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Портразза — Portrazza (Нецитумумаб)

Портразза

Портразза — Portrazza (Нецитумумаб)

Препарат Портразза — новое лекарственное средство для лечения рака легких. Одобрен для применения: США (2015). Основное действующее вещество — Нецитумумаб, является противоопухолевым моноклональным антителом.

Эксперты проанализировали результаты клинических исследований экспериментального противоопухолевого препарата Портразза, предназначенного для лечения немелкоклеточного рака легкого. Согласно выводам экспертов — лекарственное средство эффективно в лечении немелкоклеточного рака легкого, однако его использование связано с повышенным риском тромбозов.

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Описание

Препарат Портразза — новое лекарственное средство для лечения рака легких. . Одобрен для применения: США (2015). Основное действующее вещество — Нецитумумаб, является противоопухолевым моноклональным антителом.

Эксперты проанализировали результаты клинических исследований экспериментального противоопухолевого препарата Портразза, предназначенного для лечения немелкоклеточного рака легкого. Согласно выводам экспертов — лекарственное средство эффективно в лечении немелкоклеточного рака легкого, однако его использование связано с повышенным риском тромбозов.

Состав Портразза

В одном флаконе содержится:

активное вещество: Нецитумумаб — 1X50 ML

Фармакодинамика

В клинических исследованиях приняло участие более тысячи пациентов с немелкоклеточным раком легкого. Согласно полученным результатам исследований, средняя продолжительность жизни у пациентов, принимавших нецитумумаб в комбинации с гемцитабином и цисплатином, составила 11,5 месяца. В группе участников, принимавших только гемцитабин и цисплатин, данный показатель был равен 9,9 месяца. При этом отличалось и количество серьезных побочных эффектов, связанных с применением препаратов. Так, в группе экспериментального препарата они развивались у 48 процентов, а в группе плацебо – у 38 процентов.

Препарат Портразза является анти-EGFR (рецептор эпидермального фактора роста) рекомбинантным человеческим моноклональным антителом изотипа иммуноглобулинаG1 каппа, который специфически взаимосвязывается с сайтом связывания человеческого лиганда EGF. Нецитумумаб имеет приблизительную молекулярную массу 144,8 кДа. Нецитумумаб производится в генно-инженерных клетках NS0 млекопитающих.

Нецитумумаб представляет собой моноклональное антитело рекомбинантный человеческий иммуноглобулинG1 , который взаимодействует с рецептором человеческого эпидермального фактора роста (EGFR) и блокирует связывание EGFR с его лигандами EGF. Активация и экспрессия и EGFR коррелируется со злокачественной прогрессией, индукцией ангиогенеза и подавлением апоптоза. Взамиодействие с нецитумумабом индуцирует поглощение клеткой и деградацию EGFR in vitro. In vitrо связывание с нецитумумабом также приводило к развитию антителозависимой клеточной цитотоксичности (ADCC) в ЕGFR-экспрессирующих клетках.

In vivо исследованиях с использованием моделей ксенотрансплантата рака человека, включая немелкоклеточную карциному легкого, применение нецитумумаба имплантированным мышам приводило к увеличенной противоопухолевой активности в сочетании с гемцитабином и цисплатином по сравнению с мышами, принимавшими только цисплатин и гемцитабин.

Фармакокинетика

На основе популяционного фармакокинетического анализа препарат Портразза демонстрирует дозозависимую кинетику. После введения 800 мг нецитумумаба в 1 и 8 дни каждого 21-дневного цикла расчетный средний общий системный клиренс (CLtot) в установившемся состоянии составляет 14,1 мл / ч (CV = 39 процентов), объем распределения (Vss ) составляет 7,0 л (CV = 31 процент), а период полувыведения составляет приблизительно 14 дней. Прогнозируемое время достижения устойчивого состояния составляет приблизительно 100 дней.

Применение препарата Портразза

Препарат Портразза показан для лечения пациентов с метастатическим плоскоклеточным немелкоклеточным раком легкого в сочетании с цисплатином и гемцитабином.

Применение при беременности и кормлении грудью

Препарат Портразза противопоказан при беременности и лактации. Пациентки репродуктивного возраста должны использовать эффективные методы контрацепции во время лечения препаратом Портразза и в течение трех месяцев после приема последней дозировки.

Меры предосторожности

Кардиопульмональный шок

Кардиопульмональный шок или внезапная смерть произошли у 15 (3 процентов) из 538 пациентов, получавших нецитумумаб в комбинации с цисплатином и гемцитабином по сравнению с 3 (0,6 процента) из 541 пациентов, получавших только гемцитабин и цисплатин. Двенадцать из пятнадцати пациентов умерли в течение 30 дней после приема последней дозировки препарата Портразза и имели сопутствующие заболевания, включая историю ИБС (n = 3), гипомагниемию (n = 4), хроническую обструктивную болезнь легких (n = 7) и гипертонию (n = 5). Пациенты с инфарктом миокарда, с выраженными поражениями коронарных артерий в течение предшествующих шести месяцев, неконтролируемой гипертонией и неконтролируемой застойной сердечной недостаточностью не были включены в данное исследовании. Повышение риска сердечно-легочного шока или внезапной смерти у пациентов с историей ИБС, застойной сердечной недостаточностью или аритмией по сравнению с теми, кто не имел данных сопутствующих заболеваний, не был выявлен.

