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Халавен — Halaven (Эрибулин)

Халавен

Халавен — Halaven (Эрибулин)

Препарат Халавен — это современное противораковое средство, которое применяют в терапии недоброкачественных новообразований в молочной железе и липосарком. Основным действующим веществом является цитостатическое вещество — эрибулин, который относится к синтетическим кетоновым аналогам halichondrin B. По структуре синтетический цитостатик практически не отличается от галихондрина В (halichondrin В), извлеченного из Halichondria okadai.

Эрибулин — мощный митотический ингибитор, препятствующий образованию микротрубочек в патологичных клетках, что приводит к активации программы их самоуничтожения (апоптоза). Халавен обладает клинической эффективностью без отрицательного влияния на качество жизни. Дополнительные исследования III фазы демонстрируют улучшение общей выживаемости у пациентов с метастатическим или местнораспространенным раком молочной железы при лечении препаратом Халавеном.

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Описание

Препарат Халавен — это современное противораковое средство, которое применяют в терапии недоброкачественных новообразований в молочной железе и липосарком. Основным действующим веществом является цитостатическое вещество — эрибулин, который относится к синтетическим кетоновым аналогам halichondrin B. По структуре синтетический цитостатик практически не отличается от галихондрина В (halichondrin В), извлеченного из Halichondria okadai.

Эрибулин — мощный митотический ингибитор, препятствующий образованию микротрубочек в патологичных клетках, что приводит к активации программы их самоуничтожения (апоптоза). Халавен обладает клинической эффективностью без отрицательного влияния на качество жизни. Дополнительные исследования III фазы демонстрируют улучшение общей выживаемости у пациентов с метастатическим или местнораспространенным раком молочной железы при лечении препаратом Халавеном.

Препарат Халавен был объектом нескольких масштабных клинических испытаний. В ходе этих испытаний препарат Халавен показал отличные результаты. По сравнению с другими цитотоксическими средствами, препарат Халавен статистически достоверно повышал выживаемость у пациенток даже с распространенными формами злокачественных опухолей молочной железы. Также, одной из его особенностей являлось и меньшее количество отмечавшихся у пациенток побочных эффектов.

Состав Халавен

1 мл препарата содержит:

  • активное вещество: эрибулина мезилат 0,5 мг;
  • вспомогательные вещества: этанол, метилкарбинол, хлористоводородная кислота, натрия гидроксид, вода для инъекций.

Показания к применению Халавен

Препарат Халавен может применяться как в монотерапии, так и в общей схеме комбинированного лечения опухолей. Абсолютными показаниями к применению цитостатического средства считаются:

  • в терапии у пациенток с метастатическим или местнораспространенным раком молочной железы, у которых, после применения как минимум одной схемы химиотерапии, отмечается прогрессирование заболевания;
  • в терапии у неоперабельных форм липосарком у пациентов, которые ранее проходили лечение антрациклиновыми антибиотиками по поводу ракового заболевания.

Фармакодинамика

Эрибулин, в классе галихондриновых ингибиторов динамики микротрубочек, является первым препаратом, обладающих новым механизмом действия. Молекула эрибулина по структуре является упрощенной синтезированной копией галихондрина B (вещества природного происхождения, выделенного из морской губки Halichondria okadai). Считается, что препарат Халавен препятствует делению клеток тем, что тормозит фазу роста микротрубочек.

Препарат Халавен блокирует формирование нетаксановых микротрубочек, что в дальнейшем ведет к нарушению митотического цикла в патологических клетках. Активные компоненты препарата Халавен приостанавливают фазу сборки и роста микротрубочек, вследствие этого происходит образование тубулиновых агрегатов, не обладающих необходимой для митотической активностью. Противораковое действие препарата Халавена осуществляется через антимитотические реакции, которые приводят к ингиброванию клеточного цикла, а также повреждению биосинтеза митотических верен.

Курсовое использование эрибулина сопровождается апоптотической гибелью раковых клеток. Это обусловлавливает практически необратимой и продолжительной блокадой митоза. Метаболиты препарата Халавен воздействуют и на фенотип недоброкачественных новообразований при помощи реакций, которые никак не связаны с антимитотическим действием.

