[{"data":1,"prerenderedAt":183},["ShallowReactive",2],{"drug-cladribine":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":36,"contraindications":61,"warnings":71,"renal":86,"monitoring":87,"interactions":88,"review":89,"examples":92,"atc":93,"iran":95,"usApproval":115,"links":121,"populations":141},"cladribine",1,{"fa":7,"en":8},"کلادریبین (خوراکی)","Cladribine (oral)","antineoplastic-immunomodulating",{"fa":11,"en":12},"آنالوگ پورین","Purine analogue",[14],{"name":15,"market":16},"Mavenclad","US",[18,19,20],"mavenclad","ماونکلاد","کلادریبین",[22],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":31,"refs":32},"tab-10","tablet","oral","10 mg tablet",{"amount":28,"unit":29,"perUnit":24,"scored":30},10,"mg",false,[16],[33],{"source":34,"section":35},"fda-mavenclad","3",[37],{"id":38,"disease":39,"label":40,"population":43,"type":47,"unit":29,"dose":48,"refs":52},"ms","multiple-sclerosis",{"fa":41,"en":42},"ام‌اس عودکننده بزرگسال — مجموع ۳٫۵ mg\u002Fkg طی ۲ دوره سالانه (هر دوره ۱٫۷۵ mg\u002Fkg در ۲ سیکل ۴ تا ۵ روزه)","Relapsing MS, adults — cumulative 3.5 mg\u002Fkg over 2 yearly courses (1.75 mg\u002Fkg per course in two 4–5-day cycles)",{"minAge":44},{"value":45,"unit":46},18,"year","notCalculated",{"reason":49},{"fa":50,"en":51},"تعداد قرص هر روز از جدول ۱ برچسب بر اساس دسته وزنی تعیین می‌شود (نه محاسبه مستقیم). سیکل دوم ۲۳ تا ۲۷ روز پس از اولی. پیش از هر دوره CBC و لنفوسیت؛ پروفیلاکسی هرپس اگر لنفوسیت زیر ۲۰۰. با سایر داروهای خوراکی ۳ ساعت فاصله.","Daily tablet numbers come from label Table 1 by weight band (not a direct calculation). Second cycle 23–27 days after the first. CBC with lymphocytes before each course; herpes prophylaxis if lymphocytes \u003C200. Separate other oral drugs by 3 h.",[53,55,57,59],{"source":34,"section":54},"2.2",{"source":34,"section":56},"2.5",{"source":34,"section":58},"2.6",{"source":34,"section":60},"2.4",[62],{"id":63,"severity":64,"text":65,"refs":68},"ci","block",{"fa":66,"en":67},"بدخیمی فعلی؛ بارداری و افراد بارور بدون پیشگیری مؤثر (تا ۶ ماه زن، ۱۴ هفته مرد)؛ HIV؛ عفونت مزمن فعال (هپاتیت، سل)؛ حساسیت؛ شیردهی در روزهای درمان و ۱۰ روز بعد.","Current malignancy; pregnancy and people of reproductive potential without effective contraception (6 months women, 14 weeks men); HIV; active chronic infections (hepatitis, TB); hypersensitivity; breastfeeding on treatment days and for 10 days after.",[69],{"source":34,"section":70},"4",[72,79],{"text":73,"refs":76},{"fa":74,"en":75},"هشدار جعبه‌ای: بدخیمی و خطر ناهنجاری جنینی.","Boxed warning: malignancies and risk of teratogenicity.",[77],{"source":34,"section":78},"Boxed Warning",{"text":80,"refs":83},{"fa":81,"en":82},"لنفوپنی؛ عفونت (هرپس زوستر، سل)؛ سمیت خونی؛ GVHD با خون اشعه‌ندیده؛ آسیب کبد؛ نارسایی قلب.","Lymphopenia; infections (zoster, TB); haematologic toxicity; GVHD with non-irradiated blood; liver injury; cardiac failure.",[84],{"source":34,"section":85},"5",[],[],[],{"status":90,"reviewer":91,"date":91},"unverified",null,[],[94],"L04AA40",{"status":96,"forms":97,"refs":110},"registered",[98,102,106],{"code":99,"en":100,"fa":101},"00305","CLADRIBINE 10MG\u002F10ML VIAL","ویال کلادریبین ۱۰ میلی‌گرم \u002F ۱۰ میلی‌لیتر",{"code":103,"en":104,"fa":105},"02377","CLADRIBINE 10MG\u002F5ML VIAL","ویال کلادریبین ۱۰ میلی‌گرم \u002F ۵ میلی‌لیتر",{"code":107,"en":108,"fa":109},"52958","CLADRIBINE 10 mg TABLET","قرص کلادریبین ۱۰ میلی‌گرم",[111],{"source":112,"section":113,"url":114},"darooyab-generic","G-971\u002FCladribine","https:\u002F\u002Fwww.darooyab.ir\u002FG-971\u002FCladribine",{"kind":116,"refs":117,"id":120},"NDA",[118],{"source":34,"section":119},"SPL approval \u002F marketing category","NDA022561",[122,125,129,133,136,139],{"kind":123,"url":124,"label":120},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=022561",{"kind":126,"url":127,"label":128},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=9c75e30a-a410-40f1-b653-04d532bd9144","FDA Mavenclad",{"kind":130,"url":131,"label":132},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa619038.html","Cladribine",{"kind":130,"url":134,"label":135},"https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa693015.html","Cladribine Injection",{"kind":137,"url":138,"label":94},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L04AA40",{"kind":140,"url":114,"label":132},"darooyab",{"pregnancy":142,"lactation":150,"pediatric":157,"geriatric":166,"reproductive":175},{"level":143,"text":144,"quote":147,"refs":148},"contraindicated",{"fa":145,"en":146},"برچسب: در بارداری منع مصرف دارد.","Label: contraindicated in pregnancy.","MAVENCLAD is contraindicated: in patients with current malignancy [see Warnings and Precautions (5.1) ]. in pregnant women and in females and males of reproductive potential who do not plan to use effective contraception during MAVENCLAD dosing and for 6 months after the last dose in each treatment course for females, …",[149],{"source":34,"section":70},{"level":143,"text":151,"quote":154,"refs":155},{"fa":152,"en":153},"برچسب: در شیردهی منع مصرف دارد.","Label: contraindicated while breastfeeding.","… atients with a history of hypersensitivity to cladribine [see Warnings and Precautions (5.8) ]. in females intending to breastfeed on a MAVENCLAD treatment day and for 10 days after the last dose [see Use in Specific Populations (8.2) ].",[156],{"source":34,"section":70},{"level":158,"text":159,"quote":162,"refs":163},"not-established",{"fa":160,"en":161},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","The safety and effectiveness in pediatric patients (below 18 years of age) have not been established.",[164],{"source":34,"section":165},"8.4",{"level":167,"text":168,"quote":171,"refs":172},"caution",{"fa":169,"en":170},"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.","Caution is recommended when MAVENCLAD is used in elderly patients, taking into account the potential greater frequency of decreased hepatic, renal, or cardiac function, concomitant diseases, and other drug therapy.",[173],{"source":34,"section":174},"8.5",{"level":167,"text":176,"quote":179,"refs":180},{"fa":177,"en":178},"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 Females of reproductive potential should prevent pregnancy by use of effective contraception during MAVENCLAD dosing and for at least 6 months after the last dose in each treatment course.",[181],{"source":34,"section":182},"8.3",1792191533964]