Механизм действияЛираглутид представляет собой аналог челове... Инструкция
Показания к применению
Препарат Саксенда показан в качестве дополнения к низкокалорийной диете и усиленной физической нагрузке для длительного применения с целью коррекции массы тела у взрослых пациентов с ИМТ:- ≥30 кг/м2 (ожирение) или- ≥ 27 кг/м2 до меньше 30 кг/м (избыточная масса тела) при наличии хотя бы одного связанного с избыточной массой тела сопутствующего заболевания, ...
повышенная чувствительность к лираглутиду или любому из вспомогательных компонентов препарата; - медуллярный рак щитовидной железы в анамнезе, в том числе в семейном; - множественная эндокринная неоплазия 2 типа; - тяжелая депрессия, суицидальные мысли или поведение, в том числе в анамнезе. Противопоказано применение у следующих групп пациентов и при следующих состояниях/заболеваниях в связи с отсутствием данных по эффективности и безопасности:- нарушение функции почек тяжелой степени; - нарушение функции печени тяжелой степени; - детский возраст до 18 лет; - период беременности и грудного вскармливания; - сердечная недостаточность III-IV функционального класса (в соответствии с классификацией NYHA (Нью-Йоркская кардиологическая ассоциация)); - одновременное применение других препаратов для коррекции массы тела; - одновременное применение с инсулином; - вторичное ожирение на фоне эндокринологических заболеваний или расстройств пищевого поведения, или на фоне применения лекарственных препаратов, которые могут привести к увеличению массы тела. Опыт применения препарата Саксенда у пациентов с воспалительными заболеваниями кишечника и диабетическим парезом желудка ограничен. Применение лираглутида у таких пациентов не рекомендуется, поскольку оно связано с транзиторными нежелательными реакциями со стороны желудочно-кишечного тракта, включая тошноту, рвоту и диарею.
В 1 мл содержится: Действующее вещество: лираглутид 6 мг (в одной предварительно заполненной шприц-ручке содержится 3 мл раствора, что соответствует 18 мг лираглутида); Вспомогательные вещества: натрия гидрофосфата дигидрат 1,42 мг, фенол 5,5 мг, пропиленгликоль 14,0 мг; кислота хлористоводородная/натрия гидроксид (для коррекции pH), вода для инъекций до 1 мл.
Фармакологические свойства
Механизм действияЛираглутид представляет собой аналог человеческого глюкагоноподобного пептида-1 (ГПП-1), произведенный методом биотехнологии рекомбинантной ДНК с использованием штамма Saccharomyces cerevisiae, имеющий 97% гомологичности с человеческим ГПП-1, который связывается и активирует рецепторы ГПП-1 у человека. Рецептор ГПП-1 служит мишенью для нативного ГПП-1 - эндогенного гормона инкретина, вызывающего стимуляцию глюкозозависимой секреции инсулина в бета-клетках поджелудочной железы. В отличие от нативного ГПП-1, фармакокинетический и фармакодинамический профили лираглутида позволяют вводить его пациентам 1 раз/сут. Профиль длительного действия лираглутида при п/к инъекции обеспечивается тремя механизмами: самоассоциацией, в результате которой происходит замедленное всасывание препарата, связыванием с альбумином и более высоким уровнем ферментативной стабильности по отношению к дипептидилпептидазе-4 (ДПП-4) и ферменту нейтральной эндопептидазы (НЭП), за счет чего обеспечивается длительный T1/2 препарата из плазмы. Действие лираглутида осуществляется за счет взаимодействия со специфическими рецепторами ГПП-1, в результате чего повышается концентрация цАМФ. Под действием лираглутида происходит глюкозозависимая стимуляция секреции инсулина и улучшение функции бета-клеток поджелудочной железы. Одновременно лираглутид подавляет излишне высокую глюкозозависимую секрецию глюкагона. Таким образом, при повышении концентрации глюкозы крови происходит стимуляция секреции инсулина и подавление секреции глюкагона. С другой стороны, во время гипогликемии лираглутид снижает секрецию инсулина, но не подавляет секрецию глюкагона. Механизм снижения уровня гликемии включает также небольшую задержку опорожнения желудка. Лираглутид снижает массу тела и уменьшает жировую массу тела при помощи механизмов, вызывающих уменьшение чувства голода и снижение расхода энергии. Исследования на экспериментальных животных моделях с предиабетом показали, что лираглутид замедляет развитие сахарного диабета. Диагностика in vitro показала, что лираглутид является мощным фактором специфической стимуляции пролиферации бета-клеток поджелудочной железы и предупреждает образование цитокинов и свободных жирных кислот, индуцирующих смерть бета-клеток (апоптоз). In vivo лираглутид повышает биосинтез инсулина и увеличивает массу бета-клеток у экспериментальных животных моделей с сахарным диабетом. Когда концентрация глюкозы нормализуется, лираглутид перестает увеличивать массу бета-клеток поджелудочной железы.
