Описание
Препарат Кипролис представляет собой тетрапептидэпоксикетонный ингибитор протеасомы. Основное действующее вещество препарата Кипролис — карфилзомиб, ингибитор протеасомы, который необратимо и избирательно взаимодействует с N-терминальным треонином, содержащимся в активном центре 20S протеосомы. Препарат Кипролис в доклинических моделях гематологических опухолей показал антипролиферативный и проапоптический эффекты. У животных препарат Кипролис ингибировал активность протеасомы в клетках крови и тканях и в моделях множественной миеломы замедлял опухолевый рост . В экспериментах In vitro препарат Кипролис демонстрировал минимальную нейротоксичность и минимальную реактивность в отношении непротеасомных протеаз.
Показания к применению Кипролис
- В составе комбинированной схемы лечения рецидивирующей множественной миеломы у больных, получивших минимум одну линию предшествующей терапии, в сочетании с дексаметазоном и леналидомидом.
- Монотерапия рецидивирующей и рефрактерной множественной миеломы у больных, получивших минимум две предыдущие линии терапии, включая иммуномодулирующее средство и бортезомиб.
Состав Кипролис
Лиофилизат для приготовления раствора — один флакон.
- Активные вещества: карфилзомиб — 30 мг или 60 мг;
- Вспомогательные вещества: сульфобутиловый эфир бетадекс натрия, лимонная кислота, натрия гидроксид (для регулирования pH).
Фармакодинамика
Препарат Кипролис представляет собой тетрапептидэпоксикетонный ингибитор протеасомы, который необратимо и избирательно взаимодействует с N-терминальным треонином, содержащимся в активном центре 20S протеосомы. Данная протеосома является протеолитической центральной частицей в 26S-протеасоме, и способна оказывать незначительное влияние на протеазы других классов. Препарат Кипролис в доклинических моделях гематологических опухолей показал антипролиферативный и проапоптический эффекты. У животных препарат Кипролис ингибировал активность протеасомы в клетках крови и тканях и в моделях множественной миеломы замедлял опухолевый рост. В экспериментах In vitro препарат Кипролис демонстрировал минимальную нейротоксичность и минимальную реактивность в отношении непротеасомных протеаз.
Внутривенное введение препарата Кипросил приводило к подавлению химотрипсиноподобной активности (CT-L) протеасомы при измерении в крови через один час после введения первой дозировки. Дозировки ≥ 15 мг/м2 последовательно индуцировали (≥ 80 процентов) ингибирование активности CT-L протеасомы. Кроме того, введение карфилзомиба в дозировке 20 мг/м2 приводило к ингибированию латентного мембранного белка типа 2 (LMP2) и субъединиц, напоминающих мультикаталитический эндопептидазный комплекс типа 1 (МЕСL1) иммунопротеасомы в пределах от 26 процентов до 32 процентов и от 41 процентов до 49 процентов, соответственно. Ингибирование протеасомы сохранялось ≥ 48 часов после введения первой дозировки препарата Кипросил при его введении раз в неделю. Комбинированное применение препарата Кипросил с леналидомидом и дексаметазоном на ингибирование протеасомы не влияло.
При дозе более 56 мг/м2 наблюдалось не только увеличение ингибирования субъединиц CT-L (≥ 90 процентов) по сравнению с таковым при введении дозы 15-20 мг/м2, но также увеличение ингибирования других субъединиц протеасомы (LMP7, МЕСL1 и LMP2). Наблюдалось увеличение ингибирования на 8 процентов, 23 процента и 34 процента для субъединиц LMP7, МЕСL1 и LMP2, соответственно, в дозе 56 мг/м2 по сравнению с дозой 15-20 мг/м2. Схожее ингибирование протеасомы с помощью карфилзомиба было достигнуто с 2 до 10-минутными и 30-минутными инфузиями для двух протестированных доз препарата (20 и 36 мг/м2).
