{"id":7809,"date":"2019-04-03T16:21:45","date_gmt":"2019-04-03T09:21:45","guid":{"rendered":"https:\/\/pharmog.com\/wp\/?p=7809"},"modified":"2025-01-08T23:01:47","modified_gmt":"2025-01-08T16:01:47","slug":"osimertinib-tagrisso","status":"publish","type":"post","link":"https:\/\/pharmog.com\/wp\/osimertinib-tagrisso\/","title":{"rendered":"Osimertinib &#8211; Tagrisso"},"content":{"rendered":"\r\n<p><em>Thu\u1ed1c Tagrisso l\u00e0 thu\u1ed1c g\u00ec ? D\u01b0\u1edbi \u0111\u00e2y l\u00e0 n\u1ed9i dung t\u1edd h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng g\u1ed1c c\u1ee7a Thu\u1ed1c Tagrisso (Th\u00f4ng tin bao g\u1ed3m li\u1ec1u d\u00f9ng, c\u00e1ch d\u00f9ng, ch\u1ec9 \u0111\u1ecbnh, ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh, th\u1eadn tr\u1ecdng, d\u01b0\u1ee3c l\u00fd&#8230;)<\/em><\/p>\r\n\r\n<p><strong>1. T\u00ean ho\u1ea1t ch\u1ea5t v\u00e0 bi\u1ec7t d\u01b0\u1ee3c: <\/strong><\/p>\r\n<p><strong><em>Ho\u1ea1t ch\u1ea5t :<\/em> <a href=\"https:\/\/pharmog.com\/wp\/osimertinib\/\">Osimertinib mesylate<\/a><\/strong><\/p>\r\n<p><strong><em>Ph\u00e2n lo\u1ea1i: <\/em><\/strong><em>Thu\u1ed1c ch\u1ed1ng ung th\u01b0, ch\u1ea5t \u1ee9c ch\u1ebf protein kinase.<\/em><\/p>\r\n<p><strong><em>Nh\u00f3m<\/em><\/strong> <strong><em>ph\u00e1p l\u00fd: <\/em><\/strong><em>Thu\u1ed1c k\u00ea \u0111\u01a1n ETC \u2013 (Ethical drugs, prescription drugs, Prescription only medicine)<\/em><\/p>\r\n<p><strong><em>M\u00e3 ATC<\/em><\/strong> (Anatomical Therapeutic Chemical): L01XE35.<\/p>\r\n<p><strong><em>Brand name:<\/em><\/strong> TAGRISSO<\/p>\r\n<p><strong><em>H\u00e3ng s\u1ea3n xu\u1ea5t <\/em><\/strong>: AstraZeneca<\/p>\r\n<p><script src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-5528370293090692\" async=\"\" crossorigin=\"anonymous\"><\/script><ins class=\"adsbygoogle\" style=\"display: block; text-align: center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-5528370293090692\" data-ad-slot=\"8909623906\"><\/ins><script> (adsbygoogle = window.adsbygoogle || []).push({}); <\/script><\/p>\r\n<p><strong>2. D\u1ea1ng b\u00e0o ch\u1ebf &#8211; H\u00e0m l\u01b0\u1ee3ng: <\/strong><\/p>\r\n<p><strong><em>D\u1ea1ng thu\u1ed1c v\u00e0 h\u00e0m l\u01b0\u1ee3ng<\/em><\/strong><\/p>\r\n<p>Vi\u00ean n\u00e9n Osimertinib 40mg ho\u1eb7c 80mg.<\/p>\r\n<p>TAGRISSO 40mg: Vi\u00ean m\u00e0u be, h\u00ecnh tr\u00f2n, \u0111\u01b0\u1eddng k\u00ednh 9 mm, hai m\u1eb7t l\u1ed3i, c\u00f3 kh\u1eafc \u201cAZ\u201d v\u00e0 \u201c40\u201d \u1edf m\u1ed9t m\u1eb7t v\u00e0 m\u1ed9t m\u1eb7t tr\u01a1n.<\/p>\r\n<p>TAGRISSO 80mg: Vi\u00ean m\u00e0u be, h\u00ecnh b\u1ea7u d\u1ee5c, k\u00edch th\u01b0\u1edbc 7,25&#215;14,5 mm, hai m\u1eb7t l\u1ed3i, c\u00f3 kh\u1eafc \u201cAZ\u201d v\u00e0 \u201c80\u201d \u1edf m\u1ed9t m\u1eb7t v\u00e0 m\u1ed9t m\u1eb7t tr\u01a1n.<\/p>\r\n<p><strong><em>Thu\u1ed1c tham kh\u1ea3o:<\/em><\/strong><\/p>\r\n<table>\r\n<tbody>\r\n<tr>\r\n<td colspan=\"2\"><strong><em>TAGRISSO 80 mg<\/em><\/strong><\/td>\r\n<td>\u00a0<\/td>\r\n<\/tr>\r\n<tr>\r\n<td colspan=\"2\"><em>M\u1ed7i vi\u00ean n\u00e9n bao phim c\u00f3 ch\u1ee9a:<\/em><\/td>\r\n<td>\u00a0<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>Osimertinib<\/td>\r\n<td>&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;.<\/td>\r\n<td>80 mg<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>T\u00e1 d\u01b0\u1ee3c<\/td>\r\n<td>&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;.<\/td>\r\n<td>v\u1eeba \u0111\u1ee7 (Xem m\u1ee5c 6.1)<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>\r\n<p><img loading=\"lazy\" decoding=\"async\" width=\"520\" height=\"293\" class=\"wp-image-7810\" src=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/word-image-362.png\" srcset=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/word-image-362.png 520w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/word-image-362-300x169.png 300w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/word-image-362-330x186.png 330w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/word-image-362-318x180.png 318w\" sizes=\"auto, (max-width: 520px) 100vw, 520px\" \/><\/p>\r\n<p><strong>3. Video by Pharmog:<\/strong><\/p>\r\n<p><strong>[VIDEO D\u01af\u1ee2C L\u00dd]<\/strong><\/p>\r\n<p>&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;<\/p>\r\n<p>\u25ba K\u1ecbch B\u1ea3n: PharmogTeam<\/p>\r\n<p>\u25ba Youtube: https:\/\/www.youtube.com\/c\/pharmog<\/p>\r\n<p>\u25ba Facebook: https:\/\/www.facebook.com\/pharmog\/<\/p>\r\n<p>\u25ba Group : H\u1ed9i nh\u1eefng ng\u01b0\u1eddi m\u00ea d\u01b0\u1ee3c l\u00fd<\/p>\r\n<p>\u25ba Instagram : https:\/\/www.instagram.com\/pharmogvn\/<\/p>\r\n<p>\u25ba Website: pharmog.com<\/p>\r\n<p><strong>4. \u1ee8ng d\u1ee5ng l\u00e2m s\u00e0ng: <\/strong><\/p>\r\n<p><strong>4.1. Ch\u1ec9 \u0111\u1ecbnh:<\/strong><\/p>\r\n<p>TAGRISSO \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh cho b\u1ec7nh nh\u00e2n tr\u01b0\u1edfng th\u00e0nh ung th\u01b0 ph\u1ed5i lo\u1ea1i kh\u00f4ng t\u1ebf b\u00e0o nh\u1ecf (NSCLC) giai \u0111o\u1ea1n ti\u1ebfn tri\u1ec3n t\u1ea1i ch\u1ed7 ho\u1eb7c di c\u0103n c\u00f3 \u0111\u1ed9t bi\u1ebfn (EGFR) T790M d\u01b0\u01a1ng t\u00ednh.<\/p>\r\n<p><strong>4.2. Li\u1ec1u d\u00f9ng &#8211; C\u00e1ch d\u00f9ng:<\/strong><\/p>\r\n<p><strong><em>C\u00e1ch d\u00f9ng<\/em><\/strong> :<\/p>\r\n<p>Thu\u1ed1c d\u00f9ng \u0111\u01b0\u1eddng u\u1ed1ng. Nu\u1ed1t nguy\u00ean vi\u00ean v\u1edbi n\u01b0\u1edbc v\u00e0 kh\u00f4ng \u0111\u01b0\u1ee3c nghi\u1ec1n, b\u1ebb ho\u1eb7c nhai.<\/p>\r\n<p>Tr\u01b0\u1eddng h\u1ee3p b\u1ec7nh nh\u00e2n kh\u00f4ng th\u1ec3 nu\u1ed1t nguy\u00ean vi\u00ean thu\u1ed1c, c\u00f3 th\u1ec3 ph\u00e2n t\u00e1n vi\u00ean thu\u1ed1c trong 50mL n\u01b0\u1edbc kh\u00f4ng ch\u1ee9a carbonate. Th\u1ea3 nguy\u00ean vi\u00ean thu\u1ed1c v\u00e0o n\u01b0\u1edbc, kh\u00f4ng \u0111\u01b0\u1ee3c nghi\u1ec1n, khu\u1ea5y \u0111\u1ec1u cho \u0111\u1ebfn khi thu\u1ed1c ph\u00e2n t\u00e1n v\u00e0 u\u1ed1ng d\u1ecbch thu\u1ed1c ngay l\u1eadp t\u1ee9c. N\u00ean d\u00f9ng th\u00eam n\u1eeda ly n\u01b0\u1edbc tr\u00e1ng ly \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o kh\u00f4ng c\u00f2n c\u1eb7n thu\u1ed1c v\u00e0 u\u1ed1ng ngay. Kh\u00f4ng d\u00f9ng th\u00eam b\u1ea5t k\u1ef3 ch\u1ea5t l\u1ecfng n\u00e0o kh\u00e1c.