Описание
Препарат Эксиджад — оральный хелатор, с основным действующим веществoм Деферазирокс. Главное свойство деферазирокса состоит в снижении хронической перегрузки железом у лиц, длительно получающих переливание крови (например, для таких условий, как бета-талассемии и других хронических анемий).
Применение деферазирокса в суточной дозе 10 мг/кг в течение 1 года позволяло поддерживать в норме содержание железа в печени, концентрацию ферритина в сыворотке крови и способствовало достижению баланса железа (равновесия между поступлением и выведением железа) у пациентов, редко получающих гемотрансфузии или обменные переливания крови.
Состав
Одна таблетка содержит:
- 250 мг или 500 мг деферасирокса;
- вспомогательные вещества: лактозы моногидрат, кросповидон, целлюлоза микрокристаллическая, повидон (K3O), натрия лаурилсульфат, кремния диоксид коллоидный безводный, магния стеарат.
Показания к применению
- хроническая перегрузка железом у взрослых и детей в возрасте 2 лет и старше;
Фармакодинамика
Комплексообразующее средство. Является тройным лигандом, обладающим высоким сродством к железу (III) и связывающим его в соотношении 2:1.
Усиливает экскрецию железа, преимущественно с калом. Деферазирокс обладает низким сродством к цинку и меди и не вызывает стойкого снижения содержания этих металлов в сыворотке.
Применение деферазирокса было изучено у взрослых пациентов и детей в возрасте 2 лет и старше с хронической посттрансфузионной перегрузкой железом. Основные заболевания, требующие регулярных трансфузий, включали β-талассемию, серповидно-клеточную анемию и другие врожденные и приобретенные анемии (миелодиспластические синдромы, врожденная гипопластическая анемия Даймонда-Блэкфена, приобретенная апластическая анемия и другие редкие формы анемий).
Показано, что при ежедневном применении деферазирокса в дозах 20 мг/кг и 30 мг/кг в течение 1 года у взрослых и детей с β-талассемией на фоне продолжающихся гемотрансфузий уменьшались запасы общего железа в организме; содержание железа в печени снижалось в среднем соответственно почти на 0.4 мг Fe/г и 0.9 мг Fe/г сухого вещества печени, концентрация ферритина в сыворотке крови уменьшалась в среднем почти на 36 мкг/л и 926 мкг/л соответственно. При применении в тех же дозах соотношение экскреции железа к поступлению железа в организм составляло 1.02 (что является показателем нормального баланса железа) и 1.67 (что соответствует повышенному выведению железа из организма). Подобный терапевтический ответ наблюдался при применении деферазирокса у пациентов с перегрузкой железа и при других типах анемий.
Применение деферазирокса в суточной дозе 10 мг/кг в течение 1 года позволяло поддерживать в норме содержание железа в печени, концентрацию ферритина в сыворотке крови и способствовало достижению баланса железа (равновесия между поступлением и выведением железа) у пациентов, редко получающих гемотрансфузии или обменные переливания крови. Поскольку уровень ферритина в сыворотке крови, определяемый ежемесячно, отражал изменения содержания железа в печени, динамика концентрации ферритина в сыворотке крови может являться критерием для оценки эффективности терапии. Влияние препарата на содержание ферритина в сыворотке крови и соотношение экскреции железа к поступлению его в организм было дозозависимым в диапазоне доз 5-30 мг/кг/сут.
Фармакокинетика
Всасывание
Деферазирокс хорошо абсорбируется после приема внутрь, среднее Тmax в плазме крови составляет около 1.5-4 ч. Абсолютная биодоступность (по AUC) деферазирокса при приеме внутрь составляет около 70% по сравнению с в/в введением. AUC увеличивалась приблизительно в 2 раза при приеме во время завтрака с высоким содержанием жира (содержание жира обуславливает >50% энергетической ценности) и почти на 50% при приеме во время стандартного завтрака. Биодоступность (по AUC) деферазирокса умеренно (приблизительно 13-25%) повышалась при приеме за 30 мин до приема пищи с нормальным или высоким содержанием жиров.
Общая экспозиция (AUC) деферазирокса при приеме в виде суспензии с апельсиновым или яблочным соком была эквивалентной экспозиции препарата при применении в виде водной суспензии (относительные значения AUC 103% и 90% соответственно).
В равновесном состоянии Cmax и AUC0 -24 ч деферазирокса повышаются почти линейно с дозой. Деферазирокс накапливается в организме, фактор кумуляции — 1.3-2.3.
Распределение
В высокой степени деферазирокс связывается с белками плазмы крови (99%), главным образом с альбумином. Имеет небольшой объем распределения — приблизительно 14 литров у взрослых.
Метаболизм
Главным путем метаболизма деферазирокса является глюкуронизация с последующей экскрецией с желчью. Деферазирокс подвергается энтерогепатической рециркуляции. Происходит деконъюгация глюкуронатов в кишечнике и последующая их реабсорбция. У здоровых пациентов, получавших колестирамин после однократного приема деферазирокса, AUC деферазирокса снижалась на 45%. Деферазирокс подвергается глюкуронизации главным образом с помощью UGT1A1 (уридиндифосфатглюкуронилтрансферазы /УГТ/ семейства 1, полипептид А1) и в меньшей степени — UGT1A3 (УГТ семействa 1, пoлипептид A3).
Окислительный метаболизм деферазирокса, опосредуемый CYP450, выражен в небольшой степени (около 8%). In vitro не наблюдалось ингибирования метаболизма деферазирокса гидроксикарбамидом.
Выведение
Деферазирокс и его метаболиты выводятся преимущественно с калом (84% дозы). Почечная экскреция деферазирокса и его метаболитов минимальна (8% дозы). Средний период полувыведения колеблется от 8 до 16 часов.
Фармакокинетика в особых клинических случаях.
Детский возраст.
После однократного и многократного приемов деферазирокса у детей (от 2 до 12 лет) и подростков (от 12 до 17 лет) oбщая биодоступность была ниже, чем у взрослых. У детей младше 6 лет биодoступность ниже на 50%, чем у взрослых. Вместе с тем, это не имеет клинического значения, поскольку режим дозирования препарата устанавливают индивидуально.
Пожилой возраст.
Фармакокинетика деферазирокса у пациентов пожилого возраста (старше 65 лет) не изучена.
Нарушения функции печени пли почек.
У пациентов с нарушениями функции печени пли почек фармакокинетика деферазирокса не изучена. Среднее AUC деферазирокса у пациентов с нарушениями функции печени (А и В по шкале Чайлд-Пью) было выше, чем у пациентов с нормальной функцией печени на 16% и 76%, соответственно. Среднее максимальнaя концентрация у пациентов с нарушениями функции печени легкой и средней степени тяжести превышало на 22% значение данного показателя у пациентов с нормальной функцией печени.
Повышение активности печеночных трансаминаз до 5 раз по сравнению с ВГН не оказывает влияния на фармакокинетику деферазирокса.
Фармацевтические характеристики.
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