Описание
Лекарственный препарат Ервой применяется для иммунотерапии меланомы с метастазами и действует уникально. Он не взаимодействует с самими злокачественными клетками, а способствует восстановлению нормального иммунного ответа организма.
Он представляет из себя опалесцирующую или прозрачную жидкость от бесцветного до светло-желтого цвета. Содержит действующее вещество: Ипилимумаб. Относится к фармакотерапевтической группе противоопухолевых средств (антитела моноклональные). Производится в виде концентрата для приготовления раствора инфузий, 5 мг/мл.
Состав:
Один флакон препарата с концентратом для приготовления раствора для инфузий включает:
- активное вещество: ипилимумаб 53.5 мг,
- также: трометамола гидрохлорид 33.7 мг; маннитол 107.0 мг; натрия хлорид 62.6 мг; полисорбат 80 1.18 мг; пентетовая кислота 0.42 мг; натрия гидроксид и хлористоводородная кислота для pH 7.0; вода для инъекций до 10.7 мл.
Фармакодинамика:
Активное вещество Ипилимумаб является рекомбинантным человеческим моноклональным антителом, которое связывается с цитотоксическим Т-лимфоцит-ассоциированным антигеном 4 (CTLA-4). Действующее вещество является иммуноглобулином G1 каппа (IgGlк). Его получают при помощи генной инженерии при выделении культуры клеток млекопитающих. Его молекулярная масса составляет примерно 148 кДа.
Антиген CTLA-4 является ключевым регулятором активации для Т-лимфоцитов. Вещество Ипилимумаб является ингибитором CTLA-4, который блокирует тормозные сигналы каскада CTLA-4, тем самым увеличивая количество противоопухолевых Т-хэлперов, вызывающих в этот момент рост количества прямых Т-киллеров. Доказано, что блокада CTLA-4 также уменьшает регуляторную функцию Т-клеток, что в последствии приводит к усилению иммунного противоопухолевого ответа организма пациента.
Также препарат Ипилимумаб способен селективно уменьшать количество Т-регуляторных клеток в области новообразования, приводя к росту противоопухолевых Т-хэлперов по отношению к Т-регуляторам, что и приводит к гибели раковых клеток.
Фармакокинетика:
Фармакокинетику действующего вещества ипилимумаб изучали у пациентов с прогрессирующей меланомой, которые получали его каждые 3 недели в дозировках от 0,3 до 10 мг/кг (совокупно 4 дозы). Установлено, что в изученном диапазоне дозировок Смин и Смакс (минимальная и максимальная концентрации), а также площадь под кривой «концентрация/время» (AUC) пропорциональны введенной пациенту дозировке.
При следующем введении каждые 3 недели клиренс не зависел от времени; минимальная системная кумуляция определялась при индексе кумуляции от 1,5 и менее. При этом равновесная концентрация активного вещества в плазме получалась при получении третей дозы пациентом.
По результатам популяционного фармакокинетического анализа данного вещества были выявлены следующие средние показатели: средний конечный период полувыведения составил 15,4 суток ; средний объем распределения при равновесной концентрации — 7,47 литров, а средний системный клиренс — 16,8 мл/ч.
При введении в дозе 3 мг/кг средняя минимальная равновесная концентрация вещества в плазме составляла 19,4 мкг/мл. При это же дозировке площадь под кривой «концентрация/время» (AUC) у детей в возрасте от 12 лет и старше сопоставима с показателями и уровнями взрослых пациентов, получавших такую же дозировку препарата.
Также необходимо отметить, что клиренс ипилимумаба был выше при увеличении массы тела, а также при увеличении активности лактатдегидрогеназы. Но однако коррекции дозы в этих случаях не нужна.
Клиренс не зависит от пола или возраста пациента, функции печени, функции почек, статуса физической активности пациента и статуса HLA-A2*0201, а также от наличия предшествующей противоопухолевой терапии у больного.
Зафиксированное среднее геометрическое значение клиренса у детей в возрасте от 12 лет и старше составило 8,72 мл/час.
При применении Ервой в дозировке 3 мг/кг совместно с ниволумабом в дозе 1 мг/кг, ниволумаб не сказывался на клиренсt вещества ипилимумаба.
Показания:
- При неоперабельной или метастатической меланоме у взрослых пациентов и детей от 12 лет и старше препарат Ервой назначается в виде монотерапии.
- При неоперабельной или метастатической меланоме для взрослых пациентов препарат Ервой назначается в комбинации с ниволумабом.
Упаковка:
По 10,7 мл во флаконе прозрачного бесцветного стекла типа I, закрыт бутилрезиновой пробкой с алюминиевым колпачком и защитной пластиковой крышкой. Размещается вместе с инструкцией по применению в картонной пачке по одному флакону.
Условия хранения и срок годности:
Препарат хранить при температуре от 2 до 8 °С, в защищенном от света и недоступном для детей месте!
Препарат нельзя замораживать!
Срок хранения: 3 года. Препарат нельзя применять по истечении срока годности.
Наша компания работает как на территории Кыргызстана, так и осуществляет доставку в страны ближнего зарубежья. Обращайтесь к нам за консультациями по контактным телефонам.
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