Неходжкинская лимфома, хронический лимфолейкоз, ревматоидный артрит, гранулематоз с полиангиитом.
Противопоказания
Острые инфекционные заболевания, Выраженный иммунодефицит (первичный или вторичный), Конечная стадия поражения сердца (IV класс по классификации NYHA) в сочетании с ревматоидным артритом, Детский и подростковый возраст до 18 лет (не установлены безопасность и эффективность применения), Период беременности, Лактация (грудное вскармливание), Повышенная ...
Ритуксимаб, дигидрат цитрата натрия, полисорбат, хлорид натрия, гидроксид натрия, вода для инъекций.
Описание
Концентрат для приготовления раствора для инфузий Мабтера - противоопухолевое средство применяемое при неходжинской лимфоме, хроническом лимфолейкозе и ревматоидном артрите.
Фармакологические свойства
Ритуксимаб - химерное моноклональное антитело мыши/человека, которое специфически связывается с трансмембранным антигеном CD20. Этот антиген расположен на пре-В-лимфоцитах и зрелых В-лимфоцитах, но отсутствует на стволовых гемопоэтических клетках, про-В-клетках, нормальных плазматических клетках, клетках других тканей и экспрессируется более чем в 95% случаев при В-клеточных неходжкинских лимфомах. Экспрессироваиный на клетке CD20 после связывания с антителом не интернализуется и перестает поступать с клеточной мембраны во внеклеточное пространство. CD20 не циркулирует в плазме в виде свободного антигена, и поэтому не конкурирует за связывание с антителом. Ритуксимаб связывается с антигеном CD20 на В-лимфоцитах и инициирует иммунологические реакции, опосредующие лизис В-клеток. Возможные механизмы клеточного лизиса включают комплемент-зависимую цитотоксичность, антитело-зависимую клеточную цитотоксичность и индукцию апоптоза. Ритуксимаб повышает чувствительность линий В-клеточной лимфомы человека к цитотоксическому действию некоторых химиотерапевтических препаратов in vitro. Число В-клеток в периферической крови после первого введения препарата снижается ниже нормы и начинает восстанавливаться у пациентов с гематологическими злокачественными заболеваниями через 6 месяцев, достигая нормальных значений через 12 месяцев после завершения терапии, однако в некоторых случаях продолжительность периода восстановления количества В-клеток может быть больше. У пациентов с ревматоидным артритом продолжительность снижения количества В-клеток варьирует, большинству пациентов последующую терапию назначают до полного восстановления их количества. У небольшого числа пациентов наблюдается длительное снижение количества В-клеток (в течение двух и более лет после последней дозы препарата). У пациентов с гранулематозом с полиангиитом и микроскопическим полиангиитом снижение числа С019-положительных В-клеток до уровня менее 10 клеток/мкл происходит после двух первых инфузий ритуксимаба, и у большинства пациентов сохраняется на данном уровне в течение 6 месяцев. Антихимерные антитела выявлены у 1.1% обследованных больных с неходжкинской лимфомой и у 10% - с ревматоидным артритом. Антимышиные антитела у обследованных больных не выявлены.
Показания к применению
Неходжкинская лимфома, хронический лимфолейкоз, ревматоидный артрит, гранулематоз с полиангиитом.
Противопоказания
Острые инфекционные заболевания, Выраженный иммунодефицит (первичный или вторичный), Конечная стадия поражения сердца (IV класс по классификации NYHA) в сочетании с ревматоидным артритом, Детский и подростковый возраст до 18 лет (не установлены безопасность и эффективность применения), Период беременности, Лактация (грудное вскармливание), Повышенная индивидуальная чувствительность к компонентам средства, ритуксимабу или белку мыши.
