Препарат предназначен для лечения пациентов с местнораспространенным или метастатическим раком ободочной и прямой кишки: в комбинации с фторурацилом и кальция фолинатом у пациентов, ранее не получавших прежде химиотерапию, в монотерапии у пациентов с прогрессированием болезни после проведения стандартной противоопухолевой терапии.
Противопоказания
Повышенная чувствительность к иринотекану или другим компонентам препарата, язвенный колит и/или нарушения кишечной проходимости, выраженное угнетение костномозгового кроветворения, концентрация билирубина в сыворотке крови, превышающая более чем в 3 раза верхнюю границу нормы, общее состояние пациентов, оцениваемое по шкале ВОЗ>2, беременность и период ...
Тригидрат гидрохлорида иринотекана, молочная кислота, гидроксид натрия, вода для инъекций.
Описание
Концентрат для приготовления раствора Иринотекан Медак - противоопухолевое средство, применяется для лечения пациентов с местнораспространенным или метастатическим раком ободочной и прямой кишки.
Фармакологические свойства
Иринотекан - полусинтетическое производное камптотецина - является специфическим ингибитором клеточного фермента топоизомеразы I. В тканях препарат метаболизируется с образованием активного метаболита SN-38, который превосходит по своей активности иринотекан. Иринотекан и метаболит SN-38 стабилизируют комплекс топоизомеразы I с ДНК, что препятствует ее репликации. В опытах in vivo было показано, что иринотекан также активен в отношении опухолей, экспрессирующих Р-гликопротеин множественной лекарственной резистентности (винкристин- и доксорубицин- резистентные лейкемии Р388).
Показания к применению
Препарат предназначен для лечения пациентов с местнораспространенным или метастатическим раком ободочной и прямой кишки: в комбинации с фторурацилом и кальция фолинатом у пациентов, ранее не получавших прежде химиотерапию, в монотерапии у пациентов с прогрессированием болезни после проведения стандартной противоопухолевой терапии.
Противопоказания
Повышенная чувствительность к иринотекану или другим компонентам препарата, язвенный колит и/или нарушения кишечной проходимости, выраженное угнетение костномозгового кроветворения, концентрация билирубина в сыворотке крови, превышающая более чем в 3 раза верхнюю границу нормы, общее состояние пациентов, оцениваемое по шкале ВОЗ>2, беременность и период кормления грудью, детский возраст (данные по безопасности и эффективности у детей отсутствуют).
Применение при беременности и в период грудного вскармливания
Противопоказано.
Способ применения и дозы
Препарат применяют внутривенно инфузионно. Перед применением препарат необходимо разбавить и применять сразу же после приготовления раствора. В режиме монотерапии препарат Иринотекан медак применяется в дозе 125 мг/м2 поверхности тела еженедельно в течение 4 недель в виде 90-минутной внутривенной инфузии с перерывом в 2 недели, а также 350 мг/м2 в виде часовой внутривенной инфузии каждые 3 недели. В составе комбинированной химиотерапии с фторурацилом и кальция фолинатом доза препарата Иринотекан составляет при еженедельном введении - 125 мг/м2 , при введении путем продолжительной инфузии 1 раз в 2 недели - 180 мг/м2. Дозы и режим введения фторурацила и кальция фолината подробно описаны в специальной литературе.
Побочное действие
Желудочно-кишечные расстройства: очень часто - тяжелая форма отложенной диареи, сильная тошнота и рвота в случае монотерапии, часто - сильная тошнота и рвота в случае комбинированной терапии, случаи обезвоживания (связанные с диареей и/или рвотой), запор, вызванный действием иринотекана и/или лоперамида, нечасто - псевдо-мембранозный колит (один случай установлен бактериологически: Clostridium difficile), почечная недостаточность, гипотония или сердечно-сосудистая недостаточность, вызванная обезвоживанием, связанным с диареей и/или рвотой, кишечная непроходимость, запор, кишечное кровотечение, редко - колит, в том числе тифлит, ишемический и язвенный колит, прободение кишечника, легкие реакции, в том числе анорексия, боли в животе, воспаление слизистой оболочки, симптомный или бессимптомный панкреатит. Расстройства системы кроветворения и лимфатической системы: очень часто - нейтропения (обратимая и некумулятивная), анемия, тромбоцитопения в случае использования комбинированной терапии, ннфекционные осложнения в случае монотерапии, часто - фебрильная нейтропения, инфекционные осложнения в случае использования комбинированной терапии, инфекционные осложнения, вызванные острой нейтропенией, приведшие к смерти в трех случаях, тромбоцитопения в случае использования монотерапии, очень редко - известен один случай периферической тромбоцитопении с образованием антител к тромбоцитам. Поражения кожных покровов и подкожно-жировой клетчатки: очень часто - алопеция (обратимая), нечасто - легкие кожные реакции. Общие расстройства и реакции на введение препарата: очень часто - лихорадка в отсутствии развития инфекций и без сопутствующей тяжелой нейтропении в случае использования монотерапии, часто - жар в отсутствие развития инфекций и без сопутствующей острой нейтропении в случае комбинированной терапии, тяжелый транзиторный холинергический синдром (основными симптомами являются ранняя диарея и ряд других признаков, таких как боли в животе, конъюнктивит, ринит, гипотония, расширение сосудов, усиленное потоотделение, озноб, недомогание, головокружение, расстройства зрения, миоз, слезотечение и повышенное слюноотделение.), слабость, нечасто - местные реакции в области введения препарата.
