Хронический миелолейкоз в фазе акселерации, бластного криза, а также в хронической фазе; лечение неоперабельных и/или метастатических злокачественных стромальных опухолей желудочно-кишечного тракта (у взрослых пациентов).
Иматиниб-ТЛ - ингибитор протеинтирозинкиназы. Ингибирует фермент Bcr-Abl-тирозинкиназу на клеточном уровне, in vitro и in vivo. Селективно подавляет пролиферацию и вызывает апоптоз клеточных линий, позитивных по Bcr-Abl, а также молодых лейкозных клеток при хроническом миелолейкозе с положительной филадельфийской хромосомой и при остром лимфобластном лейкозе.
В исследованиях по трансформации колоний, проведенных на пробах периферической крови и костного мозга, было показано, что иматиниб селективно ингибирует Bcr-Abl-позитивные колонии, полученные у больных хроническим миелолейкозом.
В исследованиях, проведенных in vivo на животных моделях с использованием Bcr-Abl-позитивных опухолевых клеток, было показано, что препарат обладает противоопухолевой активностью при монотерапии.
Кроме того, иматиниб является ингибитором рецепторов тирозин-киназы для фактора роста тромбоцитов и фактора стволовых клеток, а также подавляет клеточные реакции, опосредуемые вышеназванными факторами.
In vitro иматиниб ингибирует пролиферацию и индуцирует апоптоз клеток стромальных опухолей ЖКТ, экспрессирующих kit-мутации.
Фармакокинетика
После приема внутрь биодоступность в среднем 98%. Коэффициент вариации для AUC составляет 40-60%. При приеме с пищей с высоким содержанием жиров, по сравнению с приемом натощак, отмечается незначительное снижение степени абсорбции (уменьшение Cmax на 11%, AUC - на 7.4%) и замедление скорости абсорбции (удлинение Tmax на 1.5 ч).
При клинически значимых концентрациях иматиниба его связывание с белками плазмы составляет около 95% (главным образом с альбумином и кислым альфа-гликопротеином, в незначительной степени - с липопротеином).
Основным метаболитом иматиниба, циркулирующим в кровяном русле, является N-деметилированное пиперазиновое производное, которое in vitro обладает фармакологической активностью, сходной с таковой неизмененного активного вещества. Значение AUC для метаболита составляет 16% от AUC иматиниба.
После приема внутрь14C-меченого иматиниба за 7 дней было выведено с калом 68% введенной дозы и с мочой 13% дозы. В неизмененном виде выводится около 25% дозы (20% - с калом и 5% - с мочой). Остальное количество иматиниба выводится в виде метаболитов.
T1/2 иматиниба у здоровых добровольцев составил около 18 ч.
При нарушении функции печени возможно повышение концентрации иматиниба в плазме крови.
Показания к применению
Хронический миелолейкоз в фазе акселерации, бластного криза, а также в хронической фазе; лечение неоперабельных и/или метастатических злокачественных стромальных опухолей желудочно-кишечного тракта (у взрослых пациентов).
Противопоказания
Повышенная чувствительность к иматинибу.
Применение при беременности и в период грудного вскармливания
Назначать беременным женщинам можно лишь в том случае, если преимущества терапии превышают потенциальный риск для плода (адекватных и хорошо контролируемых исследований у беременных женщин не проводили). В случае применения при беременности или в период планируемой беременности необходимо предупредить пациентку о потенциальном риске для плода. Женщинам детородного возраста во время терапии необходимо использовать эффективные методы контрацепции.
С учетом возможности развития потенциально серьезных побочных реакций у ребенка в случае попадания ЛС в организм, иматиниба мезилат не следует назначать кормящим матерям.
Способ применения и дозы
Внутрь (во время еды, запивая полным стаканом воды), 1 раз в сутки.
Взрослым, рекомендуемая суточная доза в стадии ремиссии — 400 мг, в стадии обострения и при бластном кризе — 600 мг. При прогрессировании заболевания, недостаточном гематологическом эффекте в течение 3 месяцев терапии и отсутствии серьезных побочных эффектов возможно увеличение дозы: в стадии ремиссии — до 600 мг в сутки, в стадии обострения и при бластном кризе — до 800 мг в сутки (по 400 мг 2 раза в сутки). Лечение — длительное, с целью достижения и поддержания клинической и гематологической ремиссии.