Применение при беременности и в период грудного вскармливания
Противопоказано
Способ применения и дозы
Необходимое количество препарата набирают в асептических условиях и разводят до расчетной концентрации (1-4 мг/мл) в инфузионном флаконе (пакете) с 0.9% раствором натрия хлорида для инфузий или 5% раствором декстрозы (растворы должны быть стерильными и апирогенными). Для перемешивания аккуратно переворачивают флакон (пакет) во избежание пенообразования. Перед введением необходимо осмотреть раствор на предмет отсутствия посторонних примесей или изменения окраски. Врач отвечает за приготовление, условия и время хранения готового раствора до его использования. Так как препарат Мабтера не содержит консервантов, приготовленный раствор необходимо использовать немедленно. Приготовленный инфузионный раствор препарата физически и химически стабилен в течение 12 ч при комнатной температуре или в течение не более 24 ч при температуре от 2 до 8°С. Рекомендуемый режим дозирования при повторном применении: 1000 мг 1 раз в 2 недели, курс - 2 инфузии. Рекомендуемая начальная скорость первой инфузии 50 мг/ч, в дальнейшем ее можно увеличивать на 50 мг/ч каждые 30 мин, доводя до максимальной скорости 400 мг/ч. Время проведения инфузии - 4 ч 15 мин.
Побочное действие
Нарушения со стороны крови и лимфатической системы: очень часто - лейкопения, нейтропения, часто - тромбоцитопения, анемия, нечасто - лимфоаденопатия, нарушение свертываемости крови, транзиторная парциальная апластическая анемия, гемолитическая анемия. Нарушения со стороны дыхательной системы, органов грудной клетки и средостения: часто - ринит, бронхоспазм, кашель, респираторные заболевания, одышка, боли в грудной клетке, нечасто - гипоксия, нарушение функции легких, облитерирующий бронхиолит, бронхиальная астма. Нарушения со стороны иммунной системы: очень часто - ангионевротический отек, часто - реакции гиперчувствительности. Нарушения со стороны обмена веществ и питания: часто - гипергликемия, снижение веса, периферические отеки, отеки лица, повышение активности ЛДГ, гипокальциемия. Общие расстройства и нарушения в месте введения: очень часто - головная боль, лихорадка, озноб, астения, часто - боли в очагах опухоли, гриппоподобный синдром, приливы, слабость, нечасто - боли в месте инъекции. Нарушения со стороны желудочно-кишечного тракта: очень часто - тошнота, часто - рвота, диарея, диспепсия, отсутствие аппетита, дисфагия, стоматит, запор, боли в животе, першение в горле, нечасто - увеличение живота. Нарушения со стороны сердечно-сосудистой системы: часто - понижение артериального давления, повышение артериального давления, ортостатическая гипотензия, тахикардия, аритмия, мерцание предсердий, инфаркт миокарда, кардиальная патология, нечасто - левожелудочковая сердечная недостаточность, желудочковая и наджелудочковая тахикардия, брадикардия, ишемия миокарда, стенокардия. Нарушения со стороны нервной системы: часто - головокружение, парестезии, гипестезии, нарушение сна, чувство тревоги, возбуждение, вазодилатация, нечасто - извращение вкуса. Нарушения психики: нечасто - нервозность, депрессия. Нарушения со стороны скелетно-мышечной и соединительной ткани: часто - миалгия, артралгия, мышечный гипертонус, боли в спине, боли в области шеи, боли. Нарушения со стороны кожи и подкожных тканей: очень часто - зуд, сыпь, часто - крапивница, повышенное потоотделение ночью, потливость, алопеция. Нарушения со стороны органа зрения: часто - нарушения слезоотделения, конъюнктивит. Нарушения со стороны органа слуха и лабиринтные нарушения: часто - боль и шум в ушах.
Передозировка
Случаи передозировки у человека не наблюдались. Разовые дозы ритуксимаба выше 1000 мг не изучались. Максимальная доза 5000 мг назначалась пациентам с хроническим лимфолейкозом, дополнительных данных по безопасности не получено. В связи с увеличением риска инфекционных осложнений при истощении пула В-лимфоцитов следует отменить инфузию препарата, наблюдать за состоянием пациента и назначить развернутый общий анализ крови.