<\/p>\r\n<p>N\u1ebfu c\u1ea7n d\u00f9ng qua \u0111\u01b0\u1eddng \u1ed1ng th\u00f4ng d\u1ea1 d\u00e0y, n\u00ean theo quy tr\u00ecnh nh\u01b0 tr\u00ean nh\u01b0ng l\u01b0\u1ee3ng n\u01b0\u1edbc d\u00f9ng s\u1ebd l\u00e0 15mL \u1edf l\u1ea7n pha \u0111\u1ea7u v\u00e0 15mL khi tr\u00e1ng c\u1eb7n. T\u1ed5ng h\u1ee3p 30mL ch\u1ea5t l\u1ecfng s\u1ebd \u0111\u01b0\u1ee3c d\u00f9ng theo h\u01b0\u1edbng d\u1eabn c\u1ee7a nh\u00e0 s\u1ea3n xu\u1ea5t \u1ed1ng th\u00f4ng d\u1ea1 d\u00e0y v\u1edbi l\u01b0\u1ee3ng n\u01b0\u1edbc tr\u00e1ng \u1ed1ng th\u00f4ng (water flushes). N\u00ean d\u00f9ng d\u1ecbch ph\u00e2n t\u00e1n v\u00e0 tr\u00e1ng c\u1eb7n trong v\u00f2ng 30 ph\u00fat k\u1ec3 t\u1eeb khi thu\u1ed1c \u0111\u01b0\u1ee3c pha v\u00e0o n\u01b0\u1edbc.<\/p>\r\n<p><strong><em>Li\u1ec1u d\u00f9ng:<\/em><\/strong><\/p>\r\n<p>\u0110i\u1ec1u tr\u1ecb b\u1eb1ng TAGRISSO n\u00ean \u0111\u01b0\u1ee3c b\u1eaft \u0111\u1ea7u v\u1edbi b\u00e1c s\u1ef9 c\u00f3 kinh nghi\u1ec7m trong tr\u1ecb li\u1ec7u kh\u00e1ng ung th\u01b0.<\/p>\r\n<p>Khi xem x\u00e9t d\u00f9ng TAGRISSO trong \u0111i\u1ec1u tr\u1ecb ung th\u01b0 ph\u1ed5i lo\u1ea1i kh\u00f4ng ph\u1ea3i t\u1ebf b\u00e0o nh\u1ecf (NSCLC) giai \u0111o\u1ea1n ti\u1ebfn tri\u1ec3n t\u1ea1i ch\u1ed7 ho\u1eb7c di c\u0103n, c\u1ea7n thi\u1ebft ph\u1ea3i x\u00e1c \u0111\u1ecbnh t\u00ecnh tr\u1ea1ng \u0111\u1ed9t bi\u1ebfn EGFR T790M b\u1eb1ng ph\u01b0\u01a1ng ph\u00e1p x\u00e9t nghi\u1ec7m \u0111\u00e3 \u0111\u01b0\u1ee3c c\u00f4ng nh\u1eadn .<\/p>\r\n<p><em>Li\u1ec1u l\u01b0\u1ee3ng<\/em><\/p>\r\n<p>Li\u1ec1u khuy\u1ebfn c\u00e1o l\u00e0 80 mg TAGRISSO, 1 l\u1ea7n\/ng\u00e0y cho \u0111\u1ebfn khi b\u1ec7nh ti\u1ebfn tri\u1ec3n tr\u1edf l\u1ea1i ho\u1eb7c xu\u1ea5t hi\u1ec7n \u0111\u1ed9c t\u00ednh ph\u1ea3n \u1ee9ng ngo\u1ea1i \u00fd kh\u00f4ng th\u1ec3 ch\u1ea5p nh\u1eadn.<\/p>\r\n<p>N\u1ebfu qu\u00ean 1 li\u1ec1u TAGRISSO, n\u00ean u\u1ed1ng thu\u1ed1c ngay tr\u1eeb phi li\u1ec1u k\u1ebf ti\u1ebfp s\u1ebd \u0111\u01b0\u1ee3c d\u00f9ng trong v\u00f2ng 12 gi\u1edd.<\/p>\r\n<p><em>\u0110i\u1ec1u ch\u1ec9nh li\u1ec1u<\/em><\/p>\r\n<p>C\u00f3 th\u1ec3 c\u1ea7n ng\u01b0ng li\u1ec1u v\u00e0\/ho\u1eb7c \u0111i\u1ec1u ch\u1ec9nh li\u1ec1u d\u1ef1a tr\u00ean m\u1ee9c \u0111\u1ed9 an to\u00e0n v\u00e0 dung n\u1ea1p c\u1ee7a m\u1ed7i c\u00e1 nh\u00e2n. N\u1ebfu c\u1ea7n gi\u1ea3m li\u1ec1u, n\u00ean gi\u1ea3m xu\u1ed1ng li\u1ec1u 40 mg, 1 l\u1ea7n\/ng\u00e0y.<\/p>\r\n<p>H\u01b0\u1edbng d\u1eabn gi\u1ea3m li\u1ec1u khi g\u1eb7p \u0111\u1ed9c t\u00ednh ph\u1ea3n \u1ee9ng ngo\u1ea1i \u00fd \u0111\u01b0\u1ee3c tr\u00ecnh b\u00e0y trong B\u1ea3ng 4.<\/p>\r\n<table>\r\n<tbody>\r\n<tr>\r\n<td><strong>C\u01a1 quan \u0111\u00edch<\/strong><\/td>\r\n<td><strong>Ph\u1ea3n \u1ee9ng ngo\u1ea1i \u00fd<sup>a<\/sup><\/strong><\/td>\r\n<td><strong>Ch\u1ec9nh li\u1ec1u<\/strong><\/td>\r\n<\/tr>\r\n<tr>\r\n<td><strong>Ph\u1ed5i<\/strong><\/td>\r\n<td>B\u1ec7nh ph\u1ed5i m\u00f5 k\u1ebd (ILD)\/Vi\u00eam ph\u1ed5i<\/td>\r\n<td>Ng\u01b0ng v\u0129nh vi\u1ec5n TAGRISSO<\/td>\r\n<\/tr>\r\n<tr>\r\n<td rowspan=\"2\"><strong>Tim<\/strong><\/td>\r\n<td>Kho\u1ea3ng QTc l\u1edbn hom 500 mili gi\u00e2y tr\u1ebdn t\u1ed1i thi\u1ec3u 2 l\u1ea7n \u0111o ECGs ri\u00eang bi\u1ec7t<\/td>\r\n<td>Ng\u01b0ng d\u00f9ng TAGRISSO cho \u0111\u1ebfn khi kho\u1ea3ng QTc nh\u1ecf h\u01a1n 481 mili gi\u00e2y ho\u1eb7c h\u1ed3i ph\u1ee5c v\u1ec1 m\u1ee9c c\u01a1 b\u1ea3n n\u1ebfu m\u1ee9c c\u01a1 b\u1ea3n QTc l\u1edbn h\u01a1n ho\u1eb7c b\u1eb1ng 481 mili gi\u00e2y, sau \u0111\u00f3 kh\u1edfi \u0111\u1ea7u l\u1ea1i v\u1edbi li\u1ec1u gi\u1ea3m (40 mg)<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>Kho\u1ea3ng QTc k\u00e9o d\u00e0i k\u00e8m d\u1ea5u hi\u1ec7u\/tri\u1ec7u ch\u1ee9ng lo\u1ea1n nh\u1ecbp tr\u1ea7m tr\u1ecdng<\/td>\r\n<td>Ng\u01b0ng v\u0129nh vi\u1ec5n TAGRISSO<\/td>\r\n<\/tr>\r\n<tr>\r\n<td rowspan=\"3\"><strong>Kh\u00e1c<\/strong><\/td>\r\n<td>Ph\u1ea3n \u1ee9ng ngo\u1ea1i \u00fd c\u1ea5p \u0111\u1ed9 3 ho\u1eb7c l\u1edbn h\u01a1n<\/td>\r\n<td>Ng\u01b0ng d\u00f9ng TAGRISSO cho \u0111\u1ebfn 3 tu\u1ea7n<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>N\u1ebfu ph\u1ea3n \u1ee9ng ngo\u1ea1i \u00fd c\u1ea5p \u0111\u1ed9 3 ho\u1eb7c l\u1edbn h\u01a1n \u0111\u01b0\u1ee3c c\u1ea3i thi\u1ec7n xu\u1ed1ng c\u1ea5p \u0111\u1ed9 0-2 sau khi ng\u01b0ng d\u00f9ng TAGRISSO cho \u0111\u1ebfn 3 tu\u1ea7n<\/td>\r\n<td>C\u00f3 th\u1ec3 kh\u1edfi \u0111\u1ea7u l\u1ea1i TAGRISSO v\u1edbi c\u00f9ng li\u1ec1u (80 mg) ho\u1eb7c li\u1ec1u gi\u1ea3m (40 mg)<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>N\u1ebfu ph\u1ea3n \u1ee9ng ngo\u1ea1i \u00fd c\u1ea5p \u0111\u1ed9 3 ho\u1eb7c l\u1edbn h\u01a1n kh\u00f4ng \u0111\u01b0\u1ee3c c\u1ea3i thi\u1ec7n xu\u1ed1ng c\u1ea5p \u0111\u1ed9 0-2 sau khi ng\u01b0ng d\u00f9ng TAGRISSO cho \u0111\u1ebfn 3 tu\u1ea7n<\/td>\r\n<td>Ng\u01b0ng v\u0129nh vi\u1ec5n TAGRISSO<\/td>\r\n<\/tr>\r\n<tr>\r\n<td colspan=\"3\">a Ghi ch\u00fa: c\u1ea5p \u0111\u1ed9 ph\u1ea3n \u1ee9ng ngo\u1ea1i \u00fd tr\u1ebdn l\u00e2m s\u00e0ng d\u1ef1a tr\u00ean Ti\u00eau chu\u1ea9n \u0110\u00e1nh gi\u00e1 c\u00e1c bi\u1ebfn c\u1ed1 b\u1ea5t l\u1ee3i (CTCAE) phi\u00ean b\u1ea3n 4,0 c\u1ee7a Vi\u1ec7n Ung th\u01b0 qu\u1ed1c gia Hoa K\u1ef3 (NCI).\r\n<p>&nbsp;<\/p>\r\n<p>ECGs: \u0111i\u1ec7n t\u00e2m \u0111\u1ed3; QTc: kho\u1ea3ng QT \u0111i\u1ec1u ch\u1ec9nh tr\u1ebdn nh\u1ecbp tim.<\/p>\r\n<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>\r\n<p><em>C\u00e1c nh\u00f3m b\u1ec7nh nh\u00e2n \u0111\u1eb7c bi\u1ec7t:<\/em> Kh\u00f4ng c\u1ea7n ch\u1ec9nh li\u1ec1u do tu\u1ed5i, c\u00e2n n\u1eb7ng, gi\u1edbi t\u00ednh, ch\u1ee7ng t\u1ed9c ho\u1eb7c t\u00ecnh tr\u1ea1ng h\u00fat thu\u1ed1c c\u1ee7a b\u1ec7nh nh\u00e2n .