В случае появления нейтропении и тромбоцитопении тактика лечения зависит от стадии заболевания. В стадии ремиссии при снижении числа нейтрофилов до 1,0·109/л, тромбоцитов — до 50·109/л лечение прекращают до нормализации показателей (нейтрофилов — не менее 1,5·109/л, тромбоцитов — не менее 75·109/л), затем лечение возобновляют в прежнем режиме (400 мг в сутки); если вновь происходит снижение показателей ниже границы допустимых значений, лечение возобновляют после перерыва (необходимого для восстановления показателей крови) в сниженной дозе — 300 мг в сутки. При бластном кризе и в стадии обострения (режим дозирования — 600 мг в сутки) в случае снижения числа нейтрофилов менее 0,5·109/л и/или числа тромбоцитов — менее 10·109/л лечение прекращают. Для дифференцирования причины, вызвавшей цитопению, проводят биопсию костного мозга; если цитопения не связана с лейкемией, дозу иматиниба мезилата снижают до 400 мг; если цитопения сохраняется в течение последующих 2 недель дозу уменьшают до 300 мг; если цитопения продолжается до 4 недель, лечение прекращают до восстановления показателей крови (нейтрофилов — не менее 1,0·109/л, тромбоцитов — не менее 20,0·109/л), а затем возобновляют в сниженной дозе — 300 мг в сутки.
При нарушении функции печени (увеличение концентрации билирубина в 3 раза по сравнению с верхней границей нормы, активности печеночных трансаминаз — в 5 раз по сравнению с верхней границей нормы) лечение прекращают, пока значения показателей не снизятся до <1,5 и <2,5 соответственно. В этом случае лечение возобновляют, снижая дозы с 400 до 300 мг и с 600 до 400 мг.
Расчет дозы для детей проводится исходя из площади поверхности тела (мг/м2). Общая суточная доза для детей не должна превышать эквивалентные дозировки для взрослых (400 и 600 мг).
Побочное действие
Со стороны системы кроветворения: часто - нейтропения, тромбоцитопения, анемия, фебрильная нейтропения; возможны панцитопения, угнетение костно-мозгового кроветворения.
Со стороны пищеварительной системы: часто - анорексия, тошнота, рвота, диарея, диспепсия, боли в животе, вздутие живота, метеоризм, запор, рефлюкс-эзофагит, изъязвление полости рта, повышение активности печеночных ферментов; возможны гипербилирубинемия, желтуха, гепатит; редко - желудочно-кишечные кровотечения, мелена, асцит, язва желудка, гастрит, гастро-эзофагеальный рефлюкс, сухость во рту, печеночная недостаточность, колит, непроходимость кишечника, панкреатит, повышение аппетита.
Имеются отдельные сообщения о развитии цитолитического или холестатического гепатита и печеночной недостаточности, в некоторых случаях приводивших к летальному исходу; гастроэнтерит.
Со стороны обмена веществ: редко - дегидратация, гиперурикемия, гипокалиемия, гиперкалиемия, гипонатриемия, повышение концентрации мочевой кислоты в крови, подагра), гипофосфатемия, гиперкалиемия, гипонатриемия.
Со стороны ЦНС и периферической нервной системы: часто - головная боль, головокружение, нарушение вкуса, парестезии, бессонница; возможны геморрагический инсульт, обморок, периферическая невропатия, гипестезия, сонливость, мигрень, депрессия, нарушение памяти, тревога, снижение либидо; редко - спутанность сознания, отек мозга, повышение внутричерепного давления, судороги.
Со стороны органа зрения: часто - конъюнктивит, повышение слезоотделения, затуманивание зрения; возможны раздражение глаз, кровоизлияние в конъюнктиву, сухость конъюнктивы, отечность век; редко - макулярный отек, папиллярный отек, ретинальные геморрагии, геморрагии в стекловидное тело, глаукома.
Слуховые и вестибулярные нарушения: возможны головокружение, шум в ушах.
Со стороны сердечно-сосудистой системы: возможны сердечная недостаточность, отек легких, тахикардия, гематомы, артериальная гипертензия, артериальная гипотензия, приливы к лицу, похолодание конечностей; редко - гидроперикардит, перикардит, тромбоз/эмболия.
Со стороны дыхательной системы: часто - диспноэ; возможны плевральный выпот, боли в глотке или гортани, кашель; редко - легочный фиброз, интерстициальная пневмония.
