Вотриент таблетки

Вотриент — Votrient (Пазопаниб) 200 мг, 400 мг.

Вотриент (Пазопаниб) — современный противоопухолевый препарат с действующим веществом пазопаниб. Активное вещество препарата ингибирует VEGF-индуцируемое фосфорилирование VEGFR-2, ангиогенез, что приводит к замедлению роста определённых человеческих опухолей.

Категория:

Описание

Вотриент (Пазопаниб) — современный противоопухолевый препарат с действующим веществом пазопаниб. Активное вещество препарата ингибирует VEGF-индуцируемое фосфорилирование VEGFR-2, ангиогенез, что приводит к замедлению роста определённых человеческих опухолей.

Состав

  • Активное вещество: пазопаниба гидрохлорид 433.4 мг (содержание пазопаниба — 400 мг).
  • Вспомогательные вещества: карбоксиметилкрахмал натрия — 42.4 мг, магния стеарат — 4.2 мг, повидон К30 — 32 мг, целлюлоза микрокристаллическая — 128.1 мг.
  • Состав пленочной оболочки: опадрай белый YS-1-7706-G — 19.2 мг (гипромеллоза — 11.47 мг, титана диоксид — 6 мг, макрогол 400 — 1.54 мг, полисорбат 80 — 0.19 мг).

Показания

  • при терапии распространенного почечно-клеточного рака;
  • при терапии распространенной саркомы мягких тканей (кроме гастроинтестинальных стромальных опухолей и липосаркомы).

Фармакологическое действие

Противоопухолевый препарат, ингибитор тирозинкиназы для приема внутрь. Вотриент активно влияет на многие рецепторы-мишени.

Активное вещество способно взаимодействовать с рецепторами эндотелиального фактора роста клеток сосудов, выделенного из фактора роста тромбоцитов, а также рецептором фактора роста стволовых клеток, при этом уровни ингибирующей концентрации в 50% (IC50) составляют 10, 30, 47, 71, 84 и 74 нмоль/литр.
Пазопаниб является ингибитором множества тирозинкиназ, в т.ч. тирозинкиназы рецептора эндотелиальных факторов роста-1, 2, 3 (VEGFR-1, VEGFR-2, VEGFR-3), рецептора фактора роста тромбоцитов альфа и бета (PDGFR-α и PDGFR-β), рецептора фактора роста фибробластов-1 и -3 (FGFR-1, -3), рецептора цитокина (Kit), рецептора интерлейкина-2, который индуцируется киназой Т-клеток (Itk), лейкоцитспецифической протеин-тирозинкиназы (Lck) и трансмембранного гликопротеинового рецептора тирозинкиназы (c-Fms). Действующее вещество In vitro ингибирует лиганд-индуцируемое автофосфорилирование VEGFR-2, Kit и PDGFR-β. In vivo препарат ингибирует VEGF-индуцируемое фосфорилирование VEGFR-2, ангиогенез и рост у мышей определенных человеческих опухолевых ксенотрансплантатов.

Наблюдалось повышение АД при равновесных концентрациях пазопаниба.

Фармакокинетика

Всасывание

В среднем Сmах вещества достигается через 2-4 часа после приема препарата внутрь. Ежедневный прием приводит к 1-, 2-, 3, 4-кратному увеличению AUC. Ежедневный прием в дозировке 800 мг/сутки пазопаниба приводит к значениям Сmах и AUC 58.1 мкг/мл (эквивалентно 132 мкМ) и 1.037 ч×мкг/мл соответственно. Значительного увеличения при повышении дозировки пазопаниба более 800 мг/сутки Сmах и AUC не наблюдается .
Системная экспозиция пазопаниба увеличивалась при приеме с пищей. Прием таблеток с пищей с низким и высоким содержанием жира приводит приблизительно к 2-кратному увеличению Сmах и AUC . Препарат рекомендовано принимать, по меньшей мере, за один час до или через два часа после приема пищи.
Прием пазопаниба в дозировке 400 мг/сутки в виде раскрошенной таблетки вызывает увеличение AUC (0-72) и Сmах в 2 раза и, в сравнении с приемом целой таблетки, вызывает снижение Tmax на 1,5 часа. Такие результаты показывают, что при пероральном приеме в сравнении с целой таблеткой степень абсорбции и биодоступности активного вещества увеличивается при приеме раскрошенной таблетки. Поэтому таблетки препарата не следует измельчать, из-за возможного повышенного воздействия.

