Ингибитор резорбции костной ткани, бисфосфонат. Обладает изб... Инструкция
Показания к применению
Остеолитические, остеобластические и смешанные костные метастазы солидных опухолей и остеолитические очаги при множественной миеломе, в составе комбинированной терапии; гиперкальциемия, вызванная злокачественной опухолью
Противопоказания
Беременность; лактация (грудное вскармливание); повышенная чувствительность к золедроновой кислоте, другим бисфосфонатам
Инструкция
Состав
Золедроновая кислота 4 мг
Фармакологические свойства
Ингибитор резорбции костной ткани, бисфосфонат. Обладает избирательным действием на кость. Оказывает ингибирующее действие на резорбцию костной ткани, опосредуемую остеокластами. Селективное действие бисфосфонатов на костную ткань основано на высоком сродстве к минерализованной костной ткани, но точный молекулярный механизм, обеспечивающий ингибирование активности остеокластов, до сих пор остается невыясненным. Помимо ингибирующего действия на резорбцию костной ткани, золендроновая кислота обладает другими противоопухолевыми свойствами, обеспечивающими терапевтическую эффективность при костных метастазах. In vivo: ингибирование остеокластической резорбции костной ткани, изменяющее микросреду костного мозга, приводящее к снижению роста опухолевых клеток; антиангиогенная активность. Подавление костной резорбции клинически сопровождается также выраженным снижением болевых ощущений. In vitro: ингибирование пролиферации остеобластов, прямая цитотоксическая и проапоптическая активность, синергический цитостатический эффект с противоопухолевыми препаратами; антиадгезивная/инвазивная активность. Золедроновая кислота, подавляя пролиферацию и индуцируя апоптоз, оказывает непосредственное противоопухолевое действие в отношении клеток миеломы человека и раковой опухоли молочной железы, а также уменьшает проникновение клеток раковой опухоли молочной железы через экстрацеллюлярный матрикс, что свидетельствует о наличии у нее антиметастатических свойств. Кроме того, золедроновая кислота ингибирует пролиферацию клеток эндотелия человека и у животных вызывает антиангиогенное действие. У пациентов с гиперкальциемией, вызванной опухолью, было показано, что действие золедроновой кислоты характеризуется снижением концентрации кальция в сыворотке и уменьшением его выведения с мочой
Показания к применению
Остеолитические, остеобластические и смешанные костные метастазы солидных опухолей и остеолитические очаги при множественной миеломе, в составе комбинированной терапии; гиперкальциемия, вызванная злокачественной опухолью
Противопоказания
Беременность; лактация (грудное вскармливание); повышенная чувствительность к золедроновой кислоте, другим бисфосфонатам
Применение при беременности и в период грудного вскармливания
Противопоказан при беременности и лактации
Способ применения и дозы
Вводят в/в капельно в течение 15 мин. Рекомендуемая доза составляет 4-8 мг. Частота введения зависит от показаний, применяемой схемы лечения, терапевтической эффективности
Побочное действие
Со стороны системы кроветворения: нечасто - тромбоцитопения, анемия, лейкопения; редко - панцитопения. Со стороны нервной системы: часто - головная боль; нечасто - слабость, парестезии, нарушение вкусовых ощущений, гипестезия, гиперестезия, тремор, тревога, расстройства сна; редко - спутанность сознания. Со стороны органа зрения: часто - конъюнктивит; нечасто - затуманивание зрения. Со стороны пищеварительной системы: часто - тошнота, рвота, анорексия; нечасто - диарея, запор, абдоминальные боли, диспепсия, стоматит, сухость во рту. Со стороны дыхательной системы: нечасто - диспноэ, кашель. Дерматологические реакции: нечасто - зуд, сыпь (включая эритематозную и макулярную), повышенная потливость. Со стороны костно-мышечной системы: часто - боли в костях, миалгия, артралгия; нечасто - судороги мышц. Со стороны сердечно-сосудистой системы: редко - брадикардия. Со стороны мочевыделительной системы: часто - нарушение функции почек; нечасто - острая почечная недостаточность, гематурия, протеинурия. Аллергические реакции: нечасто - реакции повышенной чувствительности; редко - ангионевротический отек. Со стороны обмена веществ: очень часто - гипофосфатемия; часто - повышение уровня креатинина и мочевины в сыворотке крови, гипокальциемия; нечасто - гипомагниемия, увеличение массы тела; редко - гиперкалиемия, гипокалиемия, гипернатриемия. Со стороны организма в целом: часто - жар, гриппоподобный синдром, проявляющийся лихорадкой, ознобом, болями в костях и/или мышцах; нечасто - астения, периферические отеки, боль в грудной клетке.
