Адъювантная терапия колоректального рака III стадии ("С" по классификации Дьюка) после радикальной резекции первичной опухоли в комбинации с фторурацилом и кальция фолинатом, диссеминированный колоректальный рак (в качестве монотерапии или комбинированной терапии в комбинации с фторурацилом и кальция фолинатом).
Противопоказания
Повышенная чувствительность в анамнезе к оксалиплатину и другим производным платины, или другим компонентам препарата, миелосупрессия, периферическая сенсорная нейропатия с функциональными нарушениями до начала первого курса лечения, тяжелые нарушения функции почек (клиренс креатинина менее 30 мл/мин), беременность, период грудного вскармливания, детский ...
Оксалиплатин является противоопухолевым препаратом, относящимся к новому классу производных платины, в котором атом платины образует комплекс с оксалатом и 1,2-диаминоциклогексаном. Обладает широким спектром цитотоксического действия.
Фармакологические свойства
Оксалиплатин обладает широким спектром цитотоксического действия. Он также проявляет активность in vitro и in vivo на различных моделях опухолей, устойчивых к цисплатину. В комбинации с фторурацилом наблюдается синергичное цитотоксическое действие. Изучение механизма действия оксалиплатина подтверждает гипотезу о том, что биотрансформированные, водные производные оксалиплатина, взаимодействуя с ДНК путем образования меж- и внутритяжевых мостиков, подавляют синтез ДНК, что ведет к цитотоксическому и противоопухолевому эффектам.
Показания к применению
Адъювантная терапия колоректального рака III стадии ("С" по классификации Дьюка) после радикальной резекции первичной опухоли в комбинации с фторурацилом и кальция фолинатом, диссеминированный колоректальный рак (в качестве монотерапии или комбинированной терапии в комбинации с фторурацилом и кальция фолинатом).
Противопоказания
Повышенная чувствительность в анамнезе к оксалиплатину и другим производным платины, или другим компонентам препарата, миелосупрессия, периферическая сенсорная нейропатия с функциональными нарушениями до начала первого курса лечения, тяжелые нарушения функции почек (клиренс креатинина менее 30 мл/мин), беременность, период грудного вскармливания, детский возраст до 18 лет.
Применение при беременности и в период грудного вскармливания
Противопоказано применять оксалиплатин во время беременности и в период грудного вскармливания.
Способ применения и дозы
Внутривенно в виде 2-6-часовых инфузий. Гипергидратация при применении оксалиплатина не требуется. Применяется только у взрослых. Препарат следует применять сразу же после приготовления раствора. При комбинации с фторурацилом инфузия оксалиплатина должна предшествовать введению фторурацила. Адъювантная терапия колоректального рака: по 85 мг/м2 1 раз в 2 недели в течение 12 циклов (6 мес). Лечение диссеминированного колоректального рака: по 85 мг/м2 поверхности тела 1 раз в 2 недели в качестве монотерапии или в комбинации с фторурацилом. Повторное введение оксалиплатина проводят, только если количество нейтрофилов превышает 1,5x109/л и тромбоцитов 50x109/л. Вводимую дозу следует корректировать в зависимости от степени выраженности токсичности.
Побочное действие
Со стороны системы кроветворения: очень часто - анемия, лейкопения, нейтропения, тромбоцитопения, лимфопения, часто - фебрильная нейтропения (включая 3-4 степени), редко - гемолитическая анемия, аутоиммунная тромбоцитопения. Со стороны системы пищеварения: очень часто - тошнота, рвота, диарея, стоматит, мукозит, боли в области живота, запор, часто - диспепсия, гастро-эзофагеальный рефлюкс, желудочно-кишечное кровотечение, ректальное кровотечение, нечасто - кишечная непроходимость, редко - колит, включая диарею, вызванную Clostridium difficile, панкреатит. Со стороны печени и желчевыводящих путей: очень редко - синдром печеночной синусоидальной обструкции, также известный как веноокклюзионная болезнь печени, эндофлебит печеночных вен, в т.ч. печеночная пурпура (пелиоз печени), узловая регенеративная гиперплазия печеночной ткани, перисинусоидальный фиброз, клинически проявляющиеся портальной гипертензией и/или повышением концентрации "печеночных" трансаминаз в крови. Со стороны нервной системы: очень часто - периферическая сенсорная нейропатия, нарушения чувствительности, головная боль, нарушение вкуса, часто - головокружение, менингизм, неврит двигательного нерва, депрессия, бессонница, нечасто - нервозность, редко - дизартрия, синдром задней обратимой лейкоэнцефалопатии (СЗОЛ), частота не может быть определена - судороги. Со стороны костно-мышечной системы: очень часто - боли в спине, часто - артралгия, боли в костях. Со стороны обмена веществ: очень часто - анорексия, гипергликемия, гипокалиемия, гипернатриемия, часто - дегидратация, нечасто - метаболический ацидоз. Со стороны дыхательной системы, органов грудной клетки и средостения: очень часто - одышка, кашель, носовое кровотечение, часто - икота, эмболия легочной артерии, редко - фиброз легких, острое интерстициальное поражение легких, иногда со смертельным исходом. Со стороны сердечно-сосудистой системы: часто - кровотечение, "приливы", тромбоз глубоких вен, повышение артериального давления. Со стороны мочевыделительной системы: часто - гематурия, дизурия, очень редко - острый тубулярный некроз, острый интерстициальный нефрит и острая почечная недостаточность, частота не может быть оценена - гемолитико-уремический синдром. Со стороны кожи и подкожных тканей: очень часто - алопеция, кожные высыпания, часто - шелушение кожи ладоней и стоп (например, ладонно-подошвенный синдром), эритематозные высыпания, сыпь, повышенная потливость, изменения со стороны ногтей. Со стороны органа зрения: часто - конъюнктивит, нарушения зрения, редко - транзиторное снижение остроты зрения, выпадение полей зрения, неврит зрительного нерва, преходящая потеря зрения, обратимая после прекращения лечения. Со стороны органа слуха: нечасто - ототоксичность, редко - снижение слуха, неврит слухового нерва, глухота. Со стороны иммунной системы: очень часто аллергические реакции, возникающие, главным образом, во время инфузии (кожная сыпь, в частности крапивница, конъюнктивит, ринит), часто анафилактические реакции, включая бронхоспазм, ангионевротический отек, снижение артериального давления и анафилактический шок. Инфекционные и паразитарные заболевания: очень часто - инфекции, часто - ринит, инфекции верхних дыхательных путей, нейтропенический сепсис. Местные реакции: очень часто - боль, покраснение, отек и тромбоз в месте введения препарата. Экстравазация также может приводить к появлению локальных болей и воспаления вплоть до некроза, особенно при введении оксалиплатина в периферическую вену. Со стороны лабораторных показателей: очень часто - повышение концентрации щелочной фосфатазы, активности "печеночных" ферментов, содержания билирубина, лактатдегидрогеназы, изменения содержания натрия и глюкозы в сыворотке крови, часто - повышение концентрации креатинина. Прочие: очень часто - озноб, повышение температуры тела из-за развития инфекций (с фебрильной нейтропенией или без нее) или вследствие возможного иммунного механизма, повышенная усталость, слабость, боль, повышение массы тела (при адъювантной терапии), часто - снижение массы тела (при терапии диссеминированного колоректального рака).
Передозировка
Симптомы: более выраженное проявление побочных эффектов. Лечение: антидот к оксалиплатину не известен. Рекомендуется мониторинг гематологических показателей и симптоматическая терапия.
Особые указания
Лечение Оксалиплатином медак следует проводить только в специализированных онкологических отделениях и под наблюдением онколога, имеющего опыт применения цитотоксических препаратов. Постоянный контроль за возможными токсическими эффектами при терапии оксалиплатином обязателен. Ввиду ограниченной информации по безопасности применения препарата у пациентов с нарушением функции почек средней степени тяжести, применение препарата должно осуществляться только после оценки соотношения польза/риск для конкретного пациента. В этом случае необходимо тщательно контролировать функцию почек и корректировать дозу с учетом токсического воздействия. Необходимо тщательное наблюдение за состоянием пациентов при наличии аллергических реакций на другие соединения платины в анамнезе. В случае развития анафилактической реакции на оксалиплатин, инфузию следует немедленно прервать и назначить соответствующее симптоматическое лечение. Дальнейшее применение препарата Оксалиплатин медак в случае развития аллергических реакций противопоказано. Поступали сообщения о случаях перекрестных реакций, в том числе летальных, со всеми соединениями платины. В случае экстравазации инфузию следует немедленно прекратить и начать местное симптоматическое лечение. Оставшуюся дозу препарата следует ввести в другую вену. Регулярно (раз в неделю), а также перед каждым введением препарата Оксалиплатин медак следует проводить контроль форменных элементов периферической крови и показателей функции почек и печени. Должен осуществляться тщательный контроль в отношении нейротоксичности, особенно в случае одновременного применения с другими лекарственными препаратами, обладающими неврологической токсичностью. Перед началом каждого цикла терапии препаратом Оксалиплатин медак следует проводить неврологическое обследование на предмет выявления признаков нейротоксичности. Рекомендации по коррекции дозы и режима введения оксалиплатина при нейротоксичности, гематологических и желудочно-кишечных проявлениях токсичности. Пациентов следует проинформировать о возможности устойчивых симптомов периферической сенсорной нейропатии после окончания курса лечения. Локализованные умеренные парестезии с функциональными нарушениями могут сохраняться до 3 лет после окончания лечения по схеме адъювантного применения препарата.
