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Арзерра — Arzerra (Офатумумаб)

Арзерра (Офатумумаб)

Арзерра — Arzerra (Офатумумаб)

Препарат Арзерра — современный противоопухолевый препарат, с действующим веществом — офатумумаб. Препарат Арзерра вызывает выраженный лизис клеток, сопровождающийся высоким уровнем экспрессии защитных белков комплемента. Кроме того, связывание вещества офатумумаба вызывает гибель клеток и по механизму антителозависимой клеточной цитотоксичности. Было также показано, что препарат Арзерра вызывает лизис клеток, устойчивых к ритуксимабу, а также лизис клеток как с высокой, так и с низкой экспрессией CD20. Связывание вещества офатумумаба с расположенным вблизи мембраны специфическим эпитопом молекулы CD20 на поверхности клетки вызывает связывание и активацию комплемента, что приводит к развитию цитотоксической комплемент-зависимой реакции и лизису клетки опухоли.

Категория:

Описание

Препарат Арзерра — современный противоопухолевый препарат, с действующим веществом — офатумумаб. Препарат Арзерра вызывает выраженный лизис клеток, сопровождающийся высоким уровнем экспрессии защитных белков комплемента. Кроме того, связывание вещества офатумумаба вызывает гибель клеток и по механизму антителозависимой клеточной цитотоксичности. Было также показано, что препарат Арзерра вызывает лизис клеток, устойчивых к ритуксимабу, а также лизис клеток как с высокой, так и с низкой экспрессией CD20. Связывание вещества офатумумаба с расположенным вблизи мембраны специфическим эпитопом молекулы CD20 на поверхности клетки вызывает связывание и активацию комплемента, что приводит к развитию цитотоксической комплемент-зависимой реакции и лизису клетки опухоли.

Состав Арзерра

1 мл препарата содержит:

  • активное вещество: офатумумаб 20,0 мг;
  • вспомогательные вещества: натрия ацетат тригидрат, динатрия эдетат, полисорбат 80, аргинин, натрия хлорид , хлористоводородная кислота, вода для инъекций.

Показания к применению Арзерра

  • Ранее нелеченный хронический лимфоцитарный лейкоз (ХЛЛ). Препарат Арзерра в комбинации с бендамустином или хлорамбуцилом показан для терапии пациентов с ХЛЛ, которые не получали предварительную терапию, и которые не подходят для лечения на основе флударабина.
  • Хронический лимфоцитарный лейкоз («рефрактерный ХЛЛ»). При котором лечение не поддается алемтузумабу или/и флударабину.

Фармакодинамика

Препарат Арзерра представляет собой человеческое моноклональное антитело (изотип иммуноглобулина G1), специфически связывающееся с эпитопом, включающего и малую, и большую внеклеточные петли молекулы CD20. Молекула CD20 — трансмембранный фосфопротеин, экспрессирующийся на В-лимфоцитах, начиная с пре-В клеток до зрелых В-лимфоцитов, а также на В-клеточных опухолевых клетках. В-клеточные опухоли запускают хронический лимфоцитарный лейкоз (ХЛЛ) (сопровождающийся более низкой степенью экспрессии CD20) и неходжкинские лимфомы (в > 90 % опухолей уровень экспрессии CD20 высокий). Молекула CD20 при связывании с антителом остается на мембране клетки, не поступает внутрь клетки (интернализация) и не удаляется с ее поверхности (шеддинг).

Содержание В-клеток в крови у пациентов с гематологическими опухолевыми заболеваниями снижалось уже после первого введения препарата Арзерра. У устойчивых к ранее проводимому лечению, пациентов с ХЛЛ, среднее снижение содержания В-клеток в крови после первого введения составляло 22 процента, а после восьмого еженедельного введения — 92 процента. Содержание В-клеток в крови у большинства больных оставалось низким на протяжении всего курса лечения и у пациентов, отвечающих на терапию, оставалось пониженным в течение почти 15 месяцев после последнего введения препарата.

У ранее не получавших лечение, пациентов с ХЛЛ, после первого цикла и до начала шестого медиана снижения числа В-лимфоцитов ежемесячного цикла составила 94 процента и > 99 процентов для офатумумаба в комбинации с хлорамбуцилом и 73 процента и 97 процентов при применении только хлорамбуцила. Через 6 месяцев после последнего введения препаратов медиана снижения числа В-лимфоцитов составила > 99 процентов для офатумумаба в комбинации с хлорамбуцилом и 94 процента при применении только хлорамбуцила.

Иммуногенность

Белковые препараты, подобные офатумумабу, могут вызывать иммунный ответ. Были исследованы, в рамках клинической программы изучения ХЛЛ образцы сыворотки крови, полученные от 440 пациентов, на предмет выработки антител к офатумумабу во время и после лечения в период от 4 до 45 недель (с помощью электрохемилюминесценции или твердофазного иммуноферментного анализа). после терапии офатумумабом, у пациентов с ХЛЛ, не было обнаружено антител к офатумумабу.

Клиническая эффективность и безопасность

Эффективность препарата Арзерра была оценена в двух клинических исследованиях у больных с ранее нелеченным ХЛЛ, которые считались неподходящими для лечения флударабином, и двух клинических исследованиях на пациентах с рецидивирующим и неподдающимся лечению ХЛЛ.

