Противоопухолевый препарат, из группы винкаалкалоидов, представляет собой алкалоид Барвинка розового. Нарушает полимеризацию тубулина в процессе клеточного митоза. Блокирует митоз в фазе G2+M и вызывает разрушение клеток в интерфазе или при последующем митозе. Действует преимущественно на митотические микротрубочки; при применении в высоких дозах оказывает влияние и на аксональные микротрубочки. Эффект спирализации тубулина, вызываемый винорелбином, выражен слабее, чем у винкристина.
Фармакокинетика
После в/в введения препарата прослеживается трехфазная кинетика.
Распределение
Связывание с белками плазмы составляет 13.5%. Интенсивно связывается с клетками крови и особенно с тромбоцитами (78%). Хорошо проникает в ткани и задерживается в них длительное время. В больших количествах определяется в селезенке, печени, почках, легких и вилочковой железе, умеренные - в сердце и мышцах; в минимальных количествах - в жировой ткани и костном мозге. Не проникает через ГЭБ. Концентрация в легких в 300 раз превышает концентрацию в плазме.
Метаболизм
Метаболизируется в печени, главным образом под действием изофермента CYPЗА4. Образует ряд метаболитов, один из которых, диацетилвинорелбин, сохраняет противоопухолевую активность.
Выведение
Средний T1/2 в конечной фазе составляет 40 (27.7-43.6) ч.
Выводится преимущественно с желчью.
Фармакокинетика в особых клинических случаях
Фармакокинетика винорелбина, вводимого в дозе 20 мг/м2 еженедельно у пациентов с умеренной или выраженной печеночной недостаточностью, не меняется.
Фармакокинетика винорелбина не зависит от возраста пациентов.
Показания к применению
немелкоклеточный рак легкого;
рак молочной железы;
рак предстательной железы, резистентный к гормонотерапии (в комбинации с малыми дозами пероральных кортикостероидов).
Противопоказания
исходное число нейтрофилов в крови <1500/мкл, содержание тромбоцитов <75 000 /мкл;
тяжелые инфекционные заболевания во время начала терапии или перенесенные в течение последних 2 недель;
выраженная печеночная недостаточность, не связанная с опухолевым процессом;
потребность в постоянной оксигенотерапии - у больных с опухолью легкого;
беременность;
период лактации (грудное вскармливание);
повышенная чувствительность к компонентам препарата;
повышенная чувствительность к винкаалкалоидам.
С осторожностью
С осторожностью следует применять препарат при дыхательной недостаточности, угнетении костномозгового кроветворения (в т.ч. после предыдущей химиотерапии или лучевого лечения), запорах или явлениях кишечной непроходимости в анамнезе, невропатии в анамнезе.
Применение при беременности и в период грудного вскармливания
Противопоказано применение при беременности и в период лактации (грудного вскармливания).
Во время и в течение, по крайней мере, 3 месяцев после прекращения терапии необходимо использовать надежные методы контрацепции.
Способ применения и дозы
Велбин применяется как в виде монотерапии, так и в комбинации с другими противоопухолевыми препаратами. При выборе дозы и режима введения в каждом индивидуальном случае следует обращаться к специальной литературе.
Велбин вводят строго в/в в виде 6-10-минутной инфузии.
При монотерапии обычная доза препарата составляет 25-30 мг/м2 поверхности тела 1 раз/нед.
Препарат разводят в 0.9 % растворе натрия хлорида или 5% растворе декстрозы до концентрации 1.0-2.0 мг/мл. После введения препарата вену следует промыть, вводя дополнительно не менее 250 мл 0.9% раствора натрия хлорида или 5% раствора декстрозы.
Для пациентов с площадью поверхности тела >2 м2разовая доза Велбина при в/в не должна превышать 60 мг.
При полихимиотерапии доза и частота введения Велбина зависят от конкретной программы противоопухолевой терапии.
При снижении содержания нейтрофилов <1500/мкл или тромбоцитопении <75 000/мкл очередное введение Велбина откладывают на 1 неделю. Если из за гематологической токсичности пришлось воздержаться от 3 еженедельных введений препарата, применение Велбина рекомендуется прекратить.
У пациентов с выраженной печеночной недостаточностью Велбин следует назначать с осторожностью в дозе, не превышающей 20 мг/м2.
Побочное действие
Co стороны органов кроветворения: нейтропения, анемия, тромбоцитопения; на фоне угнетения костномозгового кроветворения - присоединение вторичных инфекций, лихорадка (>38°С), сепсис, септицемия, очень редко - осложненная септицемия, в некоторых случаях приводящая к летальному исходу. Наименьшее число нейтрофилов наблюдается на 7-10 день от начала терапии, восстановление происходит в последующие 5-7 дней.
