Иматиниб оказывает избирательное ингибирующее действие на фе... Инструкция
Показания к применению
Впервые выявленный положительный по филадельфийской хромосоме (Ph+) хронический миелоидный лейкоз (ХМЛ) у детей и взрослых, Ph+ ХМЛ в хронической фазе при неудаче предшествующей терапии интерфероном альфа или в фазе акселерации, или бластного криза у детей и взрослых, Впервые диагностированный положительный по филадельфийской хромосоме (Ph+) острый ...
Капсулы Гливек - швейцарский препарат, применяемый при терапии опухолевых процессов. Действующее вещество иматиниб блокирует ферментативные процессы на уровне роста и развития раковых клеток. Таким образом, включается процесс самоуничтожения злокачественного новообразования.
Фармакологические свойства
Иматиниб оказывает избирательное ингибирующее действие на фермент Bcr-Abl-тирозинкиназу, образующуюся при слиянии участка гена Bcr (breakpoint cluster region) и протоонкогена Abl (Abelson), на клеточном уровне, селективно подавляет пролиферацию и вызывает апоптоз клеточных линий, экспрессирующих Bcr-Abl-тирозинкиназу, включая незрелые лейкозные клетки, образующиеся у пациентов с положительными но филадельфийской хромосоме хроническим миелолейкозом и острым лимфобластным лейкозом. Иматиниб селективно ингибирует Всг-Abl-позитивные колонии, полученные из клеток крови больных хроническим миелолейкозом. Иматиниб ингибирует пролиферацию и индуцирует апоптоз клеток стромальных опухолей ЖКТ, экспрессирующих тирозинкиназу с мутацией c-Kit рецептора.
Показания к применению
Впервые выявленный положительный по филадельфийской хромосоме (Ph+) хронический миелоидный лейкоз (ХМЛ) у детей и взрослых, Ph+ ХМЛ в хронической фазе при неудаче предшествующей терапии интерфероном альфа или в фазе акселерации, или бластного криза у детей и взрослых, Впервые диагностированный положительный по филадельфийской хромосоме (Ph+) острый лимфобластный лейкоз (ОЛЛ) у взрослых пациентов в комбинации с химиотерапией, рецидивирующий или рефрактерный Ph+ ОЛЛ у взрослых пациентов в качестве монотерапии, Миелодиспластические/миелопролиферативные заболевания, связанные с генными перестройками рецептора фактора роста тромбоцитов, у взрослых пациентов, Системный мастоцитоз у взрослых пациентов с отсутствием D816V c-Kit мутации или с неизвестным c-Kit мутационным статусом, Гиперэозинофильный синдром и/или хронический эозинофильный лейкоз у взрослых с позитивной или негативной аномальной FIP1L1-PDGRF альфа-тирозинкиназой, Неоперабельные и/или метастатические злокачественные гастроинтестинальные стромальные опухоли позитивные по c-Kit (CD 117) у взрослых пациентов, Адъювантная терапия гастроинтестинальных стромальных опухолей позитивных по c-Kit (CD 117) у взрослых пациентов, Неоперабельная, рецидивирующая и/или метастатическая выбухающая дерматофибросаркома у взрослых пациентов.
Противопоказания
Повышенная чувствительность к компонентам препарата.
Применение при беременности и в период грудного вскармливания
Противопоказано
Способ применения и дозы
Препарат следует принимать во время еды, запивая полным стаканом воды, чтобы снизить риск развития желудочно-кишечных расстройств. Пациентам, не имеющим возможности проглотить капсулу целиком, препарат можно принимать в разведенном виде. Содержимое капсулы помещают в стакан, заливают водой или яблочным соком (50 мл жидкости для таблеток 100 мг и 100 мл - для таблеток 400 мг), размешивают, полученную суспензию следует принимать внутрь сразу после приготовления. Дозу и период терапии определяет врач на основании клинических показаний. Дозы 400 мг и 600 мг/сут следует принимать в 1 прием, суточную дозу 800 мг следует разделить на 2 приема - по 400 мг утром и вечером.
Побочное действие
Нейтропения, тромбоцитопения, анемия, головная боль, диспепсия, отеки, увеличение массы тела, тошнота, рвота, диарея, миалгии, мышечные судороги, сыпь, слабость, боль в животе.
Передозировка
Симптомы: тошнота, рвота, диарея, сыпь, эритема, отеки, припухлость (в основном лица), повышенная утомляемость, мышечные спазмы, тромбоцитопения, панцитопения, желудочно-кишечные боли, головная боль, снижение аппетита, Лечение: рекомендуется медицинское наблюдение и симптоматическая терапия. Антидот к Гливеку неизвестен.
Особые указания
При обращении с препаратом следует избегать попадания его на кожу и в глаза, а также вдыхания порошка препарата. Лечение Гливеком следует проводить только под наблюдением врача, имеющего опыт работы с противоопухолевыми препаратами. При применении Гливека рекомендуется проводить регулярные клинические исследования периферической крови и контроль функции печени (трансаминазы, билирубин, ЩФ). Следует обеспечить тщательное наблюдение за пациентами с заболеваниями сердца.
Условия хранения
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