неконтролируемая артериальная гипертензия, парциальная красноклеточная аплазия (ПККА), возникшая после лечения эритропоэтином;
пациенты, которые по каким-либо причинам не могут получать эффективное лечение для профилактики тромбозов;
пациентам с тяжелой патологией коронарных, сонных, мозговых и периферических сосудов, включая недавно перенесших инфаркт миокарда или острое нарушение мозгового кровообращения (в рамках предепозитной программы сбора крови перед обширной хирургической операцией);
Рекомбинантный эритропоэтин человека, представляет собой очищенный гликопротеин.
Стимулирует эритропоэз.
Синтезируется в клетках млекопитающих, в которые встроен ген, кодирующий эритропоэтин человека. По биологическим и иммунологическим свойствам идентичен эритропоэтину человека, выделяемому из мочи.
Синтез эндогенного эритропоэтина осуществляется в почках и зависит от уровня оксигенации крови.
Показания к применению
Лечение анемии, связанной с хронической почечной недостаточностью у взрослых и детей, находящихся на гемо- или перитонеальном диализе.
Профилактика и лечение анемии у онкологических больных (получающих или не получающих химиотерапию) при немиелоидных опухолях.
Лечение анемии у ВИЧ-инфицированных пациентов, получающих терапию зидовудином, (при уровне эндогенного эритропоэтина менее или равно 500 МЕ/мл).
В рамках предепозитной программы перед обширной хирургической операцией у пациентов с уровнем гематокрита 33-39%, для облегчения сбора аутологичной крови и уменьшения риска, связанного с использованием аллогенных гемотрансфузий (при ожидаемой потребности в переливаемой крови выше, чем количество, которое можно получить без применения эпоэтина альфа).
Перед проведением обширной операции с ожидаемой средней кровопотерей (2-4 единицы или 900-1800 мл) у взрослых пациентов с легкой или средней анемией (гемоглобин более 10 и менее или равно 13 г/дл) для уменьшения потребности в аллогенных гемотрансфузиях и улучшения восстановления эритропоэза.
Противопоказания
Повышенная чувствительность к эпоэтину альфа;
неконтролируемая артериальная гипертензия, парциальная красноклеточная аплазия (ПККА), возникшая после лечения эритропоэтином;
пациенты, которые по каким-либо причинам не могут получать эффективное лечение для профилактики тромбозов;
пациентам с тяжелой патологией коронарных, сонных, мозговых и периферических сосудов, включая недавно перенесших инфаркт миокарда или острое нарушение мозгового кровообращения (в рамках предепозитной программы сбора крови перед обширной хирургической операцией);
беременность, период грудного вскармливания.
С осторожностью
Злокачественные новообразования, эпилептический синдром (в т.ч. в анамнезе), артериальная гипертензия, хроническая печеночная недостаточность, тромбоцитоз, тромбоз (в анамнезе), острая кровопотеря, серповидно-клеточная, гемолитическая анемия, дефицит железа, В12 или фолиевой кислоты, облитерирующие заболевания периферических сосудов и другие сосудистые осложнения, подагра, порфирии, ИБС.
Применение при беременности и в период грудного вскармливания
Противопоказано применение эпоэтина альфа при беременности за исключением тех случаев, когда предполагаемая польза для матери значительно превышает риск для плода. Применение эпоэтина альфа не рекомендовано в период беременности пациенткам, участвующим в программе сбора аутологичной крови перед проведением хирургических операций.
При необходимости применения в период лактации следует решить вопрос о прекращении грудного вскармливания. Применение эпоэтина альфа не рекомендовано у кормящих матерей, участвующих в программе сбора аутологичной крови перед проведением хирургических операций.
Способ применения и дозы
Вводят п/к или в/в.
Режим дозирования устанавливают индивидуально, в зависимости от показаний, наличия сопутствующих заболеваний, схемы терапии, возраста пациента.
Побочное действие
Со стороны системы кроветворения: редко - тромбоцитемия, парциальная красноклеточная аплазия (ПККА), опосредованная через антитела к эритропоэтину.
Со стороны иммунной системы: нечасто - реакции повышенной чувствительности; редко - анафилактические реакции.
Со стороны обмена веществ: нечасто - гиперкалиемия; редко - порфирия.
Со стороны нервной системы: часто - головная боль; нечасто - судороги; частота неизвестна - инсульт, включающий церебральный инфаркт и внутримозговое кровоизлияние, транзиторная ишемическая атака, гипертоническая энцефалопатия.
Со стороны органа зрения: частота неизвестна - тромбоз сосудов сетчатки.
Со стороны сердечно-сосудистой системы: часто - венозные или артериальные тромбозы, артериальная гипертензия; частота неизвестна - гипертонический криз.
Со стороны дыхательной системы: часто - кашель; нечасто - застойные явления в дыхательных путях.
