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RU2019125238A - Препараты антител против her2 для подкожного введения - Google Patents

Препараты антител против her2 для подкожного введения Download PDF

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RU2019125238A
RU2019125238A RU2019125238A RU2019125238A RU2019125238A RU 2019125238 A RU2019125238 A RU 2019125238A RU 2019125238 A RU2019125238 A RU 2019125238A RU 2019125238 A RU2019125238 A RU 2019125238A RU 2019125238 A RU2019125238 A RU 2019125238A
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cancer
pertuzumab
administered
trastuzumab
pharmaceutical composition
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RU2019125238A
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RU2750821C2 (ru
RU2019125238A3 (ru
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Дженнифер ЭНГ-ВОНГ
Уитни КИРШБРАУН
Тарик ХАН
Джаспер ЛИН
Сридхара Алаваттам
Амит ГАРГ
Сара ХИСОН
Таня БАДОВИНАЧ-ЧРНЕВИЧ
Кристин ВУРТ
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Дженентек, Инк.
Ф. Хоффманн-Ла Рош Аг
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Claims (30)

1. Жидкая фармацевтическая композиция, содержащая 600 мг пертузумаба в концентрации 60 мг/мл, 600 мг трастузумаба в концентрации 60 мг/мл, 2000 Ед/мл рекомбинантной гиалуронидазы человека (rHuPH20), 20 мМ His-HCl pH 5,5, 105 мМ трегалозы, 100 мМ сахарозы, 0,04% полисорбата 20, 10 мМ метионина и стерильную воду для инъекций до общего объема 10 мл.
2. Жидкая фармацевтическая композиция по п. 1, содержащаяся во флаконе объемом 15 мл.
3. Жидкая фармацевтическая композиция, содержащая 1200 мг пертузумаба в концентрации 80 мг/мл, 600 мг трастузумаба в концентрации 40 мг/мл, 2000 Ед/мл рекомбинантной гиалуронидазы человека (rHuPH20), 20 мМ His-HCl pH 5,5, 70 мМ трегалозы, 133 мМ сахарозы, 0,04% полисорбата 20, 10 мМ метионина и стерильную воду для инъекций до общего объема 15 мл.
4. Жидкая фармацевтическая композиция по п. 3, содержащаяся во флаконе объемом 20 мл.
5. Изделие, содержащее жидкую фармацевтическую композицию по любому из пп. 1-4.
6. Изделие по п. 5, дополнительно содержащее листок-вкладыш с инструкциями по подкожному введению жидкой фармацевтической композиции, содержащейся в изделии, человеку с HER2-положительным онкологическим заболеванием.
7. Изделие по п. 6, отличающееся тем, что HER2-положительное онкологическое заболевание выбрано из группы, состоящей из рака молочной железы, перитонеального рака, рака маточной трубы, рака легких, колоректального рака, рака желчных путей и рака мочевого пузыря.
8. Изделие по п. 7, отличающееся тем, что онкологическое заболевание представляет собой рак молочной железы.
9. Изделие по п. 8, отличающееся тем, что рак молочной железы представляет собой ранний рак молочной железы (РРМЖ) или метастатический рак молочной железы (МРМЖ).
10. Применение пертузумаба в производстве лекарственного средства для лечения HER2-положительного онкологического заболевания, при этом пертузумаб вводят подкожно в фиксированной нагрузочной дозе 1200 мг с последующей, по меньшей мере, одной поддерживающей дозой 600 мг.
11. Применение по п. 10, в котором после введения нагрузочной дозы следует введение нескольких поддерживающих доз.
12. Применение по п. 11, в котором первую поддерживающую дозу пертузумаба вводят указанному субъекту, представляющему собой человека, спустя приблизительно две недели или приблизительно три недели после введения нагрузочной дозы пертузумаба.
13. Применение по любому из п.11 или п.12, в котором фиксированные дозы пертузумаба вводят указанному субъекту, представляющему собой человека, приблизительно каждые 2 недели или приблизительно каждые 3 недели.
14. Применение по п. 13, в котором фиксированные дозы пертузумаба вводят приблизительно каждые 3 недели.
15. Применение по п. 10, в котором HER2-положительное онкологическое заболевание выбрано из группы, состоящей из рака молочной железы, перитонеального рака, рака маточной трубы, рака легких, колоректального рака, рака желчных путей и рака мочевого пузыря.
16. Применение по п. 15, в котором онкологическое заболевание представляет собой рак молочной железы.
17. Применение по п. 16, в котором онкологическое заболевание представляет собой ранний рак молочной железы (РРМЖ) или метастатический рак молочной железы (МРМЖ).
18. Применение по любому из пп. 10-17, включающее введение второго терапевтического агента пациенту.
19. Применение по п. 18, в котором второй терапевтический агент представляет собой другое антитело против HER2.
20. Применение по п. 19, в котором другое антитело против HER2 представляет собой трастузумаб.
21. Применение по п. 20, в котором фиксированную дозу пертузумаба вводят подкожно в комбинации с подкожно вводимым трастузумабом.
22. Применение по п. 21, в котором фиксированную дозу пертузумаба и трастузумаба вводят совместно подкожно в виде двух отдельных подкожных инъекций.
23. Применение по п. 21, в котором фиксированную дозу пертузумаба смешивают с фиксированной дозой трастузумаба и вводят в виде единой подкожной инъекции.
24. Применение по п. 21, в котором фиксированную дозу пертузумаба и фиксированную дозу трастузумаба вводят в виде одного совместного препарата для подкожного введения.
25. Применение по п.21, в котором совместный препарат дополнительно включает рекомбинантную гиалуронидазу человека (rHuPH20).
26. Применение по п. 25, в котором совместный препарат представляет собой жидкую фармацевтическую композицию по любому из пп. 1-4.
27. Применение по п. 20, дополнительно включающее введение химиотерапевтического агента.
28. Применение по п. 27, в котором химиотерапевтический агент представляет собой таксан или антрациклин.
29. Применение по п. 28, в котором химиотерапевтический агент представляет собой таксан и таксан содержит паклитаксел или доцетаксел.
30. Применение по п. 28, в котором химиотерапевтический агент представляет собой антрациклин и антрациклин содержит даунорубицин, доксорубицин или эпирубицин.
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