<\/p>\r\n<p>B\u1ec7nh nh\u00e2n suy gan: Kh\u00f4ng c\u00f3 c\u00e1c nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 \u0111\u1eb7c bi\u1ec7t t\u00e1c \u0111\u1ed9ng c\u1ee7a t\u00ecnh tr\u1ea1ng suy gan tr\u00ean d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u1ee7a TAGRISSO. Kh\u00f4ng c\u1ea7n \u0111i\u1ec1u ch\u1ec9nh li\u1ec1u \u1edf b\u1ec7nh nh\u00e2n suy gan nh\u1eb9 (t\u1ed5ng bilirubin \u2264 gi\u1edbi h\u1ea1n tr\u00ean c\u1ee7a m\u1ee9c b\u00ecnh th\u01b0\u1eddng (ULN) v\u00e0 men aspartate aminotransferase (AST) &gt;ULN ho\u1eb7c t\u1ed5ng bilirubin &gt;1,0 \u0111\u1ebfn 1,5xULN v\u00e0 xu\u1ea5t hi\u1ec7n AST) ho\u1eb7c \u1edf b\u1ec7nh nh\u00e2n suy gan trung b\u00ecnh (t\u1ed5ng bilirubin t\u1eeb 1,5 \u0111\u1ebfn 3 l\u1ea7n ULN v\u00e0 c\u00f3 xu\u1ea5t hi\u1ec7n AST). Tuy nhi\u00ean th\u1eadn tr\u1ecdng khi d\u00f9ng TAGRISSO cho c\u00e1c b\u1ec7nh nh\u00e2n n\u00e0y. Hi\u1ec7u qu\u1ea3 v\u00e0 t\u00ednh an to\u00e0n c\u1ee7a thu\u1ed1c ch\u01b0a \u0111\u01b0\u1ee3c thi\u1ebft l\u1eadp tr\u00ean b\u1ec7nh nh\u00e2n suy gan n\u1eb7ng. Cho \u0111\u1ebfn khi c\u00f3 d\u1eef li\u1ec7u m\u1edbi, kh\u00f4ng khuy\u1ebfn c\u00e1o d\u00f9ng tr\u00ean b\u1ec7nh nh\u00e2n suy gan n\u1eb7ng .<\/p>\r\n<p>B\u1ec7nh nh\u00e2n suy th\u1eadn: Kh\u00f4ng c\u00f3 c\u00e1c nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 \u0111\u1eb7c bi\u1ec7t t\u00e1c \u0111\u1ed9ng c\u1ee7a t\u00ecnh tr\u1ea1ng suy th\u1eadn tr\u00ean d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u1ee7a TAGRISSO. Kh\u00f4ng c\u1ea7n ch\u1ec9nh li\u1ec1u \u1edf b\u1ec7nh nh\u00e2n suy th\u1eadn nh\u1eb9, trung b\u00ecnh ho\u1eb7c n\u1eb7ng. \u00cdt d\u1eef li\u1ec7u c\u00f3 s\u1eb5n tr\u00ean b\u1ec7nh nh\u00e2n suy th\u1eadn n\u1eb7ng. T\u00ednh an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a thu\u1ed1c ch\u01b0a \u0111\u01b0\u1ee3c thi\u1ebft l\u1eadp \u1edf b\u1ec7nh nh\u00e2n b\u1ec7nh th\u1eadn giai \u0111o\u1ea1n cu\u1ed1i [\u0111\u1ed9 thanh th\u1ea3i creatinin (CLcr) &lt; 15mL\/ph\u00fat \u0111\u01b0\u1ee3c t\u00ednh theo c\u00f4ng th\u1ee9c Cockcroft and Gault] ho\u1eb7c \u0111ang l\u1ecdc m\u00e1u. N\u00ean th\u1eadn tr\u1ecdng khi \u0111i\u1ec1u tr\u1ecb cho b\u1ec7nh nh\u00e2n suy th\u1eadn n\u1eb7ng v\u00e0 b\u1ec7nh th\u1eadn giai \u0111o\u1ea1n cu\u1ed1i .<\/p>\r\n<p>Tr\u1ebb em: T\u00ednh an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a TAGRISSO \u1edf tr\u1ebb em v\u00e0 tr\u1ebb v\u1ecb th\u00e0nh ni\u00ean &lt; 18 tu\u1ed5i ch\u01b0a \u0111\u01b0\u1ee3c thi\u1ebft l\u1eadp. Hi\u1ec7n ch\u01b0a c\u00f3 d\u1eef li\u1ec7u.<\/p>\r\n<p><strong>4.3. Ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh:<\/strong><\/p>\r\n<p>Qu\u00e1 m\u1eabn v\u1edbi ho\u1ea1t ch\u1ea5t ho\u1eb7c b\u1ea5t k\u1ef3 t\u00e1 d\u01b0\u1ee3c n\u00e0o li\u1ec7t k\u00ea t\u1ea1i ph\u1ea7n \u201cT\u00e1 d\u01b0\u1ee3c\u201d.<\/p>\r\n<p>Thu\u1ed1c St. John&#8217;s Wort kh\u00f4ng n\u00ean d\u00f9ng chung v\u1edbi TAGRISSO (xem ph\u1ea7n \u201cT\u01b0\u01a1ng t\u00e1c c\u1ee7a thu\u1ed1c v\u1edbi c\u00e1c thu\u1ed1c kh\u00e1c v\u00e0 c\u00e1c lo\u1ea1i t\u01b0\u01a1ng t\u00e1c kh\u00e1c\u201d).<\/p>\r\n<p><script src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-5528370293090692\" async=\"\" crossorigin=\"anonymous\"><\/script><ins class=\"adsbygoogle\" style=\"display: block; text-align: center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-5528370293090692\" data-ad-slot=\"8909623906\"><\/ins><script> (adsbygoogle = window.adsbygoogle || []).push({}); <\/script><\/p>\r\n<p><strong>4.4 Th\u1eadn tr\u1ecdng:<\/strong><\/p>\r\n<p><em>\u0110\u00e1nh gi\u00e1 t\u00ecnh tr\u1ea1ng \u0111\u1ed9t bi\u1ebfn EGFR T790M<\/em><\/p>\r\n<p>Khi xem x\u00e9t d\u00f9ng TAGRISSO \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb cho b\u1ec7nh nh\u00e2n ung th\u01b0 ph\u1ed5i lo\u1ea1i kh\u00f4ng ph\u1ea3i t\u1ebf b\u00e0o nh\u1ecf (NSCLC) giai \u0111o\u1ea1n ti\u1ebfn tri\u1ec3n t\u1ea1i ch\u1ed7 ho\u1eb7c di c\u0103n, vi\u1ec7c x\u00e1c \u0111\u1ecbnh t\u00ecnh tr\u1ea1ng \u0111\u1ed9t bi\u1ebfn EGFR T790M l\u00e0 r\u1ea5t quan tr\u1ecdng. N\u00ean th\u1ef1c hi\u1ec7n m\u1ed9t x\u00e9t nghi\u1ec7m \u0111\u00e3 \u0111\u01b0\u1ee3c c\u00f4ng nh\u1eadn b\u1eb1ng c\u00e1ch s\u1eed d\u1ee5ng m\u1eabu DNA kh\u1ed1i u l\u1ea5y t\u1eeb m\u1eabu m\u00f4 ho\u1eb7c m\u1eabu DNA kh\u1ed1i u trong h\u1ec7 tu\u1ea7n ho\u00e0n (ctDNA) thu th\u1eadp t\u1eeb m\u1eabu huy\u1ebft t\u01b0\u01a1ng.<\/p>\r\n<p>Ch\u1ec9 d\u00f9ng c\u00e1c ph\u01b0\u01a1ng ph\u00e1p x\u00e9t nghi\u1ec7m c\u00f3 \u0111\u1ed9 t\u00e1i l\u1eadp, \u0111\u1ed9 tin c\u1eady, \u0111\u1ed9 nh\u1ea1y c\u00f9ng v\u1edbi c\u00e1c ch\u01b0\u01a1ng tr\u00ecnh ti\u1ec7n \u00edch (utility) \u0111\u00e3 \u0111\u01b0\u1ee3c ki\u1ec3m ch\u1ee9ng \u0111\u1ec3 x\u00e1c \u0111\u1ecbnh t\u00ecnh tr\u1ea1ng \u0111\u1ed9t bi\u1ebfn T790M c\u1ee7a m\u1eabu DNA kh\u1ed1i u (t\u1eeb m\u1eabu m\u00f4 ho\u1eb7c m\u1eabu huy\u1ebft t\u01b0\u01a1ng).<\/p>\r\n<p>Vi\u1ec7c x\u00e1c \u0111\u1ecbnh t\u00ecnh tr\u1ea1ng d\u01b0\u01a1ng t\u00ednh c\u1ee7a \u0111\u1ed9t bi\u1ebfn T790M s\u1eed d\u1ee5ng x\u00e9t nghi\u1ec7m tr\u00ean m\u1eabu m\u00f4 ho\u1eb7c m\u1eabu huy\u1ebft t\u01b0\u01a1ng s\u1ebd cho bi\u1ebft c\u00f3 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n \u0111i\u1ec1u tr\u1ecb v\u1edbi TAGRISSO. Tuy nhi\u00ean, n\u1ebfu s\u1eed d\u1ee5ng x\u00e9t nghi\u1ec7m m\u1eabu DNA kh\u1ed1i u trong h\u1ec7 tu\u1ea7n ho\u00e0n d\u1ef1a tr\u00ean m\u1eabu huy\u1ebft t\u01b0\u01a1ng v\u00e0 c\u00f3 k\u1ebft qu\u1ea3 \u00e2m t\u00ednh, khuy\u1ebfn c\u00e1o n\u00ean theo d\u00f5i ti\u1ebfp b\u1eb1ng x\u00e9t nghi\u1ec7m t\u1eeb m\u1eabu m\u00f4 n\u1ebfu c\u00f3 th\u1ec3 v\u00ec c\u00f3 kh\u1ea3 n\u0103ng x\u00e9t nghi\u1ec7m m\u1eabu huy\u1ebft t\u01b0\u01a1ng cho k\u1ebft qu\u1ea3 \u00e2m t\u00ednh gi\u1ea3.<\/p>\r\n<p><em>B\u1ec7nh ph\u1ed5i m\u00f4 k\u1ebd (ILD)<\/em><\/p>\r\n<p>B\u1ec7nh ph\u1ed5i m\u00f4 k\u1ebd (ILD) tr\u1ea7m tr\u1ecdng\/\u0111e d\u1ecda \u0111\u1ebfn t\u00ednh m\u1ea1ng\/g\u00e2y t\u1eed vong ho\u1eb7c ph\u1ea3n \u1ee9ng ngo\u1ea1i \u00fd gi\u1ed1ng ILD (nh\u01b0 vi\u00eam ph\u1ed5i) \u0111\u00e3 \u0111\u01b0\u1ee3c ghi nh\u1eadn \u1edf b\u1ec7nh nh\u00e2n d\u00f9ng TAGRISSO trong c\u00e1c nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng. H\u1ea7u h\u1ebft c\u00e1c tr\u01b0\u1eddng h\u1ee3p \u0111\u01b0\u1ee3c c\u1ea3i thi\u1ec7n ho\u1eb7c bi\u1ebfn m\u1ea5t khi ng\u01b0ng \u0111i\u1ec1u tr\u1ecb. B\u1ec7nh nh\u00e2n c\u00f3 ti\u1ec1n s\u1eed ILD tr\u01b0\u1edbc \u0111\u00e2y, \u0111\u00e3 d\u00f9ng thu\u1ed1c g\u00e2y ILD, vi\u00eam ph\u1ed5i do x\u1ea1 tr\u1ecb m\u00e0 y\u00eau c\u1ea7u d\u00f9ng steroid ho\u1eb7c c\u00f3 b\u1ea5t k\u1ef3 b\u1eb1ng ch\u1ee9ng ILD ti\u1ebfn tri\u1ec3n tr\u00ean l\u00e2m s\u00e0ng \u0111\u00e3 \u0111\u01b0\u1ee3c lo\u1ea1i tr\u1eeb kh\u1ecfi c\u00e1c nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng n\u00e0y .