Дерматологические реакции: часто - периорбитальные отеки, дерматит, экзема, сыпь, отечность лица, отечность век, зуд, эритема, сухость кожи, алопеция, ночная потливость; возможны петехии, повышенное потоотделение, уртикария, повреждение ногтей, реакции фотосенсибилизации, пурпура, гипотрихоз, хейлит, гиперпигментация кожи, гипопигментация кожи, псориаз, эксфолиативный дерматит, буллезная сыпь; редко - ангионевротический отек, везикулярная сыпь, синдром Стивенса-Джонсона.
Со стороны костно-мышечной системы: часто - мышечные спазмы и судороги, мышечно-скелетные боли и артралгии, припухание суставов; возможны ишиалгии, скованность мышц и суставов.
Со стороны мочевыделительной системы: возможны почечная недостаточность, боли в почках, частое мочеиспускание, гематурия.
Со стороны репродуктивной системы: возможны гинекомастия, увеличение молочных желез, отек мошонки, боль в сосках, снижение потенции.
Со стороны организма в целом: часто - задержка жидкости, отеки; часто - лихорадка, слабость, озноб; иногда - сильное недомогание, геморрагии; редко - анасарка, геморрагии в опухоли, некроз опухоли.
Прочие: часто - увеличение массы тела, носовые кровотечения; иногда - повышение ЩФ, креатинина, КФК, ЛДГ, снижение массы тела.
Опыт применения иматиниба в дозах свыше 800 мг ограничен. В случае передозировки необходимо наблюдение за пациентом и проведение соответствующей симптоматической терапии.
Взаимодействие с другими лекарственными средствами
При одновременном применении с препаратами, ингибирующими изофермент CYP3A4 (в т.ч. кетоконазола) возможно повышение концентрации иматиниба в плазме крови.
Напротив, одновременное применение препаратов, являющихся индукторами изофермента CYP3A4 (например, дексаметазона), может привести к усилению метаболизма иматиниба и снижению его концентрации в плазме.
При одновременном применении с симвастатином отмечается увеличение Cmax и AUC симвастатина в 2 и 3.5 раза соответственно, что является следствием ингибирования изофермента CYP3A4 под влиянием иматиниба.
Рекомендуется с осторожностью применять иматиниб одновременно с препаратами, являющимися субстратами CYP3A4 и имеющих узкий диапазон терапевтической концентрации, а также препаратов, содержащих парацетамол.
В исследованиях in vitro было показано, что иматиниб ингибирует изофермент CYP2D6 в тех же концентрациях, в которых он ингибирует CYP3A4. В связи с этим следует учитывать возможность усиления эффектов препаратов, являющихся субстратами изофермента CYP2D6, при их совместном применении с иматинибом.
Особые указания
С осторожностью применять у пациентов с нарушениями функции печени, поскольку возможно усиление действия иматиниба.
Рекомендации по применению иматиниба у пациентов с нарушениями функции почек в настоящее время отсутствуют.
В период лечения следует контролировать массу тела пациента для своевременного выявления задержки жидкости в организме; систематически проводить полный клинический анализ периферической крови; регулярно проводить контроль функции печени.
При возникновении нейтропении и тромбоцитопении, а также в случае повышения активности печеночных трансаминаз, ЩФ и содержания билирубина рекомендуется временно отменить иматиниб или уменьшить дозу.
Влияние на способность к вождению автотранспорта и управлению механизмами
Учитывая, что иматиниб может вызывать головокружение и затуманивание зрения, рекомендуется соблюдать осторожность при вождении автомобиля или работе с механизмами.
