Daratumumab<\/strong> (20 mg\/ml).<\/p>\nTr\u00ecnh b\u00e0y<\/h3>\n
S\u0110K: 760410037323 (QLSP-H03-1163-19)<\/p>\n
Quy c\u00e1ch \u0111\u00f3ng g\u00f3i: H\u1ed9p 1 l\u1ecd x 20ml<\/p>\n
Xu\u1ea5t x\u1ee9: Th\u1ee5y S\u1ef9<\/p>\n
Darzalex 400mg\/20ml \u0111i\u1ec1u tr\u1ecb \u0111a u t\u1ee7y<\/figcaption><\/figure>\nT\u00e1c d\u1ee5ng c\u1ee7a thu\u1ed1c Darzalex 400mg\/20ml<\/h2>\nC\u01a1 ch\u1ebf t\u00e1c d\u1ee5ng<\/h3>\n\n- Daratumumab l\u00e0 m\u1ed9t kh\u00e1ng th\u1ec3 \u0111\u01a1n d\u00f2ng IgG1\u03ba c\u1ee7a ng\u01b0\u1eddi, c\u00f3 kh\u1ea3 n\u0103ng nh\u1eadn di\u1ec7n v\u00e0 g\u1eafn m\u1ed9t c\u00e1ch \u0111\u1eb7c hi\u1ec7u v\u00e0o protein CD38. Protein CD38 \u0111\u01b0\u1ee3c bi\u1ec3u hi\u1ec7n \u1edf m\u1ee9c \u0111\u1ed9 cao v\u00e0 \u0111\u1ed3ng nh\u1ea5t tr\u00ean b\u1ec1 m\u1eb7t c\u1ee7a c\u00e1c t\u1ebf b\u00e0o u t\u1ee7y x\u01b0\u01a1ng (t\u1ebf b\u00e0o myeloma), c\u0169ng nh\u01b0 tr\u00ean m\u1ed9t s\u1ed1 lo\u1ea1i t\u1ebf b\u00e0o kh\u00e1c c\u1ee7a h\u1ec7 mi\u1ec5n d\u1ecbch.<\/li>\n
- Khi Darzalex g\u1eafn v\u00e0o CD38 tr\u00ean t\u1ebf b\u00e0o ung th\u01b0, n\u00f3 s\u1ebd k\u00edch ho\u1ea1t h\u1ec7 th\u1ed1ng mi\u1ec5n d\u1ecbch c\u1ee7a ch\u00ednh c\u01a1 th\u1ec3 \u0111\u1ec3 ti\u00eau di\u1ec7t c\u00e1c t\u1ebf b\u00e0o n\u00e0y th\u00f4ng qua nhi\u1ec1u c\u01a1 ch\u1ebf ph\u1ee9c t\u1ea1p, bao g\u1ed3m:\n
\n- G\u00e2y \u0111\u1ed9c t\u1ebf b\u00e0o ph\u1ee5 thu\u1ed9c b\u1ed5 th\u1ec3 (CDC).<\/li>\n
- G\u00e2y \u0111\u1ed9c t\u1ebf b\u00e0o qua trung gian t\u1ebf b\u00e0o ph\u1ee5 thu\u1ed9c kh\u00e1ng th\u1ec3 (ADCC).<\/li>\n
- Th\u1ef1c b\u00e0o qua trung gian t\u1ebf b\u00e0o ph\u1ee5 thu\u1ed9c kh\u00e1ng th\u1ec3 (ADCP).<\/li>\n
- G\u00e2y ch\u1ebft t\u1ebf b\u00e0o theo ch\u01b0\u01a1ng tr\u00ecnh (Apoptosis).<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n
\u0110\u1eb7c \u0111i\u1ec3m d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc<\/h3>\n
D\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u1ee7a Daratumumab l\u00e0 phi tuy\u1ebfn t\u00ednh, tuy nhi\u00ean \u1edf li\u1ec1u \u0111i\u1ec1u tr\u1ecb 16 mg\/kg, thu\u1ed1c th\u1ec3 hi\u1ec7n d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc g\u1ea7n nh\u01b0 tuy\u1ebfn t\u00ednh. Th\u1ec3 t\u00edch ph\u00e2n b\u1ed1 c\u1ee7a thu\u1ed1c t\u01b0\u01a1ng \u0111\u01b0\u01a1ng v\u1edbi th\u1ec3 t\u00edch huy\u1ebft t\u01b0\u01a1ng, cho th\u1ea5y thu\u1ed1c ch\u1ee7 y\u1ebfu khu tr\u00fa trong l\u00f2ng m\u1ea1ch. Th\u1eddi gian b\u00e1n th\u1ea3i cu\u1ed1i c\u00f9ng (t1\/2\u200b) c\u1ee7a Daratumumab kh\u00e1 d\u00e0i, kho\u1ea3ng 18 ng\u00e0y \u1edf li\u1ec1u khuy\u1ebfn c\u00e1o, cho ph\u00e9p duy tr\u00ec n\u1ed3ng \u0111\u1ed9 \u0111i\u1ec1u tr\u1ecb v\u1edbi c\u00e1c kho\u1ea3ng c\u00e1ch d\u00f9ng thu\u1ed1c gi\u00e3n d\u1ea7n.<\/p>\n
