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ФАРМАКО-ТЕРАПЕВТИЧЕСКАЯ ГРУППА\n\nиммунодепрессанты, селективные иммунодепрессанты\n\n##### КОД АТХ\n\nL04AA37 - Барициниб\n\n##### ФАРМАКОЛОГИЧЕСКИЕ СВОЙСТВА\n\nСелективный и обратимый ингибитор янус-киназы 1 и 2 (JAK1 и JAK2). Барицитиниб ингибирует активность JAK1, JAK2, тирозинкиназы-2 и JAK3 со значениями IC50 (концентрация полумаксимального ингибирования) 5.9, 5.7, 53 и >400 нМ соответственно. В рамках внутриклеточного сигнального пути янус-киназы фосфорилируют и активируют STAT (транспортеры сигнала и активаторы транскрипции), которые в свою очередь активируют экспрессию гена в клетке. Барицитиниб модулирует эти сигнальные каскады реакций, частично ингибируя ферментативную активность JAK1 и JAK2, тем самым уменьшая фосфорилирование и активацию STAT.\n\n##### ФАРМАКОКИНЕТИКА\n\nПосле приема внутрь барицитиниб быстро всасывается, время достижения Cmax составляет приблизительно 1 ч (диапазон 0.5-3 ч), абсолютная биодоступность составляет около 79% (CV = 3.94%). Фармакокинетика барицитиниба является линейной по времени.\n\nСредний Vd после в/в введения составляет 76 л, что свидетельствует о распределении барицитиниба в тканях. Приблизительно 50% барицитиниба связывается с белками плазмы.\n\nМетаболизм барицитиниба опосредован изоферментом CYP3A4, при этом биотрансформации подвергается менее 10% дозы. В плазме крови метаболиты барицитиниба не обнаруживаются. В условиях in vitro барицитиниб является субстратом для изофермента CYP3A4, транспортера органических анионов 3 (ОАТ3), Р-гликопротеина (Pgp), белка резистентности рака молочной железы (BCRP) и белков множественной резистентности и выведения токсинов 2-К (МАТЕ 2-К). Барицитиниб может быть ингибитором транспортеров органических катионов (ОСТ) 1.\n\nВыведение почками посредством клубочковой фильтрации и активной секреции через ОАТ3, Pgp, BCRP и МАТЕ2-К является основным механизмом клиренса барицитиниба. Приблизительно 75% вводимой дозы выводится почками, около 20% - через кишечник. У пациентов с ревматоидным артритом средний клиренс и Т1/2 составляли 9.42 л/ч (CV= 34.3%) и 12.5 ч (CV= 27.4%) соответственно. Сmax и AUC барицитиниба в устойчивом состоянии фармакокинетики у пациентов с ревматоидным артритом были соответственно в 1.4 и 2 раза выше, чем у здоровых добровольцев.\n\nФункция почек значительно влияет на экспозицию барицитиниба. Среднее соотношение AUC у пациентов с легкой и умеренной почечной недостаточностью и у пациентов с нормальной функцией почек составляют 1.41 (90% ДИ: 1.15-1.74) и 2.22 (90% ДИ: 1.81-2.73) соответственно. Среднее соотношение Сmax у пациентов с легкой и умеренной почечной недостаточностью и у пациентов с нормальной функцией почек составляют 1.16 (90% ДИ: 0.92-1.45) и 1.46 (90% ДИ: 1.17-1.83) соответственно.\n\n##### ПОКАЗАНИЯ К ПРИМЕНЕНИЮ\n\nЛечение активного ревматоидного артрита умеренной или тяжелой степени у взрослых пациентов с непереносимостью или отсутствием адекватного ответа на лечение одним или несколькими базисными противоревматическими препаратами.\n\n##### ПРОТИВОПОКАЗАНИЯ\n\nПовышенная чувствительность к барицитинибу; беременность; период грудного вскармливания; возраст до 18 лет (в связи с отсутствием данных по эффективности и безопасности).\n\n##### ПРИМЕНЕНИЕ ПРИ БЕРЕМЕННОСТИ И КОРМЛЕНИИ ГРУДЬЮ\n\nПрименение барицитиниба во время беременности противопоказано.\n\nНе следует применять барицитиниб в период грудного вскармливания.\n\n##### ПРИМЕНЕНИЕ ДЕТЬМИ\n\nПротивопоказано применение барицитиниба пациентам в возрасте до 18 лет. \n\n##### ПРИМЕНЕНИЯ ПРИ ХРОНИЧЕСКИХ ЗАБОЛЕВАНИЯХ\n\nС осторожностью следует назначать барицитиниб при печеночной недостаточности тяжелой степени. \n\nС осторожностью следует назначать барицитиниб при почечной недостаточности (КК менее 30 мл/мин). \n\nС осторожностью следует назначать барицитиниб пациентам в возрасте старше 75 лет. \n\n##### СПОСОБ ПРИМЕНЕНИЯ И ДОЗЫ\n\nВнутрь. Рекомендуемая доза составляет 4 мг 1 раз/сут.\n\n##### ПОБОЧНОЕ ДЕЙСТВИЕ\n\n _Инфекции и инвазии:_ очень часто - инфекция верхних дыхательных путей; часто - опоясывающий лишай, простой герпес, гастроэнтерит, инфекция мочевыводящих путей.\n\n_Со стороны системы кроветворения:_ часто - тромбоцитоз >600×109 клеток/л; нечасто - нейтропения <1×109 клеток/л.\n\n_Со стороны обмена веществ:_ очень часто - гиперхолестеринемия; нечасто - гипертриглицеридемия.\n\n_Со стороны пищеварительной системы:_ часто - тошнота.\n\n_Со стороны кожи и подкожных тканей:_ нечасто - акне.\n\n_Прочие:_ часто - повышение активности АЛТ, АСТ; нечасто - увеличение массы тела, повышение концентрации КФК.