[{"data":1,"prerenderedAt":249},["ShallowReactive",2],{"drug-rituximab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":23,"regimens":37,"contraindications":124,"warnings":125,"renal":133,"monitoring":134,"interactions":135,"review":136,"examples":139,"atc":157,"iran":159,"usApproval":183,"links":189,"populations":206},"rituximab",1,{"fa":7,"en":8},"ریتوکسیمب","Rituximab","antineoplastic-immunomodulating",{"fa":11,"en":12},"آنتی‌بادی ضد CD20","Anti-CD20 antibody",[14],{"name":15,"market":16},"Rituxan","US",[18,19,20,21,22],"rituxan","mabthera","zytux","ریتوکسیماب","زیتوکس",[24],{"id":25,"form":26,"route":27,"label":28,"concentration":29,"markets":32,"refs":33},"vial-10","injection","iv","10 mg\u002FmL (100 mg\u002F10 mL, 500 mg\u002F50 mL vials)",{"amount":30,"unit":31,"perVolumeMl":5},10,"mg",[16],[34],{"source":35,"section":36},"fda-rituxan","3",[38,70,99],{"id":39,"disease":40,"label":41,"population":44,"type":45,"unit":31,"dose":46,"refs":48,"durationDays":51,"notes":52},"nhl","b-cell-lymphoma",{"fa":42,"en":43},"لنفوم غیرهوچکین سلول B — ۳۷۵ mg\u002Fm² هر نوبت","B-cell NHL — 375 mg\u002Fm² per infusion",{},"bsa",{"perM2PerDay":47,"dividedDoses":5},375,[49],{"source":35,"section":50},"2.2",{"min":5,"max":5},[53,62],{"text":54,"refs":57},{"fa":55,"en":56},"پیش‌دارو قبل از هر انفوزیون: استامینوفن و آنتی‌هیستامین (و کورتون طبق رژیم). فقط انفوزیون وریدی، نه بولوس.","Premedicate before each infusion: acetaminophen and an antihistamine (and steroid per regimen). IV infusion only, never push or bolus.",[58,60],{"source":35,"section":59},"2.8",{"source":35,"section":61},"2.1",{"text":63,"refs":66},{"fa":64,"en":65},"عودکننده یا مقاوم: هفته‌ای یک بار ۴ یا ۸ دوز؛ درمان‌نشده: روز ۱ هر دوره شیمی‌درمانی تا ۸ دوز. CLL: دوره ۱ ← ۳۷۵ و دوره ۲ تا ۶ ← ۵۰۰ mg\u002Fm².","Relapsed\u002Frefractory: weekly for 4 or 8 doses; untreated: day 1 of each chemo cycle up to 8 doses. CLL: cycle 1 → 375, cycles 2–6 → 500 mg\u002Fm².",[67,68],{"source":35,"section":50},{"source":35,"section":69},"2.3",{"id":71,"disease":72,"label":73,"population":76,"type":80,"unit":31,"dose":81,"refs":83,"durationDays":86,"notes":87},"ra","rheumatoid-arthritis",{"fa":74,"en":75},"آرتریت روماتوئید — دو انفوزیون ۱۰۰۰ mg با فاصله ۲ هفته (همراه متوترکسات)","Rheumatoid arthritis — two 1000 mg infusions 2 weeks apart (with methotrexate)",{"minAge":77},{"value":78,"unit":79},18,"year","fixed",{"perDose":82,"dosesPerDay":5},1000,[84],{"source":35,"section":85},"2.5",{"min":5,"max":5},[88,93],{"text":89,"refs":90},{"fa":55,"en":56},[91,92],{"source":35,"section":59},{"source":35,"section":61},{"text":94,"refs":97},{"fa":95,"en":96},"متیل‌پردنیزولون ۱۰۰ mg وریدی ۳۰ دقیقه قبل از هر انفوزیون. دوره بعدی هر ۲۴ هفته، نه زودتر از ۱۶ هفته.","Methylprednisolone 100 mg IV 30 min before each infusion. Next course every 24 weeks, not sooner than 16 weeks.",[98],{"source":35,"section":85},{"id":100,"disease":101,"label":102,"population":105,"type":80,"unit":31,"dose":107,"refs":108,"durationDays":111,"notes":112},"pv","pemphigus",{"fa":103,"en":104},"پمفیگوس ولگاریس — دو انفوزیون ۱۰۰۰ mg با فاصله ۲ هفته، همراه کاهش تدریجی کورتون","Pemphigus vulgaris — two 1000 mg infusions 2 weeks apart, with tapering steroids",{"minAge":106},{"value":78,"unit":79},{"perDose":82,"dosesPerDay":5},[109],{"source":35,"section":110},"2.7",{"min":5,"max":5},[113,118],{"text":114,"refs":115},{"fa":55,"en":56},[116,117],{"source":35,"section":59},{"source":35,"section":61},{"text":119,"refs":122},{"fa":120,"en":121},"نگهدارنده: ۵۰۰ mg در ماه ۱۲ و سپس هر ۶ ماه. عود: ۱۰۰۰ mg.","Maintenance: 500 mg at month 12 and every 6 months. Relapse: 1000 mg.",[123],{"source":35,"section":110},[],[126],{"text":127,"refs":130},{"fa":128,"en":129},"هشدار جعبه‌ای: واکنش انفوزیون کشنده (بیشتر انفوزیون اول)، واکنش شدید پوستی-مخاطی، فعال شدن هپاتیت B (غربالگری HBsAg و anti-HBc قبل)، PML.","Boxed warning: fatal infusion reactions (mostly the first), severe mucocutaneous reactions, hepatitis B reactivation (screen HBsAg and anti-HBc first), PML.",[131],{"source":35,"section":132},"Boxed