Показания к применению
Препарат Саксенда показан в качестве дополнения к низкокалорийной диете и усиленной физической нагрузке для длительного применения с целью коррекции массы тела у взрослых пациентов с ИМТ:- ≥30 кг/м2 (ожирение) или- ≥ 27 кг/м2 до меньше 30 кг/м (избыточная масса тела) при наличии хотя бы одного связанного с избыточной массой тела сопутствующего заболевания, такого как нарушение толерантности к глюкозе, сахарный диабет 2 типа, артериальная гипертензия, дислипидемия или синдром обструктивного апноэ во сне.
Противопоказания
повышенная чувствительность к лираглутиду или любому из вспомогательных компонентов препарата; - медуллярный рак щитовидной железы в анамнезе, в том числе в семейном; - множественная эндокринная неоплазия 2 типа; - тяжелая депрессия, суицидальные мысли или поведение, в том числе в анамнезе. Противопоказано применение у следующих групп пациентов и при следующих состояниях/заболеваниях в связи с отсутствием данных по эффективности и безопасности:- нарушение функции почек тяжелой степени; - нарушение функции печени тяжелой степени; - детский возраст до 18 лет; - период беременности и грудного вскармливания; - сердечная недостаточность III-IV функционального класса (в соответствии с классификацией NYHA (Нью-Йоркская кардиологическая ассоциация)); - одновременное применение других препаратов для коррекции массы тела; - одновременное применение с инсулином; - вторичное ожирение на фоне эндокринологических заболеваний или расстройств пищевого поведения, или на фоне применения лекарственных препаратов, которые могут привести к увеличению массы тела. Опыт применения препарата Саксенда у пациентов с воспалительными заболеваниями кишечника и диабетическим парезом желудка ограничен. Применение лираглутида у таких пациентов не рекомендуется, поскольку оно связано с транзиторными нежелательными реакциями со стороны желудочно-кишечного тракта, включая тошноту, рвоту и диарею.
Применение при беременности и в период грудного вскармливания
Нельзя использовать при беременности, вместо него рекомендуется проводить лечение инсулином. Если пациентка готовится к беременности, либо беременность уже наступила, терапию препаратом Виктоза необходимо немедленно прекратить. Неизвестно, выделяется ли лираглутид с грудным молоком женщин. Исследования на животных показали, что проникновение лираглутида и метаболитов близкой структурной связи в грудное молоко является низким. Опыт применения препарата Виктоза у кормящих женщин отсутствует; применение препарата в период грудного вскармливания противопоказано.
Способ применения и дозы
Препарат Саксенда предназначен только для подкожного введения. Его нельзя вводить внутривенно или внутримышечно. Препарат Саксенда вводят один раз в сутки в любое время, независимо от приема пищи. Его следует вводить в область живота, бедра или плеча. Место и время инъекции могут быть изменены без коррекции дозы. Тем не менее, желательно делать инъекции примерно в одно и то же время суток после выбора наиболее удобного времени. ДозыНачальная доза составляет 0,6 мг в сутки. Дозу увеличивают до 3 мг в сутки, прибавляя по 0,6 мг с интервалами не менее одной недели для улучшения желудочно-кишечной переносимости. Если при увеличении дозы новая доза плохо переносится пациентом в течение 2 недель подряд, следует рассмотреть вопрос о прекращении терапии. Применение препарата в суточной дозе больше 3 мг не рекомендуется. Пациенты с сахарным диабетом 2 типаПрепарат Саксенда не следует применять в комбинации с другими агонистами рецепторов ЕПП-ЕВ начале терапии препаратом Саксенда рекомендуется уменьшить дозы одновременно применяемых секретагогов инсулина (таких как препараты сульфонилмочевины) для уменьшения риска развития гипогликемии.
Побочное действие
Нарушения со стороны иммунной системыАнафилактические реакции - РедкоНарушения со стороны обмена веществ и питанияГипогликемия - ЧастоДегидратация - НечастоНарушения психикиБессонница - ЧастоНарушения со стороны нервной системыГоловокружение - ЧастоНарушения со стороны сердцаТахикардия - НечастоНарушения со стороны желудочно-кишечного трактаТошнота, рвота, диарея, запор - Очень часто Сухость во рту, диспепсия, гастрит, гастроэзофагеальный рефлюкс, боль в верхних отделах живота, метеоризм, отрыжка, вздутие живота - ЧастоПанкреатит - НечастоНарушения со стороны печени и желчевыводящих путейХолелитиаз - ЧастоХолецистит - НечастоНарушения со стороны кожи и подкожных тканейКрапивница - НечастоНарушения со стороны почек и мочевыводящих путейОстрая почечная недостаточность, нарушение функции почек - РедкоОбщие расстройства и нарушения в месте введенияРеакции в месте введения, астения, утомляемость - ЧастоНедомогание - Нечасто
Передозировка
Симптомы: в ходе клинических исследований и постмаркетинговом периоде сообщалось о случаях применения препарата в дозах, до 40 раз превышающих среднюю рекомендуемую дозу (72 мг), что сопровождалось развитием тяжелой тошноты и рвоты. Случаев тяжелой гипогликемии не отмечалось. Все пациенты выздоровели полностью без осложнений. Лечение: в случае передозировки препарата Виктоза рекомендуется проведение соответствующей симптоматической терапии.