По результатам проведенных экспериментов, эрибулин характеризуется несколькими видами функциональной активности: перевод агрессивных мезенхимальных видов липосарком и карцином в менее агрессивные фенотипы эпителиальных новообразований, а также ремоделирование капиллярного русла карцином, за счет которого улучшается перфузия центральных областей новообразований и понижается их гипоксия.

На процессы размножения опухолевых клеток с высокой избирательностью воздействует препарат Халавен. Он ингибирует формирование в клетке веретен, которые необходимы для митоза (деления). Причем эффект этот является длительным. Злокачественно перерожденная клетка погибает через некоторое время, по причине продолжающейся невозможности осуществить митоз.

Не влияя на фазу укорачивания, эрибулин ингибирует фазу роста микротрубочек, что приводит к образованию тубулиновых агрегатов, не обладающих функциональной активностью.

Противоопухолевое действие препарата Халавен реализуется через тубулин-опосредованный антимитотический механизм, который ведет к ингибированию клеточного цикла в фазах G2/M и нарушению образования митотических веретен, что, в итоге, в результате длительной блокировки митоза приводит к апоптотической гибели клетки.

Клиническая эффективность

Рак молочной железы

В двух сравнительных рандомизированных исследованиях III фазы с участием более 1800 женщин, в которых конечными точками оценки эффективности были общая выживаемость и выживаемость без прогрессирования, была подтверждена эффективность препарата Халавен при лечении местно-распространенного или метастатического рака молочной железы.

Саркомы мягких тканей

при лечении сарком мягких тканей эффективность препарата Халавен была подтверждена в ходе двух сравнительных рандомизированных исследований II фазы и одного рандомизированного исследования III фазы в сравнении с дакарбазином с участием 452 пациентов с местно-распространенными неоперабельными и/или метастатическими саркомами мягких тканей одного из следующих подтипов – липосаркома или лейомиосаркома. Конечной точкой оценки эффективности была общая выживаемость.

Фармакокинетика

Распределение

Фармакокинетика препарата Халавен характеризуется быстрой фазой распределения, которая сменяется продолжительной фазой выведения с конечным периодом полувыведения, в среднем, около 40 часов. Препарат имеет большой объем распределения (в среднем от 43 до 114 л/м2).
Эрибулин слабо связывается с белками плазмы. Доля связанного с белками плазмы эрибулина составляет от 49 процентов до 65 процентов при концентрациях в плазме человека от 100 до 1000 нг/мл.

Метаболизм

Фракция неизмененного препарата в плазме была подавляющей после введения пациентам 14С-меченного эрибулина. Концентрации метаболитов соответствовали менее 0.6процентов исходного эрибулина, подтверждая тот факт, что в организме человека не образуется значимых метаболитов эрибулина.

Выведение Халавен

Эрибулин обладает низким значением клиренса (в среднем от 1.16 до 2.42 л/ч/м2). При еженедельном введении эрибулина значимого накопления не наблюдается. Фармакокинетические параметры препарата Халавен не зависят от дозировки или времени в интервале от 0.22 до 3.53 мг/м2.
Выводится эрибулин, главным образом, с желчью.Вв настоящее время транспортный белок, отвечающий за экскрецию препарата с желчью, неизвестен. Согласно доклиническим исследованиям, считается что в этом процессе участвует Р-гликопротеина. Однако в клинически значимых концентрациях было показано, что in vitro эрибулин не является ингибитором P-гликопротеина.
In vivo на фармакокинетические параметры эрибулина (AUC и Cmax) сопутствующее введение кетоконазола, являющего ингибитором P-гликопротеина, не оказывает влияния. Исследования
После введения пациентам 14С-меченного эрибулина примерно 82% дозы выводилось с калом и 9% — с мочой, что говорит о том, что почечный клиренс не является значимым путем выведения препарата. Неизмененный эрибулин представлял большую часть радиоактивной метки в кале и моче.

