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Милотарг — Mylotarg (Гемтузумаб озогамицин)

Милотарг — Mylotarg (Гемтузумаб озогамицин)

Препарат Милотарг (с действующим веществом — гемтузумаб озогамицин) 1 сентября был одобрен FDA для лечения взрослых с недавно диагностированным с CD33 позитивным острым миелоидным лейкозом. Препарат также получил одобрение для применения у детей старше 2-х лет с острым миелоидным лейкозом , клетки которого экспрессируют CD33. Белок CD33- это рецептор является маркером ОМЛ (острого миелоидного лейкоза), и характерен для 90% случаев острого миелолейкоза. Этот препарат был ранее одобрен для лечения взрослых пациентов с недавно диагностированным CD33-положительным ОМЛ. Также Гемтузумаб озогамицин одобрен в Европейском союзе для этой группы пациентов.

Описание

Препарат Милотарг (с действующим веществом — гемтузумаб озогамицин) 1 сентября был одобрен FDA для лечения взрослых с недавно диагностированным с CD33 позитивным острым миелоидным лейкозом. Препарат также получил одобрение для применения у детей старше 2-х лет с острым миелоидным лейкозом , клетки которого экспрессируют CD33. Белок CD33- это рецептор является маркером ОМЛ (острого миелоидного лейкоза), и характерен для 90% случаев острого миелолейкоза. Этот препарат был ранее одобрен для лечения взрослых пациентов с недавно диагностированным CD33-положительным ОМЛ. Также Гемтузумаб озогамицин одобрен в Европейском союзе для этой группы пациентов.

В 2000 году Милотарг уже был одобрен для применения. Впоследствии его сняли с применения, ввиду выявления риски для здоровья больных. В настоящий момент, препарат одобрен в другом терапевтическом режиме, для иной группы пациентов и в более низкой дозировке. В аннотации к препарату FDA разместила информацию о возможных побочных эффектах и рисках.

Лекарство помогает больному достичь полной ремиссии болезни и способствует гибели раковых клеток. Средство улучшает самочувствие пациента и устраняет выраженную симптоматику заболевания. На препарат Милотарг (гемтузумаб озогамицин) отзывы пациентов встречаются положительные. Отмечают меньшее проявление побочных реакций и высокую эффективность данного лекарственного средства.

Показания к применению

  • для лечения впервые диагностированного CD33 позитивного острого миелоидного лейкоза у взрослых;
  • для лечения рефрактерного и рецидивирующего острого миелоидного лейкоза с экспрессией CD33у взрослых и детей старше 2 лет.

Фармакодинамика

Милотарг — это таргетное лекартсво, которое представляет собой антитело, соединенное с токсичным противоопухолевым компонентом. К клеткам ОМЛ, экспрессирующим антиген CD33, он переносит гемтузумаб озогамицин. Раковые клетки перестают расти и гибнут.

Было показано в клинических исследованиях, что добавление препарата Милотарга к стандартной химиотерапии позволяет достигнуть более длительной ремиссии. Показатель выживаемости у пациентов, получавших гемтузумаб озогамицин, составил 4,9 месяца, а в группе паллиативной терапии – 3,6 месяца. Согласно результатам другого исследования, 26процентов пациентов, получавших гемтузумаб озогамицин, достигли полной ремиссии, средняя продолжительность которой составила 11,6 месяца.

Гемтузумаб озогамицин представляет собой рекомбинантное, гуманизированное моноклональное антитело против CD33, ковалентно взаимосвязанное с противоопухолевым цитотоксическим антибиотиком Калихеамицином (N-ацетил-калихеамином). Препарат был разработан для лечения острого миелоидного лейкоза (ОМЛ). В данном комплексе лекарственного средства и антитела, антитело избирательно взаимодействует и поглощается опухолевыми клетками, экспрессирующими антиген CD33. Присоединенный к антителу калихеамицин поставляется внутрь клеток опухоли экспрессирующей CD33 и прицельно уничтожает их. В результате достигается существенное снижение токсичности калихеамицина.

