[{"data":1,"prerenderedAt":262},["ShallowReactive",2],{"drug-irinotecan":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":35,"contraindications":105,"warnings":115,"renal":130,"monitoring":131,"interactions":132,"review":133,"examples":136,"atc":153,"iran":155,"usApproval":195,"links":201,"populations":218},"irinotecan",1,{"fa":7,"en":8},"ایرینوتکان","Irinotecan","antineoplastic-immunomodulating",{"fa":11,"en":12},"مهارکننده توپوایزومراز I","Topoisomerase I inhibitor",[14],{"name":15,"market":16},"Camptosar","US",[18,19,20,7],"camptosar","campto","کمپتو",[22],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":30,"refs":31},"inj-20","injection","iv","20 mg\u002FmL (40 mg\u002F2 mL, 100 mg\u002F5 mL)",{"amount":28,"unit":29,"perVolumeMl":5},20,"mg",[16],[32],{"source":33,"section":34},"fda-irinotecan","3",[36,70,87],{"id":37,"disease":38,"label":39,"population":42,"type":46,"unit":29,"dose":47,"refs":49,"durationDays":52,"notes":53},"weekly","colorectal-cancer",{"fa":40,"en":41},"سرطان کولورکتال (ترکیبی رژیم ۱، با LV\u002F5-FU) — ۱۲۵ mg\u002Fm² وریدی ۹۰ دقیقه، روز ۱، ۸، ۱۵، ۲۲ هر ۶ هفته","Colorectal cancer (combination regimen 1, with LV\u002F5-FU) — 125 mg\u002Fm² IV over 90 min on days 1, 8, 15, 22 every 6 weeks",{"minAge":43},{"value":44,"unit":45},18,"year","bsa",{"perM2PerDay":48,"dividedDoses":5},125,[50],{"source":33,"section":51},"2.1, Table 1",{"min":5,"max":5},[54,61],{"text":55,"refs":58},{"fa":56,"en":57},"فقط زیر نظر پزشک متخصص شیمی‌درمانی و در مرکز مجهز. عدد ماشین‌حساب = mg\u002Fm² برچسب × سطح بدن (Mosteller)؛ پروتکل، فاصله دوره‌ها، تنظیم بر اساس CBC و عملکرد کلیه\u002Fکبد با تیم انکولوژی.","Only under an oncologist in an equipped centre. Calculator = label mg\u002Fm² × BSA (Mosteller); protocol, cycle interval and adjustment for CBC and renal\u002Fhepatic function rest with the oncology team.",[59],{"source":33,"section":60},"2.1",{"text":62,"refs":65},{"fa":63,"en":64},"تک‌دارویی هفتگی هم ۱۲۵ mg\u002Fm² (روز ۱، ۸، ۱۵، ۲۲ هر ۶ هفته). UGT1A1*28 هموزیگوت: کاهش یک سطح دوز.","Single-agent weekly is also 125 mg\u002Fm² (days 1, 8, 15, 22 every 6 weeks). UGT1A1*28 homozygous: reduce by one dose level.",[66,68],{"source":33,"section":67},"2.2, Table 3",{"source":33,"section":69},"2.3",{"id":71,"disease":38,"label":72,"population":75,"type":46,"unit":29,"dose":77,"refs":79,"durationDays":81,"notes":82},"q2w",{"fa":73,"en":74},"سرطان کولورکتال (ترکیبی رژیم ۲، با LV\u002F5-FU) — ۱۸۰ mg\u002Fm² روز ۱، ۱۵، ۲۹ هر ۶ هفته","Colorectal cancer (combination regimen 2, with LV\u002F5-FU) — 180 mg\u002Fm² on days 1, 15, 29 every 6 weeks",{"minAge":76},{"value":44,"unit":45},{"perM2PerDay":78,"dividedDoses":5},180,[80],{"source":33,"section":51},{"min":5,"max":5},[83],{"text":84,"refs":85},{"fa":56,"en":57},[86],{"source":33,"section":60},{"id":88,"disease":38,"label":89,"population":92,"type":46,"unit":29,"dose":94,"refs":96,"durationDays":98,"notes":99},"q3w",{"fa":90,"en":91},"سرطان کولورکتال تک‌دارویی (رژیم ۲) — ۳۵۰ mg\u002Fm² وریدی هر ۳ هفته","Colorectal cancer single agent (regimen 2) — 350 mg\u002Fm² IV every 3 weeks",{"minAge":93},{"value":44,"unit":45},{"perM2PerDay":95,"dividedDoses":5},350,[97],{"source":33,"section":67},{"min":5,"max":5},[100],{"text":101,"refs":102},{"fa":56,"en":57},[103],{"source":33,"section":104},"2.2",[106],{"id":107,"severity":108,"text":109,"refs":112},"hyper","block",{"fa":110,"en":111},"حساسیت به ایرینوتکان یا اجزا.","Hypersensitivity to irinotecan or excipients.",[113],{"source":33,"section":114},"4",[116,123],{"text":117,"refs":120},{"fa":118,"en":119},"هشدار جعبه‌ای: اسهال زودرس (کولینرژیک — آتروپین) و دیررس تهدیدکننده حیات (لوپرامید فوری)؛ سرکوب شدید مغز استخوان.","Boxed warning: early (cholinergic — atropine) and late life-threatening diarrhoea (prompt loperamide); severe myelosuppression.",[121],{"source":33,"section":122},"Boxed Warning",{"text":124,"refs":127},{"fa":125,"en":126},"نوتروپنی بیشتر با کاهش فعالیت UGT1A1؛ حساسیت؛ نارسایی کلیه؛ سمیت ریوی؛ سمیت جنینی.","Higher neutropenia risk with reduced UGT1A1 activity; hypersensitivity; renal failure; pulmonary toxicity; embryo-fetal