Фармакокинетика
Всасывание Кипролис
Максимальная концентрация и AUC после 2-10 минут внутривенной инфузии дозы 27 мг/м2 составили 4,232 нг/мл и 379 нг∙ч/мл, соответственно. При многократном введении препарата Кипролиса в дозировках 15 и 20 мг/м2, значения системной экспозиции (AUC) и периода полувыведения на день 1 и 15 или 16 первого цикла схемы лечения были аналогичными, что свидетельствует об отсутствии системной кумуляции препарата. При применении препарата в дозировках от 20 до 56 мг/м2 отмечалось дозозависимое увеличение экспозиции.
При 30-минутной инфузии достигались сходные параметры периода полувыведения и AUC, однако, отмечалось 2-3-кратное снижение максимальной концентрации по сравнению с концентрацией, полученной при введении той же дозировки в течение 2-10 минут инфузии. После 30-минутной инфузии дозы 56 мг/м2, отмечено 2,5-кратное превышение AUC (948 нг∙ч/мл) по сравнению с дозой 27 мг/м2, а максимальная концентрация (2,079 нг/мл) была ниже по сравнению с инфузией в течение 2-10 минут в дозе 27 мг/м2.
Распределение Кипролис
Средний объем распределения карфилзомиба в равновесном состоянии в дозе 20 мг/м2 составил 28 л. В экспериментах in vitro связывание препарата Кипросил с белками плазмы крови человека составляло в среднем 97 процентов в диапазоне концентраций от 0,4 до 4 мкмоль.
Биотрансформация
Препарат Кипросил быстро и интенсивно метаболизируется. Основные метаболиты, определяемые в плазме крови человека и моче, образовывались также in vitro гепатоцитами человека. Основные метаболиты соответствовали пептидным фрагментам и диолу карфилзомиба, что свидетельствует о его расщеплении пептидазой и эпоксидном гидролизе, являющимися основными путями метаболизма. Опосредованные цитохромом Р450 механизмы играют незначительную роль в общем метаболизме препарата Кипросил. Метаболиты препарата не обладают известной биологической активностью.
Выведение Кипролис
После внутривенного введения в дозе ≥ 15 мг/м2, карфилзомиб быстро выводится из системной циркуляции с периодом полувыведения ≤ 1 час в 1 день 1 цикла схемы лечения. Системный клиренс колеблется от 151 до 263 л/час и превышает печеночный кровоток, что свидетельствует о том, что препарат преимущественно выводится непеченочными путями. Препарат Кипросил подвергается интенсивному метаболизму с последующим выведением метаболитов с мочой.
Специальные популяции
Данные популяционного фармакокинетического анализа показывают, что в зраст, пол или раса не влияют на фармакокинетику карфилзомиба.
Применение при нарушениях функции почек
У пациентов с почечной недостаточностью фармакокинетика карфилзомиба изучалась в двух исследованиях .
По результатам обоих исследований было показано, что статус функции почек после однократной или многократных инфузий не оказывал заметного влияния на экспозицию карфилзомиба. Среднее геометрическое соотношение AUClast в дозе 15 мг/м2, день 1 для легкой, средней, тяжелой почечной недостаточности и хронического диализа по сравнению с нормальной функцией почек составило 124.36 процентов, 111.07 процентов, 84.73 процентов и 121.72 процентов соответственно. Среднее геометрическое соотношение AUClast в дозе 27 мг/м2, цикл 1, день 16 и в дозе 56 мг/м2, цикл 2 день 1 для терминальной стадии почечной недостаточности (ESRD) по сравнению с нормальной функцией почек составило 139.72% и 132.75%, соответственно. В первом исследовании метаболиты М14, фрагменты пептида и наиболее распространенные циркулирующие метаболиты, увеличились в 2 и 3 раза у пациентов со средней и тяжелой почечной недостаточностью, соответственно, и в 7 раз у пациентов, нуждающихся в диализе (на основании AUClast). Во втором исследовании экспозиция для была выше (примерно в 4 раза) у больных с терминальной стадией почечной недостаточности (ESRD), чем у больных с нормальной функцией почек. Этот метаболит не имеет известных биологических активностей. Серьезные побочные эффекты, связанные с ухудшением работы функции почек, чаще встречались у пациентов с базовой почечной дисфункцией
Применение при нарушениях функции печени
При нарушениях функции печени средней и тяжелой степени необходимо применять с осторожностью.
