Угрожающий жизни острый респираторный дистресс-синдром, сопровождающийся повышенным высвобождением цитокинов.
Фармакологические свойства
Левилимаб – рекомбинантное человеческое моноклональное антитело к рецептору интерлейкина-6 (ИЛ-6). Левилимаб связывается и блокирует как растворимые (рИЛР), так и мембранные рецепторы ИЛ-6 (мИЛ6Р).
Блокада обеих форм рецептора позволяет предотвратить развитие ИЛ-6-ассоциированного провоспалительного каскада, в том числе препятствует активации антигенпрезентирующих клеток, В- и Т-лимфоцитов, моноцитов и макрофагов, эндотелиальных клеток и фибробластов, и избыточной продукции других провоспалительных цитокинов.
ИЛ-6 участвует в активации и поддержании местных воспалительных реакций (образование паннуса в синовии, стимуляция остеокластогенеза – эрозии хрящевой ткани, остеопороз), кроме того ИЛ-6 – единственный цитокин, непосредственно индуцирующий синтез острофазовых белков в гепатоцитах: СРБ, фибриногена, сывороточного амилоидного белка А – SAA, гипсидина, лептина.
Специфическая противовоспалительная активность левилимаба продемонстрирована в тестах in vitro и in vivo. Левилимаб оказывает антипролиферативное действие на культуру клеток DS-1, вызывая дозозависимое ингибирование роста клеток.
На модели коллаген-индуцированного артрита у яванских макак (Масаса fascicularis) многократное (один раз в неделю в течение 7-ми недель) подкожное введение левилимаба сопровождается снижением выраженности воспалительной реакции в суставах, что подтверждено при гистологическом исследовании (значимое снижение выраженности воспалительных и дегенеративных изменений хрящевой ткани).
Кроме того ИЛ-6 является ключевым цитокином в развитии массивного высвобождения цитокинов («цитокинового шторма») у пациентов, получающих иммуносупрессивную терапию включая деплецирующие агенты (в частности моноклональные антитела к рецепторам Т- и В-лимфоцитов), а также в формировании острого респираторного дистресс-синдрома при тяжелых инфекционных заболеваниях, в том числе у пациентов с COVID-19.
Динамика фармакодинамических маркеров (нарастание концентрации рИЛ6Р, насыщение мИЛ6Р, нарастание ИЛ-6 и снижение концентрации СРБ) свидетельствует о высокоэффективной нейтрализации рецепторов ИЛ-6 препаратом левилимаб, что в свою очередь проявляется быстрым и выраженным снижением сывороточной концентрации СРБ, отражающим эффективное подавление воспалительного процесса у пациентов с активным ревматоидным артритом.
Противопоказания
Гиперчувствительность к левилимабу, а также к любому из вспомогательных веществ препарата.
Клинически значимые бактериальные инфекции в острой фазе, включая туберкулез.
Детский и подростковый возраст до 18 лет.
Беременность, грудное вскармливание.
Печеночная недостаточность тяжелой степени тяжести (класс С по классификации Чайлд-Пью. Почечная недостаточность тяжелой и терминальной степени тяжести (СКФ <30 мл/мин).
Способ применения и дозы
Применение препарата ИЛСИРА® должно осуществляться под наблюдением врачей.
Рекомендуемая доза препарат ИЛСИРА® составляет 324 мг однократно в виде двух подкожных инъекций по 162 мг каждая.
Подготовка к проведению подкожной инъекции
Тщательно вымойте руки.
Извлеките упаковку со шприцем из холодильника. Затем извлеките шприц с лекарственным препаратом из картонной пачки. Осмотрите шприц, а также лекарственный препарат, находящийся в нем. Нельзя использовать шприц в случае:
помутнения раствора, наличия в препарате посторонних видимых частиц;
изменения цвета;
повреждения любых частей шприца;
истечения срока годности (годен до…), указанного на картонной пачке, а также на этикетке шприца.
Оставьте шприц при комнатной температуре приблизительно на 25-30 минут. Не следует согревать шприц с препаратом каким-либо другим способом.
Подготовьте спиртовую салфетку/ватный тампон.
На данном этапе не следует снимать колпачок шприца
Техника выполнения подкожной инъекции препарата ИЛСИРА® в преднаполненном шприце
Выберите место инъекции (передняя брюшная стенка (отступая не менее 5 см от пупка), передняя и боковая поверхность бедра или средняя треть наружной части плеча.
Места инъекций и стороны следует менять с каждой последующей процедурой инъекции.
