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Перьета — Perjeta (пертузумаб) по 420 мг/14 мл

Перьета (Perjeta) 420мг/14мл , пертузумаб Рош, Швейцария

Перьета — Perjeta (пертузумаб) по 420 мг/14 мл

Перьета (Пертузумаб) — это гуманизированные моноклональные рекомбинантные антитела, способные избирательно взаимодействовать с внеклеточным субдоменом II HER-2, отвечающим за димеризацию.  Данный процесс  блокирует процесс лиганд-зависимой гетеродимеризации HER-2 с другими белками семейства HER: HER-3, HER-4 и EGFR. Таким образом, пертузумаб угнетает лиганд-инициированную передачу внутриклеточных сигналов по двум основным сигнальным путям:  путь митоген-активированной протеинкиназы (МАР) и путь фосфоинозитид-3-киназы (PI3K). Ингибирование данных сигнальных путей способно привести к остановке роста клеток и апоптозу, соответственно. Кроме того, пертузумаб активирует антитело-зависимую клеточную цитотоксичность (АЗКЦ).

Категория:

Описание

Перьета (Пертузумаб) — это гуманизированные моноклональные рекомбинантные антитела, способные избирательно взаимодействовать с внеклеточным субдоменом II HER-2, отвечающим за димеризацию.  Данный процесс  блокирует процесс лиганд-зависимой гетеродимеризации HER-2 с другими белками семейства HER: HER-3, HER-4 и EGFR. Таким образом, пертузумаб угнетает лиганд-инициированную передачу внутриклеточных сигналов по двум основным сигнальным путям:  путь митоген-активированной протеинкиназы (МАР) и путь фосфоинозитид-3-киназы (PI3K). Ингибирование данных сигнальных путей способно привести к остановке роста клеток и апоптозу, соответственно. Кроме того, пертузумаб активирует антитело-зависимую клеточную цитотоксичность (АЗКЦ).

Описание

Компания Medical&Pharma предлагает современное противоопухолевое моноклональное лекарство Перьета (пертузумаб), которое содержит активное вещество Пертузумаб (рекомбинантные гуманизированные моноклональные антитела). Прием препарата Перьета позволяет привести к остановке роста клеток и к апоптозу, соответсвенно.

Лекарство назначают при метастатическом раке молочной железы, а также неоадъювантной терапии рака молочной железы.

Состав Перьета (пертузумаб)

  • один флакон содержит:
    активное вещество: пертузумаб – 420 мг; концентрация пертузумаба 30 мг/мл.
  • вспомогательных веществ: L-гистидин – 43.5 мг, уксусная кислота ледяная – 9.2 мг, сахароза – 575.1 мг, полисорбат 20 – 2.8 мг, вода для инъекций до 14 мл.

Показания

  • В сочетании с трастузумабом и доцетакселом при метастатическом или местно-рецидивирующем, неоперабельном раке молочной железы с гиперэкспрессией HER2, при отсутствии ранее проводимой HER2 специфичной терапии
  • В сочетании с трастузумабом и химиотерапией:
  • в неоадъювантной терапии при местно-распространенном, отечно-инфильтративном или раннем (первично-операбельном) раке молочной железы (диаметр опухоли более 2 см или с поражением лимфоузлов), в составе полной схемы лечения раннего рака молочной железы с гиперэкспрессией HER-2;
  • в адъювантной терапии с гиперэкспрессией HER-2 в составе схемы раннего (первично-операбельного) рака молочной железы.

Фармакодинамика

Механизм действия

Пертузумаб — это рекомбинантные гуманизированные моноклональные антитела, способные избирательно взаимодействовать с внеклеточным субдоменом II HER-2, отвечающим за димеризацию.  Данный процесс  блокирует процесс лиганд-зависимой гетеродимеризации HER-2 с другими белками семейства HER: HER-3, HER-4 и EGFR. Таким образом, пертузумаб угнетает лиганд-инициированную передачу внутриклеточных сигналов по двум основным сигнальным путям:  путь митоген-активированной протеинкиназы (МАР) и путь фосфоинозитид-3-киназы (PI3K). Ингибирование данных сигнальных путей способно привести к остановке роста клеток и апоптозу, соответственно. Кроме того, пертузумаб активирует антитело-зависимую клеточную цитотоксичность (АЗКЦ).

Молекулярная масса пертузумаба составляет около 148 кДа, соответственно через гематоэнцефалический барьер пертузумаб практически не проходит.

Пертузумаб ингибирует пролиферацию клеток опухоли человека, что показано при его применении в комбинации с трастузумабом,  на моделях ксенотрансплантатов с гиперэкспрессией HER-2.

Иммуногенность

У 6.7% больных метастатическим раком молочной железы, получавших терапию трастузумабом в сочетании с доцетакселом, и у 3.3% больных, получавших трастузумаб в сочетании  с доцетакселом и пертузумабом, были обнаружены антитела к препарату Перьета®.

Результаты на иммуногенность во многом зависят от различных факторов: специфичность и чувствительность анализа, методология проведения анализа, время забора образцов, манипуляции с забранными образцами, характер основного заболевания и сопутствующие препараты.  Таким образом, сравнение частоты обнаружения антител к пертузумабу и частоты обнаружения антител к другим биологическим препаратам может быть неинформативным.

Фармакокинетика

Изучение  фармакокинетики  у пациентов с различными видами опухоли после внутривенного (в/в) введения в различных дозах (от 2 до 25 мг/кг) показало отсутствие зависимости клиренса пертузумаба от дозы и показания.

Фармакокинетические параметры не зависят от этнической принадлежности, возраста и пола.

Величина «тощей массы тела» (масса тела за вычетом массы жировой ткани) и начальная концентрация альбумина и оказывают незначительное влияние на клиренс пертузумаба, при этом необходимость коррекции дозы пертузумаба в зависимости от концентрации альбумина или массы тела отсутствует.

Также, отсутствуют различия в фармакокинетике пертузумаба у пациентов с метастатическим раком молочной железы и с ранним раком молочной железы.

Метаболизм
Метаболизм пертузумаба не изучался. Как и другие антитела, пертузумаб преимущественно подвергается катаболизму.

Выведение
Период полувыведения (Т­1/2) приблизительно равен 18 дням. Клиренс пертузумаба составляет приблизительно 0.235 л/сут,

Упаковка, срок годности, условия хранения

Флакон бесцветного стекла, закупоренный пробкой из бутилкаучука, обжатый алюминиевым колпачком и закрытый пластмассовой крышкой. По 420 мг/14 мл Концентрат для приготовления раствора для инфузий во флаконе. Один флакон с препаратом и с медицинской инструкцией по применению  упакованы  в картонную пачку.

Препарат хранят в недоступном для детей, защищенном от света месте, при температуре от 2° до 8°C. Срок годности — 2 года.

Не использовать по истечении срока годности, указанного на упаковке.

 

Заказать и купить Перьета (Пертузумаб) в Алматы

Заказать и купить Перьета (Пертузумаб) в Казахстане

Позвоните и узнайте цену Перьета (Пертузумаб)

Работаем и отправляем Перьета (пертузумаб) по странам СНГ: Россия, Украина, Кыргызстан (Бишкек), Белоруссия, Узбекистан (Ташкент),
а также можем отправить Перьета (пертузумаб) по регионам Казахстана: Нур-Султан (Астана), Шымкент, Талдыкорган, Актау и другие.

Детали

Производитель

Roche Pharma

Страна производитель

Германия

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