"dose":46,"refs":48,"durationDays":51,"notes":52},"load","breast-cancer",{"fa":39,"en":40},"سرطان پستان HER2 مثبت (با تراستوزوماب) — دوز اول ۸۴۰ mg وریدی ۶۰ دقیقه","HER2-positive breast cancer (with trastuzumab) — initial dose 840 mg IV over 60 min",{"minAge":42},{"value":43,"unit":44},18,"year","fixed",{"perDose":47,"dosesPerDay":5},840,[49],{"source":32,"section":50},"2.3",{"min":5,"max":5},[53],{"text":54,"refs":57},{"fa":55,"en":56},"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.",[58],{"source":32,"section":50},{"id":60,"disease":37,"label":61,"population":64,"type":45,"unit":28,"dose":66,"refs":68,"durationDays":70,"notes":71},"maint",{"fa":62,"en":63},"ادامه — ۴۲۰ mg وریدی هر ۳ هفته","Continuation — 420 mg IV every 3 weeks",{"minAge":65},{"value":43,"unit":44},{"perDose":67,"dosesPerDay":5},420,[69],{"source":32,"section":50},{"min":5,"max":5},[72],{"text":73,"refs":76},{"fa":74,"en":75},"تراستوزوماب همراه: ۸ mg\u002Fkg سپس ۶ mg\u002Fkg هر ۳ هفته. فقط انفوزیون وریدی، نه پوش یا بولوس. LVEF پیش و حین درمان.","Trastuzumab with it: 8 mg\u002Fkg then 6 mg\u002Fkg every 3 weeks. IV infusion only, not push or bolus. LVEF before and during.",[77,78],{"source":32,"section":50},{"source":32,"section":79},"2.1",[81],{"id":82,"severity":83,"text":84,"refs":87},"hyper","block",{"fa":85,"en":86},"حساسیت به پرتوزوماب یا اجزا.","Hypersensitivity to pertuzumab or excipients.",[88],{"source":32,"section":89},"4",[91],{"text":92,"refs":95},{"fa":93,"en":94},"هشدار جعبه‌ای: اختلال عملکرد بطن چپ و نارسایی قلب؛ سمیت جنینی (مرگ جنین و نقص مادرزادی).","Boxed warning: left ventricular dysfunction and heart failure; embryo-fetal toxicity (fetal death and birth defects).",[96],{"source":32,"section":97},"Boxed Warning",[],[],[],{"status":102,"reviewer":103,"date":103},"unverified",null,[105,111],{"regimen":36,"formulation":22,"input":106,"expect":109},{"ageYears":107,"weightKg":108},50,65,{"perDose":47,"mlPerDose":110},28,{"regimen":60,"formulation":22,"input":112,"expect":113},{"ageYears":107,"weightKg":108},{"perDose":67,"mlPerDose":114},14,[116],"L01FD02",{"status":118,"forms":119,"refs":124},"registered",[120],{"code":121,"en":122,"fa":123},"23986","PERTUZUMAB CONCENTRATESOLUTION 30 mg\u002F1mL Amp","آمپول پرتوزومب کونسنتراتسولوشن ۳۰ میلی‌گرم \u002F ۱ میلی‌لیتر",[125],{"source":126,"section":127,"url":128},"darooyab-generic","G-5442\u002FPertuzumab","https:\u002F\u002Fwww.darooyab.ir\u002FG-5442\u002FPertuzumab",{"kind":130,"refs":131,"id":134},"BLA",[132],{"source":32,"section":133},"SPL approval \u002F marketing category","BLA125409",[136,139,143,147,150],{"kind":137,"url":138,"label":134},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=125409",{"kind":140,"url":141,"label":142},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=17f85d17-ab71-4f5b-9fe3-0b8c822f69ff","FDA Perjeta",{"kind":144,"url":145,"label":146},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa612027.html","Pertuzumab Injection",{"kind":148,"url":149,"label":116},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L01FD02",{"kind":151,"url":128,"label":8},"darooyab",{"pregnancy":153,"lactation":161,"pediatric":170,"geriatric":178,"reproductive":187},{"level":154,"text":155,"quote":158,"refs":159},"avoid",{"fa":156,"en":157},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","Embryo-fetal Toxicity: Exposure to PERJETA can cause embryo-fetal death and birth defects.",[160],{"source":32,"section":97},{"level":162,"text":163,"quote":166,"refs":167},"caution",{"fa":164,"en":165},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary There is no information regarding the presence of pertuzumab in human milk, the effects on the breastfed infant or the effects on milk production.",[168],{"source":32,"section":169},"8.2",{"level":162,"text":171,"quote":174,"refs":175},{"fa":172,"en":173},"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 PERJETA have not been established in pediatric patients.",[176],{"source":32,"section":177},"8.4",{"level":179,"text":180,"quote":183,"refs":184},"ok",{"fa":181,"en":182},"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 efficacy of PERJETA were observed in patients aged ≥ 65 and \u003C65 years of age.",[185],{"source":32,"section":186},"8.5",{"level":162,"text":188,"quote":191,"refs":192},{"fa":189,"en":190},"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 Based on the mechanism of action and animal data, PERJETA can cause embryo-fetal harm when administered during pregnancy.",[193],{"source":32,"section":194},"8.3",1792444417316]