toxicity.",[128],{"source":33,"section":129},"5",[],[],[],{"status":134,"reviewer":135,"date":135},"unverified",null,[137,144,148],{"regimen":37,"formulation":23,"input":138,"expect":141},{"ageYears":139,"weightKg":140,"heightCm":78},55,80,{"perDose":142,"mlPerDose":143},250,12.5,{"regimen":71,"formulation":23,"input":145,"expect":146},{"ageYears":139,"weightKg":140,"heightCm":78},{"perDose":147,"mlPerDose":44},360,{"regimen":88,"formulation":23,"input":149,"expect":150},{"ageYears":139,"weightKg":140,"heightCm":78},{"perDose":151,"mlPerDose":152},700,35,[154],"L01CE02",{"status":156,"forms":157,"refs":190},"registered",[158,162,166,170,174,178,182,186],{"code":159,"en":160,"fa":161},"02088","IRINOTECAN HCL 100MG\u002F5ML POWDER VIAL","ویال ایرینوتکان هیدروکلراید ۱۰۰ میلی‌گرم \u002F ۵ میلی‌لیتر",{"code":163,"en":164,"fa":165},"02090","IRINOTECAN HCL 100MG\u002F5ML SOLUTION FOR INFUSION","محلول انفوزیون ایرینوتکان هیدروکلراید ۱۰۰ میلی‌گرم \u002F ۵ میلی‌لیتر",{"code":167,"en":168,"fa":169},"21460","IRINOTECAN HCL 300MG\u002F15ML SOLUTION FOR INFUSION","محلول انفوزیون ایرینوتکان هیدروکلراید ۳۰۰ میلی‌گرم \u002F ۱۵ میلی‌لیتر",{"code":171,"en":172,"fa":173},"01900","IRINOTECAN HCL 40MG\u002F2ML POWDER VIAL","ویال ایرینوتکان هیدروکلراید ۴۰ میلی‌گرم \u002F ۲ میلی‌لیتر",{"code":175,"en":176,"fa":177},"02089","IRINOTECAN HCL 40MG\u002F2ML SOLUTION FOR INFUSION","محلول انفوزیون ایرینوتکان هیدروکلراید ۴۰ میلی‌گرم \u002F ۲ میلی‌لیتر",{"code":179,"en":180,"fa":181},"18556","IRINOTECAN 300MG\u002F15ML VIAL","ویال ایرینوتکان ۳۰۰ میلی‌گرم \u002F ۱۵ میلی‌لیتر",{"code":183,"en":184,"fa":185},"20298","IRINOTECAN HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 40 mg","پودر تزریقی ایرینوتکان هیدروکلراید ۴۰ میلی‌گرم",{"code":187,"en":188,"fa":189},"20299","IRINOTECAN HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 100 mg","پودر تزریقی ایرینوتکان هیدروکلراید ۱۰۰ میلی‌گرم",[191],{"source":192,"section":193,"url":194},"darooyab-generic","G-1018\u002FIrinotecan","https:\u002F\u002Fwww.darooyab.ir\u002FG-1018\u002FIrinotecan",{"kind":196,"refs":197,"id":200},"ANDA",[198],{"source":33,"section":199},"SPL approval \u002F marketing category","ANDA078589",[202,205,209,213,216],{"kind":203,"url":204,"label":200},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=078589",{"kind":206,"url":207,"label":208},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=5e1fdcaa-918f-4cd8-9c7a-4c538d866198","FDA Irinotecan",{"kind":210,"url":211,"label":212},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa608043.html","Irinotecan Injection",{"kind":214,"url":215,"label":154},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L01CE02",{"kind":217,"url":194,"label":8},"darooyab",{"pregnancy":219,"lactation":228,"pediatric":236,"geriatric":245,"reproductive":254},{"level":220,"text":221,"quote":224,"refs":225},"avoid",{"fa":222,"en":223},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","Risk Summary Based on findings from animal studies and its mechanism of action, Irinotecan Hydrochloride Injection can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] .",[226],{"source":33,"section":227},"8.1",{"level":220,"text":229,"quote":232,"refs":233},{"fa":230,"en":231},"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 from Irinotecan Hydrochloride Injection in the breastfed child, advise lactating women not to breastfeed during treatment with Irinotecan Hydrochloride Injection and for 7 days after the final dose.",[234],{"source":33,"section":235},"8.2",{"level":237,"text":238,"quote":241,"refs":242},"not-established",{"fa":239,"en":240},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","The effectiveness of irinotecan in pediatric patients has not been established.",[243],{"source":33,"section":244},"8.4",{"level":246,"text":247,"quote":250,"refs":251},"caution",{"fa":248,"en":249},"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.","Patients greater than 65 years of age should be closely monitored because of a greater risk of early and late diarrhea in this population [see Clinical Pharmacology (12.3) and Adverse Reactions (6.1) ] .",[252],{"source":33,"section":253},"8.5",{"level":246,"text":255,"quote":258,"refs":259},{"fa":256,"en":257},"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 Irinotecan Hydrochloride Injection can cause fetal harm when administered to a pregnant woman.",[260],{"source":33,"section":261},"8.3",1792444404707]