Фармакокинетика у особых групп пациентов

Печеночная недостаточность

У пациентов с легкой или средней степени тяжести печеночной недостаточностью, связанной с образованием метастазов в печени, оценка фармакокинетики эрибулина по сравнению с пациентами с нормальной функцией печени, показала, что в первых двух группах пациентов экспозиция эрибулина была выше, соответственно, в 1.8 и 3 раза.

Применение препарата Халавен в дозировке 1.1 мг/м2 у пациентов с легкой печеночной недостаточностью и в дозировке 0.7 мг/м2 — у пациентов с умеренной печеночной недостаточностью предоставляло примерно такую же экспозицию, что и при применении 1.4 мг/м2 у пациентов с нормальной функцией печени.

У пациентов с тяжелой печеночной недостаточностью, а также с печеночной недостаточностью, связанной с циррозом, применение препарата Халавен не изучалось.

Почечная недостаточность

Наблюдалось увеличение экспозиции эрибулина с высокой степенью вариабельности у некоторых пациентов с почечной недостаточностью средней и тяжелой степени. У пациентов с нормальной функцией почек (КК >80 мл/мин), с почечной недостаточностью средней (КК 30-50 мл/мин) и тяжелой (КК 15-< 30 мл/мин) степени фармакокинетика эрибулина изучалась в исследовании фазы I. Величина КК оценивалась по формуле Кокрофта-Голта. Наблюдалось увеличение AUC с поправкой на дозу в 1.5 раза у пациентов с почечной недостаточностью средней и тяжелой степени.

Применение при беременности и кормлении грудью

Беременность

Данных о применении препарата Халавен у беременных нет. В доклинических исследованиях эрибулин оказывал тератогенное, фетотоксическое, эмбриотоксическое действие. Препарат Халавен не следует применять при беременности.

Лактация

О проникновении эрибулина или его метаболитов в грудное молоко человека или животных данных нет. Препарат Халавен не следует применять в период грудного вскармливания,пПоскольку риск для новорожденных и грудных детей не может быть исключен.

Фертильность

В доклинических исследованиях наблюдалась тестикулярная токсичность препарата. Поскольку при лечении препаратом Халавен существует вероятность развития необратимого бесплодия, до начала лечения пациентам мужского пола следует обратиться за консультацией по поводу консервации спермы.

Применение у детей

Применение препарата противопоказано в возрасте до 18 лет. Отсутствуют данные по безопасности и эффективности препарата Халавен у пациентов моложе 18 лет.

Применение у пожилых пациентов

Не предусмотрено специальных рекомендаций для лиц пожилого возраста по изменению дозы .

Фармацевтические характеристики Халавен

Халавен производится в виде прозрачного, бесцветого раствора для в/в инъекций.

Упаковка, срок годности, условия хранения Халавен

Выпускается в стеклянных пузырьках емкостью по 2 мл. Один пузырек с лекарственным препаратом и инструкцией по применению содержится в картонной белой пачке.

Препарат следует хранить в недоступном для детей месте при температуре от 8° до 25°С; не замораживать и не хранить в холодильнике.

Срок годности — 4 года. Не применять по истечении срока годности, указанного на упаковке.

 

 

 

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 Халавен (Эрибулин)

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

 

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    In topics with BD who have been handled with lithium, [PCr] fell
    after photic stimulation (a technique of increasing visual cortex activity) in subjects who did not reply to lithium but remained secure
    in lithium-responsive subjects and controls [161].
    This suggested that topics with BD have a deficit in PCr synthesis that is
    ameliorated by lithium. In an identical study [163], nevertheless,
    [PCr] fell in response to photic stimulation in controls, but not in bipolar subjects, despite
    the fact that PCr/ATP ratios had been reduced in BD, and [ATP] fell in BD in response to
    photic stimulation. A research utilizing magnetization switch to estimate the rate constant for the creatine
    kinase response in BD discovered that it didn’t
    differ significantly between euthymic or depressed bipolar topics and controls [162].

    In distinction, subjects with a first episode of bipolar despair (BD) or mania
    and psychotic features exhibited a 13% discount within the
    price fixed for the creatine kinase response [159].

    The difference between these studies may be because of the absence of psychosis among the many subjects within the first examine or, once more, to
    the difference in mood states, as most of the topics within the second research have been manic.