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Обладает широким спектром цитотоксического действия."}}]},{"id":3,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Оксалиплатин обладает широким спектром цитотоксического действия. Он также проявляет активность in vitro и in vivo на различных моделях опухолей, устойчивых к цисплатину. В комбинации с фторурацилом наблюдается синергичное цитотоксическое действие. Изучение механизма действия оксалиплатина подтверждает гипотезу о том, что биотрансформированные, водные производные оксалиплатина, взаимодействуя с ДНК путем образования меж- и внутритяжевых мостиков, подавляют синтез ДНК, что ведет к цитотоксическому и противоопухолевому эффектам."}}]},{"id":4,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Адъювантная терапия колоректального рака III стадии (\"С\" по классификации Дьюка) после радикальной резекции первичной опухоли в комбинации с фторурацилом и кальция фолинатом, диссеминированный колоректальный рак (в качестве монотерапии или комбинированной терапии в комбинации с фторурацилом и кальция фолинатом)."}}]},{"id":5,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность в анамнезе к оксалиплатину и другим производным платины, или другим компонентам препарата, миелосупрессия, периферическая сенсорная нейропатия с функциональными нарушениями до начала первого курса лечения, тяжелые нарушения функции почек (клиренс креатинина менее 30 мл/мин), беременность, период грудного вскармливания, детский возраст до 18 лет."}}]},{"id":6,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Противопоказано применять оксалиплатин во время беременности и в период грудного вскармливания."}}]},{"id":7,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Внутривенно в виде 2-6-часовых инфузий. Гипергидратация при применении оксалиплатина не требуется. Применяется только у взрослых. Препарат следует применять сразу же после приготовления раствора. При комбинации с фторурацилом инфузия оксалиплатина должна предшествовать введению фторурацила. Адъювантная терапия колоректального рака: по 85 мг/м2 1 раз в 2 недели в течение 12 циклов (6 мес). Лечение диссеминированного колоректального рака: по 85 мг/м2 поверхности тела 1 раз в 2 недели в качестве монотерапии или в комбинации с фторурацилом. Повторное введение оксалиплатина проводят, только если количество нейтрофилов превышает 1,5x109/л и тромбоцитов 50x109/л. Вводимую дозу следует корректировать в зависимости от степени выраженности токсичности."}}]},{"id":8,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Со стороны системы кроветворения: очень часто - анемия, лейкопения, нейтропения, тромбоцитопения, лимфопения, часто - фебрильная нейтропения (включая 3-4 степени), редко - гемолитическая анемия, аутоиммунная тромбоцитопения. Со стороны системы пищеварения: очень часто - тошнота, рвота, диарея, стоматит, мукозит, боли в области живота, запор, часто - диспепсия, гастро-эзофагеальный рефлюкс, желудочно-кишечное кровотечение, ректальное кровотечение, нечасто - кишечная непроходимость, редко - колит, включая диарею, вызванную Clostridium difficile, панкреатит. Со стороны печени и желчевыводящих путей: очень редко - синдром печеночной синусоидальной обструкции, также известный как веноокклюзионная болезнь печени, эндофлебит печеночных вен, в т.ч. печеночная пурпура (пелиоз печени), узловая регенеративная гиперплазия печеночной ткани, перисинусоидальный фиброз, клинически проявляющиеся портальной гипертензией и/или повышением концентрации \"печеночных\" трансаминаз в крови. Со стороны нервной системы: очень часто - периферическая сенсорная нейропатия, нарушения чувствительности, головная боль, нарушение вкуса, часто - головокружение, менингизм, неврит двигательного нерва, депрессия, бессонница, нечасто - нервозность, редко - дизартрия, синдром задней обратимой лейкоэнцефалопатии (СЗОЛ), частота не может быть определена - судороги. Со стороны костно-мышечной системы: очень часто - боли в спине, часто - артралгия, боли в костях. Со стороны обмена веществ: очень часто - анорексия, гипергликемия, гипокалиемия, гипернатриемия, часто - дегидратация, нечасто - метаболический ацидоз. Со стороны дыхательной системы, органов грудной клетки и средостения: очень часто - одышка, кашель, носовое кровотечение, часто - икота, эмболия легочной артерии, редко - фиброз легких, острое интерстициальное поражение легких, иногда со смертельным исходом. Со стороны сердечно-сосудистой системы: часто - кровотечение, \"приливы\", тромбоз глубоких вен, повышение артериального давления. Со стороны мочевыделительной системы: часто - гематурия, дизурия, очень редко - острый тубулярный некроз, острый интерстициальный нефрит и острая почечная недостаточность, частота не может быть оценена - гемолитико-уремический синдром. Со стороны кожи и подкожных тканей: очень часто - алопеция, кожные высыпания, часто - шелушение кожи ладоней и стоп (например, ладонно-подошвенный синдром), эритематозные высыпания, сыпь, повышенная потливость, изменения со стороны ногтей. Со стороны органа зрения: часто - конъюнктивит, нарушения зрения, редко - транзиторное снижение остроты зрения, выпадение полей зрения, неврит зрительного нерва, преходящая потеря зрения, обратимая после прекращения лечения. Со стороны органа слуха: нечасто - ототоксичность, редко - снижение слуха, неврит слухового нерва, глухота. Со стороны иммунной системы: очень часто аллергические реакции, возникающие, главным образом, во время инфузии (кожная сыпь, в частности крапивница, конъюнктивит, ринит), часто анафилактические реакции, включая бронхоспазм, ангионевротический отек, снижение артериального давления и анафилактический шок. Инфекционные и паразитарные заболевания: очень часто - инфекции, часто - ринит, инфекции верхних дыхательных путей, нейтропенический сепсис. Местные реакции: очень часто - боль, покраснение, отек и тромбоз в месте введения препарата. Экстравазация также может приводить к появлению локальных болей и воспаления вплоть до некроза, особенно при введении оксалиплатина в периферическую вену. Со стороны лабораторных показателей: очень часто - повышение концентрации щелочной фосфатазы, активности \"печеночных\" ферментов, содержания билирубина, лактатдегидрогеназы, изменения содержания натрия и глюкозы в сыворотке крови, часто - повышение концентрации креатинина. Прочие: очень часто - озноб, повышение температуры тела из-за развития инфекций (с фебрильной нейтропенией или без нее) или вследствие возможного иммунного механизма, повышенная усталость, слабость, боль, повышение массы тела (при адъювантной терапии), часто - снижение массы тела (при терапии диссеминированного колоректального рака)."}}]},{"id":9,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптомы: более выраженное проявление побочных эффектов. Лечение: антидот к оксалиплатину не известен. Рекомендуется мониторинг гематологических показателей и симптоматическая терапия."}}]},{"id":10,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Лечение Оксалиплатином медак следует проводить только в специализированных онкологических отделениях и под наблюдением онколога, имеющего опыт применения цитотоксических препаратов. Постоянный контроль за возможными токсическими эффектами при терапии оксалиплатином обязателен. Ввиду ограниченной информации по безопасности применения препарата у пациентов с нарушением функции почек средней степени тяжести, применение препарата должно осуществляться только после оценки соотношения польза/риск для конкретного пациента. В этом случае необходимо тщательно контролировать функцию почек и корректировать дозу с учетом токсического воздействия. Необходимо тщательное наблюдение за состоянием пациентов при наличии аллергических реакций на другие соединения платины в анамнезе. В случае развития анафилактической реакции на оксалиплатин, инфузию следует немедленно прервать и назначить соответствующее симптоматическое лечение. Дальнейшее применение препарата Оксалиплатин медак в случае развития аллергических реакций противопоказано. Поступали сообщения о случаях перекрестных реакций, в том числе летальных, со всеми соединениями платины. В случае экстравазации инфузию следует немедленно прекратить и начать местное симптоматическое лечение. Оставшуюся дозу препарата следует ввести в другую вену. Регулярно (раз в неделю), а также перед каждым введением препарата Оксалиплатин медак следует проводить контроль форменных элементов периферической крови и показателей функции почек и печени. Должен осуществляться тщательный контроль в отношении нейротоксичности, особенно в случае одновременного применения с другими лекарственными препаратами, обладающими неврологической токсичностью. Перед началом каждого цикла терапии препаратом Оксалиплатин медак следует проводить неврологическое обследование на предмет выявления признаков нейротоксичности. Рекомендации по коррекции дозы и режима введения оксалиплатина при нейротоксичности, гематологических и желудочно-кишечных проявлениях токсичности. Пациентов следует проинформировать о возможности устойчивых симптомов периферической сенсорной нейропатии после окончания курса лечения. Локализованные умеренные парестезии с функциональными нарушениями могут сохраняться до 3 лет после окончания лечения по схеме адъювантного применения препарата."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Оксалиплатин обладает широким спектром цитотоксического действия. Он также проявляет активность in vitro и in vivo на различных моделях опухолей, устойчивых к цисплатину. В комбинации с фторурацилом наблюдается синергичное цитотоксическое действие. 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