Требуется тщательно контролировать сывороточные электролиты, в том числе сывороточный магний, кальций и калий , перед каждой инфузией препарата Портразза и в течение не менее 8 недель после приема последней дозировки.

Гипомагнемия

Гипомагнемия наблюдалась у 83% (461/538) пациентов, получавших нецитумумаб в комбинации с гемцитабином и цисплатином, по сравнению с 70% (457/541) пациентов, получавшими только гемцитабин и цисплатин. Гипомагнемия была тяжелой (3 или 4 степени) у 20 процентов пациентов, в первой группе, по сравнению с 7 процентами пациентов, получавших только гемцитабин и цисплатин. Среднее время развития гипомагниемии и сопутствующих аномалий электролитов было 6 недель (25-й процентиль 4 недели, 75-й процентиль 9 недель) после начала приема препарата Портразза. Необходимо наблюдать пациентов с гипокалиемией, гипомагниемией, гипокальциемией и перед каждой инфузией препарата Портразза и по меньшей мере 8 недель после завершения приема. Необходимо воздержаться от приема препарата Портразза при выраженных аномалиях уровня электролитов. Возобновить циклы приема препарата Портразза можно после того, как гипомагниемия и связанные с ней аномалии электролитов восстановятся до уровня ≤ 2 от нормы.

Венозные и артериальные тромбоэмболические осложнения

Артериальные и венозные и тромбоэмболические осложнения, некоторые смертельные, наблюдались в группе нецитумумаба в сочетании с цисплатином и гемцитабином. Частота венозных тромбоэмболических осложнений составляла 9 процентов у пациентов, получавших нецитумумаб плюс гемцитабин и цисплатин против 5 процентов у пациентов, получавших только гемцитабин и цисплатин, а частота тяжелых венозных тромбоэмболических осложнений составила 5 процентов против 3 процентов соответственно. Частота смертельных венозных тромбоэмболических осложнений была сходной между группами (0,2 процента против 0,2 процентов). Наиболее распространенными осложнениями были легочная эмболия (5 процентов) и тромбоз глубоких вен (2 процента).

Частота артериальных тромбоэмболических осложнений составила 5 процентов против 4 процентов, а частота тяжелых артериальных тромбоэмболических осложнений составила 4 процента против 2 процентов в группе нецитумумаба в сочетании с цисплатином и гемцитабином, против гемцитабина и цисплатина без нецитумумаба, соответственно. Наиболее распространенными артериальными тромбоэмболическими осложнениями были ишемические инсульты (2 процента) и инфаркт миокарда (1 процент).

У больных с имеющейся историей венозных и артериальных тромбоэмболических осложнений, относительный риск артериальных и венозных тромбоэмболических осложнений, был примерно в 3 раза выше. Требуется воздержаться от приема препарата Портразза у больных с серьезными или опасными для жизни артериальными и венозными тромбоэмболическими осложнениями.

Дерматологические осложнения

У 79 процентов пациентов, получавших нецитумумаб отмечались сыпь, акнеформный дерматит, акне, сухая кожа, генерализованная сыпь, зуд, трещины кожи, эритема, макулопапулезная сыпь. Тяжелые дерматологические осложнения наблюдались у 8 процентов пациентов. Обычно дерматологические осложнения развивались в течение первых 2 недель терапии и разрешались в течение 17 недель после начала лечения. Требуется корректировка дозировки нецитумумаба, вплоть до его отмены при наличии тяжелые дерматологических осложнений. Необходимо ограничить пребывание на солнце пациента.

Реакции, связанные с инфузией Портразза

В исследовании 1,5 процентов пациентов, получавших нецитумумаб, испытывали инфузионные реакции, из них 0,4 процента- тяжелых. Ни один пациент не получал премедикацию. Большинство инфузионных реакций возникали после первого или второго введения препарата Портразза. Требуется прекратить введение препарата Портразза при развитии опасных для жизни инфузионных реакций. Неплоскоклеточный немелкоклеточный рак легкого — повышенная токсичность и повышенная смертность. Препарата Портразза не показан для лечения пациентов с неплоскоклеточным немелкоклеточным раком легкого.

Фармацевтические характеристики

Готовый раствор  для инфузий: прозрачный, бесцветный,  от видимых включений свободный.

Упаковка, срок годности, условия хранения Портразза

Готовый раствор укупорен во флаконы из стекла I типа, с прорезиненной крышечкой. Каждый флакон вместе с инструкцией по применению упакован в пачку картонную.

Хранить флаконы в холодильнике при температуре от 2 °C до 8 °C в защищенном от света месте. Не замораживать и не встряхивать.

Срок годности препарата 24 месяца. Не использовать по истечении срока годности.

 

 

 

 

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

Заказать и купить Портразза (Нецитумумаб) в Алматы

Заказать и купить Портразза (Нецитумумаб) в Казахстане

Позвоните и узнайте цену Портразза (Нецитумумаб)

Работаем и отправляем Портразза (Нецитумумаб) по странам СНГ: Россия, Украина, Кыргызстан (Бишкек), Белоруссия, Узбекистан (Ташкент),
а также можем отправить Портразза (Нецитумумаб) по регионам Казахстана: Нур-Султан (Астана), Шымкент, Талдыкорган, Актау и другие.

 

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