Фармакокинетика

Всасывание

Офатумумаб вводят путем внутривенной инфузии. Максимальные концентрации препарата Арзерра в сыворотке обычно наблюдались сразу после введения или к концу его. Были получены данные по фармакокинетике препарата на 215 пациентов с ХЛЛ, устойчивых к ранее проводимой терапии. Среднее геометрическое для максимальной концентрации в плазме крови (Сmах) после первой инфузии (300 мг) составило 61 мкг/мл, после восьмой еженедельной инфузии (седьмая инфузия в дозе 2000 мг) среднее геометрическое для Сmах было равно 1391 мкг/мл, а среднее геометрическое для площади под фармакокинетической кривой зависимости «концентрация-время» (AUQ) составило 463,418 мкг-ч/мл; после двенадцатой инфузии (четвертая ежемесячная инфузия в дозе 2000 мг) среднее геометрическое для Сmах было равно 827 мкг/мл, а среднее геометрическое для AUC составило 203,536 мкг∙ч/мл. У ранее не получавших терапию, пациентов с ХЛЛ, после лечения офатумумабом и хлорамбуцилом, средние геометрические значения максимальной концентрации (Сmах) после первого введения (300 мг), на 8 день введения 1000 мг, и в четвертом ежемесячном цикле введения 1000 мг составили, соответственно, 52 мкг/мл, 241 мкг/мл, 285 мкг/мл. Средние геометрические значения AUQ в четвертом ежемесячном цикле составили 65,100 мкг∙ч/мл.

Распределение

Объем распределения офатумумаба невелик. В стационарном состоянии (ОРсс) среднее значение объема распределения в зависимости от дозы, номера введения и в разных исследованиях варьировало от 1,7 литра до 8,1 литров.

Метаболизм

Офатумумаб — это белок, у которого основной путь метаболизма состоит в разрушении до пептидов и отдельных аминокислот протеолитическими ферментами. Поэтому исследования биотрансформации препарата не проводились.

Выведение Арзерра

Препарат Арзерра выводится из организма двумя путями: не связанным с мишенью, как и все прочие молекулы иммуноглобулинаG, и обусловленным взаимодействием с мишенью, а именно взаимодействием с В-клетками. Уже после первого введения препарата Арзерра наблюдается быстрое и стойкое снижение числа CD20+ В-клеток. При дальнейших введениях препарата Арзерра, он будет взаимодействовать уже со значительно меньшим количеством CD20+ клеток. В следствии при последующих инфузиях офатумумаба значения его клиренса будут ниже, а величина периода полувыведения (t1/2) — существенно выше, чем при первом его введении. При повторных еженедельных введениях значения фармакокинетической кривой зависимости «концентрация-время» (AUC) и максимальная концентрация (Сmах) увеличивались в большей степени, чем это ожидалось для рассчитанного на основе данных, предполагаемого накопления офатумумаба, полученных при его первой инфузии.

Особые группы пациентов

Пациенты пожилого возраста (65 лет и старше)

У пациентов в возрасте от 21 года до 87 лет в разных исследованиях, как было показано при перекрестном популяционном анализе фармакокинетики, на фармакокинетику офатумумаба возраст не оказывал существенного влияния.

Дети и подростки (до 18 лет включительно)

Не исследовались эффективность и безопасность препарата Арзерра у детей младше 18 лет.

Пол

Было показано при перекрестном анализе, что пол оказывал умеренное влияние (12 процентов) на центральный объем распределения препарата Арзерра — у женщин кривая зависимости «концентрация-время» (AUC) и максимальная концентрация (Сmах) были выше (в анализируемой группе 48 процентов пациентов были мужчинами и 52 процента — женщинами). Данные различия были сочтены, как не имеющими клинического значения, поэтому не рекомендуется корректировать дозу в зависимости от пола пациента.

Пациенты с нарушением функции почек

У больных с показателями клиренса креатинина, изменяемыми в диапазоне от 26 до 287 мл/мин, при перекрестном популяционном анализе было показано отсутствие значимой взаимосвязи между значением клиренса креатинина, определенным до введения препарата Арзерра, и фармакокинетикой последнего. Не рекомендуется корректировать дозу препарата для пациентов с легкой или средней степенью нарушения функции почек (клиренс креатинина > 30 мл/мин). Данные по фармакокинетике офатумумаба для пациентов с тяжелой степенью нарушения функции почек (клиренс креатинина < 30 мл/мин) ограничены.

Пациенты с нарушением функции печени

Не проводились специальные исследования по изучению влияния нарушений функции печени. Поскольку препарата Арзерра, как и все прочие молекулы иммуноглобулинаGl, катаболизируются протеолитическими ферментами, тканями печени, которых распространенность не ограничена, то считается, что нарушения функции печени не могут оказать какое-либо существенное влияние на скорость выведения препарата Арзерра из организма.

Фармацевтические характеристики

Концентрат для приготовления раствора для в/в инфузий 20 мг/мл, 100 мг или 1000 мг. В виде прозрачной или опалесцирующей, бесцветной или бледно-желтого цвета жидкости. После фильтрации через прилагаемый встроенный фильтр с диаметром пор 0.2 мкм должны отсутствовать видимые частицы.

Упаковка, срок годности, условия хранения Арзерра

По 5 мл или 50 мл концентрата помещают в прозрачный стеклянный флакон типа I, закупоренный бромбутиловой резиновой пробкой, алюминиевой обкаткой и полипропиленовым колпачком типа флипп-оф.

По 3 флакона, содержащих по 5 мл концентрата, в комплекте с двумя инфузионными системами со встроенными фильтрами с диаметром пор 0,2 мкм. Весь комплект помещен в пакет. Вместе с инструкцией по применению все упаковано в пачку картонную.

По одному флакону, содержащему 50 мл концентрата, в комплекте с двумя инфузионными системами со встроенными фильтрами с диаметром пор 0,2 мкм, помещенными в пакет. Вместе с инструкцией по применению все упаковано в пачку картонную.

Хранить в защищенном от света месте при температуре от 2 °С до 8 °С. Не замораживать. Хранить в недоступном для детей месте.

Срок годности 3 года. Не применять после истечения срока годности, указанного на упаковке.

 

 

 

 

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

 

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