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Гливек — Glivec (Иматиниб)

Гливек — Glivec (Иматиниб)

Основой препарата Гливек является действующее вещество Иматиниб — низкомолекулярный ингибитор протеинтирозинкиназы. Действие лекарства основано на ингибировании особого фермента, необходимого для развития клетки опухоли. После приема лекарства, злокачественные клетки начинают погибать.

In vitro иматиниб ингибирует пролиферацию и индуцирует апоптоз патологических клеток.
В исследованиях in vivo на животных моделях с использованием Bcr-Abl-позитивных опухолевых клеток, было показано, что вещество иматиниб обладает противоопухолевой способностью и при монотерапии. Иматиниб подавляет пролиферацию и вызывает апоптоз клеток стромальных опухолей ЖКТ, экспрессирующих тирозинкиназу с мутацией c-Kit рецептора, также он подавляет действие фактора роста стволовых клеток и фактора роста тромбоцитов, а также подавляет клеточные реакции, опосредуемые вышеназванными факторами.

Описание

Основой препарата Гливек является действующее вещество Иматиниб — низкомолекулярный ингибитор протеинтирозинкиназы. Действие лекарства основано на ингибировании особого фермента, необходимого для развития клетки опухоли. После приема лекарства, злокачественные клетки начинают погибать.

In vitro иматиниб ингибирует пролиферацию и индуцирует апоптоз патологических клеток.
В исследованиях in vivo на животных моделях с использованием Bcr-Abl-позитивных опухолевых клеток, было показано, что вещество иматиниб обладает противоопухолевой способностью и при монотерапии. Иматиниб подавляет пролиферацию и вызывает апоптоз клеток стромальных опухолей ЖКТ, экспрессирующих тирозинкиназу с мутацией c-Kit рецептора, также он подавляет действие фактора роста стволовых клеток и фактора роста тромбоцитов, а также подавляет клеточные реакции, опосредуемые вышеназванными факторами.

Состав Гливек (Иматиниб)

1 капсула содержит:

  • Действующее вещество: иматиниба мезилат 119,5 мг, что соответствует 100 мг иматиниба.
  • Вспомогательные вещества: целлюлоза микрокристаллическая, диоксид кремния коллоидный безводный, кросповидон, диоксид титана, стеарат магния, желатин, краситель железа оксид желтый, краситель железа оксид красный.
  • Состав чернил: краситель железа оксид красный, шеллак, лецитин соевый.

Показания к применению Гливек (Иматиниб)

  • хронический миелолейкоз;
  • острый лимфобластный лейкоз в составе химиотерапии и как монотерапия;
  • миелодиспластические/миелопролиферативные, связанные с активацией рецептора тромбоцитарного фактора роста;
  • системный мастоцитоз (с отсутствием D816V), c-Kit мутацией или при отсутствии данных о мутационном статусе c-Kit;
  • гиперэозинофильный синдром и/или хроническая эозинофильная лейкемия у взрослых;метастатические стромальные опухоли органов ЖКТ;
  • метастатические дерматофибросаркомы бугорковые.

Фармакодинамика

Иматиниб выраженно подавляет активность таких ферментов как BCR-ABL тирозинкиназы, рецепторов домена дискоитина (DDR1 и DDR2), KIT рецептора роста стволовых клеток, тромбоцитарного фактора роста альфа и бета (PDGFR-α и PDGFR-ß), колирующуюся KIT-протоонкогеном, рецептора колониестимулирующего фактора. Также Иматиниб может ингибировать клеточные процессы, запускаемые активацией этих рецепторных тирозинкиназ.

In vivo и in vitro иматиниб способен избирательно подавляеть действие фермента Bcr-Abl-тирозинкиназу на клеточном уровне, что влечет за собой ингибирование пролиферации у патологических клеток и вызывает апоптоз у клеточных линий, экспрессирующих Bcr-Abl-тирозинкиназу, включая незрелые лейкозных клеток при остром лимфобластном лейкозе и при хроническом миелолейкозе с положительной филадельфийской хромосомой.

Также, иматиниб является ингибитором рецепторов фермента тирозинкиназы для фактора стволовых клеток и фактора роста тромбоцитов, а также подавляет клеточные реакции, опосредуемые вышеназванными факторами.

Иматиниб подавляет пролиферацию и вызывает апоптоз клеток стромальных опухолей ЖКТ, экспрессирующих тирозинкиназу с мутацией c-Kit рецептора.

Фармакокинетика Гливек (Иматиниб)

Фармакокинетические величины иматиниба рассчитывались в диапазоне доз от 25 до 1000 мг. Фармакокинетические профили рассматривались в первый день, а также при достижении равновесного состояния иматиниба в плазме на 7-й или 28-й день.

