Описание
Таксотер (Taxotere) — противораковый препарат, классифицирующийся как «растительный алкалоид». Прoизводится в виде двух флаконов: в одном — концентрированный раствор, а в другoм — растворитель. Содержимое данных флаконов предварительно смешивают друг с другом, а впоследствии смешивают в растворе для инфузии.
Активное вещество препарата — Доцетаксел — таксан, принадлежащий к группе противоопухолевых препаратов. Таксаны ингибируют способность раковых клеток делиться. Препарат также мoжет применяться в комплексе с некоторыми противоопухолевыми лекарственными средствами (например, капецитабин, доксорубицин, трастузумаб).
Показания к применению
- операбельный рак молочной железы РМЖ:
- операбельный рак молочной железы с/без поражения лимфоузлов;
- метастатический и/или местно-распространенный рак молочной железы:
- немелкоклеточный рак легкого:
- местно-распространенный или метастатический немелкоклеточный рак;
- нерезектабельный местно-распространенный или метастатический немелкоклеточный рак легкого;
- метастатический рак яичников;
- метастатический гормонорезистентный (андроген-независимый) рак предстательной железы;
- метастатический рак желудка, включая рак зоны пищеводно-желудочного перехода;
- местно-распространенный плоскоклеточный рак головы и шеи.
Состав
Концентрат для приготовления раствора для инфузий — 1 флакон
- доцетаксела тригидрат (в виде доцетаксела) — 20 мг
- вспoмогательные вещества: полисорбат 80
- состав растворителя: 13% этанола в воде для инъекций объемом 7 мл.
Концентрат для приготовления раствора для инфузий — 1 флакон.
- доцетаксел — 80 мг
- вспомогательные вещества: полисорбат 80
- состав растворителя: 13% этанола в воде для инъекций объемом 15 мл.
Фармакодинамика
Противоопухолевый препарат растительного происхождения (из группы таксоидов). Нарушает фазы митоза и межфазные процессы в опухолевых клетках. Способствует накоплению тубулина в микротрубочках, что препятствует их распаду, что нарушает процесс деления опухолевых клеток. Доцетаксел способен к кумулированию в клетках, где концентрация его достигает высоких значений. Также доцетаксел активен в oтношении некоторых, клеток, продуцирующих в большом количестве Р-гликопротеин, отвечающий за множественную устойчивость к химиотерапевтическим лекарствам.
In vivo доцетаксел имеет широкий спектр активности в отношении опухолей мышей и перевиваемых опухолевых клеток человека.
Фармакокинетика
Распределение
Фармакокинетика доцетаксела является дозозависимой и соответствует трехфазной фармакокинетической модели с периодом полураспада: 4 минуты — 36 минут — 11 часов.
в дозе 100 мг/м после одночасовой инфузии доцетаксела средние значения максимальной концентрации доцетаксела в плазме составляли 3,7 мкг/мл с соответствующим значением AUC 4.6 мкг×ч/мл. Среднее значение объема распределения в равновесном состоянии составляет 113 литров.
Связывание доцетаксела с белками плазмы крови составляет более 95%.
Метаболизм и выведение
После окисления терт-бутиловой эфирной группы при участии изоферментов системы Р450 доцетаксел в течение недели (7 дней) элиминируется с мочой (6% введенной дозы) и с калом (75% введенной дозы). В течение 48 часов с калом элиминируется около 80% от введенной дозы доцетаксела в виде метаболитов (основного неактивного метаболита и трех менее значимых неактивных метаболитов) и в очень незначительном количестве — в неизмененном виде.
Фармакокинетика в особых клинических случаях
Фармакокинетика доцетаксела не зависит от возраста и пола пациента.
Общий клиренс доцетаксела снижается в среднем на 27% при слабо выраженных нарушениях функции печени.
Клиренс доцетаксела не меняется при слабой или умеренной задержке жидкости; сведений о его клиренсе при выраженной задержке жидкости нет.
При комбинированном применении доцетаксел не влияет на клиренс доксорубицина и плазменную концентрацию доксорубицинола (метаболита доксорубицина).
Фармакокинетические свойства при монoтерапии доцетакселом и терапии доцетакселом в комбинации с цисплатином и фторурацилом у детей были сходными с таковым у взрoслых.
Фармацевтические характеристики
Концентрат для приготовления раствора для инфузий. Прозрачный, маслянистый раствор от желтого до коричневато-желтого цвета.
Растворитель: прозрачный бесцветный раствор.
Упаковка, срок годности, условия хранения
- Концентрат для приготовления раствора для инфузий, 20 мг/0,5 мл и 80 мг/2 мл (в комплекте с растворителем).
- Концентрат для приготовления раствора для инфузий: по 0,61 мл (для 20 мг/0,5 мл) или 2,36 мл (для 80 мг/2 мл) концентрата во флаконе бесцветного стекла (тип I), укупоренном резиновой пробкой, обжатой алюминиевым колпачком с пластмассовой крышечкой типа «flip-off» зеленого цвета (для 20 мг/0,5 мл) или красного цвета (для 80 мг/2 мл).
- Растворитель (13% раствор этанола в воде для инъекций): по 1,98 мл (для 20 мг/0,5 мл) или 7,33 мл (для 80 мг/2 мл) растворителя во флаконе бесцветного стекла, укупоренном резиновой пробкой, обжатой алюминиевым колпачком с пластмассовой крышечкой типа «flip-off».
Флакон с концентратом вместе с флаконом с растворителем помещают в контурную ячейковую упаковку из ПВХ, запаянную ПЭ пленкой. Контурную ячейковую упаковку помещают в картонную пачку.
Хранить в защищенном от света месте, при температуре 2–25 °C. Хранить в недоступном для детей месте.
Срок годности 2 года.
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