    Reduce your intake of meals containing sugar and refined carbohydrates
    if possible during the first week of your creatine program.
    Your body will have an easier time processing all the extra energy
    and carbohydrates, which may help reduce unwanted aspect effects such as bloating.
    The major objective of creatine is to supply vitality for high-intensity activities similar to weightlifting.
    It does this by appearing as a fast power source for muscle cells,
    which increases the velocity at which they will produce short bursts of energy often recognized as ATP.

    In the diverse world of economic dietary supplements, creatine
    monohydrate stands out as being broadly utilized by high-level athletes and physically active individuals [1,2,3].
    Creatine monohydrate consumption can influence skeletal muscle through a
    quantity of mechanisms which maintain muscle reworking [4].
    Creatine supplementation is often used to maximize the consequences of resistance training, including neuromuscular recruitment, increased protein synthesis, and muscle fiber sort modifications [5,6,7,eight,9].

    However as a general guideline, if you determine on creatine
    monohydrate, it’s necessary to begin with a loading section, adopted by a upkeep
    part. Different manufacturers depart the water molecule completely out of their creatine monohydrate supplements.
    It’s been across the longest within the health and sports vitamin world and has been studied
    extensively.
    We purpose to supply a complete understanding of both forms, enabling
    readers to make an informed choice on which might best swimsuit their fitness goals and well being issues.
    A typical creatine supplementation protocol of both a loading phase of 20 to 25 g CM/d or 0.3
    g CM/kg/d split into four to 5 every day intakes of 5 g every have been recommended to
    shortly saturate creatine shops in the skeletal muscle.

    Nonetheless a more reasonable protocol the place several smaller doses of creatine are ingested
    alongside the day (20 intakes of 1 g each 30 min) could be a better
    approach to get a maximal saturation of the intramuscular creatine store.
    In order to maintain the maximal saturation of physique creatine, the loading part should be followed by a upkeep
    interval of 3-5 g CM/d or zero.03 g CM/kg/d.
    Creatine supplements improve the physique’s store of phosphocreatine, which is used to supply ATP,
    the primary energy currency of the cell, throughout short bursts of high-intensity exercise.
    This can lead to improved efficiency in activities
    such as sprinting, weightlifting, and different explosive
    actions by growing the period that high-intensity train may be sustained.
    While creatine monohydrate is more generally used and researched, creatine phosphate is one other type that some athletes and fitness fanatics think about.

    It is necessary to understand the differences in absorption, efficacy, and safety between these two types of creatine.
    Creatine HCL may be thought of better for cutting
    by some due to its potential for causing much less water retention in comparison with Creatine Monohydrate.

    In this type leaves the mitochondria and transports to the unique ATP vacation spot where the disconnection occurs.

    In addition to this, the health group has offered loads of positive suggestions on creatine HCL to indicate that the improved absorption might yield
    even better results than creatine monohydrate.
    Nevertheless, you will need to note that creatine HCL
    hasn’t been researched as extensively as creatine monohydrate.
    Subsequently, it is irresponsible to accept any claims made by those
    who market it as scientific reality. Nonetheless, early research has advised that creatine HCL may have fewer opposed side effects
    because of its higher solubility and intestinal absorption (6).
    The solely distinction is that one is attached to a hydrochloride group and
    the opposite to a water molecule. The attachment to an HCL group improves absorption while lowering water retention and gastrointestinal unwanted
    effects.
    Due To This Fact, it’s not stunning that creatine performs a critical function throughout a cardiac
    ischemic occasion [185,186]. First in vitro studies enable the hypothesis that saturation of myocardial creatine stores
    might result in protection in the occasion of a transient ischemic assault [49].
    In this context, in animal studies, crammed ATP stores have a positive inotropic, apoptosis-protective
    effect and counteract a post-ischemic inflammatory cascade [187].

    Imply peak concentrations and space underneath the curve (AUC) were considerably higher with CPY (17 and 14%,
    respectively) compared to CM. The small differences in kinetics are unlikely to have any
    clinically relevant results on muscle creatine elevation during times of creatine loading.
    A follow-up research together with muscle biopsies
    could be required to conclude if the bioavailability of this particular creatine salt was indeed higher (Fig. 
    8). Creatine supplementation is renowned for its capacity to considerably improve athletic efficiency by improving power, energy, and endurance in high-intensity
    workouts. Beyond its instant results on physical efficiency, creatine also contributes to elevated muscle mass.

