Противоопухолевое средство. Механизм действия связан с ингибированием клеточного фермента топоизомеразы I, участвующего в синтезе ДНК. Обладает иммунодепрессивной активностью.
Ингибирует ацетилхолинэстеразу.
Показания к применению
Лечение местно-распространенного или метастатического рака толстой и прямой кишки:
в комбинации с 5-фторурацилом и кальция фолинатом у больных, ранее не получавших химиотерапию;
при монотерапии у больных с прогрессированием болезни после общепринятого лечения.
Противопоказания
Повышенная чувствительность к иринотекану или другим компонентам препарата;
неспецифический язвенный колит и/или нарушения кишечной проходимости;
уровень билирубина в крови, превышающий более чем в 3 раза ВГН;
общее состояние пациентов, оцениваемое по шкале ВОЗ>2;
беременность;
лактация (грудное вскармливание).
Применение при беременности и в период грудного вскармливания
Препарат противопоказан к применению при беременности и в период лактации (грудного вскармливания).
Пациенты репродуктивного возраста должны избегать зачатия во время применения препарата и, как минимум, в течение 3 мес после его отмены.
Способ применения и дозы
Способ применения и режим дозирования конкретного препарата зависят от его формы выпуска и других факторов. Оптимальный режим дозирования определяет врач. Следует строго соблюдать соответствие используемой лекарственной формы конкретного препарата показаниям к применению и режиму дозирования.Устанавливают индивидуально, в зависимости от показаний и стадии заболевания, состояния системы кроветворения, схемы противоопухолевой терапии. Применяют в составе моно- и комбинированной терапии.
Побочное действие
Со стороны системы кроветворения: нейтропения - у 78,7% пациентов при монотерапии (у 82,5% - при комбинированной химиотерапии), в т.ч. у 22,6% больных отмечалась нейтропения тяжелой степени (количество нейтрофилов менее 500/мкл). Нейтропения является обратимой и не носит кумулятивный характер.
Полное восстановление количества нейтрофилов наступает обычно на 22 день при применении Кампто в качестве монотерапии и на 7-8 день при применении Кампто в составе комбинированной терапии. Лихорадка в сочетании с тяжелой нейтропенией была отмечена у 6,2% и 3,4% пациентов соответственно. Инфекционные осложнения при монотерапии имели место у 10,3% пациентов, у 5,3% больных - в сочетании с тяжелой нейтропенией. Инфекционные осложнения при комбинированной терапии имели место приблизительно у 2% пациентов (0,5% циклов), приблизительно у 2,1% больных и в 0,5% циклов они сочетались с тяжелой нейтропенией.
Анемия при монотерапии отмечается у 58,7% пациентов, при комбинированной химиотерапии - у 97,2%.
Тромбоцитопения (количество тромбоцитов менее 100 000/мкл) наблюдается у 7,4% больных при монотерапии, при комбинированной терапии - у 32,6% пациентов. При применении Кампто в составе комбинированной химиотерапии выраженной тромбоцитопении не наблюдалось. Количество тромбоцитов восстанавливается к 22 дню.
Наблюдался 1 случай тромбоцитопении в сочетании с образованием антитромбоцитарных антител.
Со стороны пищеварительной системы: тошнота, рвота, диарея, боли в животе, анорексия, мукозиты, запор. Сообщалось о редких случаях развития псевдомембранозного колита, кишечной непроходимости, кровотечений из ЖКТ, перфорации кишечника, повышения уровня амилазы или липазы.
При применении препарата в качестве монотерапии тяжелая диарея наблюдалась у 20% больных (в составе комбинированной терапии - у 13,1%), которые следовали рекомендациям для лечения диареи. Среднее время до появления первого жидкого стула после введения Кампто составило 5 дней.
При применении Кампто при монотерапии приблизительно у 10% пациентов, применявших противорвотные средства, отмечались выраженные тошнота и рвота. При применении Кампто в составе комбинированной терапии выраженные тошнота и рвота наблюдались реже - у 2,1% и 2,8% соответственно.
Острый холинергический синдром: ранняя диарея, боли в животе, усиление потоотделения, конъюнктивит, ринит, снижение АД, вазодилатация, слезотечение, слюнотечение, озноб, недомогание, головокружение, расстройство зрения, миоз, наблюдался у 9% пациентов, получающих Кампто в качестве монотерапии (у 1,4% - в составе комбинированной терапии). Все симптомы проходят после введения атропина.
Со стороны ЦНС и периферической нервной системы: непроизвольные мышечные подергивания или судороги, парестезии, астения.
Аллергические реакции: редко - кожная сыпь, очень редко - анафилактический шок.
