Эффективно блокирует рецепторы ErbB, и приводит к ингибирова... Инструкция
Показания к применению
В качестве монотерапии для лечения: местно-распространенного или метастатического немелкоклеточного рака легкого (НМРЛ) с мутацией (мутациями) рецептора эпидермального фактора роста EGFR, местно-распространенного или метастатического плоскоклеточного НМРЛ у пациентов, прогрессирующих на фоне или после химиотерапии на основе препаратов платины.
Противопоказания
Гиперчувствительность к афатинибу или к любому компоненту препарата, тяжелые нарушения функции печени.
Таблетки Гиотриф, покрытые пленочной оболочкой, - противоопухолевый препарат. Содержит вещество афатиниб, которое вызывает регресс опухоли или остановку ее роста.
Фармакологические свойства
Эффективно блокирует рецепторы ErbB, и приводит к ингибированию опухолевого роста или к регрессу опухоли. Особенно чувствительны к лечению афатинибом модели немелкоклеточного рака легкого (НМРЛ), вызываемого мутациями EGFR (L858R или Del 19). Афатиниб сохраняет существенную противоопухолевую активность in vitro на клеточных линиях НМРЛ и in vivo на моделях опухолей (модели с использованием ксенотрансплантатов или трансгенные модели), которые индуцируются мутантными изоформами EGFR (например, T790M) с известной резистентностью к обратимым ингибиторам EGFR, таким как эрлотиниб и гефитиниб.
Показания к применению
В качестве монотерапии для лечения: местно-распространенного или метастатического немелкоклеточного рака легкого (НМРЛ) с мутацией (мутациями) рецептора эпидермального фактора роста EGFR, местно-распространенного или метастатического плоскоклеточного НМРЛ у пациентов, прогрессирующих на фоне или после химиотерапии на основе препаратов платины.
Противопоказания
Гиперчувствительность к афатинибу или к любому компоненту препарата, тяжелые нарушения функции печени.
Применение при беременности и в период грудного вскармливания
Противопоказано
Способ применения и дозы
Принимать натощак, не менее чем за 1 час до приема пищи или спустя 3 часа после приема пищи. Таблетки проглатывают целиком, запивая водой. У пациентов с НМРЛ и положительным результатом теста на мутации EGFR, ранее не получавших терапию ингибиторами тирозинкиназы EGFR, рекомендуемая доза составляет 40 мг один раз в день. У пациентов с НМРЛ и положительным результатом теста на мутации EGFR, ранее получавших терапию ингибиторами тирозинкиназы EGFR, составляет 50 мг один раз в день. У пациентов с плоскоклеточным НМРЛ, которые ранее получали терапию первой линии на основе соединений платины, рекомендуемая доза составляет 40 мг один раз в день. Лечение должно продолжаться до прогрессирования заболевания или развития признаков неприемлемой токсичности. Максимальная суточная доза во всех клинических случаях составляет 50 мг.
Побочное действие
Нарушения вкусовой чувствительности, конъюнктивит, сухость глаз, кровотечение из носа, ринорея, диарея, тошнота, рвота, стоматит, хейлит, диспепсия, повышение активности аланинаминотрансферазы (АЛТ), аспартатаминотрансферазы (АСТ), спазмы мышц, нарушение функции почек, паронихия, цистит, снижение аппетита, пирексия.
Передозировка
Проявления: кожные высыпания (сыпь/акне) и желудочно-кишечные расстройства (в основном, диарея), тошнота, рвота, астения, головокружение, головная боль, боли в животе и повышение уровня амилазы (превышавший верхнюю границу нормы более чем в 1,5 раза). Специфического антидота на случай передозировки нет. При подозрении на передозировку необходимо отменить Гиотриф и проводить симптоматическую терапию. При наличии показаний удалить невсосавшийся афатиниб можно путем промывания желудка или вызвав рвоту.
Особые указания
Если доза препарата пропущена, ее нужно принять в тот же день, как только пациент вспомнит об этом. Но если до приема следующей запланированной дозы осталось не более 8 часов, пропущенную дозу принимать не следует.
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