Thu\u1ed1c Darzalex 400mg\/20ml \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh trong b\u1ec7nh g\u00ec?<\/h2>\n
Darzalex \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh trong \u0111i\u1ec1u tr\u1ecb b\u1ec7nh \u0110a u t\u1ee7y x\u01b0\u01a1ng (Multiple Myeloma – MM) \u1edf b\u1ec7nh nh\u00e2n ng\u01b0\u1eddi l\u1edbn, bao g\u1ed3m:<\/p>\n
\n- \u0110\u01a1n tr\u1ecb li\u1ec7u: Cho b\u1ec7nh nh\u00e2n \u0111a u t\u1ee7y x\u01b0\u01a1ng t\u00e1i ph\u00e1t v\u00e0 kh\u00e1ng tr\u1ecb, \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb tr\u01b0\u1edbc \u0111\u00f3 b\u1eb1ng c\u00e1c li\u1ec7u ph\u00e1p bao g\u1ed3m ch\u1ea5t \u1ee9c ch\u1ebf proteasome v\u00e0 ch\u1ea5t \u0111i\u1ec1u h\u00f2a mi\u1ec5n d\u1ecbch.<\/li>\n
- \u0110i\u1ec1u tr\u1ecb ph\u1ed1i h\u1ee3p:\n
\n- V\u1edbi lenalidomide v\u00e0 dexamethasone, ho\u1eb7c v\u1edbi bortezomib, melphalan v\u00e0 prednisone cho b\u1ec7nh nh\u00e2n m\u1edbi ch\u1ea9n \u0111o\u00e1n<\/strong> kh\u00f4ng ph\u00f9 h\u1ee3p v\u1edbi ph\u01b0\u01a1ng ph\u00e1p gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ef1 th\u00e2n.<\/li>\n
- V\u1edbi lenalidomide v\u00e0 dexamethasone, ho\u1eb7c v\u1edbi bortezomib v\u00e0 dexamethasone cho b\u1ec7nh nh\u00e2n \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb tr\u01b0\u1edbc \u0111\u00f3 \u00edt nh\u1ea5t m\u1ed9t li\u1ec7u tr\u00ecnh.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n
Li\u1ec1u d\u00f9ng c\u1ee7a thu\u1ed1c Darzalex 400mg\/20ml<\/h2>\n\n- Li\u1ec1u khuy\u1ebfn c\u00e1o c\u1ee7a Darzalex l\u00e0 16 mg\/kg<\/strong> tr\u1ecdng l\u01b0\u1ee3ng c\u01a1 th\u1ec3. Li\u1ec1u l\u01b0\u1ee3ng c\u1ee5 th\u1ec3 v\u00e0 l\u1ecbch tr\u00ecnh truy\u1ec1n thu\u1ed1c ph\u1ee5 thu\u1ed9c ch\u1eb7t ch\u1ebd v\u00e0o ph\u00e1c \u0111\u1ed3 \u0111i\u1ec1u tr\u1ecb (\u0111\u01a1n tr\u1ecb hay ph\u1ed1i h\u1ee3p) v\u00e0 \u0111\u01b0\u1ee3c chia th\u00e0nh c\u00e1c chu k\u1ef3.<\/li>\n
- V\u00ed d\u1ee5 v\u1ec1 m\u1ed9t l\u1ecbch tr\u00ecnh truy\u1ec1n thu\u1ed1c \u0111i\u1ec3n h\u00ecnh:\n
\n- Tu\u1ea7n 1-8: Truy\u1ec1n m\u1ed7i tu\u1ea7n m\u1ed9t l\u1ea7n.<\/li>\n
- Tu\u1ea7n 9-24: Truy\u1ec1n m\u1ed7i 2 tu\u1ea7n m\u1ed9t l\u1ea7n.<\/li>\n
- T\u1eeb tu\u1ea7n 25 tr\u1edf \u0111i: Truy\u1ec1n m\u1ed7i 4 tu\u1ea7n m\u1ed9t l\u1ea7n cho \u0111\u1ebfn khi b\u1ec7nh ti\u1ebfn tri\u1ec3n.<\/li>\n<\/ul>\n<\/li>\n