Распределение

In vivo cвязывание активного вещества пазопаниб с белками плазмы крови составило более 99% вне зависимости от концентрации в диапазонах: 10-100 мкг/мл.
По результатам исследований in vitro предполагают, что пазопаниб является субстратом для для Р-гликопротеина (P-gp) и белка резистентности рака молочной железы (BCRP).

Метаболизм

In vitro показали, что метаболизм пазопаниба обусловлен преимущественно изоферментом CYP3A4, а также в незначительной степени CYP2C8 и CYP1A2.

Выведение

Активное вещество пазопаниб выводится медленно со средним значением T1/2 равным 30,9 часов после приема в рекомендованной дозтровке 800 мг/сутки. Выведение осуществляется, в основном, кишечником, при этом только менее 4% принятой дозы выводится почками.

Фармакокинетика у особых групп пациентов

Пациенты с нарушением функции почек

Выведение пазопаниба из организма человека не зависит от клиренса креатинина (30–150 мл/мин). Нарушения функции почек не значительно влияет на системное воздействие пазопаниба, поэтому пациентов с клиренсом креатинина ≥ 30 мл/мин не требуется коррекции дозировки.

Пациенты с нарушением функции печени

У больных с легкой степенью нарушения функции печени (нормальный уровень концентрации билирубина, но повышенная активность аланинаминотрансферазы (АЛТ) или повышенная концентрация билирубина до 1,5 × верхней границы нормы (ВГН), независимо от уровня АЛТ) после однократной дозировки пазопаниба 800 мг/сутки средние значения (AUC(0-24)841,8 мкг × ч/мл, интервал 600,4–1078 и C max 30,9 мкг/мл, интервал 12,5–47,3) сопоставимы со средними значениями и уровянми пациентов с нормальной функцией печени (C max 49,4 мкг/мл, интервал 17,1–85,7 и AUC(0-24)888,2 мкг × ч/мл, интервал 345,5–1482).
У пациентов с умеренной степенью нарушений функции печени (повышение концентрации билирубина > 1,5 × до 3 × ВГН, независимо от уровня АЛТ) максимально переносимая дозировка пазопаниба — 200 мг/сутки. Средние значения C max (22,4 мкг/мл, интервал 6,4–32,9) и AUC(0-24)(350,0 мкг × ч/мл, интервал 131,8–487,7) после приема 200 мг активного вещества 1 раз в сутки у больных с умеренным нарушением функции печени составляли около 45 % и 39 %, соответственно, от средних значений у больных с нормальной функцией печени после приема препарата в дозировке 800 мг/сутки. Не рекомендовано применять препарат больным с тяжелым нарушением функции печени (концентрация общего билирубина> 3 × ВГН, независимо от уровня АЛТ) пациентов из-за недостаточного количества данных.

Фармацевтические характеристики

Капсулированные таблетки с надписью на одной стороне «GS UHL».

  • Дозировка 200 мг: покрытые пленочной оболочкой розового цвета.
  • Дозировка 400 мг: покрытые пленочной оболочкой белого цвета.

Упаковка, срок годности, условия хранения

Распространяется во флаконах по 30 или 60 таблеток из ПЭ высокой плотности с крышкой из полипропилена с защитой от детей. Флакон и инструкция по медицинскому применению размещаются в картонной пачке.
Срок годности 2 года при температуре не выше 30 °C.
Хранить в недоступном для детей месте.

 

 

Наша компания работает как на территории Кыргызстана, так и осуществляет доставку в страны ближнего зарубежья. Обращайтесь к нам за консультациями по контактным телефонам.

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Работаем и отправляем Вотриент (Пазопаниб) по странам СНГ: Казахстан (Алматы и Нур-Султан), Россия, Украина,  Белоруссия, Узбекистан (Ташкент),
а также можем отправить Вотриент (Пазопаниб) по регионам Кыргызстана: Ош, Джалал-Абад, Каракол, Узген, Балыкчы и другие.

 

 

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