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Ингибирует фермент Bcr-Abl-тирозинкиназу на клеточном уровне, in vitro и in vivo. Селективно подавляет пролиферацию и вызывает апоптоз клеточных линий, позитивных по Bcr-Abl, а также молодых лейкозных клеток при хроническом миелолейкозе с положительной филадельфийской хромосомой и при остром лимфобластном лейкозе."}},{"type":"paragraph","data":{"text":"В исследованиях по трансформации колоний, проведенных на пробах периферической крови и костного мозга, было показано, что иматиниб селективно ингибирует Bcr-Abl-позитивные колонии, полученные у больных хроническим миелолейкозом."}},{"type":"paragraph","data":{"text":"В исследованиях, проведенных in vivo на животных моделях с использованием Bcr-Abl-позитивных опухолевых клеток, было показано, что препарат обладает противоопухолевой активностью при монотерапии."}},{"type":"paragraph","data":{"text":"Кроме того, иматиниб является ингибитором рецепторов тирозин-киназы для фактора роста тромбоцитов и фактора стволовых клеток, а также подавляет клеточные реакции, опосредуемые вышеназванными факторами."}},{"type":"paragraph","data":{"text":"In vitro иматиниб ингибирует пролиферацию и индуцирует апоптоз клеток стромальных опухолей ЖКТ, экспрессирующих kit-мутации."}},{"type":"paragraph","data":{"text":"\u003cb\u003eФармакокинетика\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"После приема внутрь биодоступность в среднем 98%. Коэффициент вариации для AUC составляет 40-60%. При приеме с пищей с высоким содержанием жиров, по сравнению с приемом натощак, отмечается незначительное снижение степени абсорбции (уменьшение Cmax на 11%, AUC - на 7.4%) и замедление скорости абсорбции (удлинение Tmax на 1.5 ч)."}},{"type":"paragraph","data":{"text":"При клинически значимых концентрациях иматиниба его связывание с белками плазмы составляет около 95% (главным образом с альбумином и кислым альфа-гликопротеином, в незначительной степени - с липопротеином)."}},{"type":"paragraph","data":{"text":"Основным метаболитом иматиниба, циркулирующим в кровяном русле, является N-деметилированное пиперазиновое производное, которое in vitro обладает фармакологической активностью, сходной с таковой неизмененного активного вещества. Значение AUC для метаболита составляет 16% от AUC иматиниба."}},{"type":"paragraph","data":{"text":"После приема внутрь14C-меченого иматиниба за 7 дней было выведено с калом 68% введенной дозы и с мочой 13% дозы. В неизмененном виде выводится около 25% дозы (20% - с калом и 5% - с мочой). Остальное количество иматиниба выводится в виде метаболитов."}},{"type":"paragraph","data":{"text":"T\u003csub\u003e1/2\u003c/sub\u003e иматиниба у здоровых добровольцев составил около 18 ч."}},{"type":"paragraph","data":{"text":"При нарушении функции печени возможно повышение концентрации иматиниба в плазме крови."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Хронический миелолейкоз в фазе акселерации, бластного криза, а также в хронической фазе; лечение неоперабельных и/или метастатических злокачественных стромальных опухолей желудочно-кишечного тракта (у взрослых пациентов)."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Повышенная чувствительность к иматинибу."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Назначать беременным женщинам можно лишь в том случае, если преимущества терапии превышают потенциальный риск для плода (адекватных и хорошо контролируемых исследований у беременных женщин не проводили). В случае применения при беременности или в период планируемой беременности необходимо предупредить пациентку о потенциальном риске для плода. Женщинам детородного возраста во время терапии необходимо использовать эффективные методы контрацепции."}},{"type":"paragraph","data":{"text":"С учетом возможности развития потенциально серьезных побочных реакций у ребенка в случае попадания ЛС в организм, иматиниба мезилат не следует назначать кормящим матерям."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Внутрь (во время еды, запивая полным стаканом воды), 1 раз в сутки."}},{"type":"paragraph","data":{"text":"Взрослым, рекомендуемая суточная доза в стадии ремиссии — 400 мг, в стадии обострения и при бластном кризе — 600 мг. При прогрессировании заболевания, недостаточном гематологическом эффекте в течение 3 месяцев терапии и отсутствии серьезных побочных эффектов возможно увеличение дозы: в стадии ремиссии — до 600 мг в сутки, в стадии обострения и при бластном кризе — до 800 мг в сутки (по 400 мг 2 раза в сутки). Лечение — длительное, с целью достижения и поддержания клинической и гематологической ремиссии."