Действие Милотарга ведет к внутриклеточному освобождению диметилгидразина N-ацетил-гамма-калихеамицина путем гидролитического расщепления линкера. Активация диметилгидразида N-ацетил-гамма-калихеамицина вызывает разрывы двухцепочечной ДНК, что приводит к снижению роста раковых клеток. Препарат Милотарг активно взаимосвязывается с белками плазмы человека и метаболизируется путем неферментативного восстановления дисульфидной части.

Действие средства нацелено на купирование, а затем и уничтожение раковых клеток, согласно инструкции по применению Милотарга. В основе состава Милотарга лежит специальное антитело направленного действия. Милотарг направлен на ускорение ремиссии у пациентов, которые ранее его применяли в качестве основного средства при терапии острого миелоидного лейкоза (ОМЛ). Однако, с целью снизить риски для пациентов, схему терапии дополнили другими препаратами.

Компоненты гемтузумаб озогамицин распознают человеческий антиген CD33 и ингибируют активность опухоли. Под действием медикаментозного препарата происходит гидролитическое расщепление линкера. Лекарственное средство прерывает реакции, способствующих развитию болезни, и блокирует патологический клеточный цикл.

Этот препарат:

  •  разрывает способствующие развитию недуга реакции;
  •  останавливает болезнетворный цикл болезни;
  •  улучшает самочувствие, сглаживает и устраняет симптомы болезни;
  •  вызывает гибель раковых клеток;
  •  способствует достижению пациентом полной ремиссии при минимальных побочных явлениях.

Гемтузумаб озогамицин является CD33-направленным конъюгатом антитело-лекарственного препарат. Участок антитела (hP67.6) распознает антиген CD33 человека. N-ацетил гамма калихеамицин, представляет собой цитотоксический агент, которые ковалентно присоединен к антителу. Данные показывают, что противоопухолевая активность гемтузумаба озогамицина обусловлена связыванием с экспрессирующими CD33 опухолевыми клетками с конъюгатом антитело-лекарственное средство с последующей интернализацией комплекса А-ЛС-CD33 и внутриклеточного высвобождения диметилгидразида N-ацетил-гамма-калихеамицина путем гидролитического расщепления линкера. Активация диметилгидразида N-ацетил-гамма-калихеамицина вызывает разрывы двухцепочечной ДНК, что ведет к торможению клеточного цикла и апоптотической гибели клеток.

Фармакокинетика

При фракционированном режиме введения клинических данных фармакокинетического профиля гемтузумаба озогамицина нет. При вводении гемтузумаба озогамицина в дозе 9 мг/м² (2 дозы через 14 дней), максимальная концентрация после введения первой дозы составляла 3,0 мг/мл и увиличивалась до 3,6 мг/мл после второй инфузии.

Распределение

N-ацетил гамма калихеамицин диметилгидразид приблизительно на 97% связывается с белками плазмы человека in vitro. Общий объем распределения антитела hP67.6 составляет приблизительно 21,4 л.

Элиминация

Клиренс (CL) hP67.6 из плазмы составлял 0,35 л/часов после первой инфузии и 0,15 л/часа после второй инфузии препарата Милотарга. Период полувыведения из плазмы для hP67.6 составляет 62 часа после первой дозировки и 90 часов после второй дозировки.

Метаболизм

in vitro исследования показали, что диметилгидразид N-ацетил гамма калихеамицин главным образом интенсивно метаболизируется путем неферментативного восстановления дисульфидной части.

Меры предосторожности

  • Гепатотоксичность, включая веноокклюзионную болезнь печени

Говорилось о случаях гепатотоксичности, включая опасные для жизни и иногда фатальные случаи веноокклюзионной болезни печени у пациентов.

  • Инфузионные реакции, включая анафилаксию

В течение 24 часов во время или после инфузии могут возникать жизнеугрожающие или летальные инфузионные реакции . Симптомы и признаки и инфузионных реакций могут включать озноб, лихорадку, тахикардию, гипотонию, респираторную недостаточность и гипоксию.