Со стороны пищеварительной системы: очень часто - диарея, тошнота, рвота.
Со стороны кожи и подкожных тканей: часто - кожная сыпь; нечасто - крапивница; частота неизвестна - ангионевротический отек.
Со стороны костно-мышечной системы: часто - артралгия, миалгия, боль в костях, боль в конечностях.
Прочие: очень часто - повышение температуры тела; часто - озноб, гриппоподобный синдром, периферические отеки, положительный тест на антитела к эритропоэтину, местные реакции.
Взаимодействие с другими лекарственными средствами
Действие эпоэтина альфа может усиливаться при одновременном введении препаратов крови.
Одновременное применение препаратов, подавляющих эритропоэз, может приводить к снижению эффективности эпоэтина альфа.
При одновременном применении эпоэтина альфа с циклоспорином возможно снижение концентрации последнего в плазме из-за увеличения степени его связывания с эритроцитами (при применении данной комбинации необходимо контролировать концентрацию циклоспорина в плазме и при необходимости увеличить его дозу).
Эпоэтин альфа нельзя смешивать с растворами других лекарственных средств.
Особые указания
Эпоэтин альфа следует с осторожностью применять у пациентов с эпилепсией, наличием судорожных припадков в анамнезе или состояниями, предрасполагающими к повышению судорожной готовности, такими как инфекции ЦНС или метастатическое поражение головного мозга.
Увеличение частоты развития тромботических осложнений наблюдалось у пациентов, получающих препараты, стимулирующие эритропоэз. Осложнения включают в себя тромбозы вен и артерий (в т.ч. летальные случаи), такие как тромбоз глубоких вен, эмболию легочной артерии, тромбоз сетчатки глаза и инфаркт миокарда. Также отмечались случаи острого нарушения мозгового кровоснабжения (включая ишемический инсульт, геморрагический инсульт и транзиторную ишемическую атаку). Пациентам с повышенным риском развития тромбоза или других сосудистых осложнений требуется тщательный медицинский контроль.
С осторожностью применяют при подагре.
До начала применения следует убедиться, что пациенты с артериальной гипертензией получали эффективную антигипертензивную терапию.
На фоне применения необходимо контролировать уровень АД, обращая внимание на возникновение или усиление необычных головных болей. При этом может потребоваться коррекция проводимой терапии или назначение антигипертензивных средств. Если несмотря на адекватную терапию АД не снижается, эпоэтин альфа следует отменить.
До начала применения эпоэтина альфа следует оценить состояние депо железа в организме. У большинства больных с хронической почечной недостаточностью, у онкологических и ВИЧ-инфицированных больных уровень ферритина в плазме крови уменьшается одновременно с увеличением гематокрита. Уровень ферритина необходимо определять в течение всего курса лечения. Если он составляет менее 100 нг/мл, рекомендуется заместительная терапия препаратами железа. Пациенты, сдающие аутологичную кровь и находящиеся в пред- или послеоперационном периоде, также должны получать дополнительно адекватное количество железа.
В период применения следует контролировать уровень гемоглобина, по крайней мере, 1 раз в неделю до достижения стабильного уровня, затем несколько реже.
С осторожностью следует применять у пациентов с порфирией. При хронической почечной недостаточности на фоне терапии эпоэтином альфа возможно обострение порфирии.
Пациентам, находящимся на гемодиализе, на фоне терапии эпоэтином альфа часто требуется увеличение дозы гепарина во время диализа из-за повышения гематокрита. При неадекватной дозе гепарина возможна окклюзия диализной системы.
У пациентов с хронической почечной недостаточностью и клинически выраженной ИБС или застойной сердечной недостаточностью поддерживающий уровень гемоглобина не должен превышать верхний предел оптимального рекомендованного уровня (не более 10-12 г/дл у взрослых).
При применении у пациентов с нарушениями функции печени возможно замедление биотрансформации эпоэтина альфа и выраженное усиление эритропоэза.
Нельзя полностью исключить возможность влияния эпоэтина альфа на рост некоторых типов опухолей, особенно на злокачественные новообразования костного мозга.
Следует соблюдать все специальные предупреждения и меры предосторожности, связанные с программой сбора аутологичной крови (это распространяется на всех пациентов, получающих эпоэтин альфа).