<\/p>\r\n<p>\u0110\u00e3 ghi nh\u1eadn b\u1ec7nh ph\u1ed5i m\u00f4 k\u1ebd (ILD) ho\u1eb7c ph\u1ea3n \u1ee9ng ngo\u1ea1i \u00fd gi\u1ed1ng ILD (nh\u01b0 vi\u00eam ph\u1ed5i) \u1edf 3,5% b\u1ec7nh nh\u00e2n v\u00e0 t\u1eed vong \u1edf 0,6% tr\u00ean t\u1ed5ng s\u1ed1 833 b\u1ec7nh nh\u00e2n d\u00f9ng TAGRISSO trong c\u00e1c nghi\u00ean c\u1ee9u AURA. T\u1ea7n xu\u1ea5t x\u1ea3y ra ILD l\u00e0 8,2% \u1edf b\u1ec7nh nh\u00e2n l\u00e0 ng\u01b0\u1eddi Nh\u1eadt b\u1ea3n, 1,9% \u1edf b\u1ec7nh nh\u00e2n Ch\u00e2u \u00c1 v\u00e0 2,9% \u1edf nh\u00f3m b\u1ec7nh nh\u00e2n kh\u00f4ng thu\u1ed9c ch\u1ee7ng t\u1ed9c Ch\u00e2u \u00c1 .<\/p>\r\n<p>C\u1ea7n \u0111\u00e1nh gi\u00e1 th\u1eadn tr\u1ecdng \u0111\u1ec3 lo\u1ea1i tr\u1eeb ILD \u0111\u1ed1i v\u1edbi t\u1ea5t c\u1ea3 b\u1ec7nh nh\u00e2n kh\u1edfi ph\u00e1t c\u1ea5p t\u00ednh tri\u1ec7u ch\u1ee9ng \u0111\u01b0\u1eddng h\u00f4 h\u1ea5p (kh\u00f3 th\u1edf, ho, s\u1ed1t) v\u00e0\/ho\u1eb7c c\u00e1c tri\u1ec7u ch\u1ee9ng n\u00e0y tr\u1edf n\u00ean n\u1eb7ng h\u01a1n kh\u00f4ng gi\u1ea3i th\u00edch \u0111\u01b0\u1ee3c. N\u00ean ng\u01b0ng \u0111i\u1ec1u tr\u1ecb b\u1eb1ng thu\u1ed1c n\u00e0y trong khi \u0111ang ki\u1ec3m tra c\u00e1c tri\u1ec7u ch\u1ee9ng tr\u00ean. N\u1ebfu \u0111\u00e3 ch\u1ea9n \u0111o\u00e1n l\u00e0 ILD, n\u00ean ng\u01b0ng v\u0129nh vi\u1ec5n TAGRISSO v\u00e0 b\u1eaft \u0111\u1ea7u c\u00e1c li\u1ec7u ph\u00e1p \u0111i\u1ec1u tr\u1ecb c\u1ea7n thi\u1ebft.<\/p>\r\n<p><em>K\u00e9o d\u00e0i kho\u1ea3ng QTc<\/em><\/p>\r\n<p>Kho\u1ea3ng QTc k\u00e9o d\u00e0i xu\u1ea5t hi\u1ec7n tr\u00ean b\u1ec7nh nh\u00e2n d\u00f9ng TAGRISSO v\u00e0 c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ebfn t\u0103ng nguy c\u01a1 nh\u1ecbp nhanh th\u1ea5t (nh\u01b0 xo\u1eafn \u0111\u1ec9nh) ho\u1eb7c t\u1eed vong \u0111\u1ed9t ng\u1ed9t. Kh\u00f4ng c\u00f3 bi\u1ebfn c\u1ed1 lo\u1ea1n nh\u1ecbp n\u00e0o \u0111\u01b0\u1ee3c ghi nh\u1eadn trong c\u00e1c nghi\u00ean c\u1ee9u AURAex or AURA2 . B\u1ec7nh nh\u00e2n c\u00f3 b\u1ea5t th\u01b0\u1eddng v\u1ec1 nh\u1ecbp v\u00e0 d\u1eabn truy\u1ec1n n\u1eb7ng tr\u00ean l\u00e2m s\u00e0ng khi \u0111o \u0111i\u1ec7n t\u00e2m \u0111\u1ed3 l\u00fac ngh\u1ec9 (ECG) (nh\u01b0 l\u00e0 kho\u1ea3ng QTc l\u1edbn h\u01a1n 470 mili gi\u00e2y) \u0111\u00e3 \u0111\u01b0\u1ee3c lo\u1ea1i tr\u1eeb trong c\u00e1c nghi\u00ean c\u1ee9u n\u00e0y .<\/p>\r\n<p>Khi c\u00f3 th\u1ec3, n\u00ean tr\u00e1nh d\u00f9ng TAGRISSO tr\u00ean b\u1ec7nh nh\u00e2n c\u00f3 h\u1ed9i ch\u1ee9ng QT k\u00e9o d\u00e0i b\u1ea9m sinh. N\u00ean theo d\u00f5i \u0111\u1ecbnh k\u1ef3 \u0111i\u1ec7n t\u00e2m \u0111\u1ed3 (ECGs) v\u00e0 ch\u1ea5t \u0111i\u1ec7n gi\u1ea3i tr\u00ean b\u1ec7nh nh\u00e2n suy tim sung huy\u1ebft, r\u1ed1i lo\u1ea1n \u0111i\u1ec7n gi\u1ea3i ho\u1eb7c \u1edf b\u1ec7nh nh\u00e2n \u0111ang d\u00f9ng thu\u1ed1c \u0111\u00e3 bi\u1ebft l\u00e0m k\u00e9o d\u00e0i kho\u1ea3ng QTc. N\u00ean ng\u01b0ng \u0111i\u1ec1u tr\u1ecb \u1edf b\u1ec7nh nh\u00e2n c\u00f3 kho\u1ea3ng QTc l\u1edbn h\u01a1n 500 mili gi\u00e2y \u0111\u01b0\u1ee3c ghi nh\u1eadn tr\u00ean \u00edt nh\u1ea5t 2 l\u1ea7n \u0111o \u0111i\u1ec7n t\u00e2m \u0111\u1ed3 t\u00e1ch bi\u1ec7t cho \u0111\u1ebfn khi kho\u1ea3ng QTc nh\u1ecf h\u01a1n 481 mili gi\u00e2y ho\u1eb7c ph\u1ee5c h\u1ed3i v\u1ec1 tr\u1ecb s\u1ed1 c\u0103n b\u1ea3n n\u1ebfu kho\u1ea3ng QTc l\u1edbn h\u01a1n ho\u1eb7c b\u1eb1ng 481 mili gi\u00e2y, sau \u0111\u00f3 c\u00f3 th\u1ec3 d\u00f9ng l\u1ea1i TAGRISSO \u1edf m\u1ee9c li\u1ec1u gi\u1ea3m nh\u01b0 tr\u00ecnh b\u00e0y t\u1ea1i B\u1ea3ng 4. N\u00ean ng\u01b0ng TAGRISSO v\u0129nh vi\u1ec5n \u1edf b\u1ec7nh nh\u00e2n c\u00f3 kho\u1ea3ng QTc k\u00e9o d\u00e0i \u0111i k\u00e8m v\u1edbi c\u00e1c bi\u1ebfn c\u1ed1 sau: xo\u1eafn \u0111\u1ec9nh, nh\u1ecbp nhanh th\u1ea5t \u0111a d\u1ea1ng, c\u00f3 d\u1ea5u hi\u1ec7u\/ tri\u1ec7u ch\u1ee9ng lo\u1ea1n nh\u1ecbp tr\u1ea7m tr\u1ecdng.<\/p>\r\n<p><em>Thay \u0111\u1ed5i t\u00ednh co th\u1eaft c\u01a1 tim:<\/em> Trong c\u00e1c nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng, ph\u00e2n su\u1ea5t t\u1ed1ng m\u00e1u th\u1ea5t tr\u00e1i (Left Ventricular Ejection Fraction &#8211; LVEF) gi\u1ea3m \u2265 10% v\u00e0 m\u1ed9t s\u1ef1 s\u1ee5t gi\u1ea3m &lt; 50% \u0111\u00e3 x\u1ea3y ra trong 4,0% (26\/655) b\u1ec7nh nh\u00e2n d\u00f9ng TAGRISSO, l\u00e0 nh\u1eefng ng\u01b0\u1eddi c\u00f3 \u0111\u00e1nh gi\u00e1 LVEF khi kh\u1edfi \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb v\u00e0 t\u1ed1i thi\u1ec3u 1 l\u1ea7n theo d\u00f5i sau \u0111\u00f3. Qua c\u00e1c d\u1eef li\u1ec7u l\u00e2m s\u00e0ng c\u00f3 s\u1eb5n, m\u1ed1i li\u00ean h\u1ec7 nh\u00e2n qu\u1ea3 gi\u1eefa t\u00e1c \u0111\u1ed9ng tr\u00ean co th\u1eaft c\u01a1 tim v\u00e0 TAGRISSO ch\u01b0a \u0111\u01b0\u1ee3c thi\u1ebft l\u1eadp. Tr\u00ean b\u1ec7nh nh\u00e2n c\u00f3 c\u00e1c y\u1ebfu t\u1ed1 nguy c\u01a1 tr\u00ean tim v\u00e0 nh\u1eefng ng\u01b0\u1eddi c\u00f3 c\u00e1c t\u00ecnh tr\u1ea1ng c\u00f3 th\u1ec3 \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn LVEF, n\u00ean xem x\u00e9t theo d\u00f5i tim, bao g\u1ed3m \u0111\u00e1nh gi\u00e1 LVEF khi kh\u1edfi \u0111\u1ea7u (at baseline) v\u00e0 trong khi \u0111i\u1ec1u tr\u1ecb. Tr\u00ean b\u1ec7nh nh\u00e2n c\u00f3 d\u1ea5u hi\u1ec7u\/tri\u1ec7u ch\u1ee9ng tim li\u00ean quan trong khi \u0111i\u1ec1u tr\u1ecb, vi\u1ec7c theo d\u00f5i tim bao g\u1ed3m \u0111\u00e1nh gi\u00e1 LVEF n\u00ean \u0111\u01b0\u1ee3c xem x\u00e9t.<\/p>\r\n<p><em>Vi\u00eam gi\u00e1c m\u1ea1c:<\/em> Vi\u00eam gi\u00e1c m\u1ea1c \u0111\u00e3 \u0111\u01b0\u1ee3c ghi nh\u1eadn \u1edf 0,7% (n=6) tr\u00ean t\u1ed5ng s\u1ed1 833 b\u1ec7nh nh\u00e2n \u0111i\u1ec1u tr\u1ecb b\u1eb1ng TAGRISSO trong c\u00e1c nghi\u00ean c\u1ee9u AURA. N\u00ean th\u0103m kh\u00e1m b\u00e1c s\u1ef9 chuy\u00ean khoa m\u1eaft ngay l\u1eadp t\u1ef1c khi b\u1ec7nh nh\u00e2n c\u00f3 c\u00e1c d\u1ea5u hi\u1ec7u v\u00e0 tri\u1ec7u ch\u1ee9ng nghi ng\u1edd vi\u00eam k\u1ebft m\u1ea1c nh\u01b0 t\u00ecnh tr\u1ea1ng c\u1ea5p ho\u1eb7c tr\u1ea7m tr\u1ecdng h\u01a1n c\u1ee7a vi\u00eam m\u1eaft, ch\u1ea3y n\u01b0\u1edbc m\u1eaft, nh\u1ea1y c\u1ea3m \u00e1nh s\u00e1ng, m\u1edd m\u1eaft, \u0111au m\u1eaft v\u00e0\/ho\u1eb7c m\u1eaft \u0111\u1ecf.