Особые указания
Пациенты должны быть предупреждены о том, что им следует соблюдать меры предосторожности во избежание развития гипогликемии во время управления транспортными средствами и при работе с механизмами
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мл содержится: Действующее вещество: лираглутид 6 мг (в одной предварительно заполненной шприц-ручке содержится 3 мл раствора, что соответствует 18 мг лираглутида); Вспомогательные вещества: натрия гидрофосфата дигидрат 1,42 мг, фенол 5,5 мг, пропиленгликоль 14,0 мг; кислота хлористоводородная/натрия гидроксид (для коррекции pH), вода для инъекций до 1 мл."}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Механизм действияЛираглутид представляет собой аналог человеческого глюкагоноподобного пептида-1 (ГПП-1), произведенный методом биотехнологии рекомбинантной ДНК с использованием штамма Saccharomyces cerevisiae, имеющий 97% гомологичности с человеческим ГПП-1, который связывается и активирует рецепторы ГПП-1 у человека. Рецептор ГПП-1 служит мишенью для нативного ГПП-1 - эндогенного гормона инкретина, вызывающего стимуляцию глюкозозависимой секреции инсулина в бета-клетках поджелудочной железы. В отличие от нативного ГПП-1, фармакокинетический и фармакодинамический профили лираглутида позволяют вводить его пациентам 1 раз/сут. Профиль длительного действия лираглутида при п/к инъекции обеспечивается тремя механизмами: самоассоциацией, в результате которой происходит замедленное всасывание препарата, связыванием с альбумином и более высоким уровнем ферментативной стабильности по отношению к дипептидилпептидазе-4 (ДПП-4) и ферменту нейтральной эндопептидазы (НЭП), за счет чего обеспечивается длительный T1/2 препарата из плазмы. Действие лираглутида осуществляется за счет взаимодействия со специфическими рецепторами ГПП-1, в результате чего повышается концентрация цАМФ. Под действием лираглутида происходит глюкозозависимая стимуляция секреции инсулина и улучшение функции бета-клеток поджелудочной железы. Одновременно лираглутид подавляет излишне высокую глюкозозависимую секрецию глюкагона. Таким образом, при повышении концентрации глюкозы крови происходит стимуляция секреции инсулина и подавление секреции глюкагона. С другой стороны, во время гипогликемии лираглутид снижает секрецию инсулина, но не подавляет секрецию глюкагона. Механизм снижения уровня гликемии включает также небольшую задержку опорожнения желудка. Лираглутид снижает массу тела и уменьшает жировую массу тела при помощи механизмов, вызывающих уменьшение чувства голода и снижение расхода энергии. Исследования на экспериментальных животных моделях с предиабетом показали, что лираглутид замедляет развитие сахарного диабета. Диагностика in vitro показала, что лираглутид является мощным фактором специфической стимуляции пролиферации бета-клеток поджелудочной железы и предупреждает образование цитокинов и свободных жирных кислот, индуцирующих смерть бета-клеток (апоптоз). In vivo лираглутид повышает биосинтез инсулина и увеличивает массу бета-клеток у экспериментальных животных моделей с сахарным диабетом. Когда концентрация глюкозы нормализуется, лираглутид перестает увеличивать массу бета-клеток поджелудочной железы."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат Саксенда показан в качестве дополнения к низкокалорийной диете и усиленной физической нагрузке для длительного применения с целью коррекции массы тела у взрослых пациентов с ИМТ:- ≥30 кг/м2 (ожирение) или- ≥ 27 кг/м2 до меньше 30 кг/м (избыточная масса тела) при наличии хотя бы одного связанного с избыточной массой тела сопутствующего заболевания, такого как нарушение толерантности к глюкозе, сахарный диабет 2 типа, артериальная гипертензия, дислипидемия или синдром обструктивного апноэ во сне."}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["повышенная чувствительность к лираглутиду или любому из вспомогательных компонентов препарата; - медуллярный рак щитовидной железы в анамнезе, в том числе в семейном; - множественная эндокринная неоплазия 2 типа; - тяжелая депрессия, суицидальные мысли или поведение, в том числе в анамнезе. Противопоказано применение у следующих групп пациентов и при следующих состояниях/заболеваниях в связи с отсутствием данных по эффективности и безопасности:- нарушение функции почек тяжелой степени; - нарушение функции печени тяжелой степени; - детский возраст до 18 лет; - период беременности и грудного вскармливания; - сердечная недостаточность III-IV функционального класса (в соответствии с классификацией NYHA (Нью-Йоркская кардиологическая ассоциация)); - одновременное применение других препаратов для коррекции массы тела; - одновременное применение с инсулином; - вторичное ожирение на фоне эндокринологических заболеваний или расстройств пищевого поведения, или на фоне применения лекарственных препаратов, которые могут привести к увеличению массы тела. Опыт применения препарата Саксенда у пациентов с воспалительными заболеваниями кишечника и диабетическим парезом желудка ограничен. Применение лираглутида у таких пациентов не рекомендуется, поскольку оно связано с транзиторными нежелательными реакциями со стороны желудочно-кишечного тракта, включая тошноту, рвоту и диарею."]