{"id":4090,"date":"2019-03-09T09:22:56","date_gmt":"2019-03-09T02:22:56","guid":{"rendered":"https:\/\/www.vnras.com\/drug\/?p=4090"},"modified":"2019-03-09T09:22:56","modified_gmt":"2019-03-09T02:22:56","slug":"ema-de-xuat-cap-phep-luu-hanh-cho-thuoc-giai-qua-lieu-nguoc-chong-dong-bang-thuoc-uc-che-yeu-to-xa-apixaban-va-rivaroxaban","status":"publish","type":"post","link":"https:\/\/vnras.com\/drug\/ema-de-xuat-cap-phep-luu-hanh-cho-thuoc-giai-qua-lieu-nguoc-chong-dong-bang-thuoc-uc-che-yeu-to-xa-apixaban-va-rivaroxaban\/","title":{"rendered":"EMA: \u0110\u1ec1 xu\u1ea5t c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh cho thu\u1ed1c gi\u1ea3i qu\u00e1 li\u1ec1u ng\u01b0\u1ee3c ch\u1ed1ng \u0111\u00f4ng b\u1eb1ng thu\u1ed1c \u1ee9c ch\u1ebf y\u1ebfu t\u1ed1 Xa apixaban v\u00e0 rivaroxaban"},"content":{"rendered":"<p><strong>U\u1ef7 ban v\u1ec1 thu\u1ed1c d\u00f9ng cho ng\u01b0\u1eddi c\u1ee7a EMA (CHMP) \u0111\u00e3 khuy\u1ebfn ngh\u1ecb c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh c\u00f3 \u0111i\u1ec1u ki\u1ec7n tr\u00ean to\u00e0n Li\u00ean minh ch\u00e2u \u00c2u \u0111\u1ed1i v\u1edbi Ondexxya (andexanet alfa)<\/strong>. Thu\u1ed1c n\u00e0y \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng nh\u1eb1m m\u1ee5c \u0111\u00edch \u0111i\u1ec1u tr\u1ecb qu\u00e1 li\u1ec1u \u1edf b\u1ec7nh nh\u00e2n tr\u01b0\u1edfng th\u00e0nh s\u1eed d\u1ee5ng thu\u1ed1c ch\u1ed1ng \u0111\u00f4ng (ng\u0103n ng\u1eeba huy\u1ebft kh\u1ed1i) apixaban ho\u1eb7c rivaroxaban, khi c\u1ea7n ph\u1ea3i \u0111\u1ea3o ng\u01b0\u1ee3c t\u00e1c d\u1ee5ng c\u1ee7a ch\u00fang do g\u00e2y ch\u1ea3y m\u00e1u n\u1eb7ng \u0111e do\u1ea1 t\u00ednh m\u1ea1ng ho\u1eb7c kh\u00f4ng ki\u1ec3m so\u00e1t.<\/p>\n<p>Thu\u1ed1c ch\u1ed1ng \u0111\u00f4ng \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb huy\u1ebft kh\u1ed1i v\u00e0 l\u00e0m gi\u1ea3m nguy c\u01a1 h\u00ecnh th\u00e0nh huy\u1ebft kh\u1ed1i trong \u0111\u1ed9ng v\u00e0 t\u0129nh m\u1ea1ch, c\u00e1c huy\u1ebft kh\u1ed1i n\u00e0y c\u00f3 th\u1ec3 d\u1eabn t\u1edbi t\u1eafc m\u1ea1ch ph\u1ed5i, \u0111\u1ed9t qu\u1ecb ho\u1eb7c t\u1ed5n th\u01b0\u01a1ng c\u00e1c c\u01a1 quan kh\u00e1c. C\u00e1c thu\u1ed1c ch\u1ed1ng \u0111\u00f4ng apixaban v\u00e0 rivaroxaban thu\u1ed9c nh\u00f3m thu\u1ed1c ch\u1ed1ng \u0111\u00f4ng th\u1ebf h\u1ec7 m\u1edbi, g\u1ecdi l\u00e0 c\u00e1c thu\u1ed1c \u1ee9c ch\u1ebf y\u1ebfu t\u1ed1 Xa, y\u1ebfu t\u1ed1 trong m\u00e1u \u0111\u00f3ng vai tr\u00f2 then ch\u1ed1t trong h\u00ecnh th\u00e0nh huy\u1ebft kh\u1ed1i.