Особые указания
При повторном применении перед каждым введением следует определять концентрацию креатинина в сыворотке крови. Если полученные данные свидетельствуют об ухудшении функции почек, необходимо оценить риск и пользу проводимой терапии. Не рекомендуется применять у пациентов с тяжелыми нарушениями функции почек (концентрация сывороточного креатинина ≥400 мкмоль/л или ≥4.5 мг/дл) за исключением случаев, когда ожидаемая польза терапии преобладает над потенциальным риском. Перед инфузией следует исключить наличие дегидратации у пациента. Для обеспечения адекватной гидратации рекомендуется введение физиологического раствора до, во время или после инфузии золедроновой кислоты. Следует избегать гипергидратации пациента из-за риска возникновения осложнений со стороны сердечно-сосудистой системы. После введения золедроновой необходим постоянный контроль за концентрацией кальция, фосфора, магния и креатинина в сыворотке крови. Если развивается гипокальциемия, гипофосфатемия или гипомагниемия, необходима краткосрочная поддерживающая терапия. Имеются отдельные сообщения о нарушении функции почек на фоне применения бисфосфонатов. К факторам риска развития таких осложнений относятся предшествующая почечная недостаточность и длительное применение золедроновой кислоты в высоких дозах (8 мг), сокращение времени инфузии. Эффективность и безопасность применения золедроновой кислоты в педиатрической практике не установлены
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Обладает избирательным действием на кость. Оказывает ингибирующее действие на резорбцию костной ткани, опосредуемую остеокластами. Селективное действие бисфосфонатов на костную ткань основано на высоком сродстве к минерализованной костной ткани, но точный молекулярный механизм, обеспечивающий ингибирование активности остеокластов, до сих пор остается невыясненным. Помимо ингибирующего действия на резорбцию костной ткани, золендроновая кислота обладает другими противоопухолевыми свойствами, обеспечивающими терапевтическую эффективность при костных метастазах. In vivo: ингибирование остеокластической резорбции костной ткани, изменяющее микросреду костного мозга, приводящее к снижению роста опухолевых клеток; антиангиогенная активность. Подавление костной резорбции клинически сопровождается также выраженным снижением болевых ощущений. In vitro: ингибирование пролиферации остеобластов, прямая цитотоксическая и проапоптическая активность, синергический цитостатический эффект с противоопухолевыми препаратами; антиадгезивная/инвазивная активность. Золедроновая кислота, подавляя пролиферацию и индуцируя апоптоз, оказывает непосредственное противоопухолевое действие в отношении клеток миеломы человека и раковой опухоли молочной железы, а также уменьшает проникновение клеток раковой опухоли молочной железы через экстрацеллюлярный матрикс, что свидетельствует о наличии у нее антиметастатических свойств. Кроме того, золедроновая кислота ингибирует пролиферацию клеток эндотелия человека и у животных вызывает антиангиогенное действие. У пациентов с гиперкальциемией, вызванной опухолью, было показано, что действие золедроновой кислоты характеризуется снижением концентрации кальция в сыворотке и уменьшением его выведения с мочой"}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Остеолитические, остеобластические и смешанные костные метастазы солидных опухолей и остеолитические очаги при множественной миеломе, в составе комбинированной терапии; гиперкальциемия, вызванная злокачественной опухолью"}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Беременность; лактация (грудное вскармливание); повышенная чувствительность к золедроновой кислоте, другим бисфосфонатам"}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Противопоказан при беременности и лактации"}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Вводят в/в капельно в течение 15 мин. 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Со стороны костно-мышечной системы: часто - боли в костях, миалгия, артралгия; нечасто - судороги мышц. Со стороны сердечно-сосудистой системы: редко - брадикардия. Со стороны мочевыделительной системы: часто - нарушение функции почек; нечасто - острая почечная недостаточность, гематурия, протеинурия. Аллергические реакции: нечасто - реакции повышенной чувствительности; редко - ангионевротический отек. Со стороны обмена веществ: очень часто - гипофосфатемия; часто - повышение уровня креатинина и мочевины в сыворотке крови, гипокальциемия; нечасто - гипомагниемия, увеличение массы тела; редко - гиперкалиемия, гипокалиемия, гипернатриемия. Со стороны организма в целом: часто - жар, гриппоподобный синдром, проявляющийся лихорадкой, ознобом, болями в костях и/или мышцах; нечасто - астения, периферические отеки, боль в грудной клетке."}}]},{"id":8,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При повторном применении перед каждым введением следует определять концентрацию креатинина в сыворотке крови. Если полученные данные свидетельствуют об ухудшении функции почек, необходимо оценить риск и пользу проводимой терапии. Не рекомендуется применять у пациентов с тяжелыми нарушениями функции почек (концентрация сывороточного креатинина ≥400 мкмоль/л или ≥4.5 мг/дл) за исключением случаев, когда ожидаемая польза терапии преобладает над потенциальным риском. Перед инфузией следует исключить наличие дегидратации у пациента. Для обеспечения адекватной гидратации рекомендуется введение физиологического раствора до, во время или после инфузии золедроновой кислоты. Следует избегать гипергидратации пациента из-за риска возникновения осложнений со стороны сердечно-сосудистой системы. После введения золедроновой необходим постоянный контроль за концентрацией кальция, фосфора, магния и креатинина в сыворотке крови. Если развивается гипокальциемия, гипофосфатемия или гипомагниемия, необходима краткосрочная поддерживающая терапия. Имеются отдельные сообщения о нарушении функции почек на фоне применения бисфосфонатов. К факторам риска развития таких осложнений относятся предшествующая почечная недостаточность и длительное применение золедроновой кислоты в высоких дозах (8 мг), сокращение времени инфузии. Эффективность и безопасность применения золедроновой кислоты в педиатрической практике не установлены"}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Ингибитор резорбции костной ткани, бисфосфонат. Обладает избирательным действием на кость. 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