Описание
Препарат Газива относится к противоопухолевым средствам. Препарат Газива — это гуманизированное, рекомбинантное, моноклональное антитело II типа с модифицированным механизмом гликозилирования, обладающей специфичностью к CD20 рецетору. С действующим веществом — Обинутузумаб. Терапия обинутузумабом вызывает делецию NK-клеток у пациентов с хроническим лимфолейкозом. В доклинических исследованиях обинутузумаб показал более высокую противолейкемическую активность по сравнению с таковой у анти-CD20-антител — ритуксимаба и офатумумаба.
Состав
1 флакон содержит:
- действующее вещество: обинутузумаб – 1000 мг/ 40 мл, что соответствует концентрации 25 мг/мл до разведения.
- вспомогательные вещества: L-гистидин, L-гистидина гидрохлорида моногидрат, α,α-трегалозы дигидрат, полоксамер 188, вода для инъекций.
Показания к применению
Хронический лимфолейкоз;
в сочетании с хлорамбуцилом у лиц с нелеченным ранее хроническим лимфолейкозом;
Фолликулярная лимфома:
в сочетании с бендамустином и дальнейшей поддерживающей монотерапией препаратом Газива;
не ответивших на лечение ритуксимабом или на лечение по содержащей ритуксимаб, или у которых развилось прогрессирование заболевания во время или после такого лечения.
Фармакодинамика
Вещество избирательно взаимодействует с внеклеточным участком трансмембранного антигена CD20, расположенного на поверхности нормальных и злокачественных зрелых В-лимфоцитов и их предшественников. При этом обинутузумаб не взаимодействует с плазматическими клетками, со стволовыми гемопоэтическими клетками, про-В-лимфоцитами, а также другими нормальными тканями.
В результате изменения механизма гликозилирования Fc фрагмента, обинутузумаб характеризуется повышенным сродством к FcγRIII-рецепторам на поверхности эффекторных клеток иммунной системы (в частности натуральных киллеров, макрофагов и моноцитов) по сравнению с антителами, не прошедшими такую трансформацию.
Обинутузумаб непосредственно индуцирует антителозависимый клеточный фагоцитоз, апоптоз и опосредует антителозависимую клеточную цитотоксичность путем привлечения FcγRIII-положительных эффекторных клеток иммунной системы. Кроме того, препарат газива в меньшей степени индуцирует комплемент-зависимую цитотоксичность. По сравнению с анти-CD20 антителами I типа препарат (антитело II типа) характеризуется повышенной способностью к прямой индукции апоптоза на фоне пониженной способности вызывать комплемент-зависимую цитотоксичность. В результате трансформации механизма гликозилирования вещество очень эффективно индуцирует антителозависимую клеточную цитотоксичность и антителозависимый клеточный фагоцитоз (по сравнению с анти-CD20 антителами, не прошедшими такую модификацию), что проявляется в более выраженном истощении пула В-клеток и увеличенной противоопухолевой активности.
Истощение пула CD19+ В-клеток (до значений <0.07×109/л) наблюдалось у 91% пациентов с хроническим лимфолейкозом после окончания терапии обинутузумабом в сочетании с хлорамбуцилом и сохранялось в течение 6 месяцев.
Восстановление числа В-клеток происходило в течение 12-18 месяцев у 35% пациентов при отсутствии прогрессирования и у 13% пациентов с прогрессированием заболевания.
Иммуногенность
Тестирование на наличие антител к лекарственному препарату проводилось в различные временные периоды. У 10 из 146 лиц, получавших препарат Газива, были обнаружены антитела спустя 12 месяцев после завершения последнего курса терапии. У данных лиц не выявлено случаев анафилаксии или реакций гиперчувствительности, связанных с антителами или негативного влияния на клинический ответ.
У 2 пациентов с индолентной неходжкинской лимфомой из группы терапии препаратом Газива в сочетании с бендамустином и имевших положительные результаты при исходном определении антител человека к человеческим антителам (НАНА — HumanAnti-HumanAntibodies) проявились инфузионные реакции. Образование НАНА к препарату Газива во время или после его применения не наблюдалось.
Результаты анализа иммуногенности в значительной мере зависят от различных факторов, концентрации препарата Газива/антител в сыворотке крови, методологии проведения анализа, сопутствующих препаратов и характера основного заболевания. Вероятно, что сравнение частоты обнаружения антител к препарату Газива и частоты выявления антител к другим биологическим препаратам может оказаться неинформативным.