<\/p>\n<p>Tuy nhi\u00ean, do c\u00e1c thu\u1ed1c ch\u1ed1ng \u0111\u00f4ng ng\u0103n ch\u1eb7n s\u1ef1 \u0111\u00f4ng m\u00e1u di\u1ec5n ra theo c\u00e1ch b\u00ecnh th\u01b0\u1eddng, b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng c\u00e1c thu\u1ed1c n\u00e0y l\u1ea1i c\u00f3 nguy c\u01a1 b\u1ecb ch\u1ea3y m\u00e1u nghi\u00eam tr\u1ecdng v\u00e0 kh\u00f4ng ki\u1ec3m so\u00e1t \u0111\u01b0\u1ee3c, nh\u1ea5t l\u00e0 trong c\u00e1c t\u00ecnh hu\u1ed1ng c\u1ea5p c\u1ee9u. Cho t\u1edbi nay, ch\u01b0a c\u00f3 thu\u1ed1c gi\u1ea3i \u0111\u1ed9c \u0111\u1eb7c hi\u1ec7u n\u00e0o c\u00f3 th\u1ec3 ng\u0103n ch\u1eb7n t\u00e1c d\u1ee5ng ch\u1ed1ng \u0111\u00f4ng c\u1ee7a apixaban hay rivaroxaban m\u1ed9t khi \u0111\u00e3 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng.<\/p>\n<p>Andexanet alfa, ho\u1ea1t ch\u1ea5t c\u1ee7a Ondexxya, l\u00e0 m\u1ed9t protein t\u00e1i t\u1ed5 h\u1ee3p t\u00e1c d\u1ee5ng nh\u01b0 m\u1ed9t c\u00e1i b\u1eaby b\u1eaft c\u00e1c ch\u1ea5t \u1ee9c ch\u1ebf y\u1ebfu t\u1ed1 Xa l\u00e0 apixaban v\u00e0 rivaroxaban trong m\u00e1u. K\u1ebft qu\u1ea3 l\u00e0 ch\u1ea5t n\u00e0y trung ho\u00e0 t\u00e1c d\u1ee5ng ch\u1ed1ng \u0111\u00f4ng c\u1ee7a c\u00e1c thu\u1ed1c \u1ee9c ch\u1ebf Xa n\u00f3i tr\u00ean.<\/p>\n<p>T\u00e1c d\u1ee5ng c\u1ee7a Ondexxya \u0111\u01b0\u1ee3c nghi\u00ean c\u1ee9u tr\u00ean 352 b\u1ec7nh nh\u00e2n v\u1ec1 \u0111\u1ed9 an to\u00e0n v\u00e0 tr\u00ean 167 b\u1ec7nh nh\u00e2n v\u1ec1 t\u00ednh hi\u1ec7u qu\u1ea3. Hi\u1ec7u qu\u1ea3 l\u00e2m s\u00e0ng c\u1ee7a ho\u1ea1t ch\u1ea5t \u0111\u01b0\u1ee3c d\u1ef1a tr\u00ean m\u1ee9c \u0111\u1ed9 \u0111\u1ea3o ng\u01b0\u1ee3c ho\u1ea1t t\u00ednh ch\u1ed1ng y\u1ebfu t\u1ed1 Xa \u1edf ng\u01b0\u1eddi t\u00ecnh nguy\u1ec7n kho\u1ebb m\u1ea1nh v\u00e0 c\u00e1c k\u1ebft qu\u1ea3 \u0111\u1ea7u ra t\u01b0\u01a1ng t\u1ef1 \u1edf nghi\u00ean c\u1ee9u tr\u00ean ng\u01b0\u1eddi m\u1ea5t m\u00e1u n\u1eb7ng \u0111e do\u1ea1 t\u00ednh m\u1ea1ng. Ondexxya gi\u00fap \u0111\u1ea3o ng\u01b0\u1ee3c t\u00e1c d\u1ee5ng ch\u1ed1ng \u0111\u00f4ng c\u1ee7a apixaban v\u00e0 rivaroxaban trong v\u00f2ng 2 ph\u00fat k\u1ec3 t\u1eeb khi d\u00f9ng thu\u1ed1c.