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По биологическим и иммунологическим свойствам идентичен эритропоэтину человека, выделяемому из мочи."}},{"type":"paragraph","data":{"text":"Синтез эндогенного эритропоэтина осуществляется в почках и зависит от уровня оксигенации крови."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Лечение анемии, связанной с хронической почечной недостаточностью у взрослых и детей, находящихся на гемо- или перитонеальном диализе."}},{"type":"paragraph","data":{"text":"Профилактика и лечение анемии у онкологических больных (получающих или не получающих химиотерапию) при немиелоидных опухолях."}},{"type":"paragraph","data":{"text":"Лечение анемии у ВИЧ-инфицированных пациентов, получающих терапию зидовудином, (при уровне эндогенного эритропоэтина менее или равно 500 МЕ/мл)."}},{"type":"paragraph","data":{"text":"В рамках предепозитной программы перед обширной хирургической операцией у пациентов с уровнем гематокрита 33-39%, для облегчения сбора аутологичной крови и уменьшения риска, связанного с использованием аллогенных гемотрансфузий (при ожидаемой потребности в переливаемой крови выше, чем количество, которое можно получить без применения эпоэтина альфа)."}},{"type":"paragraph","data":{"text":"Перед проведением обширной операции с ожидаемой средней кровопотерей (2-4 единицы или 900-1800 мл) у взрослых пациентов с легкой или средней анемией (гемоглобин более 10 и менее или равно 13 г/дл) для уменьшения потребности в аллогенных гемотрансфузиях и улучшения восстановления эритропоэза."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"list","data":{"style":"ordered","items":["Повышенная чувствительность к эпоэтину альфа;","неконтролируемая артериальная гипертензия, парциальная красноклеточная аплазия (ПККА), возникшая после лечения эритропоэтином;","пациенты, которые по каким-либо причинам не могут получать эффективное лечение для профилактики тромбозов;","пациентам с тяжелой патологией коронарных, сонных, мозговых и периферических сосудов, включая недавно перенесших инфаркт миокарда или острое нарушение мозгового кровообращения (в рамках предепозитной программы сбора крови перед обширной хирургической операцией);","беременность, период грудного вскармливания."]}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Злокачественные новообразования, эпилептический синдром (в т.ч. в анамнезе), артериальная гипертензия, хроническая печеночная недостаточность, тромбоцитоз, тромбоз (в анамнезе), острая кровопотеря, серповидно-клеточная, гемолитическая анемия, дефицит железа, В12 или фолиевой кислоты, облитерирующие заболевания периферических сосудов и другие сосудистые осложнения, подагра, порфирии, ИБС."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Противопоказано применение эпоэтина альфа при беременности за исключением тех случаев, когда предполагаемая польза для матери значительно превышает риск для плода. Применение эпоэтина альфа не рекомендовано в период беременности пациенткам, участвующим в программе сбора аутологичной крови перед проведением хирургических операций."}},{"type":"paragraph","data":{"text":"При необходимости применения в период лактации следует решить вопрос о прекращении грудного вскармливания. Применение эпоэтина альфа не рекомендовано у кормящих матерей, участвующих в программе сбора аутологичной крови перед проведением хирургических операций."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Вводят п/к или в/в."}},{"type":"paragraph","data":{"text":"Режим дозирования устанавливают индивидуально, в зависимости от показаний, наличия сопутствующих заболеваний, схемы терапии, возраста пациента."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Со стороны системы кроветворения: редко - тромбоцитемия, парциальная красноклеточная аплазия (ПККА), опосредованная через антитела к эритропоэтину."}},{"type":"paragraph","data":{"text":"Со стороны иммунной системы: нечасто - реакции повышенной чувствительности; редко - анафилактические реакции."}},{"type":"paragraph","data":{"text":"Со стороны обмена веществ: нечасто - гиперкалиемия; редко - порфирия."}},{"type":"paragraph","data":{"text":"Со стороны нервной системы: часто - головная боль; нечасто - судороги; частота неизвестна - инсульт, включающий церебральный инфаркт и внутримозговое кровоизлияние, транзиторная ишемическая атака, гипертоническая энцефалопатия."}},{"type":"paragraph","data":{"text":"Со стороны органа зрения: частота неизвестна - тромбоз сосудов сетчатки."}},{"type":"paragraph","data":{"text":"Со стороны сердечно-сосудистой системы: часто - венозные или артериальные тромбозы, артериальная гипертензия; частота неизвестна - гипертонический криз."}},{"type":"paragraph","data":{"text":"Со стороны дыхательной системы: часто - кашель; нечасто - застойные явления в дыхательных путях."}},{"type":"paragraph","data":{"text":"Со стороны пищеварительной системы: очень часто - диарея, тошнота, рвота."}},{"type":"paragraph","data":{"text":"Со стороны кожи и подкожных тканей: часто - кожная сыпь; нечасто - крапивница; частота неизвестна - ангионевротический отек."}},{"type":"paragraph","data":{"text":"Со стороны костно-мышечной системы: часто - артралгия, миалгия, боль в костях, боль в конечностях."