Кумулирования гематотоксичности не отмечено.
Аллергические реакции: редко - анафилактический шок или ангионевротический отек.
Со стороны нервной системы: парестезии, гиперестезии, снижение или выпадение глубоких сухожильных рефлексов, слабость в ногах, боль в области челюстей, редко тяжелые парестезии с сенсорными и моторными симптомами, как правило, обратимого характера.
Со стороны сердечно-сосудистой системы: повышение или снижение АД, приливы жара и похолодание конечностей, ИБС (стенокардия, инфаркт миокарда), выраженная гипотензия, коллапс; крайне редко - тахикардия, сердцебиение и нарушение сердечного ритма.
Со стороны дыхательной системы: одышка, бронхоспазм, интерстициальная пневмония (при комбинированной терапии с митомицином С), острый респираторный дистресс-синдром.
Со стороны пищеварительной системы: тошнота, рвота, анорексия, стоматит, запор, диарея, панкреатит, парез кишечника, преходящее повышение уровня билирубина и повышение активности печеночных трансаминаз.
Со стороны кожи и кожных придатков: алопеция, кожные высыпания.
Местные реакции: боль/жжение или покраснение в месте инъекции, изменение окраски вены, флебит; при экстравазации - воспаление подкожной жировой клетчатки, некроз окружающих тканей.
Прочие: слабость, миалгия, артралгия, лихорадка, боли различной локализации, включая боль в области грудной клетки и в области опухолевых образований, гипонатриемия, геморрагический цистит и синдром неадекватной секреции АДГ
Передозировка
Симптомы: возможны подавление функции костного мозга и проявления нейротоксичности.
Лечение: специфический антидот не известен. В случае передозировки больного следует госпитализировать и тщательно контролировать функции жизненно важных органов. Проведение симптоматической терапии.
Взаимодействие с другими лекарственными средствами
При совместном применении с другими цитостатиками возможно взаимное усугубление побочных эффектов, в первую очередь - миелосупрессии.
При совместном применении с митомицином С возможно развитие острой дыхательной недостаточности.
При применении совместно с паклитакселом повышается риск нейротоксичности.
Применение на фоне лучевой терапии приводит к радиосенсибилизации. При применении винорелбина после лучевой терапии может привести к повторному появлению лучевых реакций.
Одновременное применение препарата с индукторами и ингибиторами цитохрома Р450 может привести к изменению фармакокинетики винорелбина.
Условия хранения препарата Велбин
Особые указания
Лечение препаратом Велбин следует проводить под наблюдением врача, имеющего опыт работы с противоопухолевыми препаратами.
Лечение проводят под строгим гематологическим контролем, определяя число лейкоцитов, нейтрофилов, тромбоцитов и уровень гемоглобина перед каждой очередной инъекцией или приемом внутрь. При содержании нейтрофилов ниже 1500 клеток/мкл и/или тромбоцитов ниже 75 000 клеток/мкл введение очередной дозы следует отложить до восстановления нормального уровня.
При выраженном нарушении функции печени дозы Велбина следует снизить на 33%.
При нарушении функции почек необходимо усиленное наблюдение за больным.
При появлении признаков нейротоксичности 2 и более степени применение Велбина следует прекратить.
При появлении одышки, кашля или гипоксии невыясненной этиологии следует обследовать больного для исключения легочной токсичности.
При экстравазации инфузию препарата следует немедленно прекратить, оставшуюся дозу вводят в другую вену.
При попадании Велбина в глаза их следует обильно и тщательно промыть водой.
Какие-либо специальные инструкции по применению препарата Велбин у пациентов пожилого возраста отсутствуют.
Использование с педиатрии
Безопасность и эффективность Велбина у детей не изучена.
