[{"data":1,"prerenderedAt":246},["ShallowReactive",2],{"drug-trastuzumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":22,"regimens":37,"contraindications":108,"warnings":109,"renal":117,"monitoring":118,"interactions":119,"review":120,"examples":123,"atc":142,"iran":144,"usApproval":176,"links":182,"populations":202},"trastuzumab",1,{"fa":7,"en":8},"تراستوزوماب","Trastuzumab","antineoplastic-immunomodulating",{"fa":11,"en":12},"آنتی‌بادی ضد HER2","Anti-HER2 antibody",[14],{"name":15,"market":16},"Herceptin","US",[18,19,7,20,21],"herceptin","هرسپتین","aryotrust","آریوتراست",[23],{"id":24,"form":25,"route":26,"label":27,"concentration":28,"markets":32,"refs":33},"vial-150","powder-for-injection","iv","150 mg vial",{"amount":29,"unit":30,"perUnit":31},150,"mg","vial",[16],[34],{"source":35,"section":36},"fda-herceptin","3",[38,72,84,96],{"id":39,"disease":40,"label":41,"population":44,"type":48,"unit":30,"dose":49,"refs":52,"durationDays":55,"notes":56},"load3w","breast-cancer",{"fa":42,"en":43},"سرطان پستان HER2 مثبت (کمکی) یا معده — دوز اول ۸ mg\u002Fkg طی ۹۰ دقیقه","HER2-positive breast (adjuvant) or gastric cancer — first dose 8 mg\u002Fkg over 90 min",{"minAge":45},{"value":46,"unit":47},18,"year","weightBased",{"perKgPerDose":50,"intervalHours":51},8,24,[53],{"source":35,"section":54},"2.3",{"min":5,"max":5},[57,65],{"text":58,"refs":61},{"fa":59,"en":60},"سپس ۶ mg\u002Fkg هر ۳ هفته (کمکی تا ۵۲ هفته). پیش از شروع و منظم LVEF. با تراستوزوماب امتانسین یا دروکستکان جایگزین نشود. وریدی، بولوس نه.","Then 6 mg\u002Fkg every 3 weeks (adjuvant up to 52 weeks). LVEF before and regularly. Not interchangeable with ado-trastuzumab emtansine or fam-trastuzumab deruxtecan. IV infusion, never bolus.",[62,63],{"source":35,"section":54},{"source":35,"section":64},"2.1",{"text":66,"refs":69},{"fa":67,"en":68},"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.",[70],{"source":35,"section":71},"2",{"id":73,"disease":40,"label":74,"population":77,"type":48,"unit":30,"dose":79,"refs":81,"durationDays":83},"m3w",{"fa":75,"en":76},"نگهدارنده — ۶ mg\u002Fkg هر ۳ هفته","Maintenance — 6 mg\u002Fkg every 3 weeks",{"minAge":78},{"value":46,"unit":47},{"perKgPerDose":80,"intervalHours":51},6,[82],{"source":35,"section":54},{"min":5,"max":5},{"id":85,"disease":40,"label":86,"population":89,"type":48,"unit":30,"dose":91,"refs":93,"durationDays":95},"load1w",{"fa":87,"en":88},"رژیم هفتگی (کمکی یا متاستاتیک) — دوز اول ۴ mg\u002Fkg، سپس ۲ mg\u002Fkg هفتگی","Weekly regimen (adjuvant or metastatic) — first dose 4 mg\u002Fkg, then 2 mg\u002Fkg weekly",{"minAge":90},{"value":46,"unit":47},{"perKgPerDose":92,"intervalHours":51},4,[94],{"source":35,"section":54},{"min":5,"max":5},{"id":97,"disease":40,"label":98,"population":101,"type":48,"unit":30,"dose":103,"refs":105,"durationDays":107},"m1w",{"fa":99,"en":100},"نگهدارنده هفتگی — ۲ mg\u002Fkg","Weekly maintenance — 2 mg\u002Fkg",{"minAge":102},{"value":46,"unit":47},{"perKgPerDose":104,"intervalHours":51},2,[106],{"source":35,"section":54},{"min":5,"max":5},[],[110],{"text":111,"refs":114},{"fa":112,"en":113},"هشدار جعبه‌ای: کاردیومیوپاتی (بیشتر با آنتراسایکلین)؛ واکنش انفوزیون و سمیت ریوی؛ سمیت جنینی (الیگوهیدرآمنیوس).","Boxed warning: cardiomyopathy (higher with anthracyclines); infusion reactions and pulmonary toxicity; embryo-fetal toxicity (oligohydramnios).",[115],{"source":35,"section":116},"Boxed