Нельзя вводить препарат в место на коже, где имеется болезненность, покраснение, уплотнение или кровоподтек. Эти признаки могут указывать на наличие инфекции.
Место укола необходимо обработать спиртовой салфеткой круговыми движениями.
Шприц не встряхивать.
Снимите колпачок с иглы, не дотрагиваясь до иглы и избегая прикосновения к другим поверхностям;
Одной рукой возьмите в складку обработанную кожу.
В другую руку возьмите шприц, держа его градуированной поверхностью вверх. Введение препарата необходимо осуществлять под углом 45 или 90 градусов к поверхности кожи в зависимости от толщины кожи и выраженности подкожно-жирового слоя (у худощавых пациентов введение препарата осуществляется под углом 45 градусов, у пациентов с толщиной кожной складки более 1,5 см допустимо введение под углом 90 градусов).
Одним быстрым движением полностью введите иглу в кожную складку.
После введения иглы отпустите складку кожи.
Введите весь раствор медленным постоянным надавливанием на поршень шприца в течение 2-5 секунд.
Когда шприц будет пустым, выньте иглу из кожи под тем же углом.
Кусочком марли слегка прижмите область инъекции в течение 10 секунд, но ни в коем случае не трите поверхность. Из места инъекции может выделиться небольшое количество крови. При желании можно воспользоваться пластырем.
После инъекции шприц повторно не использовать.
Для описания товара использована информация от партнера 36.6
Мобильное приложение «Все аптеки»
Начните сравнивать цены и заказывать лекарства прямо в приложении
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Информация предоставляется в справочных целях. Не занимайтесь самолечением. При первых признаках заболевания обратитесь к врачу.
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Левилимаб связывается и блокирует как растворимые (рИЛР), так и мембранные рецепторы ИЛ-6 (мИЛ6Р). "}},{"type":"paragraph","data":{"text":"Блокада обеих форм рецептора позволяет предотвратить развитие ИЛ-6-ассоциированного провоспалительного каскада, в том числе препятствует активации антигенпрезентирующих клеток, В- и Т-лимфоцитов, моноцитов и макрофагов, эндотелиальных клеток и фибробластов, и избыточной продукции других провоспалительных цитокинов. "}},{"type":"paragraph","data":{"text":"ИЛ-6 участвует в активации и поддержании местных воспалительных реакций (образование паннуса в синовии, стимуляция остеокластогенеза – эрозии хрящевой ткани, остеопороз), кроме того ИЛ-6 – единственный цитокин, непосредственно индуцирующий синтез острофазовых белков в гепатоцитах: СРБ, фибриногена, сывороточного амилоидного белка А – SAA, гипсидина, лептина."}},{"type":"paragraph","data":{"text":"Специфическая противовоспалительная активность левилимаба продемонстрирована в тестах in vitro и in vivo. Левилимаб оказывает антипролиферативное действие на культуру клеток DS-1, вызывая дозозависимое ингибирование роста клеток. "}},{"type":"paragraph","data":{"text":"На модели коллаген-индуцированного артрита у яванских макак (Масаса fascicularis) многократное (один раз в неделю в течение 7-ми недель) подкожное введение левилимаба сопровождается снижением выраженности воспалительной реакции в суставах, что подтверждено при гистологическом исследовании (значимое снижение выраженности воспалительных и дегенеративных изменений хрящевой ткани). "}},{"type":"paragraph","data":{"text":"Кроме того ИЛ-6 является ключевым цитокином в развитии массивного высвобождения цитокинов («цитокинового шторма») у пациентов, получающих иммуносупрессивную терапию включая деплецирующие агенты (в частности моноклональные антитела к рецепторам Т- и В-лимфоцитов), а также в формировании острого респираторного дистресс-синдрома при тяжелых инфекционных заболеваниях, в том числе у пациентов с COVID-19."}},{"type":"paragraph","data":{"text":"Динамика фармакодинамических маркеров (нарастание концентрации рИЛ6Р, насыщение мИЛ6Р, нарастание ИЛ-6 и снижение концентрации СРБ) свидетельствует о высокоэффективной нейтрализации рецепторов ИЛ-6 препаратом левилимаб, что в свою очередь проявляется быстрым и выраженным снижением сывороточной концентрации СРБ, отражающим эффективное подавление воспалительного процесса у пациентов с активным ревматоидным артритом."