Для описания товара использована информация от партнера 36.6
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средство"}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"Противоопухолевый препарат, из группы винкаалкалоидов, представляет собой алкалоид Барвинка розового. Нарушает полимеризацию тубулина в процессе клеточного митоза. Блокирует митоз в фазе G2+M и вызывает разрушение клеток в интерфазе или при последующем митозе. Действует преимущественно на митотические микротрубочки; при применении в высоких дозах оказывает влияние и на аксональные микротрубочки. Эффект спирализации тубулина, вызываемый винорелбином, выражен слабее, чем у винкристина."}},{"type":"header","data":{"text":"Фармакокинетика","level":4}},{"type":"paragraph","data":{"text":"После в/в введения препарата прослеживается трехфазная кинетика."}},{"type":"paragraph","data":{"text":"\u003ci\u003eРаспределение\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Связывание с белками плазмы составляет 13.5%. Интенсивно связывается с клетками крови и особенно с тромбоцитами (78%). Хорошо проникает в ткани и задерживается в них длительное время. В больших количествах определяется в селезенке, печени, почках, легких и вилочковой железе, умеренные - в сердце и мышцах; в минимальных количествах - в жировой ткани и костном мозге. Не проникает через ГЭБ. Концентрация в легких в 300 раз превышает концентрацию в плазме."}},{"type":"paragraph","data":{"text":"\u003ci\u003eМетаболизм\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Метаболизируется в печени, главным образом под действием изофермента CYPЗА4. Образует ряд метаболитов, один из которых, диацетилвинорелбин, сохраняет противоопухолевую активность."}},{"type":"paragraph","data":{"text":"\u003ci\u003eВыведение\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Средний T\u003csub\u003e1/2 \u003c/sub\u003eв конечной фазе составляет 40 (27.7-43.6) ч."}},{"type":"paragraph","data":{"text":"Выводится преимущественно с желчью."}},{"type":"paragraph","data":{"text":"\u003ci\u003eФармакокинетика в особых клинических случаях\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Фармакокинетика винорелбина, вводимого в дозе 20 мг/м\u003csup\u003e2\u003c/sup\u003e еженедельно у пациентов с умеренной или выраженной печеночной недостаточностью, не меняется."}},{"type":"paragraph","data":{"text":"Фармакокинетика винорелбина не зависит от возраста пациентов."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"list","data":{"style":"ordered","items":["немелкоклеточный рак легкого;","рак молочной железы;","рак предстательной железы, резистентный к гормонотерапии (в комбинации с малыми дозами пероральных кортикостероидов)."]}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"list","data":{"style":"ordered","items":["исходное число нейтрофилов в крови <1500/мкл, содержание тромбоцитов <75 000 /мкл;","тяжелые инфекционные заболевания во время начала терапии или перенесенные в течение последних 2 недель;","выраженная печеночная недостаточность, не связанная с опухолевым процессом;","потребность в постоянной оксигенотерапии - у больных с опухолью легкого;","беременность;","период лактации (грудное вскармливание);","повышенная чувствительность к компонентам препарата;","повышенная чувствительность к винкаалкалоидам."]}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":" С \u003ci\u003eосторожностью \u003c/i\u003eследует применять препарат при дыхательной недостаточности, угнетении костномозгового кроветворения (в т.ч. после предыдущей химиотерапии или лучевого лечения), запорах или явлениях кишечной непроходимости в анамнезе, невропатии в анамнезе. "}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Противопоказано применение при беременности и в период лактации (грудного вскармливания)."}},{"type":"paragraph","data":{"text":"Во время и в течение, по крайней мере, 3 месяцев после прекращения терапии необходимо использовать надежные методы контрацепции."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Велбин применяется как в виде монотерапии, так и в комбинации с другими противоопухолевыми препаратами. При выборе дозы и режима введения в каждом индивидуальном случае следует обращаться к специальной литературе."}},{"type":"paragraph","data":{"text":"Велбин вводят строго в/в в виде 6-10-минутной инфузии."}},{"type":"paragraph","data":{"text":"При \u003cb\u003eмонотерапии\u003c/b\u003e обычная доза препарата составляет 25-30 мг/м\u003csup\u003e2\u003c/sup\u003e поверхности тела 1 раз/нед."}},{"type":"paragraph","data":{"text":"Препарат разводят в 0.9 % растворе натрия хлорида или 5% растворе декстрозы до концентрации 1.0-2.0 мг/мл. После введения препарата вену следует промыть, вводя дополнительно не менее 250 мл 0.9% раствора натрия хлорида или 5% раствора декстрозы."}},{"type":"paragraph","data":{"text":"Для\u003cb\u003e пациентов с площадью поверхности тела >2 м\u003csup\u003e2\u003c/sup\u003e \u003c/b\u003eразовая доза Велбина при в/в не должна превышать 60 мг."