Прочие: алопеция, лихорадка, местные реакции, транзиторное повышение уровня трансаминаз, ЩФ, билирубина и креатинина в сыворотке крови. В редких случаях наблюдалось развитие почечной недостаточности, артериальной гипотензии, недостаточности кровообращения у пациентов, перенесших эпизоды обезвоживания, связанные с диареей и/или рвотой, или у пациентов с сепсисом.
Передозировка
Основные ожидаемые симптомы передозировки - нейтропения и диарея.
При необходимости проводят симптоматическую терапию. Специфического антидота нет.
Взаимодействие с другими лекарственными средствами
Так как Кампто обладает антихолинэстеразной активностью, возможно увеличение продолжительности нервно-мышечной блокады при одновременном применении с суксаметонием и антагонистическое взаимодействие в отношении нервно-мышечной блокады при сочетании с недеполяризующими миорелаксантами.
Фармацевтическое взаимодействие
Кампто не следует смешивать с другими препаратами в одном флаконе.
Особые указания
Лечение препаратом следует проводить в специализированных химиотерапевтических отделениях и только под наблюдением врача, имеющего опыт работы с противоопухолевыми препаратами.
Препарат следует назначать с осторожностью пациентам, получавшим ранее лучевую терапию на область брюшной полости или таза, пациентам, у которых ранее отмечался гиперлейкоцитоз, а также пациентам с общим состоянием по шкале ВОЗ≥2, пациентам женского пола; во всех этих случаях повышается риск развития диареи.
Диарея, возникающая как следствие цитостатического действия препарата (отсроченная диарея), обычно отмечается не ранее 24 ч после введения Кампто (у большинства больных в среднем через 5 дней).
При появлении первого эпизода жидкого стула необходимо назначение обильного питья, содержащего электролиты, и немедленное проведение противодиарейной терапии, включающей лоперамид в высоких дозах (4 мг на первый прием, затем по 2 мг каждые 2 ч). Эту терапию продолжают еще в течение 12 ч вслед за последним эпизодом жидкого стула (но не более 48 ч из-за риска развития пареза кишечника).
Если диарея расценивается как тяжелая (более 6 эпизодов жидкого стула в течение суток или тяжелые тенезмы), а также, если она сопровождается рвотой или лихорадкой, больной должен быть срочно госпитализирован для проведения комплексного лечения, включающего антибиотики широкого спектра действия. При умеренной или слабовыраженной диарее (менее 6 эпизодов жидкого стула в течение суток и умеренные тенезмы), которая не купируется в течение первых 48 ч, начинают прием внутрь антибиотиков широкого спектра действия, при этом больного рекомендуется госпитализировать. При одновременном возникновении диареи и тяжелой нейтропении (количество лейкоцитов менее 500/мкл) в дополнении к антидиарейной терапии с профилактической целью назначают внутрь антибиотики широкого спектра действия.
Не следует назначать лоперамид профилактически, в т.ч. больным, у которых диарея отмечалась во время предшествующих введений Кампто.
Пациент должен быть информирован о возможности развития у него диареи. Пациенты должны сразу информировать своего врача о возникновении диареи (чтобы немедленно начать противодиарейную терапию).
При неадекватном лечении диареи может развиться состояние, угрожающее жизни больного, особенно, если диарея развилась на фоне нейтропении.
Пациентам с фебрильной нейтропенией (температура тела ≥38° и количество нейтрофилов ≤1000/мкл) следует немедленно начать антибиотикотерапию в условиях стационара.
При развитии острого холинергического синдрома при отсутствии противопоказаний показано п/к введение атропина в дозе 0,25 мг. Следует соблюдать осторожность при применении препарата у пациентов с бронхиальной астмой. Пациентам, имеющим в анамнезе указания на развитие острого холинергического синдрома (в т.ч. в тяжелой форме), перед назначением Кампто рекомендовано профилактическое назначение атропина сульфата.
Учитывая, что Кампто содержит сорбитол, препарат не назначают пациентам с наследственной непереносимостью фруктозы.
У пациентов, получающих Кампто, необходимо еженедельно проводить развернутый клинический анализ крови и контролировать функцию печени.
Влияние на способность управлять автомобилем и движущимися механизмами
Влияние на способность управлять транспортными средствами и другими механизмами, требующими повышенной концентрации внимания
Пациентов необходимо предупредить о возможности появления во время лечения Кампто головокружения и зрительных расстройств, которые развиваются в течение 24 ч после введения Кампто. При возникновении этих симптомов пациентам рекомендуется воздерживаться от управления автомобилем и другими механизмами.
Форма выпуска
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Условия хранения
Хранить в недоступном для детей и защищенном от света месте, при температуре не выше 25°С.
Приготовленный раствор должен быть использован сразу после разведения.