<\/p>\r\n<p><strong>T\u00e1c \u0111\u1ed9ng c\u1ee7a thu\u1ed1c tr\u00ean ng\u01b0\u1eddi l\u00e1i xe v\u00e0 v\u1eadn h\u00e0nh m\u00e1y m\u00f3c.<\/strong><\/p>\r\n<p>\u1ea2nh h\u01b0\u1edfng tr\u00ean kh\u1ea3 n\u0103ng l\u00e1i xe v\u00e0 v\u1eadn h\u00e0nh m\u00e1y m\u00f3c: TAGRISSO kh\u00f4ng c\u00f3 ho\u1eb7c \u00edt \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn vi\u1ec7c l\u00e1i xe ho\u1eb7c v\u1eadn h\u00e0nh m\u00e1y m\u00f3c.<\/p>\r\n<p><strong>4.5 S\u1eed d\u1ee5ng cho ph\u1ee5 n\u1eef c\u00f3 thai v\u00e0 cho con b\u00fa:<\/strong><\/p>\r\n<p><em>X\u1ebfp h\u1ea1ng c\u1ea3nh b\u00e1o<\/em><\/p>\r\n<p>AU TGA pregnancy category: D<\/p>\r\n<p>US FDA pregnancy category: NA<\/p>\r\n<p><em>Th\u1eddi k\u1ef3 mang thai:<\/em><\/p>\r\n<p>Ch\u01b0a c\u00f3 ho\u1eb7c \u00edt d\u1eef li\u1ec7u v\u1ec1 vi\u1ec7c d\u00f9ng TAGRISSO cho ph\u1ee5 n\u1eef c\u00f3 thai. C\u00e1c nghi\u00ean c\u1ee9u tr\u00ean \u0111\u1ed9ng v\u1eadt cho th\u1ea5y thu\u1ed1c g\u00e2y \u0111\u1ed9c t\u00ednh tr\u00ean h\u1ec7 sinh s\u1ea3n (g\u00e2y ch\u1ebft ph\u00f4i thai, gi\u1ea3m ph\u00e1t tri\u1ec3n ph\u00f4i thai v\u00e0 t\u1eed vong chu sinh). Theo c\u01a1 ch\u1ebf t\u00e1c \u0111\u1ed9ng v\u00e0 d\u1eef li\u1ec7u ti\u1ec1n l\u00e2m s\u00e0ng, TAGRISSO c\u00f3 th\u1ec3 l\u00e0m t\u1ed5n h\u1ea1i ph\u00f4i thai khi d\u00f9ng thu\u1ed1c tr\u00ean ph\u1ee5 n\u1eef c\u00f3 thai. TAGRISSO kh\u00f4ng n\u00ean d\u00f9ng cho ph\u1ee5 n\u1eef c\u00f3 thai tr\u1eeb phi t\u00ecnh tr\u1ea1ng l\u00e2m s\u00e0ng c\u1ee7a b\u1ec7nh nh\u00e2n n\u00e0y b\u1eaft bu\u1ed9c ph\u1ea3i \u0111i\u1ec1u tr\u1ecb v\u1edbi TAGRISSO.<\/p>\r\n<p><em>Bi\u1ec7n ph\u00e1p ng\u1eeba thai \u0111\u1ed1i v\u1edbi nam gi\u1edbi v\u00e0 ph\u1ee5 n\u1eef:<\/em><\/p>\r\n<p>Ph\u1ee5 n\u1eef c\u00f3 kh\u1ea3 n\u0103ng mang thai \u0111\u01b0\u1ee3c khuy\u1ebfn c\u00e1o n\u00ean tr\u00e1nh c\u00f3 thai khi d\u00f9ng TAGRISSO. B\u1ec7nh nh\u00e2n n\u00ean d\u00f9ng c\u00e1c bi\u1ec7n ph\u00e1p ng\u1eeba thai hi\u1ec7u qu\u1ea3 t\u1ed1i thi\u1ec3u l\u00e0 2 th\u00e1ng \u1edf ph\u1ee5 n\u1eef v\u00e0 4 th\u00e1ng \u1edf nam gi\u1edbi sau khi ho\u00e0n t\u1ea5t li\u1ec7u tr\u00ecnh \u0111i\u1ec1u tr\u1ecb b\u1eb1ng thu\u1ed1c. Kh\u00f4ng lo\u1ea1i tr\u1eeb nguy c\u01a1 thu\u1ed1c l\u00e0m gi\u1ea3m n\u1ed3ng \u0111\u1ed9 v\u00e0 th\u1eddi gian ti\u1ebfp x\u00fac c\u1ee7a hormon ng\u1eeba thai.<\/p>\r\n<p><em>Kh\u1ea3 n\u0103ng sinh s\u1ea3n:<\/em><\/p>\r\n<p>Ch\u01b0a c\u00f3 d\u1eef li\u1ec7u v\u1ec1 \u1ea3nh h\u01b0\u1edfng c\u1ee7a TAGRISSO tr\u00ean kh\u1ea3 n\u0103ng sinh s\u1ea3n \u1edf ng\u01b0\u1eddi. K\u1ebft qu\u1ea3 t\u1eeb c\u00e1c nghi\u00ean c\u1ee9u tr\u00ean s\u00fac v\u1eadt cho th\u1ea5y TAGRISSO c\u00f3 \u1ea3nh h\u01b0\u1edfng tr\u00ean c\u00e1c c\u01a1 quan sinh s\u1ea3n c\u1ee7a nam gi\u1edbi\/ph\u1ee5 n\u1eef v\u00e0 c\u00f3 th\u1ec3 g\u00e2y t\u1ed5n h\u1ea1i kh\u1ea3 n\u0103ng sinh s\u1ea3n.<\/p>\r\n<p><em>Th\u1eddi k\u1ef3 cho con b\u00fa:<\/em><\/p>\r\n<p>Ch\u01b0a bi\u1ebft r\u00f5 li\u1ec7u TAGRISSO ho\u1eb7c ch\u1ea5t chuy\u1ec3n h\u00f3a c\u00f3 b\u00e0i ti\u1ebft qua s\u1eefa m\u1eb9 hay kh\u00f4ng. Kh\u00f4ng c\u00f3 th\u00f4ng tin \u0111\u1ea7y \u0111\u1ee7 v\u1ec1 vi\u1ec7c b\u00e0i ti\u1ebft TAGRISSO ho\u1eb7c ch\u1ea5t chuy\u1ec3n h\u00f3a v\u00e0o s\u1eefa tr\u00ean \u0111\u1ed9ng v\u1eadt. Tuy nhi\u00ean, TAGRISSO v\u00e0 c\u00e1c ch\u1ea5t chuy\u1ec3n h\u00f3a \u0111\u00e3 \u0111\u01b0\u1ee3c ph\u00e1t hi\u1ec7n tr\u00ean l\u1ee9a ch\u00f3 con \u0111ang b\u00fa v\u00e0 \u0111\u00e3 ghi nh\u1eadn c\u00f3 ph\u1ea3n \u1ee9ng ngo\u1ea1i \u00fd tr\u00ean s\u1ef1 ph\u00e1t tri\u1ec3n v\u00e0 s\u1ed1ng c\u00f2n c\u1ee7a l\u1ee9a ch\u00f3 con n\u00e0y. Ch\u01b0a lo\u1ea1i tr\u1eeb nguy c\u01a1 tr\u00ean tr\u1ebb em \u0111ang b\u00fa n\u1ebfu ng\u01b0\u1eddi m\u1eb9 d\u00f9ng thu\u1ed1c. N\u00ean ng\u01b0ng cho con b\u00fa khi ng\u01b0\u1eddi m\u1eb9 d\u00f9ng thu\u1ed1c TAGRISSO.<\/p>\r\n<p><script src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-5528370293090692\" async=\"\" crossorigin=\"anonymous\"><\/script><ins class=\"adsbygoogle\" style=\"display: block; text-align: center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-5528370293090692\" data-ad-slot=\"8909623906\"><\/ins><script> (adsbygoogle = window.adsbygoogle || []).push({}); <\/script><\/p>\r\n<p><strong>4.6 T\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n (ADR):<\/strong><\/p>\r\n<p><em>T\u00f3m t\u1eaft d\u1eef li\u1ec7u an to\u00e0n thu\u1ed1c<\/em><\/p>\r\n<p>C\u00e1c nghi\u00ean c\u1ee9u tr\u00ean b\u1ec7nh nh\u00e2n ung th\u01b0 ph\u1ed5i kh\u00f4ng t\u1ebf b\u00e0o nh\u1ecf (NSCLC) c\u00f3 \u0111\u1ed9t bi\u1ebfn EGFR T790M d\u01b0\u01a1ng t\u00ednh, \u0111\u00e3 \u0111i\u1ec1u tr\u1ecb b\u1eb1ng EGFR TKI tr\u01b0\u1edbc \u0111\u00e2y<\/p>\r\n<p>D\u1eef li\u1ec7u \u0111\u1ec1 c\u1eadp d\u01b0\u1edbi \u0111\u00e2y ph\u1ea3n \u00e1nh vi\u1ec7c ti\u1ebfp x\u00fac v\u1edbi thu\u1ed1c TAGRISSO tr\u00ean 690 b\u1ec7nh nh\u00e2n ung th\u01b0 ph\u1ed5i lo\u1ea1i kh\u00f4ng ph\u1ea3i t\u1ebf b\u00e0o nh\u1ecf (NSCLC) c\u00f3 \u0111\u1ed9t bi\u1ebfn EGFR T790M d\u01b0\u01a1ng t\u00ednh \u0111\u00e3 \u0111\u01b0\u1ee3c d\u00f9ng li\u1ec7u ph\u00e1p EGFR TKI tr\u01b0\u1edbc \u0111\u00e2y. C\u00e1c b\u1ec7nh nh\u00e2n n\u00e0y \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb v\u1edbi TAGRISSO li\u1ec1u 80 mg m\u1ed7i ng\u00e0y trong m\u1ed9t nghi\u00ean c\u1ee9u ng\u1eabu nhi\u00ean pha 3 (AURA 3-b\u01b0\u1edbc 2) v\u00e0 2 nghi\u00ean c\u1ee9u \u0111\u01a1n nh\u00e1nh (AURAex v\u00e0 AURA2-b\u01b0\u1edbc 2 ho\u1eb7c l\u1edbn h\u01a1n) . Trong nghi\u00ean c\u1ee9u AURA3, th\u1eddi gian trung v\u1ecb \u0111i\u1ec1u tr\u1ecb b\u1eb1ng thu\u1ed1c l\u00e0 8,1 th\u00e1ng \u1edf nh\u00e1nh b\u1ec7nh nh\u00e2n d\u00f9ng TAGRISSO (n=279) v\u00e0 4,2 th\u00e1ng \u1edf nh\u00e1nh