}},{"type":"paragraph","data":{"text":"При \u003cb\u003eполихимиотерапии\u003c/b\u003e доза и частота введения Велбина зависят от конкретной программы противоопухолевой терапии."}},{"type":"paragraph","data":{"text":"При снижении содержания нейтрофилов <1500/мкл или тромбоцитопении <75 000/мкл очередное введение Велбина откладывают на 1 неделю. Если из за гематологической токсичности пришлось воздержаться от 3 еженедельных введений препарата, применение Велбина рекомендуется прекратить."}},{"type":"paragraph","data":{"text":"У\u003cb\u003e пациентов с выраженной печеночной недостаточностью\u003c/b\u003e Велбин следует назначать с осторожностью в дозе, не превышающей 20 мг/м\u003csup\u003e2\u003c/sup\u003e."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eCo стороны органов кроветворения: \u003c/i\u003eнейтропения, анемия, тромбоцитопения; на фоне угнетения костномозгового кроветворения - присоединение вторичных инфекций, лихорадка (>38°С), сепсис, септицемия, очень редко - осложненная септицемия, в некоторых случаях приводящая к летальному исходу. Наименьшее число нейтрофилов наблюдается на 7-10 день от начала терапии, восстановление происходит в последующие 5-7 дней."}},{"type":"paragraph","data":{"text":"Кумулирования гематотоксичности не отмечено."}},{"type":"paragraph","data":{"text":"\u003ci\u003eАллергические реакции: \u003c/i\u003eредко - анафилактический шок или ангионевротический отек."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны нервной системы: \u003c/i\u003eпарестезии, гиперестезии, снижение или выпадение глубоких сухожильных рефлексов, слабость в ногах, боль в области челюстей, редко тяжелые парестезии с сенсорными и моторными симптомами, как правило, обратимого характера."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны сердечно-сосудистой системы: \u003c/i\u003eповышение или снижение АД, приливы жара и похолодание конечностей, ИБС (стенокардия, инфаркт миокарда), выраженная гипотензия, коллапс; крайне редко - тахикардия, сердцебиение и нарушение сердечного ритма."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны дыхательной системы: \u003c/i\u003eодышка, бронхоспазм, интерстициальная пневмония (при комбинированной терапии с митомицином С), острый респираторный дистресс-синдром."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны пищеварительной системы: \u003c/i\u003eтошнота, рвота, анорексия, стоматит, запор, диарея, панкреатит, парез кишечника, преходящее повышение уровня билирубина и повышение активности печеночных трансаминаз."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны кожи и кожных придатков: \u003c/i\u003eалопеция, кожные высыпания."}},{"type":"paragraph","data":{"text":"\u003ci\u003eМестные реакции: \u003c/i\u003eболь/жжение или покраснение в месте инъекции, изменение окраски вены, флебит; при экстравазации - воспаление подкожной жировой клетчатки, некроз окружающих тканей."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПрочие: \u003c/i\u003eслабость, миалгия, артралгия, лихорадка, боли различной локализации, включая боль в области грудной клетки и в области опухолевых образований, гипонатриемия, геморрагический цистит и синдром неадекватной секреции АДГ"}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eСимптомы:\u003c/i\u003e возможны подавление функции костного мозга и проявления нейротоксичности."}},{"type":"paragraph","data":{"text":"\u003ci\u003eЛечение:\u003c/i\u003e специфический антидот не известен. В случае передозировки больного следует госпитализировать и тщательно контролировать функции жизненно важных органов. Проведение симптоматической терапии."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"При совместном применении с другими цитостатиками возможно взаимное усугубление побочных эффектов, в первую очередь - миелосупрессии."}},{"type":"paragraph","data":{"text":"При совместном применении с митомицином С возможно развитие острой дыхательной недостаточности."}},{"type":"paragraph","data":{"text":"При применении совместно с паклитакселом повышается риск нейротоксичности."}},{"type":"paragraph","data":{"text":"Применение на фоне лучевой терапии приводит к радиосенсибилизации. При применении винорелбина после лучевой терапии может привести к повторному появлению лучевых реакций."}},{"type":"paragraph","data":{"text":"Одновременное применение препарата с индукторами и ингибиторами цитохрома Р\u003csub\u003e450\u003c/sub\u003e может привести к изменению фармакокинетики винорелбина."}},{"type":"header","data":{"text":"Условия хранения препарата Велбин","level":4}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Лечение препаратом Велбин следует проводить под наблюдением врача, имеющего опыт работы с противоопухолевыми препаратами."}},{"type":"paragraph","data":{"text":"Лечение проводят под строгим гематологическим контролем, определяя число лейкоцитов, нейтрофилов, тромбоцитов и уровень гемоглобина перед каждой очередной инъекцией или приемом внутрь. 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