Warning",[],[],[],{"status":137,"reviewer":138,"date":138},"unverified",null,[140,148,154],{"regimen":39,"formulation":25,"input":141,"expect":145},{"ageYears":142,"weightKg":143,"heightCm":144},55,81,180,{"perDose":146,"mlPerDose":147},754.67,75.47,{"regimen":71,"formulation":25,"input":149,"expect":152},{"ageYears":150,"weightKg":151},50,70,{"perDose":82,"mlPerDose":153},100,{"regimen":100,"formulation":25,"input":155,"expect":156},{"ageYears":150,"weightKg":151},{"perDose":82,"mlPerDose":153},[158],"L01FA01",{"status":160,"forms":161,"refs":178},"registered",[162,166,170,174],{"code":163,"en":164,"fa":165},"02473","RITUXIMAB 100MG\u002F10ML VIAL","ویال ریتوکسیمب ۱۰۰ میلی‌گرم \u002F ۱۰ میلی‌لیتر",{"code":167,"en":168,"fa":169},"02474","RITUXIMAB 500MG\u002F50ML VIAL","ویال ریتوکسیمب ۵۰۰ میلی‌گرم \u002F ۵۰ میلی‌لیتر",{"code":171,"en":172,"fa":173},"52048","RITUXIMAB INJECTION PARENTERAL 120 mg\u002F1mL 11.7 mL","فرآورده تزریقی ریتوکسیمب ۱۲۰ میلی‌گرم \u002F ۱ میلی‌لیتر ۱۱٫۷ میلی‌لیتر",{"code":175,"en":176,"fa":177},"52049","RITUXIMAB INJECTION PARENTERAL 120 mg\u002F1mL 13.4 mL","فرآورده تزریقی ریتوکسیمب ۱۲۰ میلی‌گرم \u002F ۱ میلی‌لیتر ۱۳٫۴ میلی‌لیتر",[179],{"source":180,"section":181,"url":182},"darooyab-generic","G-1062\u002FRituximab","https:\u002F\u002Fwww.darooyab.ir\u002FG-1062\u002FRituximab",{"kind":184,"refs":185,"id":188},"BLA",[186],{"source":35,"section":187},"SPL approval \u002F marketing category","BLA103705",[190,193,197,201,204],{"kind":191,"url":192,"label":188},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=103705",{"kind":194,"url":195,"label":196},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=b172773b-3905-4a1c-ad95-bab4b6126563","FDA Rituxan",{"kind":198,"url":199,"label":200},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa607038.html","Rituximab Injection",{"kind":202,"url":203,"label":158},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L01FA01",{"kind":205,"url":182,"label":8},"darooyab",{"pregnancy":207,"lactation":216,"pediatric":225,"geriatric":233,"reproductive":241},{"level":208,"text":209,"quote":212,"refs":213},"caution",{"fa":210,"en":211},"برچسب خطر مشخصی برای بارداری ذکر نکرده یا داده کافی ندارد؛ فقط در صورت لزوم و با نظر پزشک.","Label states no clear risk or has limited data; use only if needed, under medical advice.","Risk Summary Based on human data, RITUXAN can cause adverse developmental outcomes including B-cell lymphocytopenia in infants exposed to RITUXAN in-utero ( see Clinical Considerations ).",[214],{"source":35,"section":215},"8.1",{"level":217,"text":218,"quote":221,"refs":222},"avoid",{"fa":219,"en":220},"برچسب: شیردهی توصیه نمی‌شود یا باید بین دارو و شیردهی یکی انتخاب شود.","Label: breastfeeding not recommended, or choose between the drug and breastfeeding.","Given that the clinical significance of this finding for children is not known, advise women not to breastfeed during treatment with RITUXAN and for 6 months after the last dose due to the potential of serious adverse reactions in breastfed children.",[223],{"source":35,"section":224},"8.2",{"level":208,"text":226,"quote":229,"refs":230},{"fa":227,"en":228},"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.","Mature B-Cell NHL\u002FB-AL The safety and effectiveness of RITUXAN in combination with chemotherapy for the treatment of previously untreated, advanced stage, CD20-positive DLBCL\u002FBL\u002FBLL\u002FB-AL have been established in pediatric patients aged 6 months and older.",[231],{"source":35,"section":232},"8.4",{"level":208,"text":234,"quote":237,"refs":238},{"fa":235,"en":236},"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 70 years or older received lower dose intensity of fludarabine and cyclophosphamide compared to younger patients, regardless of the addition of RITUXAN.",[239],{"source":35,"section":240},"8.5",{"level":208,"text":242,"quote":245,"refs":246},{"fa":243,"en":244},"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 Advise females of reproductive potential to use effective contraception during treatment with RITUXAN and for 12 months after the last dose.",[247],{"source":35,"section":248},"8.3",1792156194158]