h\u00f3a tr\u1ecb (n=136). Ph\u1ea7n l\u1edbn b\u1ec7nh nh\u00e2n trong c\u00e1c nghi\u00ean c\u1ee9u g\u1ed9p pha 2 \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb t\u00edch c\u1ef1c tr\u01b0\u1edbc \u0111\u00f3: 68% \u0111\u00e3 d\u00f9ng t\u1ed1i thi\u1ec3u 2 ph\u00e1c \u0111\u1ed3 \u0111i\u1ec1u tr\u1ecb tr\u01b0\u1edbc v\u00e0 46% \u0111\u00e3 nh\u1eadn 3 ph\u00e1c \u0111\u1ed3 \u0111i\u1ec1u tr\u1ecb ho\u1eb7c nhi\u1ec1u h\u01a1n. Ngo\u00e0i \u0111i\u1ec1u tr\u1ecb v\u1edbi EGFR-TKI, c\u00f3 kho\u1ea3ng 2\/3 s\u1ed1 b\u1ec7nh nh\u00e2n (63%) \u0111\u00e3 d\u00f9ng h\u00f3a tr\u1ecb platinum tr\u01b0\u1edbc \u0111\u00f3. Th\u1eddi gian trung v\u1ecb t\u1ed5ng qu\u00e1t \u0111i\u1ec1u tr\u1ecb b\u1ec7nh trong AURAex v\u00e0 AURA2 l\u00e0 13 th\u00e1ng (N=411). C\u00e1c ph\u1ea3n \u1ee9ng ngo\u1ea1i \u00fd th\u01b0\u1eddng g\u1eb7p nh\u1ea5t \u0111\u01b0\u1ee3c ghi nh\u1eadn l\u00e0 ti\u00eau ch\u1ea3y (44%) v\u00e0 n\u1ed5i m\u1eabn (41%). C\u00e1c ph\u1ea3n \u1ee9ng ngo\u1ea1i \u00fd c\u1ea5p \u0111\u1ed9 3 v\u00e0 4 trong c\u1ea3 2 nghi\u00ean c\u1ee9u n\u00e0y chi\u1ebfm t\u00fd l\u1ec7 t\u01b0\u01a1ng \u1ee9ng l\u00e0 26% v\u00e0 2%. Vi\u1ec7c gi\u1ea3m li\u1ec1u do ADR x\u1ea3y ra chi\u1ebfm t\u00fd l\u1ec7 2,3% tr\u00ean t\u1ed5ng s\u1ed1 b\u1ec7nh nh\u00e2n \u0111ang d\u00f9ng TAGRISSO 80 mg, 1 l\u1ea7n\/ng\u00e0y. Ng\u01b0ng thu\u1ed1c do g\u1eb7p ph\u1ea3n \u1ee9ng ngo\u1ea1i \u00fd ho\u1eb7c c\u00f3 c\u00e1c tham s\u1ed1 x\u00e9t nghi\u1ec7m b\u1ea5t th\u01b0\u1eddng chi\u1ebfm t\u00fd l\u1ec7 6,5%.<\/p>\r\n<p>B\u1ec7nh nh\u00e2n c\u00f3 ti\u1ec1n s\u1eed b\u1ec7nh ph\u1ed5i m\u00f4 k\u1ebd (ILD) tr\u01b0\u1edbc \u0111\u00e2y, \u0111\u00e3 d\u00f9ng thu\u1ed1c g\u00e2y ILD, vi\u00eam ph\u1ed5i do x\u1ea1 tr\u1ecb ph\u1ea3i d\u00f9ng steroid, ho\u1eb7c c\u00f3 b\u1ea5t k\u1ef3 b\u1eb1ng ch\u1ee9ng ILD ti\u1ebfn tri\u1ec3n tr\u00ean l\u00e2m s\u00e0ng \u0111\u00e3 \u0111\u01b0\u1ee3c lo\u1ea1i tr\u1eeb kh\u1ecfi c\u00e1c nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng n\u00e0y. B\u1ec7nh nh\u00e2n c\u00f3 b\u1ea5t th\u01b0\u1eddng v\u1ec1 nh\u1ecbp v\u00e0 d\u1eabn truy\u1ec1n quan tr\u1ecdng tr\u00ean l\u00e2m s\u00e0ng \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh b\u1eb1ng ECG l\u00fac ngh\u1ec9 (v\u00ed d\u1ee5 kho\u1ea3ng QTc l\u1edbn h\u01a1n 470 mili gi\u00e2y) \u0111\u00e3 \u0111\u01b0\u1ee3c lo\u1ea1i tr\u1eeb. B\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 LVEF khi t\u1ea7m so\u00e1t v\u00e0 m\u1ed7i 12 tu\u1ea7n theo d\u00f5i sau \u0111\u00f3.<\/p>\r\n<p><em>B\u1ea3ng ph\u00e2n lo\u1ea1i ph\u1ea3n \u1ee9ng ngo\u1ea1i \u00fd<\/em><\/p>\r\n<p>C\u00e1c ph\u1ea3n \u1ee9ng ngo\u1ea1i \u00fd \u0111\u01b0\u1ee3c \u1ea5n \u0111\u1ecbnh theo nh\u00f3m t\u1ea7n xu\u1ea5t x\u1ea3y ra t\u1ea1i B\u1ea3ng 6 d\u1ef1a tr\u00ean t\u00fd l\u1ec7 b\u00e1o c\u00e1o ph\u1ea3n \u1ee9ng ngo\u1ea1i \u00fd trong d\u1eef li\u1ec7u g\u1ed9p t\u1eeb 690 b\u1ec7nh nh\u00e2n c\u00f3 \u0111\u1ed9t bi\u1ebfn EGFR T790M d\u01b0\u01a1ng t\u00ednh \u0111\u00e3 \u0111\u01b0\u1ee3c d\u00f9ng li\u1ec7u ph\u00e1p EGFR TKI tr\u01b0\u1edbc \u0111\u00e2y v\u00e0 \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb v\u1edbi TAGRISSO li\u1ec1u 80 mg m\u1ed7i ng\u00e0y trong c\u00e1c nghi\u00ean c\u1ee9u AURA3, AURAex v\u00e0 AURA 2.<\/p>\r\n<p>C\u00e1c ph\u1ea3n \u1ee9ng ngo\u1ea1i \u00fd do thu\u1ed1c \u0111\u01b0\u1ee3c li\u1ec7t k\u00ea theo nh\u00f3m h\u1ec7 c\u01a1 quan (SOC) trong MedDRA. Tr\u00ean m\u1ed7i nh\u00f3m h\u1ec7 c\u01a1 quan, c\u00e1c ph\u1ea3n \u1ee9ng ngo\u1ea1i \u00fd \u0111\u01b0\u1ee3c x\u1ebfp h\u1ea1ng d\u1ef1a theo t\u1ea7n xu\u1ea5t x\u1ea3y ra v\u1edbi c\u00e1c ph\u1ea3n \u1ee9ng x\u1ea3y ra th\u01b0\u1eddng xuy\u00ean nh\u1ea5t \u0111\u01b0\u1ee3c li\u1ec7t k\u00ea \u0111\u1ea7u ti\u00ean. Trong m\u1ed7i nh\u00f3m t\u1ea7n xu\u1ea5t, ph\u1ea3n \u1ee9ng ngo\u1ea1i \u00fd \u0111\u01b0\u1ee3c li\u1ec7t k\u00ea theo m\u1ee9c nghi\u00eam tr\u1ecdng gi\u1ea3m d\u1ea7n. Ngo\u00e0i ra, ph\u00e2n lo\u1ea1i t\u1ea7n xu\u1ea5t t\u01b0\u01a1ng \u1ee9ng cho m\u1ed7i ADR \u0111\u01b0\u1ee3c d\u1ef1a tr\u00ean quy \u01b0\u1edbc CIOMS III v\u00e0 \u0111\u1ecbnh ngh\u0129a nh\u01b0 sau: r\u1ea5t th\u01b0\u1eddng g\u1eb7p (\u22651\/10); th\u01b0\u1eddng g\u1eb7p (\u22651\/100 &#8211; &lt;1\/10); kh\u00f4ng th\u01b0\u1eddng g\u1eb7p (\u22651\/1.000 &#8211; &lt;1\/100); hi\u1ebfm g\u1eb7p (\u22651\/10.000 &#8211; &lt;1\/1.000); r\u1ea5t hi\u1ebfm (&lt;1\/10.000); ch\u01b0a r\u00f5 (kh\u00f4ng th\u1ec3 d\u1ef1 \u0111o\u00e1n t\u1eeb d\u1eef li\u1ec7u s\u1eb5n c\u00f3). D\u1eef li\u1ec7u \u1edf B\u1ea3ng l\u00e0 d\u1eef li\u1ec7u g\u1ed9p t\u1eeb nghi\u00ean c\u1ee9u AURAex (Pha II), AURA2 v\u00e0 AURA3; ch\u1ec9 t\u1ed5ng h\u1ee3p c\u00e1c bi\u1ebfn c\u1ed1 tr\u00ean b\u1ec7nh nh\u00e2n d\u00f9ng t\u1ed1i thi\u1ec3u 1 li\u1ec1u TAGRISSO.<\/p>\r\n<p>&#8211; xem B\u1ea3ng 5 &amp; B\u1ea3ng 6.<\/p>\r\n<p><img loading=\"lazy\" decoding=\"async\" width=\"2186\" height=\"1442\" class=\"wp-image-7811\" src=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-552.png\" alt=\"Image from Drug Label Content\" srcset=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-552.png 2186w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-552-300x198.png 300w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-552-768x507.png 768w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-552-1024x675.png 1024w\" sizes=\"auto, (max-width: 2186px) 100vw, 2186px\" \/><\/p>\r\n<p><img loading=\"lazy\" decoding=\"async\" width=\"2187\" height=\"1850\" class=\"wp-image-7812\" src=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-553.png\" alt=\"Image from Drug Label Content\" srcset=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-553.png 2187w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-553-300x254.png 300w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-553-768x650.png 768w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-553-1024x866.png 1024w\" sizes=\"auto, (max-width: 2187px) 100vw, 2187px\" \/><\/p>\r\n<p>C\u00e1c ph\u00e1t hi\u1ec7n v\u1ec1 t\u00ednh an to\u00e0n trong c\u00e1c nghi\u00ean c\u1ee9u m\u1ed9t nh\u00e1nh pha 2 AURAex v\u00e0 AURA2 nh\u00ecn chung \u0111\u1ed3ng nh\u1ea5t v\u1edbi nh\u1eefng quan s\u00e1t tr\u00ean nh\u00e1nh d\u00f9ng TAGRISSO c\u1ee7a nghi\u00ean c\u1ee9u AURA3. Kh\u00f4ng ghi nh\u1eadn c\u00f3 \u0111\u1ed9c t\u00ednh kh\u00e1c ho\u1eb7c b\u1ea5t ng\u1edd v\u00e0 c\u00e1c bi\u1ebfn c\u1ed1 ngo\u1ea1i \u00fd l\u00e0 t\u01b0\u01a1ng t\u1ef1 v\u1ec1 lo\u1ea1i, m\u1ee9c \u0111\u1ed9 nghi\u00eam tr\u1ecdng v\u00e0 t\u1ea7n s\u1ed1.