\n\n##### ВЗАИМОДЕЙСТВИЕ С ДРУГИМИ ЛЕКАРСТВЕННЫМИ ПРЕПАРАТАМИ И ДРУГИЕ ВИДЫ ВЗАИМОДЕЙСТВИЯ\n\nПри применении барицитиниба в комбинации с мощными иммунодепрессантами, такими как азатиоприн, такролимус или циклоспорин, невозможно исключить риск аддитивной иммуносупрессии.\n\nПрименение пробенецида приводило к приблизительно двукратному увеличению AUC(0-∞) без изменения Тmax или Сmax барицитиниба. Следовательно, у пациентов, которые принимают ингибиторы ОАТ3 с сильной ингибирующей активностью, такие как пробенецид, рекомендуемая доза барицитиниба составляет 2 мг 1 раз/сут.\n\nСледует соблюдать осторожность при одновременном назначении лефлуномида или терифлуномида и барицитиниба.\n\n##### ОСОБЫЕ УКАЗАНИЯ\n\nС осторожностью следует назначать барицитиниб при почечной недостаточности (КК менее 30 мл/мин); печеночной недостаточности тяжелой степени; активных, хронических или рецидивирующих инфекциях (включая туберкулез); активной форме вирусного гепатита В и С; снижении числа нейтрофилов (<1×109/л), снижение числа лейкоцитов (<0.5×109/л), снижение гемоглобина (<8 г/дл); в комбинации с биологическими базисными противоревматическими препаратами или другими ингибиторами янус-киназы; в комбинации с мощными иммунодепрессантами (например, азатиоприном, такролимусом, циклоспорином); одновременном применении живых вакцин; пациентам с факторами риска ТГВ/ТЭЛА; пациентам в возрасте старше 75 лет.\n\nУ пациентов с активными, хроническими или рецидивирующими инфекциями до начала терапии рекомендуется тщательно оценивать соотношение польза/риск применения барицитиниба.\n\nПеред началом применения барицитиниба пациенты должны пройти скрининг на туберкулез. Барицитиниб не рекомендуется применять у пациентов с активной формой туберкулеза. У пациентов с латентной формой туберкулеза, которые ранее не получали лечение, перед началом терапии барицитинибом необходимо рассмотреть возможность проведения противотуберкулезной терапии.\n\nНе рекомендуется начинать терапию или следует временно прекратить применение барицитиниба в случае снижения числа нейтрофилов <1×109/л, снижения числа лейкоцитов <0.5×109/л или снижения гемоглобина <8 г/дл.\n\nУ пожилых пациентов с ревматоидным артритом увеличивается риск развития лимфоцитоза. Есть данные о редких случаях развития лимфопролиферативных заболеваний.\n\nВ случае развития у пациента опоясывающего герпеса применение барицитиниба следует временно прекратить до разрешения заболевания.\n\nПеред началом терапии барицитинибом следует проводить скрининг пациентов для выявления вирусного гепатита. При выявлении ДНК вируса гепатита В пациента следует направить к гепатологу, чтобы определить возможность продолжения или прекращения терапии.\n\nНе рекомендуется использование живых аттенуированных вакцин во время или непосредственно перед применением барицитиниба. При рассмотрении вопроса о проведении вакцинации против ветряной оспы перед началом применения барицитиниба следует придерживаться международных рекомендаций по проведению вакцинации у пациентов с ревматоидным артритом.\n\nПриблизительно через 12 недель после начала применения барицитиниба следует оценивать липидный профиль, после чего лечение пациентов следует проводить в соответствии с международными клиническими рекомендациями по ведению пациентов с гиперлипидемией.\n\nВ случае выявления повышения активности АЛТ или ACT во время обследования пациентов и подозрения на лекарственное поражение печени применение барицитиниба следует временно прекратить до тех пор, пока этот диагноз не будет исключен.\n\nУ пациентов с ревматоидным артритом повышается риск возникновения злокачественных новообразований, включая риск лимфомы. Применение иммуномодулирующих лекарственных средств может увеличить риск возникновения злокачественных новообразований, включая риск лимфомы.\n\nПри выявлении клинических признаков ТГВ/ТЭЛА применение барицитиниба следует временно прекратить, немедленно оценить состояние пациента и провести соответствующее лечение.\n\n##### СРОК ГОДНОСТИ\n\n3 года\n\n##### УСЛОВИЯ ХРАНЕНИЯ\n\nПри температуре не выше 30 град.\n\n##### УСЛОВИЯ ОТПУСКА\n\nПо рецепту\n\n##### ПРОТИВОПОКАЗАНИЯ\n\nПовышенная чувствительность к барицитинибу; беременность; период грудного вскармливания; возраст до 18 лет (в связи с отсутствием данных по эффективности и безопасности).","overSized","imageComparisonOptions",[],"reviewsCounters",{},"redemptionStats",[],"saleEndsDateIso","cashback","showMultipleFractionsCounter","promoTitle","promoDescription","promoLegalDescription","lowestRecentPrice","productDisclaimers",[1102],{"_1103":1104,"_274":1105},"details","Цена действительна только при заказе онлайн. 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ОЛУМИАНТ ТАБ П/П/О 4МГ №28

ФАРМАКО-ТЕРАПЕВТИЧЕСКАЯ ГРУППА