    Some research have proven that creatine additionally carries a therapeutic effect on muscles
    (12). Creatine dietary supplements improve your efficiency, delays fatigue,
    serving to you to train better and longer. Nonetheless, should you
    experience abdomen pain or any discomfort with creatine monohydrate, you can strive creatine HCL.
    Your body needs time to adjust with any type of creatine; hence give enough time while making
    an attempt for the primary time. We can conclude, saying that creatine HCL is best, as it is better absorbed, however there
    might be not sufficient proof to assist this principle.

    Graef et al [35] examined the results of four weeks of creatine citrate supplementation and high-intensity interval
    training on cardio respiratory fitness. A
    greater improve of the ventilatory threshold was observed within the creatine group respect to
    placebo; however, oxygen consumption showed no vital variations between the
    groups. The total work offered no interaction and no major effect for time for any of
    the teams. Thompson et al [36] reported no effects of a 6 week 2 g CM/d in cardio and anaerobic endurance
    efficiency in female swimmers. In addition, of the
    concern associated to the dosage used in these research, it could be
    possible that the potential advantages of creatine supplementation on endurance efficiency had been extra
    related to results of anaerobic threshold localization. Creatine ethyl ester has been purported to
    be a superior form of creatine in comparison to
    CM. However, prior research have shown that it degrades rather shortly to creatinine when exposed to low pH levels as
    could be found in the abdomen (Giese and Lecher 2009a; Katseres et al.

    2009).
    Creatine generates adenosine triphosphate (ATP) to maintain a continuing provide of power throughout exercise, to
    maintain up with the production of your working muscles.
    Thanks to its capability to ramp up your ATP production in moments of want, creatine supplementation has been shown to improve muscle strength and increase lean muscle mass, says Bogden. In truth, one 2021 review published in Nutrients discovered that those that supplemented with
    creatine skilled larger will increase in relative muscle energy during lifts than those who didn’t complement.
    Throughout training and train, elevated out there power can even translate to increased explosivity during actions such as
    plyometrics and Olympic lifts, in accordance with Bogden. Although creatine has been principally studied as an ergogenic
    assist for train, coaching, and sport, a number of health and potential therapeutic
    advantages have been reported. This is as a end result
    of creatine plays a critical role in cellular metabolism,
    significantly throughout metabolically stressed states, and limitations in the ability to move and/or store
    creatine can impair metabolism. Moreover, growing availability of creatine in tissue could
    improve cellular metabolism and thereby reduce the
    severity of damage and/or illness situations, particularly when oxygen availability is
    compromised.
    To date, excluding Japan, CM is the one form of creatine to
    be officially accredited or accepted in key markets such as the USA, European Union (EU),
    Canada and South Korea. The continued presence of other forms of creatine within the market, particularly in the US, could also be as a outcome
    of a multitude of factors. These include,
    but may not be restricted to, a ignorance or understanding
    on the part of marketers of relevant laws and laws,
    intentional noncompliance with the legislation, and/or insufficient enforcement of the legislation.
    The public health implications of widespread distribution and use of these unauthorized types of creatine is
    unknown and warrants cautious monitoring. To some
    extent, you presumably can say that creatine nitrate could be better than Monohydrate
    as it is intentionally different in type and many other elements.
    However,  the proof to support the efficacy isn’t much and creatine monohydrate already holds plenty of
    scientific help to spice up performance and improve muscle progress.

    Feminine rats receiving 4% creatine exhibited significantly longer latency to immobility on the FST than controls,
    suggesting reduced depression-like habits, although there
    was no difference between groups within the WST. Surprisingly, male rats maintained
    on 4% creatine confirmed lowered time to immobility and elevated immobility within the FST, and once more no
    difference within the WST. In a later study, the investigators used an analogous protocol to assess the influence
    of creatine supplementation on response to the antidepressant
    fluoxetine. They discovered that female rats maintained
    on 4% creatine by weight for five weeks exhibited reduction in depressive behavior on the FST,
    and that the addition of creatine to fluoxetine enhanced the antidepressant effect of fluoxetine.