}},{"type":"paragraph","data":{"text":"Прочие: очень часто - повышение температуры тела; часто - озноб, гриппоподобный синдром, периферические отеки, положительный тест на антитела к эритропоэтину, местные реакции."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Действие эпоэтина альфа может усиливаться при одновременном введении препаратов крови."}},{"type":"paragraph","data":{"text":"Одновременное применение препаратов, подавляющих эритропоэз, может приводить к снижению эффективности эпоэтина альфа."}},{"type":"paragraph","data":{"text":"При одновременном применении эпоэтина альфа с циклоспорином возможно снижение концентрации последнего в плазме из-за увеличения степени его связывания с эритроцитами (при применении данной комбинации необходимо контролировать концентрацию циклоспорина в плазме и при необходимости увеличить его дозу)."}},{"type":"paragraph","data":{"text":"Эпоэтин альфа нельзя смешивать с растворами других лекарственных средств."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Эпоэтин альфа следует с осторожностью применять у пациентов с эпилепсией, наличием судорожных припадков в анамнезе или состояниями, предрасполагающими к повышению судорожной готовности, такими как инфекции ЦНС или метастатическое поражение головного мозга."}},{"type":"paragraph","data":{"text":"Увеличение частоты развития тромботических осложнений наблюдалось у пациентов, получающих препараты, стимулирующие эритропоэз. Осложнения включают в себя тромбозы вен и артерий (в т.ч. летальные случаи), такие как тромбоз глубоких вен, эмболию легочной артерии, тромбоз сетчатки глаза и инфаркт миокарда. Также отмечались случаи острого нарушения мозгового кровоснабжения (включая ишемический инсульт, геморрагический инсульт и транзиторную ишемическую атаку). Пациентам с повышенным риском развития тромбоза или других сосудистых осложнений требуется тщательный медицинский контроль."}},{"type":"paragraph","data":{"text":"С осторожностью применяют при подагре."}},{"type":"paragraph","data":{"text":"До начала применения следует убедиться, что пациенты с артериальной гипертензией получали эффективную антигипертензивную терапию."}},{"type":"paragraph","data":{"text":"На фоне применения необходимо контролировать уровень АД, обращая внимание на возникновение или усиление необычных головных болей. При этом может потребоваться коррекция проводимой терапии или назначение антигипертензивных средств. Если несмотря на адекватную терапию АД не снижается, эпоэтин альфа следует отменить."}},{"type":"paragraph","data":{"text":"До начала применения эпоэтина альфа следует оценить состояние депо железа в организме. У большинства больных с хронической почечной недостаточностью, у онкологических и ВИЧ-инфицированных больных уровень ферритина в плазме крови уменьшается одновременно с увеличением гематокрита. Уровень ферритина необходимо определять в течение всего курса лечения. Если он составляет менее 100 нг/мл, рекомендуется заместительная терапия препаратами железа. Пациенты, сдающие аутологичную кровь и находящиеся в пред- или послеоперационном периоде, также должны получать дополнительно адекватное количество железа."}},{"type":"paragraph","data":{"text":"В период применения следует контролировать уровень гемоглобина, по крайней мере, 1 раз в неделю до достижения стабильного уровня, затем несколько реже."}},{"type":"paragraph","data":{"text":"С осторожностью следует применять у пациентов с порфирией. При хронической почечной недостаточности на фоне терапии эпоэтином альфа возможно обострение порфирии."}},{"type":"paragraph","data":{"text":"Пациентам, находящимся на гемодиализе, на фоне терапии эпоэтином альфа часто требуется увеличение дозы гепарина во время диализа из-за повышения гематокрита. При неадекватной дозе гепарина возможна окклюзия диализной системы."}},{"type":"paragraph","data":{"text":"У пациентов с хронической почечной недостаточностью и клинически выраженной ИБС или застойной сердечной недостаточностью поддерживающий уровень гемоглобина не должен превышать верхний предел оптимального рекомендованного уровня (не более 10-12 г/дл у взрослых)."}},{"type":"paragraph","data":{"text":"При применении у пациентов с нарушениями функции печени возможно замедление биотрансформации эпоэтина альфа и выраженное усиление эритропоэза."}},{"type":"paragraph","data":{"text":"Нельзя полностью исключить возможность влияния эпоэтина альфа на рост некоторых типов опухолей, особенно на злокачественные новообразования костного мозга."}},{"type":"paragraph","data":{"text":"Следует соблюдать все специальные предупреждения и меры предосторожности, связанные с программой сбора аутологичной крови (это распространяется на всех пациентов, получающих эпоэтин альфа)."}},{"type":"paragraph","data":{"text":"Терапевтическая эффективность эпоэтина альфа может уменьшиться при дефиците железа, фолиевой кислоты, витамина B12, интоксикации алюминием, интеркуррентных заболеваниях, скрытом кровотечении, гемолизе, фиброзе костного мозга."}}]}],"source":null},"description_toggle":false,"short_description":"Рекомбинантный эритропоэтин человека, представляет собой очищенный гликопротеин. 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