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Этот антиген расположен на пре-В-лимфоцитах и зрелых В-лимфоцитах, но отсутствует на стволовых гемопоэтических клетках, про-В-клетках, нормальных плазматических клетках, клетках других тканей и экспрессируется более чем в 95% случаев при В-клеточных неходжкинских лимфомах. Экспрессироваиный на клетке CD20 после связывания с антителом не интернализуется и перестает поступать с клеточной мембраны во внеклеточное пространство. CD20 не циркулирует в плазме в виде свободного антигена, и поэтому не конкурирует за связывание с антителом. Ритуксимаб связывается с антигеном CD20 на В-лимфоцитах и инициирует иммунологические реакции, опосредующие лизис В-клеток. Возможные механизмы клеточного лизиса включают комплемент-зависимую цитотоксичность, антитело-зависимую клеточную цитотоксичность и индукцию апоптоза. Ритуксимаб повышает чувствительность линий В-клеточной лимфомы человека к цитотоксическому действию некоторых химиотерапевтических препаратов in vitro. Число В-клеток в периферической крови после первого введения препарата снижается ниже нормы и начинает восстанавливаться у пациентов с гематологическими злокачественными заболеваниями через 6 месяцев, достигая нормальных значений через 12 месяцев после завершения терапии, однако в некоторых случаях продолжительность периода восстановления количества В-клеток может быть больше. У пациентов с ревматоидным артритом продолжительность снижения количества В-клеток варьирует, большинству пациентов последующую терапию назначают до полного восстановления их количества. У небольшого числа пациентов наблюдается длительное снижение количества В-клеток (в течение двух и более лет после последней дозы препарата). У пациентов с гранулематозом с полиангиитом и микроскопическим полиангиитом снижение числа С019-положительных В-клеток до уровня менее 10 клеток/мкл происходит после двух первых инфузий ритуксимаба, и у большинства пациентов сохраняется на данном уровне в течение 6 месяцев. Антихимерные антитела выявлены у 1.1% обследованных больных с неходжкинской лимфомой и у 10% - с ревматоидным артритом. Антимышиные антитела у обследованных больных не выявлены."}}]},{"id":4,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Неходжкинская лимфома, хронический лимфолейкоз, ревматоидный артрит, гранулематоз с полиангиитом."}}]},{"id":5,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Острые инфекционные заболевания, Выраженный иммунодефицит (первичный или вторичный), Конечная стадия поражения сердца (IV класс по классификации NYHA) в сочетании с ревматоидным артритом, Детский и подростковый возраст до 18 лет (не установлены безопасность и эффективность применения), Период беременности, Лактация (грудное вскармливание), Повышенная индивидуальная чувствительность к компонентам средства, ритуксимабу или белку мыши."}}]},{"id":6,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Противопоказано"}}]},{"id":7,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Необходимое количество препарата набирают в асептических условиях и разводят до расчетной концентрации (1-4 мг/мл) в инфузионном флаконе (пакете) с 0.9% раствором натрия хлорида для инфузий или 5% раствором декстрозы (растворы должны быть стерильными и апирогенными). Для перемешивания аккуратно переворачивают флакон (пакет) во избежание пенообразования. Перед введением необходимо осмотреть раствор на предмет отсутствия посторонних примесей или изменения окраски. Врач отвечает за приготовление, условия и время хранения готового раствора до его использования. Так как препарат Мабтера не содержит консервантов, приготовленный раствор необходимо использовать немедленно. Приготовленный инфузионный раствор препарата физически и химически стабилен в течение 12 ч при комнатной температуре или в течение не более 24 ч при температуре от 2 до 8°С. Рекомендуемый режим дозирования при повторном применении: 1000 мг 1 раз в 2 недели, курс - 2 инфузии. Рекомендуемая начальная скорость первой инфузии 50 мг/ч, в дальнейшем ее можно увеличивать на 50 мг/ч каждые 30 мин, доводя до максимальной скорости 400 мг/ч. Время проведения инфузии - 4 ч 15 мин."