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Иларис — Ilaris (Канакинумаб) 150 мг

Иларис (канакинумаб) 150мг Ilaris 150mg

Иларис — Ilaris (Канакинумаб) 150 мг

Иларис (канакинумаб) эффективно при лечении аутовоспалительных синдромов периодической лихорадки. Отпускается в виде лиофилизированного порошка белого цвета c прозрачным бесцветным растворителем в дозировке 150 миллиграмм.

Категория:

Описание

Иларис (Канакинумаб) — лиофилизированный порошок белого цвета c прозрачным бесцветным растворителем для приготовления раствора и подкожного введения. Средство – иммунодепрессивного действия (антитела моноклональные к интерлейкину-1ß).

Состав препарата

Один флакон лиофилизата для приготовления раствора подкожного применения содержит:

  • активное вещество: канакинумаб 150 мг,
  • вспомогательные вещества: L-гистидин 3,186 мг, полисорбат-80 0,60 мг, L-гистидина гидрохлорид моногидрат 1,983 мг, сахароза 92,38 мг, кислота хлористоводородная 0,1 М для рН 6,5.

Если предполагается наличие растворителя, то один флакон растворителя включает: вода для инъекций 5 мл.

Фармакокинетика

У больных в возрасте с различными фенотипами CAPS после одного подкожного введения 150 мг препарата период достижения максимальной концентрации (Сmах) активного вещества составило около семи дней. Средний конечный период полувыведения равен 26-ти дням. При подкожном введении вещества абсолютная биодоступность составила около 60% при популяционном фармакокинетическом анализе. Клиренс — Сl, а также объем распределения — Vss вещества изменяются в зависимости от массы тела пациента. Для больных с разными фенотипами CAPS эти уровни составляют 0.17 л/сутки и 6.01 литра для типичного пациента с массой тела 70 кг. Для пациентов с подагрическим артритом и весом 93 кг С1 = 0,23 л/сут, а Vss равен  7,76  литра.  Также не  было  установлено существенной  разницы  в фармакокинетических свойствах вещества для пациентов с подагрическим артритом и  различными фенотипами CAPS. При подкожном введении препарата на протяжении шести месяцев в дозе 150 мг каждые 8 недель коэффициент кумуляции активного вещества составил 1.3, а каждые двенадцать недель — 1,1.

Параметры фармакокинетики, такие как Сmах и AUC (площадь под кривой «концентрация — время») увеличиваются пропорционально дозе в диапазоне от 0.30 до 10.0 мг/кг при при подкожном введении (в дозе от 150 до 300 мг) или внутривенной инфузии. При последующем применении препарата не наблюдается увеличения С1, а также каких-либо других изменений, зависящих от времени приема. Назначение с учетом пола, массы тела или возраста больного не оказывает влияние на фармакокинетику препарата Иларис.

Фармакодинамика

Вещество Канакинумаб — это полностью человеческое моноклональное антитело IgGl/каппа изотипа к интерлейкину-1ß (ИЛ-1ß), которое с высоким аффинитетом связывается с человеческим ИЛ-1ß, тем самым нейтрализуя его биологическое действие и блокируя взаимодействие ИЛ-1β с его рецепторами, а также ИЛ-1β-индуцированную активацию генов и воспроизведение медиаторов воспаления, таких как циклооксигеназа-2 и ИЛ-6.

При лечении больных с сЮИА (системным ювенильным идиопатическим артритом) отмечалось быстрое и продолжительное улучшение суставных и системных проявлений болезни: значительное уменьшение количества воспаленных суставов, быстрое исчезновение лихорадки и уменьшение реактантов острой фазы у большинства больных.

У 33 процентов пациентов на 29 день терапии было замечено улучшение течения болезни на 106% по педиатрическим критериям Американской коллегии реаниматологов в сравнении с полным отсутствием эффекта в группе плацебо. Использование канакинумаба позволяет значительно снизить или полностью отменить использование глюкокортикостероидов при терапии сЮИА. Препарат позволяет удлинить временной период до обострения заболевания, а также улучшить качество жизни пациентов и выполнение ими ежедневных задач в период заболевания.

У больных с различными фенотипами криопирин-ассоциированного периодического синдрома и подагрическим артритом, включая семейный холодовой аутовоспалительный синдром и Синдром Макл-Уэльса, а также мультисистемное младенческое воспалительное заболевание/хронический младенческий неврологический кожно-артикулярный синдром, препарат снижает выраженность системных воспалительных и местных реакций, вызываемых избыточной ИЛ-10 продукцией.

При использовании препарата у пациентов с острым приступом подагрического артрита снижается концентрация воспалительных лабораторных маркеров, а также в течение короткого времени уходят признаки воспаления пораженных суставов (отек, покраснение и боль). Также у больных, которые получали лечение Иларисом уменьшается частота возникновения приступов подагрического артрита. Эффективность Илариса при подагрическом артрите была сопоставима у пациентов в различном возрасте до 65 лет и более 65. При применении активного вещества у больных с различными фенотипами CAPS отмечается снижение уже в течение первых суток таких проявлений заболевания как: повышенной утомляемости, слабости, лихорадки, артралгии, кожной сыпи, головной боли/мигрени, миалгии, конъюнктивита, а также уменьшение (за несколько дней) продукции маркеров воспаления, таких как СРБ и САА, что приводит к нормализации количества лейкоцитов и тромбоцитов при их повышенном уровне.

В случае продолжительного применения канакинумаба, на протяжении 48 недель, полноценный ответ на терапию, определяемый как совместное уменьшение (до минимальной степени или полного исчезновения) симптомов аутовоспалительного заболевания, а также поражения кожи (сыпь по типу крапивницы),  и снижения уровней СРБ и САА менее 10 мг/л, наблюдался в 97 процентах случаев в течение семи дней после начала приема препарата. При использовании препарата у пациентов не отмечалось развития рецидивов болезни ( тогда как в группе  больных,  не  получивших  лечение  препаратом, рецидивы наблюдались у 81-ого процента наблюдаемых).

Показания к применению препарата Иларис

Иларис при остром подагрическом артрите:

Лечение острых приступов подагрического артрита, а также предупреждение развития новых приступов при неэффективности или непереносимости, а также при наличии противопоказаний к применению колхицина и/или нестероидных противовоспалительных препаратов.

Иларис при криопирин-ассоциированном периодическом синдроме (CAPS) у взрослых и детей в возрасте до 2 лет и старше, включая:

  • Синдром Макл-Уэльса (MWS).
  • FCU (Семейная холодовая крапивница) или FCAS (Семейный холодовой аутовоспалительный синдром).
  • У детей в возрасте до 2 лет и старше при активной фазе сЮИА (системного ювенильного идиопатического артрита) .
  • CINCA (Хронический младенческий неврологический кожно-артикулярный синдром) / NOMID (Младенческое мультисистемное воспалительное заболевание)/.

Условия хранения и срок годности

Препарат необходимо хранить при температуре от 2 до 8 °С в защищенном от света  и детей месте. Также его нельзя замораживать.
Срок годности три года. По истечении срока годности не применять.

 

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

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