Передозировка
Имеются сообщения о передозировке при применении доз, превышающих рекомендуемые терапевтические дозы до двух раз и способных оказаться смертельными. Наиболее значительными из известных побочных эффектов были тяжелые формы нейтропении и диареи. Антидот неизвестен. Для предотвращения обезвоживания, вызванного диареей, и лечения всех типов инфекционных осложнений необходимо предпринимать максимум мер.
Особые указания
Использование иринотекана должно проводиться только в отделениях, специализирующихся в области проведения цитотоксической терапии. Лечение Иринотеканом медак должен осуществлять врач, имеющий опыт применения цитотоксических препаратов. В случае контакта препарата в виде концентрата или приготовленного раствора для инфузий с кожей, место контакта необходимо сразу же тщательно промыть водой с мылом. В случае контакта препарата со слизистой оболочкой ее необходимо сразу же тщательно промыть водой. В случае экстравазации инфузию следует немедленно прекратить и начать местное симптоматическое лечение. Оставшуюся дозу препарата следует ввести в другую вену. При использовании препарата Иринотекан медак должны соблюдаться все инструкции, принятые для применения цитотоксических препаратов.
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В тканях препарат метаболизируется с образованием активного метаболита SN-38, который превосходит по своей активности иринотекан. Иринотекан и метаболит SN-38 стабилизируют комплекс топоизомеразы I с ДНК, что препятствует ее репликации. 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Дозы и режим введения фторурацила и кальция фолината подробно описаны в специальной литературе."}}]},{"id":8,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Желудочно-кишечные расстройства: очень часто - тяжелая форма отложенной диареи, сильная тошнота и рвота в случае монотерапии, часто - сильная тошнота и рвота в случае комбинированной терапии, случаи обезвоживания (связанные с диареей и/или рвотой), запор, вызванный действием иринотекана и/или лоперамида, нечасто - псевдо-мембранозный колит (один случай установлен бактериологически: Clostridium difficile), почечная недостаточность, гипотония или сердечно-сосудистая недостаточность, вызванная обезвоживанием, связанным с диареей и/или рвотой, кишечная непроходимость, запор, кишечное кровотечение, редко - колит, в том числе тифлит, ишемический и язвенный колит, прободение кишечника, легкие реакции, в том числе анорексия, боли в животе, воспаление слизистой оболочки, симптомный или бессимптомный панкреатит. Расстройства системы кроветворения и лимфатической системы: очень часто - нейтропения (обратимая и некумулятивная), анемия, тромбоцитопения в случае использования комбинированной терапии, ннфекционные осложнения в случае монотерапии, часто - фебрильная нейтропения, инфекционные осложнения в случае использования комбинированной терапии, инфекционные осложнения, вызванные острой нейтропенией, приведшие к смерти в трех случаях, тромбоцитопения в случае использования монотерапии, очень редко - известен один случай периферической тромбоцитопении с образованием антител к тромбоцитам. Поражения кожных покровов и подкожно-жировой клетчатки: очень часто - алопеция (обратимая), нечасто - легкие кожные реакции. Общие расстройства и реакции на введение препарата: очень часто - лихорадка в отсутствии развития инфекций и без сопутствующей тяжелой нейтропении в случае использования монотерапии, часто - жар в отсутствие развития инфекций и без сопутствующей острой нейтропении в случае комбинированной терапии, тяжелый транзиторный холинергический синдром (основными симптомами являются ранняя диарея и ряд других признаков, таких как боли в животе, конъюнктивит, ринит, гипотония, расширение сосудов, усиленное потоотделение, озноб, недомогание, головокружение, расстройства зрения, миоз, слезотечение и повышенное слюноотделение.), слабость, нечасто - местные реакции в области введения препарата."}}]},{"id":9,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Имеются сообщения о передозировке при применении доз, превышающих рекомендуемые терапевтические дозы до двух раз и способных оказаться смертельными. 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