<\/p>\n<p>CHMP khuy\u1ebfn ngh\u1ecb c\u1ea5p ph\u00e9p c\u00f3 \u0111i\u1ec1u ki\u1ec7n cho ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb n\u00e0y. \u0110\u00e2y l\u00e0 m\u1ed9t trong c\u00e1c c\u01a1 ch\u1ebf ph\u00e1p l\u00ed c\u1ee7a EU nh\u1eb1m t\u1ea1o \u0111i\u1ec1u ki\u1ec7n s\u1edbm ti\u1ebfp c\u1eadn v\u1edbi c\u00e1c thu\u1ed1c \u0111\u00e1p \u1ee9ng \u0111\u01b0\u1ee3c nhu c\u1ea7u y t\u1ebf cao. C\u1ea5p ph\u00e9p c\u00f3 \u0111i\u1ec1u ki\u1ec7n nh\u01b0 v\u1eady cho ph\u00e9p C\u01a1 quan qu\u1ea3n l\u00ed d\u01b0\u1ee3c khuy\u1ebfn kh\u00edch c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh thu\u1ed1c v\u00ec l\u1ee3i \u00edch s\u1ee9c kho\u1ebb c\u1ed9ng \u0111\u1ed3ng khi m\u00e0 l\u1ee3i \u00edch c\u1ee7a n\u00f3 ngay khi \u0111\u01b0\u1ee3c l\u01b0u h\u00e0nh v\u01b0\u1ee3t tr\u1ed9i h\u1eb3n so v\u1edbi nguy c\u01a1 v\u1ed1n c\u00f3 trong khi c\u00e1c d\u1eef li\u1ec7u v\u1eabn ch\u01b0a \u0111\u1ea7y \u0111\u1ee7. Trong tr\u01b0\u1eddng h\u1ee3p c\u1ee7a andexanet alfa, ch\u1ea5t n\u00e0y ch\u01b0a \u0111\u01b0\u1ee3c nghi\u00ean c\u1ee9u khi d\u00f9ng thu\u1ed1c \u1ee9c ch\u1ebf Xa tr\u01b0\u1edbc ph\u1eabu thu\u1eadt ho\u1eb7c c\u00e1c th\u1ee7 thu\u1eadt x\u00e2m l\u1ea5n kh\u00e1c; ch\u01b0a c\u00f3 \u0111\u1ee7 d\u1eef li\u1ec7u l\u00e2m s\u00e0ng \u0111\u1ec3 \u1ee7ng h\u1ed9 vi\u1ec7c s\u1eed d\u1ee5ng tr\u00ean b\u1ec7nh nh\u00e2n ch\u1ea3y m\u00e1u n\u1eb7ng do d\u00f9ng c\u00e1c thu\u1ed1c ch\u1ed1ng \u0111\u00f4ng tr\u1ef1c ti\u1ebfp \u0111\u01b0\u1eddng u\u1ed1ng kh\u00e1c ngo\u00e0i apixaban v\u00e0 rivaroxaban; \u0111\u00e3 ghi nh\u1eadn tr\u01b0\u1eddng h\u1ee3p xu\u1ea5t hi\u1ec7n huy\u1ebft kh\u1ed1i sau khi d\u00f9ng Ondexxya; v\u00e0 li\u1ec1u d\u00f9ng khuy\u1ebfn c\u00e1o ch\u01b0a \u0111\u01b0\u1ee3c kh\u1eb3ng \u0111\u1ecbnh. V\u1edbi c\u01a1 ch\u1ebf c\u1ea5p ph\u00e9p n\u00eau tr\u00ean, doanh nghi\u1ec7p \u0111\u0103ng k\u00ed \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u ho\u00e0n thi\u1ec7n m\u1ed9t s\u1ed1 nghi\u00ean c\u1ee9u sau c\u1ea5p ph\u00e9p \u0111\u1ec3 t\u00ecm hi\u1ec3u s\u00e2u h\u01a1n v\u1ec1 an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a thu\u1ed1c trong m\u1ed9t khung th\u1eddi gian c\u1ee5 th\u1ec3.<\/p>\n<p>\u00dd ki\u1ebfn ch\u1ea5p thu\u1eadn \u0111\u01b0\u1ee3c CHMP \u0111\u01b0a ra v\u00e0o bu\u1ed5i h\u1ecdp th\u00e1ng 2\/2019 l\u00e0 b\u01b0\u1edbc trung gian tr\u00ean con \u0111\u01b0\u1eddng \u0111\u01b0a Ondexxya \u0111\u1ebfn v\u1edbi b\u1ec7nh nh\u00e2n. \u00dd ki\u1ebfn n\u00e0y gi\u1edd s\u1ebd \u0111\u01b0\u1ee3c g\u1eedi t\u1edbi U\u1ef7 ban ch\u00e2u \u00c2u \u0111\u1ec3 \u0111\u01b0a ra quy\u1ebft \u0111\u1ecbnh c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh tr\u00ean