Warning",[],[],[],{"status":121,"reviewer":122,"date":122},"unverified",null,[124,130,134,138],{"regimen":39,"formulation":24,"input":125,"expect":128},{"ageYears":126,"weightKg":127},50,70,{"perDose":129},560,{"regimen":73,"formulation":24,"input":131,"expect":132},{"ageYears":126,"weightKg":127},{"perDose":133},420,{"regimen":85,"formulation":24,"input":135,"expect":136},{"ageYears":126,"weightKg":127},{"perDose":137},280,{"regimen":97,"formulation":24,"input":139,"expect":140},{"ageYears":126,"weightKg":127},{"perDose":141},140,[143],"L01FD01",{"status":145,"forms":146,"refs":171},"registered",[147,151,155,159,163,167],{"code":148,"en":149,"fa":150},"05283","TRASTUZUMAB 150MG VIAL","ویال تراستوزومب ۱۵۰ میلی‌گرم",{"code":152,"en":153,"fa":154},"02481","TRASTUZUMAB 440MG VIAL","ویال تراستوزومب ۴۴۰ میلی‌گرم",{"code":156,"en":157,"fa":158},"50986","TRASTUZUMAB 100MG VIAL","ویال تراستوزومب ۱۰۰ میلی‌گرم",{"code":160,"en":161,"fa":162},"50882","TRASTUZUMAB 160MG VIAL","ویال تراستوزومب ۱۶۰ میلی‌گرم",{"code":164,"en":165,"fa":166},"52414","TRASTUZUMAB INJECTION, SOLUTION PARENTERAL 600 mg\u002F5mL","محلول تزریقی تراستوزومب ۶۰۰ میلی‌گرم \u002F ۵ میلی‌لیتر",{"code":168,"en":169,"fa":170},"53090","TRASTUZUMAB DERUXTECAN INJECTION, POWDER, FOR SOLUTION PARENTERAL 100 mg","پودر برای تهیه محلول تزریقی تراستوزومب دروکستکان ۱۰۰ میلی‌گرم",[172],{"source":173,"section":174,"url":175},"darooyab-generic","G-1083\u002FTrastuzumab","https:\u002F\u002Fwww.darooyab.ir\u002FG-1083\u002FTrastuzumab",{"kind":177,"refs":178,"id":181},"BLA",[179],{"source":35,"section":180},"SPL approval \u002F marketing category","BLA103792",[183,186,190,194,197,200],{"kind":184,"url":185,"label":181},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=103792",{"kind":187,"url":188,"label":189},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=492dbdb2-077e-4064-bff3-372d6af0a7a2","FDA Herceptin",{"kind":191,"url":192,"label":193},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa620006.html","Fam-trastuzumab deruxtecan-nxki Injection",{"kind":191,"url":195,"label":196},"https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa699019.html","Trastuzumab Injection",{"kind":198,"url":199,"label":143},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L01FD01",{"kind":201,"url":175,"label":8},"darooyab",{"pregnancy":203,"lactation":211,"pediatric":220,"geriatric":229,"reproductive":238},{"level":204,"text":205,"quote":208,"refs":209},"avoid",{"fa":206,"en":207},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY See full prescribing information for complete boxed warning Cardiomyopathy: Herceptin can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered …",[210],{"source":35,"section":116},{"level":212,"text":213,"quote":216,"refs":217},"caution",{"fa":214,"en":215},"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 trastuzumab in human milk, the effects on the breastfed infant, or the effects on milk production.",[218],{"source":35,"section":219},"8.2",{"level":221,"text":222,"quote":225,"refs":226},"not-established",{"fa":223,"en":224},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","The safety and effectiveness of Herceptin in pediatric patients have not been established.",[227],{"source":35,"section":228},"8.4",{"level":230,"text":231,"quote":234,"refs":235},"ok",{"fa":232,"en":233},"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.",[236],{"source":35,"section":237},"8.5",{"level":212,"text":239,"quote":242,"refs":243},{"fa":240,"en":241},"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 Herceptin can cause embryo-fetal harm when administered during pregnancy.",[244],{"source":35,"section":245},"8.3",1792444710150]