Противоопухолевое средство, ингибитор ароматазы, по структуре сходен с естественным стероидным гормоном андростендионом. У женщин в постменопаузе эстрогены продуцируются преимущественно путем превращения андрогенов в эстрогены под действием фермента ароматазы в периферических тканях. Механизм действия эксеместана обусловлен необратимым связыванием с активным фрагментом ароматазы, что приводит к инактивации фермента. Эксеместан не обладает прогестагенной и эстрогенной активностью. При применении в высоких дозах проявляется лишь незначительная андрогенная активность. Не оказывает влияния на биосинтез кортизола и альдостерона в надпочечниках. Незначительное увеличение уровней ЛГ и ФСГ в сыворотке отмечается даже при низких дозах эксеместана. Этот эффект, однако, является нехарактерным для препаратов данной фармакологической группы. Вероятно, он развивается по принципу обратной связи, на уровне гипофиза: снижение концентрации эстрогенов стимулирует секрецию гонадотропинов в гипофизе также и у женщин в постменопаузе.
Противопоказания
Беременность, лактация (грудное вскармливание), повышенная чувствительность к эксеместану.
Применение при беременности и в период грудного вскармливания
Противопоказан к применению при беременности и в период лактации.
Способ применения и дозы
При приеме внутрь рекомендуемая доза для взрослых и пациенток пожилого возраста - по 25 мг 1 раз/сут ежедневно, предпочтительно после приема пищи. Лечение следует продолжать до появления признаков прогрессирования опухолевого заболевания, после этого рекомендуется скорректировать врачебную тактику. При печеночной или почечной недостаточности коррекции дозы не требуется.
Побочное действие
Со стороны ЦНС: часто - утомляемость, головокружение иногда - головная боль, бессонница, депрессия, астения. Со стороны пищеварительной системы: часто - тошнота иногда - боли в области живота, анорексия, запор, диспепсия редко - увеличение показателей функциональных печеночных тестов в сыворотке, повышение уровня ЩФ. Со стороны эндокринной системы: часто - приступообразные ощущения жара (приливы). Дерматологические реакции: возможны - кожная сыпь, алопеция. Со стороны системы кроветворения: часто - снижение уровня лимфоцитов редко - тромбоцитопения, лейкопения. Со стороны обмена веществ: возможны - периферические отеки (отеки стоп, голеней). Прочие: часто - усиление потоотделения.
Особые указания
Не следует применять у женщин с пременопаузным эндокринным статусом, поскольку оценка эффективности и безопасности препарата у этой категории пациентов не проводилась. В тех случаях, когда необходимость применения клинически обоснована, постменопаузный статус следует подтверждать определением уровня ЛГ, ФСГ и эстрадиола. У пациенток с исходной лимфопенией повышен риск снижения количества лимфоцитов. Увеличение показателей функциональных печеночных тестов в сыворотке и повышение уровня ЩФ отмечалось преимущественно у пациенток с метастазами в печень и в кости, а также при наличии других поражений печени. Не рекомендуется применять у детей. Влияние на способность к вождению автотранспорта и управлению механизмами При выполнении работы, связанной с необходимостью концентрации внимания и высокой скорости психомоторных реакций, пациентам следует иметь в виду, что при применении эксеметана возможно появление сонливости и головокружения.
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