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"list","data":{"style":"ordered","items":["Гиперчувствительность к левилимабу, а также к любому из вспомогательных веществ препарата.","Клинически значимые бактериальные инфекции в острой фазе, включая туберкулез.","Детский и подростковый возраст до 18 лет.","Беременность, грудное вскармливание.","Печеночная недостаточность тяжелой степени тяжести (класс С по классификации Чайлд-Пью. 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Нельзя использовать шприц в случае:"}},{"type":"list","data":{"style":"ordered","items":["помутнения раствора, наличия в препарате посторонних видимых частиц;","изменения цвета;","повреждения любых частей шприца;","истечения срока годности (годен до…), указанного на картонной пачке, а также на этикетке шприца."]}},{"type":"paragraph","data":{"text":"Оставьте шприц при комнатной температуре приблизительно на 25-30 минут. Не следует согревать шприц с препаратом каким-либо другим способом."}},{"type":"paragraph","data":{"text":"Подготовьте спиртовую салфетку/ватный тампон."}},{"type":"paragraph","data":{"text":"На данном этапе не следует снимать колпачок шприца"}},{"type":"paragraph","data":{"text":"Техника выполнения подкожной инъекции препарата ИЛСИРА® в преднаполненном шприце"}},{"type":"list","data":{"style":"ordered","items":["Выберите место инъекции (передняя брюшная стенка (отступая не менее 5 см от пупка), передняя и боковая поверхность бедра или средняя треть наружной части плеча."]}},{"type":"paragraph","data":{"text":"Места инъекций и стороны следует менять с каждой последующей процедурой инъекции."}},{"type":"paragraph","data":{"text":"Нельзя вводить препарат в место на коже, где имеется болезненность, покраснение, уплотнение или кровоподтек. Эти признаки могут указывать на наличие инфекции."}},{"type":"paragraph","data":{"text":"Место укола необходимо обработать спиртовой салфеткой круговыми движениями."}},{"type":"paragraph","data":{"text":"Шприц не встряхивать."}},{"type":"paragraph","data":{"text":"Снимите колпачок с иглы, не дотрагиваясь до иглы и избегая прикосновения к другим поверхностям;"}},{"type":"paragraph","data":{"text":"Одной рукой возьмите в складку обработанную кожу."}},{"type":"paragraph","data":{"text":"В другую руку возьмите шприц, держа его градуированной поверхностью вверх. Введение препарата необходимо осуществлять под углом 45 или 90 градусов к поверхности кожи в зависимости от толщины кожи и выраженности подкожно-жирового слоя (у худощавых пациентов введение препарата осуществляется под углом 45 градусов, у пациентов с толщиной кожной складки более 1,5 см допустимо введение под углом 90 градусов)."}},{"type":"paragraph","data":{"text":"Одним быстрым движением полностью введите иглу в кожную складку."}},{"type":"paragraph","data":{"text":"После введения иглы отпустите складку кожи."}},{"type":"paragraph","data":{"text":"Введите весь раствор медленным постоянным надавливанием на поршень шприца в течение 2-5 секунд."}},{"type":"list","data":{"style":"ordered","items":["Когда шприц будет пустым, выньте иглу из кожи под тем же углом.","Кусочком марли слегка прижмите область инъекции в течение 10 секунд, но ни в коем случае не трите поверхность. Из места инъекции может выделиться небольшое количество крови. При желании можно воспользоваться пластырем."]}},{"type":"paragraph","data":{"text":"После инъекции шприц повторно не использовать."}}]}],"source":null},"description_toggle":false,"short_description":"Левилимаб – рекомбинантное человеческое моноклональное антитело к рецептору интерлейкина-6 (ИЛ-6). Левилимаб связывается и блокирует как растворимые (рИЛР), так и мембранные рецепторы ИЛ-6 (мИЛ6Р). Блокада обеих форм рецептора позволяет предотвратить развитие ИЛ-6-ассоциированного провоспалительного каскада, в том числе препятствует активации антигенпрезентирующих клеток, В- и Т-лимфоцитов, моноцитов и макрофагов, эндотелиальных клеток и фибробластов, и избыточной продукции других провоспалительных цитокинов. 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Кроме того ИЛ-6 является ключевым цитокином в развитии массивного высвобождения цитокинов («цитокинового шторма») у пациентов, получающих иммуносупрессивную терапию включая деплецирующие агенты (в частности моноклональные антитела к рецепторам Т- и В-лимфоцитов), а также в формировании острого респираторного дистресс-синдрома при тяжелых инфекционных заболеваниях, в том числе у пациентов с COVID-19. 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