- Vi\u1ec7c t\u00ednh to\u00e1n li\u1ec1u l\u01b0\u1ee3ng v\u00e0 l\u1ecbch tr\u00ecnh ph\u1ea3i do b\u00e1c s\u0129 \u0111i\u1ec1u tr\u1ecb quy\u1ebft \u0111\u1ecbnh.<\/li>\n<\/ul>\n
C\u00e1ch d\u00f9ng c\u1ee7a thu\u1ed1c Darzalex 400mg\/20ml<\/h2>\n\n- T\u1ed1c \u0111\u1ed9 truy\u1ec1n: Thu\u1ed1c \u0111\u01b0\u1ee3c pha v\u1edbi dung d\u1ecbch Natri Clorid 0,9% \u0111\u1ec3 truy\u1ec1n t\u0129nh m\u1ea1ch. T\u1ed1c \u0111\u1ed9 truy\u1ec1n \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t ch\u1eb7t ch\u1ebd, th\u01b0\u1eddng b\u1eaft \u0111\u1ea7u ch\u1eadm \u1edf l\u1ea7n truy\u1ec1n \u0111\u1ea7u ti\u00ean v\u00e0 c\u00f3 th\u1ec3 t\u0103ng d\u1ea7n trong c\u00e1c l\u1ea7n truy\u1ec1n sau n\u1ebfu b\u1ec7nh nh\u00e2n dung n\u1ea1p t\u1ed1t.<\/li>\n
- Thu\u1ed1c d\u1ef1 ph\u00f2ng: B\u1ec7nh nh\u00e2n b\u1eaft bu\u1ed9c ph\u1ea3i s\u1eed d\u1ee5ng c\u00e1c thu\u1ed1c d\u1ef1 ph\u00f2ng tr\u01b0\u1edbc v\u00e0 sau khi truy\u1ec1n Darzalex \u0111\u1ec3 gi\u1ea3m nguy c\u01a1 v\u00e0 m\u1ee9c \u0111\u1ed9 n\u1eb7ng c\u1ee7a c\u00e1c ph\u1ea3n \u1ee9ng li\u00ean quan \u0111\u1ebfn ti\u00eam truy\u1ec1n. C\u00e1c thu\u1ed1c n\u00e0y th\u01b0\u1eddng bao g\u1ed3m:\n
\n- Tr\u01b0\u1edbc truy\u1ec1n: Corticosteroid, thu\u1ed1c h\u1ea1 s\u1ed1t (v\u00ed d\u1ee5: paracetamol) v\u00e0 thu\u1ed1c kh\u00e1ng histamin.<\/li>\n
- Sau truy\u1ec1n: Corticosteroid li\u1ec1u th\u1ea5p trong 1-2 ng\u00e0y sau truy\u1ec1n.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n
Kh\u00f4ng s\u1eed d\u1ee5ng thu\u1ed1c Darzalex 400mg\/20ml trong tr\u01b0\u1eddng h\u1ee3p n\u00e0o?<\/h2>\n
Ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n c\u00f3 ti\u1ec1n s\u1eed qu\u00e1 m\u1eabn n\u1eb7ng v\u1edbi ho\u1ea1t ch\u1ea5t Daratumumab ho\u1eb7c v\u1edbi b\u1ea5t k\u1ef3 t\u00e1 d\u01b0\u1ee3c n\u00e0o c\u1ee7a thu\u1ed1c.<\/p>\n
L\u01b0u \u00fd \u0111\u1eb7c bi\u1ec7t khi s\u1eed d\u1ee5ng thu\u1ed1c Darzalex 400mg\/20ml<\/h2>\nTh\u1eadn tr\u1ecdng<\/h3>\n
Daratumumab c\u00f3 th\u1ec3 g\u1eafn v\u00e0o CD38 tr\u00ean b\u1ec1 m\u1eb7t h\u1ed3ng c\u1ea7u, g\u00e2y nhi\u1ec5u c\u00e1c x\u00e9t nghi\u1ec7m s\u00e0ng l\u1ecdc kh\u00e1ng th\u1ec3 b\u1ea5t th\u01b0\u1eddng v\u00e0 x\u00e9t nghi\u1ec7m t\u01b0\u01a1ng h\u1ee3p m\u00e1u (cross-matching), d\u1eabn \u0111\u1ebfn k\u1ebft qu\u1ea3 d\u01b0\u01a1ng t\u00ednh gi\u1ea3. C\u1ea7n th\u00f4ng b\u00e1o cho ng\u00e2n h\u00e0ng m\u00e1u v\u1ec1 vi\u1ec7c b\u1ec7nh nh\u00e2n \u0111ang \u0111i\u1ec1u tr\u1ecb b\u1eb1ng Darzalex.<\/p>\n