<\/p>\r\n<p><strong><em>M\u00f4 t\u1ea3 m\u1ed9t s\u1ed1 ph\u1ea3n \u1ee9ng ngo\u1ea1i \u00fd ch\u1ecdn l\u1ecdc<\/em><\/strong><\/p>\r\n<p>Vi\u00eam ph\u1ed5i m\u00f4 k\u1ebd (ILD): Trong c\u00e1c nghi\u00ean c\u1ee9u AURA, t\u1ea7n xu\u1ea5t x\u1ea3y ra ILD l\u00e0 8,2% \u1edf b\u1ec7nh nh\u00e2n Nh\u1eadt B\u1ea3n, 1,9% \u1edf b\u1ec7nh nh\u00e2n Ch\u00e2u \u00c1 kh\u00f4ng ph\u1ea3i ng\u01b0\u1eddi Nh\u1eadt B\u1ea3n v\u00e0 2,9% \u1edf nh\u00f3m kh\u00f4ng ph\u1ea3i b\u1ec7nh nh\u00e2n Ch\u00e2u \u00c1. Th\u1eddi gian trung v\u1ecb kh\u1edfi ph\u00e1t ILD ho\u1eb7c ph\u1ea3n \u1ee9ng ngo\u1ea1i \u00fd gi\u1ed1ng ILD l\u00e0 2,8 th\u00e1ng (xem ph\u1ea7n \u201cC\u1ea3nh b\u00e1o\u201d).<\/p>\r\n<p><em>Kho\u1ea3ng QTc k\u00e9o d\u00e0i:<\/em> Tr\u00ean 833 b\u1ec7nh nh\u00e2n trong c\u00e1c nghi\u00ean c\u1ee9u AURA \u0111i\u1ec1u tr\u1ecb b\u1eb1ng TAGRISSO 80 mg, c\u00f3 0,7% s\u1ed1 b\u1ec7nh nh\u00e2n (n=6) \u0111\u01b0\u1ee3c ph\u00e1t hi\u1ec7n c\u00f3 kho\u1ea3ng QTc &gt; 500 mili gi\u00e2y, v\u00e0 2,9% s\u1ed1 b\u1ec7nh nh\u00e2n (n=24) c\u00f3 kho\u1ea3ng QTc &gt; 60 mili gi\u00e2y so v\u1edbi tr\u1ecb s\u1ed1 c\u0103n b\u1ea3n. M\u1ed9t ph\u00e2n t\u00edch d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc v\u1edbi TAGRISSO \u0111\u00e3 d\u1ef1 b\u00e1o nguy c\u01a1 gia t\u0103ng kho\u1ea3ng QTc k\u00e9o d\u00e0i ph\u1ee5 thu\u1ed9c v\u00e0o li\u1ec1u. Kh\u00f4ng ghi nh\u1eadn bi\u1ebfn c\u1ed1 lo\u1ea1n nh\u1ecbp li\u00ean quan \u0111\u1ebfn QTc trong c\u00e1c nghi\u00ean c\u1ee9u AURA (xem ph\u1ea7n \u201cC\u1ea3nh b\u00e1o\u201d v\u00e0 \u201c\u0110\u1eb7c t\u00ednh d\u01b0\u1ee3c l\u1ef1c\u201d).<\/p>\r\n<p><em>\u1ea2nh h\u01b0\u1edfng tr\u00ean d\u1ea1 d\u00e0y-ru\u1ed9t:<\/em> Trong nghi\u00ean c\u1ee9u AURA, ti\u00eau ch\u1ea3y \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o \u1edf 43,5% b\u1ec7nh nh\u00e2n trong \u0111\u00f3 36,8% \u1edf c\u1ea5p \u0111\u1ed9 1, 5,5% c\u1ea5p \u0111\u1ed9 2 v\u00e0 1,0% \u1edf c\u1ea5p \u0111\u1ed9 3; kh\u00f4ng c\u00f3 b\u00e1o c\u00e1o \u1edf c\u1ea5p \u0111\u1ed9 4 ho\u1eb7c 5. C\u00f3 0,3% b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u gi\u1ea3m li\u1ec1u v\u00e0 0,7% b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u ng\u01b0ng thu\u1ed1c t\u1ea1m th\u1eddi. M\u1ed9t bi\u1ebfn c\u1ed1 (0,1%) d\u1eabn \u0111\u1ebfn ng\u01b0ng \u0111i\u1ec1u tr\u1ecb. Trong nghi\u00ean c\u1ee9u AURA3, th\u1eddi gian trung v\u1ecb kh\u1edfi ph\u00e1t l\u00e0 22 ng\u00e0y v\u00e0 th\u1eddi gian trung v\u1ecb c\u1ee7a bi\u1ebfn c\u1ed1 c\u1ea5p \u0111\u1ed9 2 l\u00e0 5,5 ng\u00e0y.<\/p>\r\n<p><em>Ng\u01b0\u1eddi cao tu\u1ed5i:<\/em> Trong nghi\u00ean c\u1ee9u AURA3 (N=279), c\u00f3 41% s\u1ed1 b\u1ec7nh nh\u00e2n \u1edf \u0111\u1ed9 tu\u1ed5i \u2265 65 tu\u1ed5i, trong \u0111\u00f3 c\u00f3 15% b\u1ec7nh nh\u00e2n \u2265 75 tu\u1ed5i. T\u1ef7 l\u1ec7 ph\u1ea3n \u1ee9ng ngo\u1ea1i \u00fd d\u1eabn \u0111\u1ebfn ch\u1ec9nh li\u1ec1u thu\u1ed1c nghi\u00ean c\u1ee9u (ng\u01b0ng thu\u1ed1c ho\u1eb7c gi\u1ea3m li\u1ec1u) \u0111\u01b0\u1ee3c ghi nh\u1eadn nhi\u1ec1u h\u01a1n \u1edf b\u1ec7nh nh\u00e2n \u2265 65 tu\u1ed5i so v\u1edbi nh\u00f3m b\u1ec7nh nh\u00e2n tr\u1ebb h\u01a1n (&lt; 65) (5,3% so v\u1edbi 4,2%). Lo\u1ea1i ph\u1ea3n \u1ee9ng ngo\u1ea1i \u00fd l\u00e0 t\u01b0\u01a1ng t\u1ef1 nhau b\u1ea5t k\u1ec3 tu\u1ed5i t\u00e1c. B\u1ec7nh nh\u00e2n cao tu\u1ed5i g\u1eb7p nhi\u1ec1u ph\u1ea3n \u1ee9ng ngo\u1ea1i \u00fd c\u1ea5p \u0111\u1ed9 3 ho\u1eb7c cao h\u01a1n so v\u1edbi nh\u00f3m b\u1ec7nh nh\u00e2n tr\u1ebb tu\u1ed5i h\u01a1n (5,3% so v\u1edbi 2,4%). Kh\u00f4ng ghi nh\u1eadn c\u00f3 s\u1ef1 kh\u00e1c bi\u1ec7t v\u1ec1 hi\u1ec7u qu\u1ea3 c\u1ee7a thu\u1ed1c gi\u1eefa nh\u00f3m b\u1ec7nh nh\u00e2n cao tu\u1ed5i n\u00e0y v\u00e0 nh\u00f3m tr\u1ebb tu\u1ed5i h\u01a1n. M\u1ed9t k\u1ebft qu\u1ea3 t\u01b0\u01a1ng t\u1ef1 v\u1ec1 t\u00ednh an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u0169ng \u0111\u01b0\u1ee3c quan s\u00e1t th\u1ea5y khi ph\u00e2n t\u00edch c\u00e1c nghi\u00ean c\u1ee9u AURA pha 2.<\/p>\r\n<p><em>B\u00e1o c\u00e1o ph\u1ea3n \u1ee9ng ngo\u1ea1i \u00fd nghi ng\u1edd do thu\u1ed1c:<\/em> B\u00e1o c\u00e1o c\u00e1c ph\u1ea3n \u1ee9ng ngo\u1ea1i \u00fd nghi ng\u1edd do thu\u1ed1c sau khi thu\u1ed1c \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh l\u00e0 quan tr\u1ecdng. \u0110i\u1ec1u n\u00e0y cho ph\u00e9p ti\u1ebfp t\u1ee5c theo d\u00f5i s\u1ef1 c\u00e2n b\u1eb1ng gi\u1eefa nguy c\u01a1\/l\u1ee3i \u00edch c\u1ee7a thu\u1ed1c. C\u00e1n b\u1ed9 y t\u1ebf \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u b\u00e1o c\u00e1o b\u1ea5t k\u1ef3 ph\u1ea3n \u1ee9ng c\u00f3 h\u1ea1i n\u00e0o qua h\u1ec7 th\u1ed1ng b\u00e1o c\u00e1o qu\u1ed1c gia.<\/p>\r\n<p><em>Th\u00f4ng b\u00e1o cho B\u00e1c s\u0129 nh\u1eefng t\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n g\u1eb7p ph\u1ea3i khi s\u1eed d\u1ee5ng thu\u1ed1c.<\/em><\/p>\r\n<p><script src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-5528370293090692\" async=\"\" crossorigin=\"anonymous\"><\/script><ins class=\"adsbygoogle\" style=\"display: block; text-align: center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-5528370293090692\" data-ad-slot=\"8909623906\"><\/ins><script> (adsbygoogle = window.adsbygoogle || []).push({}); <\/script><\/p>\r\n<p><strong>4.7 H\u01b0\u1edbng d\u1eabn c\u00e1ch x\u1eed tr\u00ed ADR:<\/strong><\/p>\r\n<p>Ng\u1eebng s\u1eed d\u1ee5ng thu\u1ed1c. V\u1edbi c\u00e1c ph\u1ea3n \u1ee9ng b\u1ea5t l\u1ee3i nh\u1eb9, th\u01b0\u1eddng ch\u1ec9 c\u1ea7n ng\u1eebng thu\u1ed1c. Tr\u01b0\u1eddng h\u1ee3p m\u1eabn c\u1ea3m n\u1eb7ng ho\u1eb7c ph\u1ea3n \u1ee9ng d\u1ecb \u1ee9ng, c\u1ea7n ti\u1ebfn h\u00e0nh \u0111i\u1ec1u tr\u1ecb h\u1ed7 tr\u1ee3 (gi\u1eef tho\u00e1ng kh\u00ed v\u00e0 d\u00f9ng epinephrin, th\u1edf oxygen, d\u00f9ng kh\u00e1ng histamin, corticoid&#8230;).