Описание
Зеджула — современный противоопухолевый препарат. Недавно FDA одобрило дополнительное показание к применению препарата Зеджула, разрешив его использование у женщин, страдающих рецидивирующим раком яичника.
Зеджула – это современный препарат с цитостатическим эффектом. Его назначают для препятствия распространению и развитию раковых клеток в организме. Действующим активным компонентом является Нирапариб. Нирапариб — это ингибитор PARP нового поколения для перорального приема, вещество, блокирующее ферменты PARP-1, PARP-2 и восстанавливающее поврежденные ДНК. Нирапариб же способен продлевать жизнь пациенткам независимо от статуса мутации BRCA. Этo большой шаг вперед, потому чтo действенное лекарство теперь могут применять гораздо больше больных раком яичников. Действие препарата направлено на поддержание стабильного состояния больного и предотвращение рецидива некоторых видов онкологических заболеваний. К таким относят рак:
- яичников;
- фаллопиевых труб;
- брюшной полости, покрывающей некоторые внутренние органы.
Медикамент для лечения назначается по окончании химиотерапии при положительной реакции организма.
Препарат Зеджула представляет собой пероральный ингибитор поли (АДФ-рибоза) полимеразы (poly (ADP-ribose) polymerase — PARP). Первоначально препарат был зарегистрирован для паллиативной терапии взрослых пациентов с рецидивирующим эпителиальным раком яичников и фаллопиевых труб, a также первичным раком брюшины, которые ранее прошли не менее трех курсов химиотераптического лечения. Зеджула – это действенный ингибитор PARP, который создан для терапии при раке яичников, молочной железы и злокачественных опухолей мaточных труб.
Показанием для расширения показаний к использованию препарата Зеджула (нирапариб) явились результаты многоцентрового клинического исследования II фазы. данная программа клинических исследований лекарства содержала в себя проведение клинического исследования III фазы в качестве поддерживающей монотерапии у больных с раком яичников первой линии, исследования III фазы в качестве поддерживающей терапии первой линии при раке яичников, а также исследования II фазы в сочетании с поддерживающим лечением бевацизумабом при распространенном раке яичникoв.
В 2017 году препарат был одобрен FDA США для лечения второй линии взрослых женщин с раком яичников, маточных труб и брюшины. Изначально препарат использовался исключительно в качестве дополнительной терапии после курса химиотерапии или совместно с ним.
Состав
- Действующее вещество: Нирапариб (Niraparib).
Показания к применению
- показано пациентам с серозной карциномой яичников при рецидиве,
- показано пациентам, кому требуется поддерживающая монотерапия. Сюда относятся и пациенты с онкологией фаллопиевых труб, если был отмечен полный или частичный ответ на платиновое химиотерапевтическое.
Фармакокинетика
Зеджула (Нирапариб) представляет группу противоопухолевых средств с цитостатическим эффектом. Активное вещество Нирапариб вызывает блокировку ферментов PARP-1 и PARP-2, которые, как правило, принимают участие в репарации поврежденной ДНК. Ингибирование ферментов PARP приводит к тому, что поврежденная ДНК в раковой клетке не может регенерировать, а следовательно происходит ее гибель. Использование средства Зеджула позволяет сократить или полностью остановить рост опухоли.
При однократном приеме капсул Зеджула натощак основное действующее вещество поступало в плазму спустя 30 минут. Достижение пиковой концентрации происходит примерно через 3 часа. Абсолютная биодоступность вещества Нирапариб составляет приблизительно 73процента. Прием высококалорийной пищи с высоким содержанием жиров не оказывает особого влияния на фармакокинетику препарата. Нирапариб умеренно связывается с белками в плазме человека (83,0%), преимущественно с сывороточным альбумином.
Лечение ведется строго под наблюдением врача, имеющего опыт использования противоопухолевых лекарств. Капсулы необходимо проглатывать целиком, запивая обильно водой. Не рекомендуется разжевывать или открывать. Употребление средства никак не связано с режимом питания пациента.
Суточная доза Зеджула составляет 300 мг или 3 капсулы по 100 мг для пациентов, которые весят более 58 кг. При меньшем весе назначается для начала 200 мг. Рекомендуется принимать препарат в одно время на ежедневной основе – желательно перед сном. Терапия продолжается до прогрессирования болезни. При пропуске дозы, следует принять следующую, как и положено.
Фармакодинамика
Зеджула разработан для лечения рака яичников, рака молочной железы, лечит перитонеальный рак и злокачественные опухоли фаллопиевых труб, он является активным и мощным ингибитором PARP, это активная и сильнодействующая полимеразой (АДФ-рибоза).
Основываясь на результатах исследований Зеджула рекомендуется принимать в дозе 300 мг один раз в сутки. Механизм действия препарата заключается в том, что PARP — это семейство белков, участвующих во многих функциях в клетке, включая репарацию ДНК, экспрессию генов, контроль клеточного цикла, энергетический обмен ивнутриклеточный перенос. Белки PARP играют ключевую роль в восстановлении эксцизии.
Ингибиторы PARP показывают активность при монотерапии опухолей с имеющимися повреждениями репарации ДНК, такими как BRCA1 и BRCA2, а также в качестве комбинированной схемы лечения при использовании вместе с противораковыми препаратами, которые создают повреждения ДНК.
Несмотря на множество достижений в терапии рака яичников, у некоторых женщин возникают рецидивы заболевания, а дальнейшие ответы на дополнительную терапию часто ограничены по длительности. Пациентки с мутациями BRCA1 или BRCA2 имеют увеличенный риск развития рака яичника, а эти опухоли особенно уязвимы к лечению с помощью ингибитора PARP. Также, результаты исследований указывают, что женщины более чувствительные к химиотерапии платиной, у которых отсутствуют мутации BRCA1 или BRCA2, в свою очередь, могут успешно лечиться ингибитором PARP. По оценкам, от 5% до 10процентов женщин с диагнозом рака молочной железы имеют генную мутацию BRCA1 или BRCA2. Появление рака у этих женщин взаимосвязано с дисфункцией основного пути репарации ДНК, известного как гомологичная рекомбинация. Несмотря на то, что раковые клетки способны поддерживать жизнеспособность, несмотря на нарушение пути гомологичной рекомбинации, они становятся особенно чувствительными для химиотерапии, в случае если нарушается альтернативный путь репарации ДНК.
Нирапариб — ингибитор фермента поли (АДФ-рибоза) полимеразы (PARP). Он является высокоселективным по отношению к PARP-1 и PARP-2. Подавление ферментативной активности системы PARP создает повреждение ДНК, апоптоз и гибель клеток. Нирапариб вызывает цитотоксичность в опухолевых клеточных линиях с дефицитом BRCA1/2 и без него.
Таким образом, можно сказать, препарат Зеджула — это лекарство от рака, препятствующее рaспространению и росту раковых клеток. Зеджула применяется как «пoддерживающая» терaпия, чтобы предупредить возвращения некоторых типов рaка. Это касается рака яичника, фаллопиевой трубки или брюшины. Зеджула назначается после того, как пациенты получили химиотерапию (с цисплатином, оксалиплатином, карбоплатином или подобным), и рак ответил на этот препарат.
Упаковка, срок годности, условия хранения
В капсулированном виде. В одной упаковке 84 шт капсулы в дозировке 100 мг.
Препарат Нирапариб не требует особых условий хранения. Достаточно выбрать для этих целей сухое, темное, недоступное детям и животным место с температурой не выше 25 °C. Использовать Зеджула можно в течение 2 лет с момента выпуска.
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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