Опдиво (Opdivo) ниволумаб 40мг и 100 мг BMS США-Италия
Опдиво - Opdivo (Ниволумаб) 40мг и 100 мг — изображение 2

Опдиво — Opdivo (Ниволумаб) 40мг и 100 мг

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Описание

Опдиво (ниволумаб) – это препарат в одном из новых направлений онкологии – иммуно-онкологии. В отличие от стандартной химиотерапии и таргетной терапии, препарат не обладает прямым противоопухолевым воздействием. Лекарство уникально тем, что оно активирует иммунную систему человека и нацеливает ее на борьбу с опухолевыми клетками. Активированные цитотоксические Т-лимфоциты обладают естественной противоопухолевой активностью. Они проникают в опухолевую ткань клетки и вызывают ее гибель.

В проведенных исследованиях по всем зарегистрированным показаниям, в сравнении со стандартной терапией, лекарственный препарат Опдиво продемонстрировал крайне высокую эффективность общей выживаемости, выживаемости без длительности и прогрессирования ответа на лечение при благоприятном профиле безопасности. Применение Опдиво для лечения пациентов с метастатической меланомой увеличивает частоту объективных ответов и показатели безпрогрессивной выживаемости. По многим показателям является новым этапом в иммуноонкологии, которая доказала свою высокую эффективность для пациентов с неоперабельной или метастатической меланомой.

Состав

  • один флакон препарата с концентратом для приготовления раствора для инфузий содержит действующее вещество: ниволумаб 47,0 мг или 107,0 мг.
  • вспомогательные вещества: натрия хлорид; натрия цитрата дигидрат; маннитол; полисорбат; натрия гидроксид; пентетовая кислота; хлористоводородная кислота; вода для инъекций.

Показания

• при неоперабельной или метастатической меланоме;
• при метастатическом или местнораспространенном немелкоклеточном раке легкого (HMPJI) после предшествующей системной терапии;
• при распространенном почечно-клеточном раке (ПКР) после предшествующей химиотерапии;

Фармакодинамика

Активное вещество Ниволумаб — это моноклональное человеческое антитело, который представляет из себя иммуноглобулин G4 (IgG4), блокирующий активность между лигандами программируемой смерти (PD-L1; PD-L2) и их рецепторами (PD-1 — является негативным регулятором активности Т-клеток). Взаимодействие PD-1 с лигандами PD-L1 и PD-L2 (способны экспрессироваться клетками злокачественных образований или иными клетками микроокружения новообразований), приводит к ингибированию секреции цитокинов и увеличению количества Т-клеток. Ниволумаб активирует иммунный ответ путем блокады связывания PD-1 с лигандами PD-L1 и PD-L2. В исследованиях на мышах, блокировка активности PD-1 приводило к снижению числа опухолевых клеток.

Фармакокинетика

У действующего вещества ниволумаб в диапазоне дозировки от 0,1 до 10 мг/кг — фармакокинетика линейна.
По результатам исследований установлено, что средний период полувыведения T1/2 равен 26,7 дней (коэффициент вариабельности — 101 %); средний системный клиренс вещества равен 9,5 мл/ч (коэффициент вариабельности — 49,7 %); средний Vd вещества в равновесном состоянии равен 8,0 л (коэффициент вариабельности — 30,4 %). Минимальная, средняя и максимальная концентрация вещества в плазме в течение 2 недель после введения в дозировке 3 мг/кг равны 57, 75.3 и 116 мкг/мл соответственно.
При росте массы тела пациента клиренс вещества увеличивался, однако данная методика расчета дозировки в крови пациентов с различной массой тела (от 34 до 162 кг ) приводила к равновесным терапевтическим концентрациям активного вещества препаратата.
Метаболизм активного вещества ниволумаб не изучен, но по причине идентичности структуры действующего вещества с человеческим моноклональным антителом IgG4, его метаболизм такой же как у эндогенного иммуноглобулина — преобразование в аминокислоты в каталитическом пути обмена белка.

 

Фармацевтические характеристики

Концентрат для изготовления раствора для инфузий опалесцирующий или прозрачный; от бесцветного до светло-желтого цвета.

Упаковка, срок годности, условия хранения

Фасовка препарата производится в прозрачные флаконы из стекла, с учетом объема 0.7 мл, это нужно для гарантии наличия полной дозировки. Количество активного вещества ниволумаб (объем раствора) в одном флаконе — 40 мг (4,0 мл) и 100 мг (10,0 мл) соответственно. Каждый флакон с инструкцией упакован в картонную коробку.

 

 

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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Работаем и отправляем Опдиво (Ниволумаб) по странам СНГ: Казахстан (Алматы и Нур-Султан), Россия, Украина,  Белоруссия, Узбекистан (Ташкент),
а также можем отправить Опдиво (Ниволумаб) по регионам Кыргызстана: Ош, Джалал-Абад, Каракол, Узген, Балыкчы и другие.

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