{"id":10140,"date":"2019-05-24T11:00:40","date_gmt":"2019-05-24T04:00:40","guid":{"rendered":"https:\/\/www.vnras.com\/drug\/?p=10140"},"modified":"2019-05-27T11:08:20","modified_gmt":"2019-05-27T04:08:20","slug":"ton-thuong-gan-lien-quan-den-actemra-tocilizumab","status":"publish","type":"post","link":"https:\/\/vnras.com\/drug\/ton-thuong-gan-lien-quan-den-actemra-tocilizumab\/","title":{"rendered":"T\u1ed5n th\u01b0\u01a1ng gan li\u00ean quan \u0111\u1ebfn ACTEMRA\u00ae (tocilizumab)"},"content":{"rendered":"<h2>Trong th\u00e1ng 05\/2019, hai c\u01a1 quan qu\u1ea3n l\u00fd an to\u00e0n d\u01b0\u1ee3c ph\u1ea9m c\u1ee7a Canada v\u00e0 New Zealand \u0111\u1ec1u \u0111\u01b0a ra c\u1ea3nh b\u00e1o v\u1ec1 nguy c\u01a1 t\u1ed5n th\u01b0\u01a1ng gan li\u00ean quan \u0111\u1ebfn li\u00ean quan \u0111\u1ebfn ACTEMRA\u00ae (tocilizumab) v\u00e0 y\u00eau c\u1ea7u b\u1ed5 sung th\u00f4ng tin n\u00e0y v\u00e0o t\u1edd h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng thu\u1ed1c.<\/h2>\n<p>Ng\u00e0y 15\/05\/2019, Medsafe \u0111\u0103ng th\u01b0 th\u00f4ng b\u00e1o c\u1ee7a Roche Products (New Zealand) Limited v\u1ec1 nguy c\u01a1 \u0111\u1ed9c t\u00ednh tr\u00ean gan li\u00ean quan \u0111\u1ebfn Actemra.<\/p>\n<p>Actemra (tocilizumab) c\u00f3 th\u1ec3 g\u00e2y t\u1ed5n th\u01b0\u01a1ng gan nghi\u00eam tr\u1ecdng, bao g\u1ed3m c\u1ea3 suy gan c\u1ea5p, vi\u00eam gan, v\u00e0ng da, trong m\u1ed9t s\u1ed1 tr\u01b0\u1eddng h\u1ee3p c\u00f2n y\u00eau c\u1ea7u ph\u1ea3i gh\u00e9p gan.<\/p>\n<h2>Medsafe khuy\u1ebfn c\u00e1o:<\/h2>\n<p>&#8211; Kh\u00f4ng khuy\u1ebfn c\u00e1o s\u1eed d\u1ee5ng tocilizumab cho nh\u1eefng b\u1ec7nh nh\u00e2n t\u0103ng ALT ho\u1eb7c AST tr\u00ean 5 l\u1ea7n gi\u1edbi h\u1ea1n b\u00ecnh th\u01b0\u1eddng (ULN).<\/p>\n<p>&#8211; C\u1ea7n th\u1eadn tr\u1ecdng khi kh\u1edfi \u0111\u1ea7u tocilizumab tr\u00ean nh\u1eefng b\u1ec7nh nh\u00e2n c\u00f3 ALT or AST t\u0103ng tr\u00ean 1.5 ULN.<\/p>\n<p>&#8211; \u1ede nh\u1eefng b\u1ec7nh nh\u00e2n b\u1ecb vi\u00eam kh\u1edbp d\u1ea1ng th\u1ea5p (RA), vi\u00eam \u0111\u1ed9ng m\u1ea1ch t\u1ebf b\u00e0o l\u1edbn (Giant Cell Arteritis &#8211; GCA), vi\u00eam \u0111a kh\u1edbp t\u1ef1 ph\u00e1t thi\u1ebfu ni\u00ean (Polyarticular Juvenile Idiopathic Arthritis &#8211; pJIA) v\u00e0 vi\u00eam kh\u1edbp t\u1ef1 ph\u00e1t h\u1ec7 th\u1ed1ng \u1edf thi\u1ebfu ni\u00ean (Systemic Juvenile Idiopathic Arthritis &#8211; SJIA), c\u1ea7n theo d\u00f5i ALT v\u00e0 AST m\u1ed7i t\u1eeb 4 \u0111\u1ebfn 8 tu\u1ea7n trong 6 \u0111\u1ea7u ti\u00ean sau \u0111i\u1ec1u tr\u1ecb v\u00e0 m\u1ed7i 12 tu\u1ea7n sau \u0111\u00f3. Khuy\u1ebfn c\u00e1o hi\u1ec7u ch\u1ec9nh li\u1ec1u c\u1ee7a tocilizumab n\u1ebfu c\u00f3 b\u1ea5t th\u01b0\u1eddng men gan, tham kh\u1ea3o th\u00f4ng tin trong t\u1edd h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng thu\u1ed1c.