Описание
Компания Medical&Pharma предлагает современное лекарство Вектибикс (Панитумумаб). Его относят к группе противоопухолевых препаратов, который содержит активное вещество Панитумумаб. Панитумумаб представляет собой полностью человеческое моноклональное антитело IgG2, полученное путем рекомбинантной ДНК-технологии из клеточной линии яичников китайского хомячка, обладающее высокой специфичностью и сродством к рецепторам эпидермального фактора роста человека (ЭФР). ЭФР представляет собой трансмембранный гликопротеин семейства рецепторов тирозинкиназ типа I. Данный рецептор ЭФР стимулирует рост нормальных эпителиальных клеток, включая клетки волосяных фолликулов и кожи , и экспрессируется на различных типах опухолевых клеток.
В клинических исследованиях применение Вектибикса у пациентов с метастатическим колоректальным раком, с прогрессией заболевания на фоне или после предшествующего курса химиотерапии, приводящее к увеличению выживаемости без прогрессии (ВБП), при этом значение ВБП было выше у пациентов с KRAS дикого типа в опухолевых клетках по сравнению с группой пациентов с мутациями KRAS в опухолями.
Состав Вектибикс (Панитумумаб)
- 1 мл концентрата содержит активное вещество: панитумумаб – 20 мг
- вспомогательные вещества: натрия хлорид; кислота уксусная ледяная; натрия ацетата тригидрат; вода для инъекций.
Показания
При лечении у пациентов с генами RAS дикого типа метастатического колоректального рака:
- в качестве монотерапии на фоне применения стандартной химиотерапии при прогрессировании заболевания
- в комбинации с химиотерапией на основе оксалиплатина и фторпиримидина;
- в комбинации с химиотерапией на основе иринотекана и фторпиримидина;.
Фармакодинамика препарата Вектибикс (Панитумумаб)
В исследованиях на животных было показано, что панитумумаб ингибирует рост и выживаемость опухолевых клеток, экспрессирующих рецептор ЭФР. Каких-либо противоопухолевых эффектов панитумумаба в ксенотрансплантатах опухоли человека, лишенных экспрессии рецептора ЭФР, не наблюдалось. Добавление панитумумаба к химиотерапии, лучевой терапии, или другим таргетным терапевтическим агентам в исследованиях на животных увеличивало противоопухолевые эффекты по сравнению с только таргетными препаратами, лучевой терапией или химиотерапией.
Панитумумаб обладает высоким сходством и специфичностью к рецепторам эпителиального фактора роста человека (ЭФР), трансмембранному гликопротеину из семейства рецепторов тирозинкиназ I типа. Рецептор ЭФР это белок, стимулирующий рост нормальных эпителиальных клеток, включая клетки волосяных фолликулов, кожи и экспрессируется на различных типах опухолевых клеток.
Механизм действия
Панитумумаб связывается с доменом рецептора ЭФР, что приводит к ингибированию процесса аутофосфорилирования, который индуцируется лигандами рецептора ЭФР. Связывание лекарственного вещества с рецептором ЭФР приводит к интернализации рецептора, индукции апоптоза, ингибированию процессов клеточного роста и уменьшению продукции интерлейкина-8 и фактора роста эндотелия сосудов. KRAS-ген — это гомолог вирусного онкогена крысиной саркомы Кирстена 2, который участвует в трансдукции сигнала, путем кодирования небольшого гуанозинтрифосфат-связывающего белка. KRAS-ген активируется различными сигналами, и от рецептора ЭФР в том числе, стимулирующих синтез других внутриклеточных белков, вовлеченных в процессы клеточной пролиферации, ангиогенеза и выживаемости .