  • Кровотечения

Гемтузумаб озогамицин является миелосупрессором. Может вызвать опасные для жизни или смертельные кровотечения из-за развивающейся тромбоцитопении.

 

Упаковка, срок годности, условия хранения

Препарат выпускается в форме концентрата для внутривенных инъекций, во флаконах 4,5 мг.

Хранить следует в холодильнике, вдали от света. но не подвергать замораживанию, обеспечивая оптимальную температуру 2-8℃.

 

 

 

 

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

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Позвоните и узнайте цену Милотарг (Гемтузумаб озогамицин)

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

 

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    Most athletes will select to do it from prime to bottom,
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    They quietly support your every move, maintain you upright, and assist you to raise
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    Let’s say you needed to use a cut up training method
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    the place the arm is positioned overhead. To fix this, keep away from totally straightening your
    legs at the start of every rep. Cease barely
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    This is in all probability going as a result of the seated place stretches
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    One of those muscular tissues solely crosses the knee, so
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    8-12 weeks.
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    significantly reduced3. When you begin training in your teenagers, you begin studying these habits.
    Many match people will tell you that going to the gym is just part of their day,
    very related to brushing your tooth. Bear In Mind, knowing if a teenager has gone
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    Preserving your muscle tissue robust and lean helps to enhance the method in which you
    look, your bodily and practical skills and
    also offsets pure muscle loss as a end result
    of reduced testosterone and protein synthesis. However you’ll be
    happy to know though that strength training has been proven to boost testosterone ranges
    and go some way to reversing low T in males over 50 [6].

    That is the weight that you will perform your
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    nonetheless get a great quantity of coaching volume in however
    it will enable your physique to recover from the high-intensity work, and reduce your risk of injury.
    Be sure to follow your lifts exactly how they’re supposed to be performed within the competitors.

    This first section might final one month or one year, relying
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    on to more difficult exercises‌ using extra weight and depth.
    They can give consideration to correct kind on the bench
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    Olympic weightlifting differs from other forms of weight training, like powerlifting, because it’s extra
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    Take lean physique weight in kilos and multiply by 1.0 to
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    on training and non-training days. So our man with 180 pounds of lean body
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    programmed properly. This overview of evaluations synthetizes the literature on the effect of train coaching programs on weight reduction,
    physique composition modifications together with visceral adipose tissue, and weight upkeep.
    Two essential research questions were not addressed in this overview.

    When we discuss physical activity, we are referring to increasing your daily motion. Whereas
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    Luckily, a latest meta-analysis discovered that exercise effectively treats the signs and onset of migraines³.

    Select a few exercises on your decrease body and a few in your higher body.
    Simply doing squats and lunges is adequate to target
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    You can target your shoulders, arms, back and chest with chest presses, pullups,
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    Or you could have a busy week and can’t carry weights as
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    Going low carb can optimize insulin sensitivity,
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    Another thing to suppose about is the breakdown of your
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    This weblog provides a woman’s information to gaining
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    It’s confirmed that beginners tend to get the most muscle progress from exercising to failure.
    This primary weightlifting routine ensures your
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    Repeat this superset for a total of 3 sets to wrap up your week of coaching
    (and week of full body exercise routine). First up in Exercise three
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    If you need to lose fats or simply keep lean, cardio is a must.
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    Analysis has proven that older adults who include
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    It’s necessary to concentrate on security whenever you start a weight
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    Nevertheless, if you wish to construct up muscle mass, you’ll need to
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    Kettlebells, which are weighted balls with handles, are one other popular option.
    You need not spend hours a day lifting weights to profit from strength coaching.
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    You can use free weights or your physique weight with certain exercises to provide resistance.
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    It can be greatest for people who find themselves excessively busy with their work
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    This is a 12 week Olympic weightlifting program with three to six training days per week, relying upon your classification. It can be utilized by beginner, intermediate, and advanced weightlifters, because it provides programming for
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