to\u00e0n EU. M\u1ed9t khi \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn, c\u00e1c quy\u1ebft \u0111\u1ecbnh v\u1ec1 gi\u00e1 thu\u1ed1c v\u00e0 ho\u00e0n ph\u00ed s\u1ebd \u0111\u01b0\u1ee3c \u0111\u01b0a ra \u1edf t\u1eebng qu\u1ed1c gia th\u00e0nh vi\u00ean, c\u00f3 c\u00e2n nh\u1eafc \u0111\u1ebfn vai tr\u00f2\/ m\u1ee9c \u0111\u1ed9 s\u1eed d\u1ee5ng c\u1ee7a thu\u1ed1c trong b\u1ed1i c\u1ea3nh h\u1ec7 th\u1ed1ng y t\u1ebf c\u1ee7a t\u1eebng qu\u1ed1c gia.<\/p>\n<p>Thu\u1ed1c \u0111\u01b0\u1ee3c \u0111\u0103ng k\u00ed b\u1edfi h\u00e3ng Portola Netherlands B.V.<\/p>\n<p>Ngu\u1ed3n:\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/first-antidote-reversal-anticoagulation-factor-xa-inhibitors-apixaban-rivaroxaban?fbclid=IwAR14xeeUtO3rPF5XwH_at6KIzvx1BobLJ59I-xVCBwxa_T5aC3P-9Mkcd-A\" rel=\"noopener\">https:\/\/www.ema.europa.eu\/en\/news\/first-antidote-reversal-anticoagulation-factor-xa-inhibitors-apixaban-rivaroxaban?fbclid=IwAR14xeeUtO3rPF5XwH_at6KIzvx1BobLJ59I-xVCBwxa_T5aC3P-9Mkcd-A<\/a><\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>U\u1ef7 ban v\u1ec1 thu\u1ed1c d\u00f9ng cho ng\u01b0\u1eddi c\u1ee7a EMA (CHMP) \u0111\u00e3 khuy\u1ebfn ngh\u1ecb c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh c\u00f3 \u0111i\u1ec1u ki\u1ec7n tr\u00ean to\u00e0n Li\u00ean minh ch\u00e2u \u00c2u \u0111\u1ed1i v\u1edbi Ondexxya (andexanet alfa). Thu\u1ed1c n\u00e0y \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng nh\u1eb1m m\u1ee5c \u0111\u00edch \u0111i\u1ec1u tr\u1ecb qu\u00e1 li\u1ec1u \u1edf b\u1ec7nh nh\u00e2n tr\u01b0\u1edfng th\u00e0nh s\u1eed d\u1ee5ng thu\u1ed1c ch\u1ed1ng \u0111\u00f4ng (ng\u0103n ng\u1eeba [&#8230;]\n","protected":false},"author":1,"featured_media":4091,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-4090","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-y-te-suc-khoe"],"acf":[],"_links":{"self":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts\/4090","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/comments?post=4090"}],"version-history":[{"count":0,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts\/4090\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media\/4091"}],"wp:attachment":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media?parent=4090"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/categories?post=4090"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/tags?post=4090"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}