    Analysis of estrous cycle information for the animals indicated that
    ovarian hormones probably affected the response to creatine, with the
    antidepressant effects in females occurring within the proestrous and estrous phases [19].
    To further discover the effect of gonadal hormones on creatine’s antidepressant efficacy, Allen and colleagues later carried out two associated
    experiments. In the first experiment, male rats underwent either gonadectomy
    or sham surgery.
    Outcomes confirmed that every one groups’ power ranges, endurance,
    stamina, and body fat percentages elevated. Which Means, both
    Kre-alkalyn and creatine monohydrate considerably boost power ranges and stamina, which aid in the optimization of workouts.
    Your muscles are composed of approximately 70% water, in order that they need loads of water to perform optimally.
    This helps to increase muscle volume and power by enhancing protein synthesis and stimulating muscular hypertrophy (growth).

    Utilizing this, research was able to prove mitochondrial
    dysfunction in sufferers with bipolar problems.
    These patients additionally suffered from an impaired
    vitality production [122], increased ranges of lactate
    (hyperacidotic state) [123] and PCr concentration [114,124,125].

    Therefore, it was assumed that creatine supplementation could enhance medical end result
    in instances of mitochondrial dysfunction.
    Anabolic steroids are in essence hormones, ensuing in their having a
    large impression on many physiological processes in the human organism.

    Prolonged consumption of testosterone analogues will decrease the endogenous manufacturing
    of testosterone within the testicles, which can trigger a scarcity of this hormone after quitting the complement.
    Individuals with heart-related disorders or prostate enlargement should not take anabolic steroids, as they can worsen these and a lot of different conditions.
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    monohydrate, which has actually to be shown as the most inexpensive and efficient type.

    Whether you would like to improve your train performance, increase muscle mass, or forestall persistent illness, you could be interested
    in the benefits of creatine. Creatine is of course found within the physique and provides vitality to your skeletal
    muscle cells. Not solely is creatine thought of a protected supplement for many people, but it’s also some of the well-liked and efficient dietary supplements for constructing muscle and boosting athletic efficiency.
    Creatine monohydrate’s effectiveness is backed by a long time of scientific research,
    making it essentially the most dependable and trusted form of creatine out there.
    It has been shown to be highly efficient in growing muscle creatine ranges, which is crucial for
    bettering train performance, promoting muscle development, and aiding in restoration. When evaluating the cost of creatine hcl vs
    monohydrate, creatine monohydrate is also
    cheaper, providing a more accessible possibility for people seeking to incorporate creatine into their
    supplementation regimen without breaking the financial institution. Analysis shows that creatine plays a direct
    function in drastically enhancing high-intensity train efficiency.

    This could have hindered the detection of small differences in the anaerobic metabolism (Doherty et al., 2000, 2002).

    Creatinol in the type of creatinol-O-phosphate (COP) has been described and utilized in topics with
    deficient myocardial circulation (Guglielmi and Mammarella 1979).
    The elevated urinary values are derived from the degradation of creatine into creatinine via the everyday biochemical pathways.
    Solely one research investigated the power of COP to enhance muscular performance (Nicaise 1975).

    Breaking down PCr into Pi and Cr with the enzyme CK yields about 10.3 kcals of free vitality that can be
    used to resynthesize ADP -+ Pi into ATP [38,39,fifty six,57].
    Creapure creatine monohydrate presents a quantity of advantages like improved strength, lean muscle mass, & enhanced recovery.
    It’s additionally known for its purity and for
    being the creatine efficiently used in most sports science studies.

    Sure, it’s renowned for enhancing strength, promoting lean muscle mass, and speeding
    up muscle restoration. Both types of creatine have been studied
    for his or her influence on muscle creatine content, with research displaying that
    they will promote significant adjustments in muscle
    creatine levels. Additionally, resistance coaching promoted extensive interstitial remodeling in both
    skeletal muscle varieties.

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