Абсорбция.

После приема внутрь биодоступность препарата составляет в среднем 98%. Коэффициент вариации для показателя AUC составляет 40–60%. Существует прямая линейная зависимость значения AUC от величины дозы, в диапазоне доз от 25 до 1000 мг. При приеме лекарства с едой с высоким содержанием жиров, в сравнении с приемом натощак, отмечается незначительное уменьшение степени всасывания (уменьшение Cmax иматиниба в плазме крови на 11%, AUC — на 7,4%) и замедление скорости всасывания (увеличение Tmax иматиниба в плазме крови на 1,5 часа).

Распределение Гливек (Иматиниб) .

Исходя из полученных данных в исследованиях in vitro, при клинически значимых концентрациях иматиниб на 95% связывается с белками плазмы крови, в основном с альбумином и альфа-кислотным-гликопротеином, и в меньшей степени — с липопротеином.

Метаболизм.

Метаболизм иматиниба осуществляется главным образом, в печени с помощью изофермента CYP3A4, с образованием основного метаболита (N-деметилированное пиперазиновоое производное), циркулирующего в кровяном русле. In vitro данный метаболит иматиниба характеризуется фармакологической активностью, сходной с активностью исходного вещества. Значение AUC метаболита составляет 16% от AUC иматиниба. Степень связывания N-деметилированного метаболита с белками плазмы крови подобно таковому для иматиниба (аналогична степени связывания исходного соединения)

Выведение Гливек (Иматиниб).

После использования одной дозы иматиниб выводится из организма в течение 7 дней, преимущественно в виде метаболитов (68% — кишечником и 13% — почками). В неизмененном виде выводится около 25% дозы (20% — кишечником и 5% — почками). Период полувыведения иматиниба составляет около 18 часов.

При повторных приемах препарата раз в сутки, фармакокинетические параметры не меняются, а концентрация иматиниба становится больше исходной в 1,5–2,5 раза.

Фармакокинетика в особых клинических случаях

У больных старше 65 лет объем распределения повышается незначительно, только на 12%. Фармакокинетика иматиниба не зависит от пола, веса. Изменения данных клиренса и объема распределения иматиниба при одновременном приеме с другими ЛС незначительны и не требуют коррекции дозы.

У детей и подростков младше 18 лет, как и у взрослых пациентов, при приеме внутрь происходит быстрое всасывание препарата. AUC у детской группы пациентов в диапазоне доз 260 и 340 мг/м2 схожа с таковой у взрослых в диапазоне доз 400 и 600 мг. При сопоставлении у детей и подростков значений AUС на 1-й и 8-й дни после повторного приема препарата в дозе 340 мг/м2 раз в сутки отмечается увлечение значения этого показателя в 1,7 раза, что говорит о кумуляции иматиниба.

У больных с различными степенями нарушений функции печени средние значения AUC не повышаются. У больных с легкой или умеренной степенью тяжести функции почек (Cl креатинина >30 мл/мин) применение иматиниба отмечается увеличением экспозиции вещества в плазме в 1,5–2 раза, что соответствует повышению концентрации кислых альфа-гликопротеинов (основных белков плазмы, связывающихся с иматинибом). Препарат незначительно выводится почками. Клиренс свободного иматиниба одинаков как для пациентов с нарушениями функции почек, так и для здоровых добровольцев. Корреляции между тяжестью почечных нарушений и экспозицией препарата не выявлено.

Фармацевтические характеристики

Капсулы с порошком белого с желтоватым оттенком цвета:

  • По 50 мг — от светло-желтого до оранжево-желтого оттенка, непрозрачные, размером №3. Имеют маркировку «NVR SH» красными чернилами.
  • По 100 мг — от оранжевого до серовато-оранжевого цвета, непрозрачные, размером № 1. Имеют маркировку «NVR SI» красными чернилами.

Упаковка, срок годности, условия хранения

  • Капсулы 50 мг. 10 шт. в блистере из ПВХ/ПЭ/ПВДХ. 3 блистера помещают в картонную пачку.
  • Капсулы 100 мг. 12 шт. в блистере из ПВХ/ПЭ/ПВДХ. 2, 3, 4, 8, 10 и 15 блистеров помещают в картонную пачку.

По 12 капсул в блистере. 10 блистеров с инструкцией по применению в картонной коробке.
Материал блистера: ПВХ/алюминий (ПВХ/А1)

Хранить препарат необходимо при температуре не выше 30 °C, а также в недоступном для детей месте, .

Срок годности 2 года.

 

 

 

 

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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Позвоните и узнайте цену Гливек (Иматиниб)

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

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