Противоопухолевое средство алкилирующего действия, имеет ими... Инструкция
Показания к применению
Злокачественные глиомы (в т.ч. мультиформная глиобластома, анапластическая астроцитома) при наличии рецидива или прогрессирования заболевания после стандартной терапии распространенная метастазирующая злокачественная меланома (в качестве терапевтического средства первого ряда).
Противопоказания
Тяжелая миелодепрессия, беременность, лактация (грудное вскармливание), повышенная чувствительность к темозоломиду или к дакарбазину.
Противоопухолевое средство алкилирующего действия, имеет имидазотетразиновую структуру. В системном кровотоке при физиологических значениях рН подвергается быстрому химическому превращению с образованием активного соединения - монометилтриазеноимидазолкарбоксамида (МТИК). Считается, что цитотоксичность МТИК обусловлена, в первую очередь, алкилированием гуанина в положении О6 и дополнительным алкилированием в положении N7. По-видимому, цитотоксические повреждения, возникающие вследствие этого, запускают механизм аберрантного восстановления метилового остатка.
Показания к применению
Злокачественные глиомы (в т.ч. мультиформная глиобластома, анапластическая астроцитома) при наличии рецидива или прогрессирования заболевания после стандартной терапии распространенная метастазирующая злокачественная меланома (в качестве терапевтического средства первого ряда).
Противопоказания
Тяжелая миелодепрессия, беременность, лактация (грудное вскармливание), повышенная чувствительность к темозоломиду или к дакарбазину.
Применение при беременности и в период грудного вскармливания
Противопоказан при беременности и в период лактации (грудного вскармливания). Мужчины и женщины детородного возраста должны пользоваться эффективными противозачаточными средствами во время лечения и в течение как минимум 6 мес после окончания лечения.
Способ применения и дозы
Индивидуальный, в зависимости от возраста и предшествующей химиотерапии.
Побочное действие
Со стороны пищеварительной системы: тошнота, рвота, запор, анорексия, диарея, боли в животе, диспепсия, нарушение вкуса. Со стороны ЦНС: утомляемость, головная боль, сонливость, головокружение, парестезии. Дерматологические реакции: кожные высыпания, алопеция, кожный зуд. Со стороны дыхательной системы: одышка. Со стороны системы кроветворения: тромбоцитопения и нейтропения 3 или 4 степени, панцитопения, лейкопения и анемия. Прочие: лихорадка, астения, снижение массы тела, недомогание, озноб.
Особые указания
С осторожностью применять у пациентов с тяжелыми нарушениями функции печени или почек, больных пожилого возраста (т.к. у лиц старше 70 лет риск развития нейтропении и тромбоцитопении выше, чем у более молодых). Клинический опыт применения при мультиформной глиобластоме у детей до 3 лет и при злокачественной меланоме у детей и подростков до 18 лет отсутствует. Клинический опыт применения при глиоме у детей старше 3 лет ограничен. Влияние на способность к вождению автотранспорта и управлению механизмами Темозоломид может вызывать сонливость и чувство усталости и поэтому отрицательно влиять на способность к вождению автотранспорта и управлению сложными механизмами.
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