<\/p>\n<p>Health Canada th\u00f4ng b\u00e1o \u0111\u00e3 ghi nh\u1eadn m\u1ed9t s\u1ed1 b\u00e1o c\u00e1o v\u1ec1 ph\u1ea3n \u1ee9ng c\u00f3 h\u1ea1i tr\u00ean gan li\u00ean quan \u0111\u1ebfn tocilizumab. Ph\u1ea3n \u1ee9ng n\u00e0y tuy hi\u1ebfm g\u1eb7p nh\u01b0ng c\u00f3 th\u1ec3 \u0111\u1ec3 l\u1ea1i h\u1eadu qu\u1ea3 nghi\u00eam tr\u1ecdng.<\/p>\n<h2>Khuy\u1ebfn c\u00e1o c\u1ee7a Health Canada c\u00f3 m\u1ed9t s\u1ed1 \u0111i\u1ec3m ch\u1eb7t ch\u1ebd h\u01a1n khuy\u1ebfn c\u00e1o c\u1ee7a Medsafe New Zealand, c\u1ee5 th\u1ec3 nh\u01b0 sau:<\/h2>\n<p>&#8211; Kh\u00f4ng khuy\u1ebfn c\u00e1o d\u00f9ng ACTEMRA \u1edf b\u1ec7nh nh\u00e2n m\u1eafc b\u1ec7nh gan ho\u1eb7c c\u00f3 ti\u1ec1n s\u1eed suy gan;<\/p>\n<p>&#8211; Kh\u00f4ng b\u1eaft \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb b\u1eb1ng ACTEMRA \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n c\u00f3 n\u1ed3ng \u0111\u1ed9 men gan trong m\u00e1u cao h\u01a1n 3 l\u1ea7n gi\u1edbi h\u1ea1n tr\u00ean c\u1ee7a m\u1ee9c b\u00ecnh th\u01b0\u1eddng (ULN);<\/p>\n<p>&#8211; Ng\u1eebng \u0111i\u1ec1u tr\u1ecb b\u1eb1ng ACTEMRA \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n c\u00f3 n\u1ed3ng \u0111\u1ed9 men gan trong m\u00e1u cao h\u01a1n 5 l\u1ea7n so v\u1edbi ULN;<\/p>\n<p>&#8211; Th\u1eadn tr\u1ecdng khi xem x\u00e9t b\u1eaft \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb ACTEMRA \u1edf b\u1ec7nh nh\u00e2n c\u00f3 n\u1ed3ng \u0111\u1ed9 men gan tr\u00ean 1,5 l\u1ea7n so v\u1edbi ULN;<\/p>\n<p>&#8211; Theo d\u00f5i c\u00e1c x\u00e9t nghi\u1ec7m ch\u1ee9c n\u0103ng gan (LFT) \u1edf b\u1ec7nh nh\u00e2n vi\u00eam kh\u1edbp d\u1ea1ng th\u1ea5p v\u00e0 vi\u00eam \u0111\u1ed9ng m\u1ea1ch t\u1ebf b\u00e0o kh\u1ed5ng l\u1ed3 sau 4 \u0111\u1ebfn 8 tu\u1ea7n trong 6 th\u00e1ng \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb, c\u1ea7n theo d\u00f5i x\u00e9t nghi\u1ec7m m\u1ed7i 12 tu\u1ea7n sau \u0111\u00f3;<\/p>\n<p>&#8211; Theo d\u00f5i LFT \u1edf b\u1ec7nh nh\u00e2n vi\u00eam kh\u1edbp t\u1ef1 ph\u00e1t thi\u1ebfu ni\u00ean \u0111a kh\u1edbp v\u00e0 vi\u00eam kh\u1edbp t\u1ef1 ph\u00e1t thi\u1ebfu ni\u00ean to\u00e0n th\u00e2n tr\u01b0\u1edbc khi b\u1eaft \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb, t\u1ea1i th\u1eddi \u0111i\u1ec3m \u0111i\u1ec1u tr\u1ecb ACTEMRA, v\u00e0 c\u1ee9 sau 2 \u0111\u1ebfn 4 tu\u1ea7n;<\/p>\n<p>&#8211; Tham kh\u1ea3o t\u1edd h\u01b0\u1edbng d\u1eabn SD c\u1ee7a s\u1ea3n ph\u1ea9m \u0111\u00e3 \u0111\u01b0\u1ee3c Canada ph\u00ea duy\u1ec7t \u0111\u1ec3 \u0111\u01b0\u1ee3c h\u01b0\u1edbng d\u1eabn \u0111i\u1ec1u ch\u1ec9nh li\u1ec1u khuy\u1ebfn