Если разведение выполнено с соблюдением правил асептики (например, в установке ламинарно
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д/и."}}]},{"id":6,"name":"Фармакотерапевтическая группа","slug":"","body":[{"type":"paragraph","data":{"text":"\u003ca href=\"https://www.vidal.ru/drugs/pharm-group/503\"\u003eПротивоопухолевое средство, алкалоид\u003c/a\u003e"}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"Противоопухолевое средство. Механизм действия связан с ингибированием клеточного фермента топоизомеразы I, участвующего в синтезе ДНК. Обладает иммунодепрессивной активностью."}},{"type":"paragraph","data":{"text":"Ингибирует ацетилхолинэстеразу."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Лечение местно-распространенного или метастатического рака толстой и прямой кишки:"}},{"type":"list","data":{"style":"ordered","items":["в комбинации с 5-фторурацилом и кальция фолинатом у больных, ранее не получавших химиотерапию;","при монотерапии у больных с прогрессированием болезни после общепринятого лечения."]}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"list","data":{"style":"ordered","items":["Повышенная чувствительность к иринотекану или другим компонентам препарата;","неспецифический язвенный колит и/или нарушения кишечной проходимости;","выраженное угнетение костно-мозгового кроветворения;","уровень билирубина в крови, превышающий более чем в 3 раза ВГН;","общее состояние пациентов, оцениваемое по шкале ВОЗ>2;","беременность;","лактация (грудное вскармливание)."]}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Препарат противопоказан к применению при беременности и в период лактации (грудного вскармливания)."}},{"type":"paragraph","data":{"text":"Пациенты репродуктивного возраста должны избегать зачатия во время применения препарата и, как минимум, в течение 3 мес после его отмены."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eСпособ применения и режим дозирования конкретного препарата зависят от его формы выпуска и других факторов. Оптимальный режим дозирования определяет врач. Следует строго соблюдать соответствие используемой лекарственной формы конкретного препарата показаниям к применению и режиму дозирования.\u003c/i\u003eУстанавливают индивидуально, в зависимости от показаний и стадии заболевания, состояния системы кроветворения, схемы противоопухолевой терапии. Применяют в составе моно- и комбинированной терапии. "}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Со стороны системы кроветворения: нейтропения - у 78,7% пациентов при монотерапии (у 82,5% - при комбинированной химиотерапии), в т.ч. у 22,6% больных отмечалась нейтропения тяжелой степени (количество нейтрофилов менее 500/мкл). Нейтропения является обратимой и не носит кумулятивный характер."}},{"type":"paragraph","data":{"text":"Полное восстановление количества нейтрофилов наступает обычно на 22 день при применении Кампто в качестве монотерапии и на 7-8 день при применении Кампто в составе комбинированной терапии. Лихорадка в сочетании с тяжелой нейтропенией была отмечена у 6,2% и 3,4% пациентов соответственно. Инфекционные осложнения при монотерапии имели место у 10,3% пациентов, у 5,3% больных - в сочетании с тяжелой нейтропенией. Инфекционные осложнения при комбинированной терапии имели место приблизительно у 2% пациентов (0,5% циклов), приблизительно у 2,1% больных и в 0,5% циклов они сочетались с тяжелой нейтропенией."}},{"type":"paragraph","data":{"text":"Анемия при монотерапии отмечается у 58,7% пациентов, при комбинированной химиотерапии - у 97,2%."}},{"type":"paragraph","data":{"text":"Тромбоцитопения (количество тромбоцитов менее 100 000/мкл) наблюдается у 7,4% больных при монотерапии, при комбинированной терапии - у 32,6% пациентов. При применении Кампто в составе комбинированной химиотерапии выраженной тромбоцитопении не наблюдалось. Количество тромбоцитов восстанавливается к 22 дню."}},{"type":"paragraph","data":{"text":"Наблюдался 1 случай тромбоцитопении в сочетании с образованием антитромбоцитарных антител."}},{"type":"paragraph","data":{"text":"Со стороны пищеварительной системы: тошнота, рвота, диарея, боли в животе, анорексия, мукозиты, запор. Сообщалось о редких случаях развития псевдомембранозного колита, кишечной непроходимости, кровотечений из ЖКТ, перфорации кишечника, повышения уровня амилазы или липазы."}},{"type":"paragraph","data":{"text":"При применении препарата в качестве монотерапии тяжелая диарея наблюдалась у 20% больных (в составе комбинированной терапии - у 13,1%), которые следовали рекомендациям для лечения диареи. Среднее время до появления первого жидкого стула после введения Кампто составило 5 дней."}},{"type":"paragraph","data":{"text":"При применении Кампто при монотерапии приблизительно у 10% пациентов, применявших противорвотные средства, отмечались выраженные тошнота и рвота. При применении Кампто в составе комбинированной терапии выраженные тошнота и рвота наблюдались реже - у 2,1% и 2,8% соответственно."