}},{"type":"paragraph","data":{"text":"В случае появления нейтропении и тромбоцитопении тактика лечения зависит от стадии заболевания. В стадии ремиссии при снижении числа нейтрофилов до 1,0·109/л, тромбоцитов — до 50·109/л лечение прекращают до нормализации показателей (нейтрофилов — не менее 1,5·109/л, тромбоцитов — не менее 75·109/л), затем лечение возобновляют в прежнем режиме (400 мг в сутки); если вновь происходит снижение показателей ниже границы допустимых значений, лечение возобновляют после перерыва (необходимого для восстановления показателей крови) в сниженной дозе — 300 мг в сутки. При бластном кризе и в стадии обострения (режим дозирования — 600 мг в сутки) в случае снижения числа нейтрофилов менее 0,5·109/л и/или числа тромбоцитов — менее 10·109/л лечение прекращают. Для дифференцирования причины, вызвавшей цитопению, проводят биопсию костного мозга; если цитопения не связана с лейкемией, дозу иматиниба мезилата снижают до 400 мг; если цитопения сохраняется в течение последующих 2 недель дозу уменьшают до 300 мг; если цитопения продолжается до 4 недель, лечение прекращают до восстановления показателей крови (нейтрофилов — не менее 1,0·109/л, тромбоцитов — не менее 20,0·109/л), а затем возобновляют в сниженной дозе — 300 мг в сутки."}},{"type":"paragraph","data":{"text":"При нарушении функции печени (увеличение концентрации билирубина в 3 раза по сравнению с верхней границей нормы, активности печеночных трансаминаз — в 5 раз по сравнению с верхней границей нормы) лечение прекращают, пока значения показателей не снизятся до <1,5 и <2,5 соответственно. В этом случае лечение возобновляют, снижая дозы с 400 до 300 мг и с 600 до 400 мг."}},{"type":"paragraph","data":{"text":"Расчет дозы для детей проводится исходя из площади поверхности тела (мг/м\u003csup\u003e2\u003c/sup\u003e). Общая суточная доза для детей не должна превышать эквивалентные дозировки для взрослых (400 и 600 мг)."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны системы кроветворения:\u003c/i\u003e часто - нейтропения, тромбоцитопения, анемия, фебрильная нейтропения; возможны панцитопения, угнетение костно-мозгового кроветворения."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны пищеварительной системы:\u003c/i\u003e часто - анорексия, тошнота, рвота, диарея, диспепсия, боли в животе, вздутие живота, метеоризм, запор, рефлюкс-эзофагит, изъязвление полости рта, повышение активности печеночных ферментов; возможны гипербилирубинемия, желтуха, гепатит; редко - желудочно-кишечные кровотечения, мелена, асцит, язва желудка, гастрит, гастро-эзофагеальный рефлюкс, сухость во рту, печеночная недостаточность, колит, непроходимость кишечника, панкреатит, повышение аппетита."}},{"type":"paragraph","data":{"text":"Имеются отдельные сообщения о развитии цитолитического или холестатического гепатита и печеночной недостаточности, в некоторых случаях приводивших к летальному исходу; гастроэнтерит."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны обмена веществ:\u003c/i\u003e редко - дегидратация, гиперурикемия, гипокалиемия, гиперкалиемия, гипонатриемия, повышение концентрации мочевой кислоты в крови, подагра), гипофосфатемия, гиперкалиемия, гипонатриемия."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны ЦНС и периферической нервной системы:\u003c/i\u003e часто - головная боль, головокружение, нарушение вкуса, парестезии, бессонница; возможны геморрагический инсульт, обморок, периферическая невропатия, гипестезия, сонливость, мигрень, депрессия, нарушение памяти, тревога, снижение либидо; редко - спутанность сознания, отек мозга, повышение внутричерепного давления, судороги."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны органа зрения:\u003c/i\u003e часто - конъюнктивит, повышение слезоотделения, затуманивание зрения; возможны раздражение глаз, кровоизлияние в конъюнктиву, сухость конъюнктивы, отечность век; редко - макулярный отек, папиллярный отек, ретинальные геморрагии, геморрагии в стекловидное тело, глаукома."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСлуховые и вестибулярные нарушения:\u003c/i\u003e возможны головокружение, шум в ушах."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны сердечно-сосудистой системы:\u003c/i\u003e возможны сердечная недостаточность, отек легких, тахикардия, гематомы, артериальная гипертензия, артериальная гипотензия, приливы к лицу, похолодание конечностей; редко - гидроперикардит, перикардит, тромбоз/эмболия."