Иммуногенность
Как и все терапевтические протеины, панитумумаб обладает потенциальной иммуногенностью. С помощью двух различных методов оценивали продукцию нейтрализующих антител к панитумумабу:с помощью иммуноанализа (ИФА — иммуноферментный анализ, который позволяет определить высокоаффинные антитела) и Биосенсора (определяющего высоко- и низкоаффинные антитела); результаты анализа показали, что возникновение последозового ответа, оценивавшимся по наличию антител к панитумумабу, в целом было низким. Антитела к панитумумабу до введения препарата были обнаружены у 5 из 636 пациентов (< 1%) и 16/635 пациентов (2.5%) по данным иммуноанализов ИФА и Биосенсор, соответственно. Антитела, нейтрализующие панитумумаб, после введения препарата были обнаружены у 1 из 447 пациентов (0.2%) и у 7 из 447 пациентов (1.6%) по данным иммуноанализов ИФА и Биосенсор, соответственно. Не отмечена взаимосвязь между наличием антител, нейтрализующих панитумумаб, и изменениями фармакокинетических параметров, при сравнении пациентов, у которых антитела не выработались, не отмечена и эффективность и безопасность препарата.
Определение антител зависит от чувствительности и специфичности используемого метода. На результат по определению антител могут оказать влияние различные факторы, включая прием сопутствующих препаратов, характер основного заболевания и методику отбора образцов, таким образом сравнение частоты возникновения антител к панитумумабу с данным показателем для других препаратов может быть недостоверным.
Клиническая эффективность
В клинических исследованиях применение препарата у пациентов с метастатическим колоректальным раком приводит к увеличению выживаемости без прогрессии (ВБП), при этом значение ВБП, по сравнению с группой пациентов с опухолями с KRAS-мутантным, было больше у пациентов с KRAS — диким типом в опухолевых клетках. Применение препарата у пациентов с метастазирующим колоректальным раком (мКРР) с типом гена KRAS-дикий, в клиническом исследовании, у которых после предшествующих или на фоне принимаемых курсов химиотерапии на основе фторпиримидина, оксалиплатина или иринотекана наблюдали прогрессию болезни, приводит к значительному увеличению выживания без прогрессирования (ВБП). У пациентов с типом гена KRAS-мутантный, положительного влияния на ВБП не было отмечено. Эффективность лекарства также наблюдали в клиническом исследовании у пациентов с мКРР с с типом гена KRAS-дикий (экзон 2), резистентных к химиотерапевтическому лечению, которые были рандомизированы в соотношении 1:1 на получение Вектибикса и цетуксимаба. Первичной конечной точкой была общая выживаемость (ОВ). Вторичные ключевые точки включали частоту объективного ответа (ЧОО) и выживание без прогрессирования (ВБП). Первичная конечная точка показала преимущество общей выживаемости (95% ДИ: 9,4, 11,6; р=0,001) в пользу Вектибикса. Не наблюдалось положительного влияния на ВБП, по сравнению с группой цетуксимаба, в группе панитумумаба отмечалось незначительное преимущество в ЧОО.
Упаковка, срок годности,
условия хранения
Концентрат (20 мг/мл) для приготовления раствора для инфузий в виде прозрачной, бесцветной жидкости, частично содержащий полупрозрачные или белые, аморфные белковые частицы.
В одном флаконе, для приготовления раствора для инфузий, содержится: 100 мг панитумумаба в 5 мл концентрата; 200 мг в 10 мл, 400 мг в 20 мл. Флаконы из прозрачного стекла с колпачком алюминиевым и эластомерной пробкой. Каждый флакон содержит надпись «Flip off». Флаконы с инструкцией по применению упакован в контурную ячейковую упаковку; в пачке картонной. На каждой пачке наклеено две прозрачные защитные этикетки с продольную цветную полосу —это контроль первого вскрытия.
Хранить при температуре от 2 °C до 8 °C, в недоступном для детей месте и в упаковке для защи ты от света. Не замораживать.
В препарате отсутствуют какие-либо бактериостатические агенты или антимикробные консерванты. Препарат должен быть использован сразу же после разведения. Не замораживать разведенный раствор.
Срок годности 3 года.
Наша компания работает как на территории Казахстана, так и осуществляет доставку в страны ближнего зарубежья. Обращайтесь к нам за консультациями по контактным телефонам.
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