}},{"type":"paragraph","data":{"text":"Острый холинергический синдром: ранняя диарея, боли в животе, усиление потоотделения, конъюнктивит, ринит, снижение АД, вазодилатация, слезотечение, слюнотечение, озноб, недомогание, головокружение, расстройство зрения, миоз, наблюдался у 9% пациентов, получающих Кампто в качестве монотерапии (у 1,4% - в составе комбинированной терапии). Все симптомы проходят после введения атропина."}},{"type":"paragraph","data":{"text":"Со стороны ЦНС и периферической нервной системы: непроизвольные мышечные подергивания или судороги, парестезии, астения."}},{"type":"paragraph","data":{"text":"Аллергические реакции: редко - кожная сыпь, очень редко - анафилактический шок."}},{"type":"paragraph","data":{"text":"Прочие: алопеция, лихорадка, местные реакции, транзиторное повышение уровня трансаминаз, ЩФ, билирубина и креатинина в сыворотке крови. В редких случаях наблюдалось развитие почечной недостаточности, артериальной гипотензии, недостаточности кровообращения у пациентов, перенесших эпизоды обезвоживания, связанные с диареей и/или рвотой, или у пациентов с сепсисом."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Основные ожидаемые симптомы передозировки - нейтропения и диарея."}},{"type":"paragraph","data":{"text":"При необходимости проводят симптоматическую терапию. Специфического антидота нет."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Так как Кампто обладает антихолинэстеразной активностью, возможно увеличение продолжительности нервно-мышечной блокады при одновременном применении с суксаметонием и антагонистическое взаимодействие в отношении нервно-мышечной блокады при сочетании с недеполяризующими миорелаксантами."}},{"type":"paragraph","data":{"text":"Фармацевтическое взаимодействие"}},{"type":"paragraph","data":{"text":"Кампто не следует смешивать с другими препаратами в одном флаконе."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Лечение препаратом следует проводить в специализированных химиотерапевтических отделениях и только под наблюдением врача, имеющего опыт работы с противоопухолевыми препаратами."}},{"type":"paragraph","data":{"text":"Препарат следует назначать с осторожностью пациентам, получавшим ранее лучевую терапию на область брюшной полости или таза, пациентам, у которых ранее отмечался гиперлейкоцитоз, а также пациентам с общим состоянием по шкале ВОЗ≥2, пациентам женского пола; во всех этих случаях повышается риск развития диареи."}},{"type":"paragraph","data":{"text":"Диарея, возникающая как следствие цитостатического действия препарата (отсроченная диарея), обычно отмечается не ранее 24 ч после введения Кампто (у большинства больных в среднем через 5 дней)."}},{"type":"paragraph","data":{"text":"При появлении первого эпизода жидкого стула необходимо назначение обильного питья, содержащего электролиты, и немедленное проведение противодиарейной терапии, включающей лоперамид в высоких дозах (4 мг на первый прием, затем по 2 мг каждые 2 ч). Эту терапию продолжают еще в течение 12 ч вслед за последним эпизодом жидкого стула (но не более 48 ч из-за риска развития пареза кишечника)."}},{"type":"paragraph","data":{"text":"Если диарея расценивается как тяжелая (более 6 эпизодов жидкого стула в течение суток или тяжелые тенезмы), а также, если она сопровождается рвотой или лихорадкой, больной должен быть срочно госпитализирован для проведения комплексного лечения, включающего антибиотики широкого спектра действия. При умеренной или слабовыраженной диарее (менее 6 эпизодов жидкого стула в течение суток и умеренные тенезмы), которая не купируется в течение первых 48 ч, начинают прием внутрь антибиотиков широкого спектра действия, при этом больного рекомендуется госпитализировать. При одновременном возникновении диареи и тяжелой нейтропении (количество лейкоцитов менее 500/мкл) в дополнении к антидиарейной терапии с профилактической целью назначают внутрь антибиотики широкого спектра действия."}},{"type":"paragraph","data":{"text":"Не следует назначать лоперамид профилактически, в т.ч. больным, у которых диарея отмечалась во время предшествующих введений Кампто."}},{"type":"paragraph","data":{"text":"Пациент должен быть информирован о возможности развития у него диареи. Пациенты должны сразу информировать своего врача о возникновении диареи (чтобы немедленно начать противодиарейную терапию)."}},{"type":"paragraph","data":{"text":"При неадекватном лечении диареи может развиться состояние, угрожающее жизни больного, особенно, если диарея развилась на фоне нейтропении."}},{"type":"paragraph","data":{"text":"Пациентам с фебрильной нейтропенией (температура тела ≥38° и количество нейтрофилов ≤1000/мкл) следует немедленно начать антибиотикотерапию в условиях стационара."}},{"type":"paragraph","data":{"text":"При развитии острого холинергического синдрома при отсутствии противопоказаний показано п/к введение атропина в дозе 0,25 мг. Следует соблюдать осторожность при применении препарата у пациентов с бронхиальной астмой. 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