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны дыхательной системы:\u003c/i\u003e часто - диспноэ; возможны плевральный выпот, боли в глотке или гортани, кашель; редко - легочный фиброз, интерстициальная пневмония."}},{"type":"paragraph","data":{"text":"\u003ci\u003eДерматологические реакции:\u003c/i\u003e часто - периорбитальные отеки, дерматит, экзема, сыпь, отечность лица, отечность век, зуд, эритема, сухость кожи, алопеция, ночная потливость; возможны петехии, повышенное потоотделение, уртикария, повреждение ногтей, реакции фотосенсибилизации, пурпура, гипотрихоз, хейлит, гиперпигментация кожи, гипопигментация кожи, псориаз, эксфолиативный дерматит, буллезная сыпь; редко - ангионевротический отек, везикулярная сыпь, синдром Стивенса-Джонсона."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны костно-мышечной системы:\u003c/i\u003e часто - мышечные спазмы и судороги, мышечно-скелетные боли и артралгии, припухание суставов; возможны ишиалгии, скованность мышц и суставов."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны мочевыделительной системы:\u003c/i\u003e возможны почечная недостаточность, боли в почках, частое мочеиспускание, гематурия."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны репродуктивной системы:\u003c/i\u003e возможны гинекомастия, увеличение молочных желез, отек мошонки, боль в сосках, снижение потенции."}},{"type":"paragraph","data":{"text":"\u003ci\u003eСо стороны организма в целом:\u003c/i\u003e часто - задержка жидкости, отеки; часто - лихорадка, слабость, озноб; иногда - сильное недомогание, геморрагии; редко - анасарка, геморрагии в опухоли, некроз опухоли."}},{"type":"paragraph","data":{"text":"\u003ci\u003eПрочие:\u003c/i\u003e часто - увеличение массы тела, носовые кровотечения; иногда - повышение ЩФ, креатинина, КФК, ЛДГ, снижение массы тела."}},{"type":"paragraph","data":{"text":"Возможны сепсис, герпес простой, герпес опоясывающий, инфекции верхних отделов дыхательных путей."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Опыт применения иматиниба в дозах свыше 800 мг ограничен. В случае передозировки необходимо наблюдение за пациентом и проведение соответствующей симптоматической терапии."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"При одновременном применении с препаратами, ингибирующими изофермент CYP3A4 (в т.ч. кетоконазола) возможно повышение концентрации иматиниба в плазме крови."}},{"type":"paragraph","data":{"text":"Напротив, одновременное применение препаратов, являющихся индукторами изофермента CYP3A4 (например, дексаметазона), может привести к усилению метаболизма иматиниба и снижению его концентрации в плазме."}},{"type":"paragraph","data":{"text":"При одновременном применении с симвастатином отмечается увеличение Cmax и AUC симвастатина в 2 и 3.5 раза соответственно, что является следствием ингибирования изофермента CYP3A4 под влиянием иматиниба."}},{"type":"paragraph","data":{"text":"Рекомендуется с осторожностью применять иматиниб одновременно с препаратами, являющимися субстратами CYP3A4 и имеющих узкий диапазон терапевтической концентрации, а также препаратов, содержащих парацетамол."}},{"type":"paragraph","data":{"text":"В исследованиях in vitro было показано, что иматиниб ингибирует изофермент CYP2D6 в тех же концентрациях, в которых он ингибирует CYP3A4. В связи с этим следует учитывать возможность усиления эффектов препаратов, являющихся субстратами изофермента CYP2D6, при их совместном применении с иматинибом."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"С осторожностью применять у пациентов с нарушениями функции печени, поскольку возможно усиление действия иматиниба."}},{"type":"paragraph","data":{"text":"Рекомендации по применению иматиниба у пациентов с нарушениями функции почек в настоящее время отсутствуют."}},{"type":"paragraph","data":{"text":"В период лечения следует контролировать массу тела пациента для своевременного выявления задержки жидкости в организме; систематически проводить полный клинический анализ периферической крови; регулярно проводить контроль функции печени."}},{"type":"paragraph","data":{"text":"При возникновении нейтропении и тромбоцитопении, а также в случае повышения активности печеночных трансаминаз, ЩФ и содержания билирубина рекомендуется временно отменить иматиниб или уменьшить дозу."}},{"type":"paragraph","data":{"text":"\u003ci\u003eВлияние на способность к вождению автотранспорта и управлению механизмами\u003c/i\u003e"}},{"type":"paragraph","data":{"text":"Учитывая, что иматиниб может вызывать головокружение и затуманивание зрения, рекомендуется соблюдать осторожность при вождении автомобиля или работе с 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