c\u00e1o (gi\u1ea3m, gi\u00e1n \u0111o\u1ea1n ho\u1eb7c ng\u1eebng thu\u1ed1c) \u1edf b\u1ec7nh nh\u00e2n t\u0103ng men gan; v\u00e0<\/p>\n<p>&#8211; T\u01b0 v\u1ea5n b\u1ec7nh nh\u00e2n li\u00ean h\u1ec7 v\u1edbi CBYT n\u1ebfu h\u1ecd g\u1eb7p ph\u1ea3i c\u00e1c d\u1ea5u hi\u1ec7u t\u1ed5n th\u01b0\u01a1ng gan nh\u01b0 ch\u00e1n \u0103n, bu\u1ed3n n\u00f4n v\u00e0 n\u00f4n, m\u1ec7t m\u1ecfi, ng\u1ee9a, n\u01b0\u1edbc ti\u1ec3u s\u1eabm m\u00e0u, v\u00e0ng da v\u00e0 m\u1eaft, s\u01b0ng b\u1ee5ng v\u00e0 \/ ho\u1eb7c \u0111au \u1edf b\u1ee5ng tr\u00ean b\u00ean ph\u1ea3i.<\/p>\n<p>B\u1ed9 Y t\u1ebf Canada \u0111ang h\u1ee3p t\u00e1c v\u1edbi nh\u00e0 s\u1ea3n xu\u1ea5t \u0111\u1ec3 \u0111\u01b0a th\u00f4ng tin an to\u00e0n m\u1edbi n\u00e0y v\u00e0o T\u1edd HDSD S\u1ea3n ph\u1ea9m c\u1ee7a Canada.<\/p>\n<p>Ngu\u1ed3n: <a href=\"https:\/\/www.medsafe.govt.nz\/safety\/DHCPLetters\/ActemraMay2019.pdf\" rel=\"noopener\">https:\/\/www.medsafe.govt.nz\/safety\/DHCPLetters\/ActemraMay2019.pdf<\/a><\/p>\n<p><a href=\"https:\/\/healthycanadians.gc.ca\/recall-alert-rappel-avis\/hc-sc\/2019\/69991a-eng.php\" rel=\"noopener\">https:\/\/healthycanadians.gc.ca\/recall-alert-rappel-avis\/hc-sc\/2019\/69991a-eng.php<\/a><\/p>\n<p>Ng\u01b0\u1eddi t\u1ed5ng h\u1ee3p: D\u01b0\u1ee3c s\u0129 Nguy\u1ec5n Ph\u01b0\u01a1ng Th\u00fay &#8211; Trung T\u00e2m\u00a0c\u1ea3nh gi\u00e1c d\u01b0\u1ee3c &#8211; trung t\u00e2m di &amp; adr qu\u1ed1c gia.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Trong th\u00e1ng 05\/2019, hai c\u01a1 quan qu\u1ea3n l\u00fd an to\u00e0n d\u01b0\u1ee3c ph\u1ea9m c\u1ee7a Canada v\u00e0 New Zealand \u0111\u1ec1u \u0111\u01b0a ra c\u1ea3nh b\u00e1o v\u1ec1 nguy c\u01a1 t\u1ed5n th\u01b0\u01a1ng gan li\u00ean quan \u0111\u1ebfn li\u00ean quan \u0111\u1ebfn ACTEMRA\u00ae (tocilizumab) v\u00e0 y\u00eau c\u1ea7u b\u1ed5 sung th\u00f4ng tin n\u00e0y v\u00e0o t\u1edd h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng thu\u1ed1c. Ng\u00e0y 15\/05\/2019, Medsafe \u0111\u0103ng [&#8230;]\n","protected":false},"author":1,"featured_media":10143,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-10140","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\/10140","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=10140"}],"version-history":[{"count":0,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts\/10140\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media\/10143"}],"wp:attachment":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media?parent=10140"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/categories?post=10140"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/tags?post=10140"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}