Описание
Компания Medical&Pharma предлагает одно из современных противоревматических лекарств — Ксельянз (Тофацитиниб). С действующим веществом Тофацитиниб. Ксельянз – это первое противоревматическое лекарство в новом классе лекарственных средств, известных как ингибиторы ферментов Янус-киназы (играющих ключевую роль в развитии воспалительного процесса, лежащего в основе ревматоидного артрита), и первый новый пероральный противоревматический препарат БПВП за последние 10 лет. Он одобрен в качестве второй линии терапии ревматоидного артрита. Что означает, что не требуется применение биологических препаратов до назначения Ксельянз.
Янус-киназы — это внутриклеточные ферменты, передающие сигналы, возникающие при взаимодействиях рецептора фактора роста или цитокина на клеточной мембране, для влияния на работу клеток иммунной системы и клеточные процессы кроветворения. Ферменты Янус-киназы фосфорилируют и активаторы транскрипции и активируют сигнальные трансдукторы, которые модулируют внутриклеточную активность, включая экспрессию генов. Тофацитиниб модулирует путь прохождения сигнала, начиная с Янус-киназы, и предотвращает фосфориляции и активации сигнальных трансдукторов и активаторов транскрипции.
Состав
- В составе одной таблетки содержится активный компонент тофацитиниб (5 мг).
- Дополнительные компоненты: целлюлоза микрокристаллическая, натрия кроскармеллоза, лактоза, магния стеарат.
- Состав оболочки: белый Опадрай II (гидроксипропилметилцеллюлоза 2910/гипромеллоза 6cP, титана диоксид, триацетат глицерина, лактозы моногидрат, макрогол/ПЭГ 3350).
Показания к применению
Лечение ревматоидного артрита у взрослых пациентов умеренно выраженной и тяжелой активной степени, с недостаточным ответом на метотрексат или в случае его непереносимости (в качестве монотерапии, а также в сочетании с метотрексатом или другими небиологическими противоревматическими препаратами.
Не рекомендуется применять Ксельжанс в сочетании с биологическими противоревматическими препаратами или с мощными иммунодепрессантами, такими как азатиоприн и циклоспорин.
Фармакодинамика
Лечение тофацитинибом сопровождалось дозозависимым снижением циркулирующих естественных киллеров CD16 / 56 +; максимальное расчетное снижение достигается спустя 8-10 недель от начала терапевтического лечения. В целом после прекращения терапии такие изменения исчезают через 2-6 недель. Лечение препаратом Ксельянз сопровождалось дозозависимым увеличением количества B-лимфоцитов. Изменения количества T-лимфоцитов и подгрупп T-лимфоцитов (CD3 +, CD4 + и CD8 +) были незначительными и непостоянными. Клиническое значение этих изменений неизвестно.
У пациентов с ревматоидным артритом после 6 месяцев применения тофацитинибу, общий уровень иммуноглобулинов IgG, IgM и IgA в сыворотке крови был ниже, чем в группе плацебо. Однако эти изменения не зависели от дозы и были незначительными.
После лечения тофацитинибом наблюдалось быстрое снижение уровня C-реактивного белка в сыворотке у пациентов с ревматоидным артритом, которое хранилось в течение всего лечения.
Фармакокинетика.
При пероральном применения тофацитиниба пиковые концентрации в плазме крови достигаются в течение 0,5-1 часа, повышение системной экспозиции пропорциональное дозе в пределах терапевтических доз, а период полувыведения составляет примерно 3:00. После применения дважды в день достигаются равновесные концентрации в течение 24-48 часов с незначительным накоплением.
Абсорбция.
Биодоступность тофацитинибу при пероральном применении составляет 74%. Применение тофацитинибу с приемом очень жирной пищитснижает C max на 32%, но не влияет на AUC. В ходе клинических исследований тофацитинибу применяли независимо от приема пищи.
Распределение.
После внутривенного применения объем распределения составляет 87 л. Примерно 40% тофацитинибу связывается с белками. Тофацитиниб связывается в основном с альбумином и, возможно, не связывается с α1-кислым гликопротеином. Тофацитиниб одинаково распределяется между эритроцитами и плазмой.
Метаболизм и выведение.
Клиренс тофацитинибу примерно на 70% происходит путем метаболизма в печени и на 30% путем выделения почками в виде неизмененной соединения. Метаболизм тофацитинибу осуществляется преимущественно изоферментами CYP3A4 с участием CYP2C19. В ходе исследований тофацитинибу, меченого радиоактивным изотопом, у пациентов более 65% общей циркулирующей радиоактивности приходилось на неизмененный тофацитиниб, а остальные 35% — на 8 метаболитов, общая радиоактивность каждого из которых составляла менее 8%. Фармакологическая активность связана с неизмененным тофацитинибом.
Фармакокинетика у пациентов с ревматоидным артритом.
Исследования фармакокинетики у больных с ревматоидным артритом показали, что нет клинически значимых изменений уровня экспозиции тофацитинибу в зависимости от пола, возраста, состояния функции почек (то есть клиренса креатинина), этнической группы и массы тела.
Фармацевтические характеристики
Препарат Ксельянз производят в виде таблеток, покрытых оболочкой белого цвета, с надписью «JKI5″на одной стороне, «Pfizer» — на другой.
Упаковка, срок годности,
условия хранения
Упаковка: в пачке из картона:
- флакон по 28 или 60 таблеток,
- 1 или 4 блистера по 14 таблеток в каждом.
Хранить препарат следует в сухом месте без попадания влаги и солнечных лучей. В недоступном для детей месте, в оригинальной упаковке и при температуре до +30°С.
Срок годности составляет 36 месяцев.
Наша компания работает как на территории Казахстана, так и осуществляет доставку в страны ближнего зарубежья. Обращайтесь к нам за консультациями по контактным телефонам.
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