}}]},{"id":8,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Нарушения со стороны крови и лимфатической системы: очень часто - лейкопения, нейтропения, часто - тромбоцитопения, анемия, нечасто - лимфоаденопатия, нарушение свертываемости крови, транзиторная парциальная апластическая анемия, гемолитическая анемия. Нарушения со стороны дыхательной системы, органов грудной клетки и средостения: часто - ринит, бронхоспазм, кашель, респираторные заболевания, одышка, боли в грудной клетке, нечасто - гипоксия, нарушение функции легких, облитерирующий бронхиолит, бронхиальная астма. Нарушения со стороны иммунной системы: очень часто - ангионевротический отек, часто - реакции гиперчувствительности. Нарушения со стороны обмена веществ и питания: часто - гипергликемия, снижение веса, периферические отеки, отеки лица, повышение активности ЛДГ, гипокальциемия. Общие расстройства и нарушения в месте введения: очень часто - головная боль, лихорадка, озноб, астения, часто - боли в очагах опухоли, гриппоподобный синдром, приливы, слабость, нечасто - боли в месте инъекции. Нарушения со стороны желудочно-кишечного тракта: очень часто - тошнота, часто - рвота, диарея, диспепсия, отсутствие аппетита, дисфагия, стоматит, запор, боли в животе, першение в горле, нечасто - увеличение живота. Нарушения со стороны сердечно-сосудистой системы: часто - понижение артериального давления, повышение артериального давления, ортостатическая гипотензия, тахикардия, аритмия, мерцание предсердий, инфаркт миокарда, кардиальная патология, нечасто - левожелудочковая сердечная недостаточность, желудочковая и наджелудочковая тахикардия, брадикардия, ишемия миокарда, стенокардия. Нарушения со стороны нервной системы: часто - головокружение, парестезии, гипестезии, нарушение сна, чувство тревоги, возбуждение, вазодилатация, нечасто - извращение вкуса. Нарушения психики: нечасто - нервозность, депрессия. Нарушения со стороны скелетно-мышечной и соединительной ткани: часто - миалгия, артралгия, мышечный гипертонус, боли в спине, боли в области шеи, боли. Нарушения со стороны кожи и подкожных тканей: очень часто - зуд, сыпь, часто - крапивница, повышенное потоотделение ночью, потливость, алопеция. Нарушения со стороны органа зрения: часто - нарушения слезоотделения, конъюнктивит. Нарушения со стороны органа слуха и лабиринтные нарушения: часто - боль и шум в ушах."}}]},{"id":9,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Случаи передозировки у человека не наблюдались. Разовые дозы ритуксимаба выше 1000 мг не изучались. Максимальная доза 5000 мг назначалась пациентам с хроническим лимфолейкозом, дополнительных данных по безопасности не получено. В связи с увеличением риска инфекционных осложнений при истощении пула В-лимфоцитов следует отменить инфузию препарата, наблюдать за состоянием пациента и назначить развернутый общий анализ крови."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Ритуксимаб - химерное моноклональное антитело мыши/человека, которое специфически связывается с трансмембранным антигеном CD20. Этот антиген расположен на пре-В-лимфоцитах и зрелых В-лимфоцитах, но отсутствует на стволовых гемопоэтических клетках, про-В-клетках, нормальных плазматических клетках, клетках других тканей и экспрессируется более чем в 95% случаев при В-клеточных неходжкинских лимфомах. Экспрессироваиный на клетке CD20 после связывания с антителом не интернализуется и перестает поступать с клеточной мембраны во внеклеточное пространство. CD20 не циркулирует в плазме в виде свободного антигена, и поэтому не конкурирует за связывание с антителом. Ритуксимаб связывается с антигеном CD20 на В-лимфоцитах и инициирует иммунологические реакции, опосредующие лизис В-клеток. Возможные механизмы клеточного лизиса включают комплемент-зависимую цитотоксичность, антитело-зависимую клеточную цитотоксичность и индукцию апоптоза. Ритуксимаб повышает чувствительность линий В-клеточной лимфомы человека к цитотоксическому действию некоторых химиотерапевтических препаратов in vitro. Число В-клеток в периферической крови после первого введения препарата снижается ниже нормы и начинает восстанавливаться у пациентов с гематологическими злокачественными заболеваниями через 6 месяцев, достигая нормальных значений через 12 месяцев после завершения терапии, однако в некоторых случаях продолжительность периода восстановления количества В-клеток может быть больше. У пациентов с ревматоидным артритом продолжительность снижения количества В-клеток варьирует, большинству пациентов последующую терапию назначают до полного восстановления их количества. 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