Беременность и лактация:
Беременность
Отсутствуют данные о возможности использования препарата Кипролис в период беременности.
Женщинам и мужчинам, обладающим репродуктивным потенциалом, следует рекомендовать применять эффективные меры контрацепции для предотвращения наступления беременности или зачатия во время лечения препаратом Кипролис. В тесте хромосомных аберраций на лимфоцитах периферической крови человека in vitro было показано, что карфилзомиб обладает кластогенным эффектом. Пациентки, с репродуктивным потенциалом, и/или их половые партнеры, должны использовать надежные меры контрацепции при использовании препарата Кипролис и в течение 30 дней после его завершения. Пациенты-мужчины, принимающие препарат Кипролис, и/или их половые партнерши, обладающие репродуктивным потенциалом, должны применять меры контрацепции во время лечения и 90 дней после завершения применения препарата Кипролис. Если препарат Кипролис применяется в период беременности или беременность наступает при использовании препарата, пациентка должна быть проинформирована о потенциальном вреде для плода.
На основании результатов экспериментов и механизма действия на животных, выявлено, что карфилзомиб может оказывать потенциальный вред для плода при использовании беременными женщинами. Препарат приводил к развитию эмбриофетотоксичности у беременных самок кроликов в дозировках, которые были ниже рекомендуемых для человека. Карфилзомиб, при применении у беременных самок крыс и кроликов в течение периода органогенеза, не являлся тератогенными при использовании дозировок до 2 мг/кг в сутки у крыс или до 0,8 мг/кг в сутки у кроликов.
Грудное вскармливание
Препарат Кипролис не должен применяться в период грудного вскармливания. Известно, что потенциально препарат Кипролис может вызывать нежелательные реакции у детей грудного возраста. Следует принять решение о прекращении грудного вскармливания.
Фертильность
Исследования влияния на фертильность не проводились.
Применение у детей
Для применения у детей и подростков в возрасте до 18 лет противопоказан.
Фармацевтические характеристики
Для приготовления раствора для инфузий в виде лиофилизата или порошка от белого до желтоватого цвета, свободный от видимых включений. Восстановленный раствор: прозрачный, от бесцветного до светло-желтого цвета, от видимых включений свободный.
Упаковка, срок годности, условия хранения Кипролис
Флакон объемом 50 мл из прозрачного стекла I гидролитического класса с 20 мм эластомерной пробкой (из хлорбутилового каучука), ламинированной фторполимером, алюминиевым колпачком и отламывающимся полипропиленовым колпачком. Флаконы помещают в картонную пачку вместе с инструкцией по применению. На каждую пачку наклеивают прозрачные защитные этикетки — контроль первого вскрытия, имеющие продольную цветную полосу.
Хранить при температуре не выше 8°С. Не замораживать. Хранить от света. Хранить препарат в недоступном для детей месте.
Срок годности 3 года. Не использовать по истечении срока годности.
Наша компания работает как на территории Казахстана, так и осуществляет доставку в страны ближнего зарубежья. Обращайтесь к нам за консультациями по контактным телефонам.
Заказать и купить Кипролис (карфилзомиб) в Алматы
Заказать и купить Кипролис (карфилзомиб) в Казахстане
Позвоните и узнайте цену Кипролис (карфилзомиб)
Работаем и отправляем Кипролис — (карфилзомиб) по странам СНГ: Россия, Украина, Кыргызстан (Бишкек), Белоруссия, Узбекистан (Ташкент),
а также можем отправить Кипролис (карфилзомиб) по регионам Казахстана: Нур-Султан (Астана), Шымкент, Талдыкорган, Актау и другие.
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