Фармакокинетика
Фармакокинетические характеристики обинутузумаба при его применении лицам с хроническим лимфолейкозом (ХЛЛ) приведены на основании фармакокинетической модели, с помощью которой был проведен анализ фармакокинетических показателей 678 лиц с неходжкинской лимфомой (НХЛ) и хроническим лимфолейкозом, участвовавших в исследованиях фаз I, II и III, где использовался обинутузумаб.
Всасывание
Обинутузумаб вводят внутривенно. Другие пути введения препарата не изучались. Рассчитанное значение медианы максимальной концентрации после инфузии в цикле 6, день 1 у пациентов с хроническим лимфолейкозом составило 465.7 мкг/мл, а значение кривой AUC за период применения составило 8961 мкг×д/мл и у пациентов с индолентной неходжкинской лимфомой (иНХЛ) — 539.3 мкг/мл и 10 956 мкг×д/мл соответственно.
Распределение
После в/в инфузии объем распределения в центральной камере составлял 2,72 литра и приблизительно был равен объему сыворотки. Согласно данным объема распределения обинутузумаба центральной камеры (2,76 л) при равновесном состоянии (Vss) приблизительно равен объему сыворотки, свидетельствует об ограниченности распределения, главным образом, распределение происходит в плазме и внеклеточной жидкости.
Метаболизм
Отдельных исследований метаболизма обинутузумаба не проводилось. Как и другие антитела, обинутузумаб преимущественно подвергается катаболизму.
Обинутузумаб — это моноклональное гуманизированное анти-СЭ20 антитело II типа подкласса IgGl, образованное путем гуманизации родительского B-Lyl антитела мыши и с помощью рекомбинантной ДНК-технологии клеточной линии яичников китайского хомячка. Метаболизм обинутузумаба непосредственно не изучался. Клиренс антител происходит в основном через катаболизм.
Выведение
Средний период полувыведения равен 30,3 суткам, а клиренс обинутузумаба во время шестого цикла у пациентов с ХЛЛ составляет приблизительно 0,083 л/суток. Элиминация препарата основана на модели динамически изменяющегося клиренса, проходящего параллельно двумя способами: линейный клиренс и нелинейный клиренс, который изменяется как функция от времени. На начальном этапе терапии преобладает нелинейный, клиренс, изменяющийся со временем. По мере продолжения терапии влияние данного пути клиренса уменьшается, и начинает преобладать линейный клиренс. Что свидетельствует о мишень-опосредованном распределении препарата, при котором первоначально большое число клеток белка CD20 приводит к быстрому снижению уровня обинутузумаба. Но в то же время, после того как большая часть клеток CD20 связывается с обинутузумабом, влияние мишень-опосредованного распределения на фармакокинетику препарата уменьшается.
Печеночная недостаточность
Не проводились формальные исследования фармакокинетики обинутузумаба у пациентов с печеночной недостаточностью.
Фармакокинетика у пожилых пациентов
Фармакокинетический популяционный анализ показал, что возраст на фармакокинетику обинутузумаба не влияет. Между пациентами в возрасте до 65 лет (n=265), 65-75 лет (n=197) и старше 75 лет (n=128) значительных различий в фармакокинетических показателях не наблюдалось.
Фармакокинетика у детей
Не проводились исследования по оценке фармакокинетических параметров обинутузумаба у детей.
Почечная недостаточность
Популяционный фармакокинетический анализ показал, что клиренс креатинина на фармакокинетику обинутузумаба не влияет. Фармакокинетика препарата у больных с легкой степенью почечной недостаточностью (клиренс креатинина 50-89 мл/мин, n=306) и средней степенью (клиренс креатинина 30-49 мл/мин, n=72) была сходной с фармакокинетикой обинутузумаба у больных с нормальной функцией почек (клиренс креатинина ≥ 90 мл/мин, n=207). Данные по фармакокинетике препарата у больных с тяжелой почечной недостаточностью (клиренс креатинина 15-29 мл/мин) ограничены (n=5), поэтому не существует определенных рекомендаций для данной категории пациентов.
Фармацевтические характеристики
Прозрачная или опалесцирующая жидкость от бесцветного дo слегка коричневатого цвета. Oдин флакон концентрата 40 мл содержит 1 000 мг обинутузумаба, что соответствует концентрации 25 мг/мл до разведения.
Упаковка, срок годности, условия хранения
По 40 мл препарата помещают во флаконы, изготовленные из бесцветного стекла (класс 1), укупоренные крышкой из бутилкаучука с покрытием из фтористого полимера и aлюминиевым колпачком и с пластиковой крышкой «flip-off». Oдин флакон вместе с инструкцией по применению помещен в пачку картонную.
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