}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Нельзя использовать при беременности, вместо него рекомендуется проводить лечение инсулином. Если пациентка готовится к беременности, либо беременность уже наступила, терапию препаратом Виктоза необходимо немедленно прекратить. Неизвестно, выделяется ли лираглутид с грудным молоком женщин. Исследования на животных показали, что проникновение лираглутида и метаболитов близкой структурной связи в грудное молоко является низким. Опыт применения препарата Виктоза у кормящих женщин отсутствует; применение препарата в период грудного вскармливания противопоказано."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат Саксенда предназначен только для подкожного введения. Его нельзя вводить внутривенно или внутримышечно. Препарат Саксенда вводят один раз в сутки в любое время, независимо от приема пищи. Его следует вводить в область живота, бедра или плеча. Место и время инъекции могут быть изменены без коррекции дозы. Тем не менее, желательно делать инъекции примерно в одно и то же время суток после выбора наиболее удобного времени. ДозыНачальная доза составляет 0,6 мг в сутки. Дозу увеличивают до 3 мг в сутки, прибавляя по 0,6 мг с интервалами не менее одной недели для улучшения желудочно-кишечной переносимости. Если при увеличении дозы новая доза плохо переносится пациентом в течение 2 недель подряд, следует рассмотреть вопрос о прекращении терапии. Применение препарата в суточной дозе больше 3 мг не рекомендуется. Пациенты с сахарным диабетом 2 типаПрепарат Саксенда не следует применять в комбинации с другими агонистами рецепторов ЕПП-ЕВ начале терапии препаратом Саксенда рекомендуется уменьшить дозы одновременно применяемых секретагогов инсулина (таких как препараты сульфонилмочевины) для уменьшения риска развития гипогликемии."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Нарушения со стороны иммунной системыАнафилактические реакции - РедкоНарушения со стороны обмена веществ и питанияГипогликемия - ЧастоДегидратация - НечастоНарушения психикиБессонница - ЧастоНарушения со стороны нервной системыГоловокружение - ЧастоНарушения со стороны сердцаТахикардия - НечастоНарушения со стороны желудочно-кишечного трактаТошнота, рвота, диарея, запор - Очень часто Сухость во рту, диспепсия, гастрит, гастроэзофагеальный рефлюкс, боль в верхних отделах живота, метеоризм, отрыжка, вздутие живота - ЧастоПанкреатит - НечастоНарушения со стороны печени и желчевыводящих путейХолелитиаз - ЧастоХолецистит - НечастоНарушения со стороны кожи и подкожных тканейКрапивница - НечастоНарушения со стороны почек и мочевыводящих путейОстрая почечная недостаточность, нарушение функции почек - РедкоОбщие расстройства и нарушения в месте введенияРеакции в месте введения, астения, утомляемость - ЧастоНедомогание - Нечасто"}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптомы: в ходе клинических исследований и постмаркетинговом периоде сообщалось о случаях применения препарата в дозах, до 40 раз превышающих среднюю рекомендуемую дозу (72 мг), что сопровождалось развитием тяжелой тошноты и рвоты. Случаев тяжелой гипогликемии не отмечалось. Все пациенты выздоровели полностью без осложнений. Лечение: в случае передозировки препарата Виктоза рекомендуется проведение соответствующей симптоматической терапии."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Пациенты должны быть предупреждены о том, что им следует соблюдать меры предосторожности во избежание развития гипогликемии во время управления транспортными средствами и при работе с механизмами"}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Механизм действияЛираглутид представляет собой аналог человеческого глюкагоноподобного пептида-1 (ГПП-1), произведенный методом биотехнологии рекомбинантной ДНК с использованием штамма Saccharomyces cerevisiae, имеющий 97% гомологичности с человеческим ГПП-1, который связывается и активирует рецепторы ГПП-1 у человека. 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