<\/p>\r\n<p><strong>4.8 T\u01b0\u01a1ng t\u00e1c v\u1edbi c\u00e1c thu\u1ed1c kh\u00e1c:<\/strong><\/p>\r\n<p><strong><em>T\u01b0\u01a1ng t\u00e1c v\u1ec1 d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc<\/em><\/strong><\/p>\r\n<p>C\u00e1c thu\u1ed1c c\u1ea3m \u1ee9ng CYP3A4 m\u1ea1nh c\u00f3 th\u1ec3 l\u00e0m gi\u1ea3m n\u1ed3ng \u0111\u1ed9 v\u00e0 th\u1eddi gian ti\u1ebfp x\u00fac c\u1ee7a TAGRISSO. TAGRISSO c\u00f3 th\u1ec3 l\u00e0m t\u0103ng n\u1ed3ng \u0111\u1ed9 v\u00e0 th\u1eddi gian ti\u1ebfp x\u00fac c\u1ee7a ch\u1ea5t n\u1ec1n BCRP.<\/p>\r\n<p><em>Ho\u1ea1t ch\u1ea5t c\u00f3 th\u1ec3 l\u00e0m t\u0103ng n\u1ed3ng \u0111\u1ed9 TAGRISSO trong huy\u1ebft t\u01b0\u01a1ng<\/em>: C\u00e1c nghi\u00ean c\u1ee9u in vitro \u0111\u00e3 cho th\u1ea5y TAGRISSO \u0111\u01b0\u1ee3c chuy\u1ec3n h\u00f3a pha I ch\u1ee7 y\u1ebfu qua CYP3A4 v\u00e0 CYP3A5. Trong m\u1ed9t nghi\u00ean c\u1ee9u d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc tr\u00ean l\u00e2m s\u00e0ng, khi d\u00f9ng chung v\u1edbi 200 mg itraconazole (ch\u1ea5t \u1ee9c ch\u1ebf CYP3A4 m\u1ea1nh) x 2 l\u1ea7n\/ng\u00e0y \u0111\u00e3 kh\u00f4ng \u1ea3nh h\u01b0\u1edfng \u0111\u00e1ng k\u1ec3 v\u1ec1 l\u00e2m s\u00e0ng tr\u00ean n\u1ed3ng \u0111\u1ed9 v\u00e0 th\u1eddi gian ti\u1ebfp x\u00fac v\u1edbi TAGRISSO (di\u1ec7n t\u00edch d\u01b0\u1edbi \u0111\u01b0\u1eddng cong (AUC) t\u0103ng 24% v\u00e0 Cmax gi\u1ea3m 20%). V\u00ec v\u1eady, ch\u1ea5t \u1ee9c ch\u1ebf CYP3A4 c\u00f3 l\u1ebd kh\u00f4ng \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn n\u1ed3ng \u0111\u1ed9 v\u00e0 th\u1eddi gian ti\u1ebfp x\u00fac c\u1ee7a TAGRISSO. Ch\u01b0a x\u00e1c \u0111\u1ecbnh \u0111\u01b0\u1ee3c c\u00e1c men x\u00fac t\u00e1c th\u00eam.<\/p>\r\n<p><em>Ho\u1ea1t ch\u1ea5t c\u00f3 th\u1ec3 l\u00e0m gi\u1ea3m n\u1ed3ng \u0111\u1ed9 TAGRISSO trong huy\u1ebft t\u01b0\u01a1ng<\/em>: Trong m\u1ed9t nghi\u00ean c\u1ee9u d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc l\u00e2m s\u00e0ng tr\u00ean b\u1ec7nh nh\u00e2n, di\u1ec7n t\u00edch n\u1ed3ng \u0111\u1ed9 TAGRISSO d\u01b0\u1edbi \u0111\u01b0\u1eddng cong \u1edf giai \u0111o\u1ea1n \u1ed5n \u0111\u1ecbnh (AUC steady state) gi\u1ea3m 78% khi d\u00f9ng chung v\u1edbi rifampicin (600 mg\/ng\u00e0y trong 21 ng\u00e0y). T\u01b0\u01a1ng t\u1ef1, n\u1ed3ng \u0111\u1ed9 v\u00e0 th\u1eddi gian ti\u1ebfp x\u00fac v\u1edbi ch\u1ea5t chuy\u1ec3n h\u00f3a AZ5104 c\u0169ng gi\u1ea3m 82% (\u0111\u1ed1i v\u1edbi tr\u1ecb s\u1ed1 AUC) v\u00e0 78% (\u0111\u1ed1i v\u1edbi tr\u1ecb s\u1ed1 Cmax). Khuy\u1ebfn c\u00e1o n\u00ean tr\u00e1nh d\u00f9ng TAGRISSO \u0111\u1ed3ng th\u1eddi v\u1edbi c\u00e1c ch\u1ea5t c\u1ea3m \u1ee9ng CYP3A m\u1ea1nh (nh\u01b0 phenytoin, rifampicin v\u00e0 carbamazepin). C\u00e1c ch\u1ea5t c\u1ea3m \u1ee9ng CYP3A4 trung b\u00ecnh (nh\u01b0 bosentan, efavirenz, etravirine, modafinil) c\u00f3 th\u1ec3 c\u0169ng l\u00e0m gi\u1ea3m n\u1ed3ng \u0111\u1ed9 v\u00e0 th\u1eddi gian ti\u1ebfp x\u00fac TAGRISSO v\u00e0 n\u00ean s\u1eed d\u1ee5ng th\u1eadn tr\u1ecdng ho\u1eb7c tr\u00e1nh d\u00f9ng n\u1ebfu c\u00f3 th\u1ec3. Ch\u01b0a c\u00f3 d\u1eef li\u1ec7u l\u00e2m s\u00e0ng \u0111\u1ec3 khuy\u1ebfn c\u00e1o ch\u1ec9nh li\u1ec1u TAGRISSO. Ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh d\u00f9ng chung v\u1edbi thu\u1ed1c St. John&#8217;s Wort .<\/p>\r\n<p>\u1ea2nh h\u01b0\u1edfng c\u1ee7a c\u00e1c thu\u1ed1c l\u00e0m gi\u1ea3m d\u1ecbch d\u1ea1 d\u00e0y tr\u00ean TAGRISSO: Trong m\u1ed9t nghi\u00ean c\u1ee9u d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc l\u00e2m s\u00e0ng, vi\u1ec7c d\u00f9ng \u0111\u1ed3ng th\u1eddi v\u1edbi omeprazole \u0111\u00e3 kh\u00f4ng thay \u0111\u1ed5i n\u1ed3ng \u0111\u1ed9 v\u00e0 th\u1eddi gian ti\u1ebfp x\u00fac c\u1ee7a TAGRISSO tr\u00ean l\u00e2m s\u00e0ng. C\u00e1c ch\u1ea5t \u0111i\u1ec1u bi\u1ebfn pH d\u1ecbch v\u1ecb c\u00f3 th\u1ec3 d\u00f9ng chung v\u1edbi TAGRISSO m\u00e0 kh\u00f4ng c\u00f3 b\u1ea5t k\u1ef3 h\u1ea1n ch\u1ebf n\u00e0o.<\/p>\r\n<p><em>Ho\u1ea1t ch\u1ea5t c\u00f3 n\u1ed3ng \u0111\u1ed9 trong huy\u1ebft t\u01b0\u01a1ng c\u00f3 th\u1ec3 thay \u0111\u1ed5i do TAGRISSO<\/em><\/p>\r\n<p>Theo c\u00e1c nghi\u00ean c\u1ee9u in vitro, TAGRISSO l\u00e0 ch\u1ea5t \u1ee9c ch\u1ebf c\u1ea1nh tranh c\u1ee7a ch\u1ea5t v\u1eadn chuy\u1ec3n BCRP.<\/p>\r\n<p>Trong m\u1ed9t nghi\u00ean c\u1ee9u d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc tr\u00ean l\u00e2m s\u00e0ng, khi d\u00f9ng \u0111\u1ed3ng th\u1eddi TAGRISSO v\u1edbi rosuvastatin (ch\u1ea5t n\u1ec1n nh\u1ea1y c\u1ea3m BCRP) s\u1ebd l\u00e0m t\u0103ng AUC v\u00e0 Cmax c\u1ee7a rosuvastatin t\u01b0\u01a1ng \u1ee9ng l\u00e0 35% v\u00e0 72%. \u1ede b\u1ec7nh nh\u00e2n \u0111ang d\u00f9ng \u0111\u1ed3ng th\u1eddi v\u1edbi c\u00e1c thu\u1ed1c c\u00f3 khuynh h\u01b0\u1edbng ph\u1ee5 thu\u1ed9c BCRP v\u00e0 c\u00f3 ch\u1ec9 s\u1ed1 \u0111i\u1ec1u tr\u1ecb th\u1ea5p, n\u00ean theo d\u00f5i ch\u1eb7t ch\u1ebd v\u1ec1 d\u1ea5u hi\u1ec7u thay \u0111\u1ed5i t\u00ednh dung n\u1ea1p c\u1ee7a thu\u1ed1c d\u00f9ng chung v\u00ec c\u00f3 th\u1ec3 l\u00e0 k\u1ebft qu\u1ea3 c\u1ee7a s\u1ef1 t\u0103ng n\u1ed3ng \u0111\u1ed9 v\u00e0 th\u1eddi gian ti\u1ebfp x\u00fac trong khi d\u00f9ng chung v\u1edbi TAGRISSO .<\/p>\r\n<p>Trong m\u1ed9t nghi\u00ean c\u1ee9u d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc tr\u00ean l\u00e2m s\u00e0ng, vi\u1ec7c d\u00f9ng \u0111\u1ed3ng th\u1eddi TAGRISSO v\u1edbi simvastatin (ch\u1ea5t n\u1ec1n nh\u1ea1y c\u1ea3m CYP3A4) s\u1ebd l\u00e0m gi\u1ea3m AUC v\u00e0 Cmax c\u1ee7a simvastatin t\u01b0\u01a1ng \u1ee9ng l\u00e0 9% v\u00e0 23%. C\u00e1c thay \u0111\u1ed5i n\u00e0y nh\u1ecf v\u00e0 c\u00f3 l\u1ebd l\u00e0 kh\u00f4ng \u0111\u00e1ng k\u1ec3 v\u1ec1 m\u1eb7t l\u00e2m s\u00e0ng. Kh\u00f4ng ch\u1eafc x\u1ea3y ra t\u01b0\u01a1ng t\u00e1c d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc tr\u00ean l\u00e2m s\u00e0ng v\u1edbi ch\u1ea5t n\u1ec1n CYP3A4. Ch\u01b0a nghi\u00ean c\u1ee9u s\u1ef1 t\u01b0\u01a1ng t\u00e1c qua men kh\u00e1c v\u1edbi CYP3A4 \u0111\u01b0\u1ee3c \u0111i\u1ec1u bi\u1ebfn b\u1eb1ng ch\u1ea5t th\u1ee5 th\u1ec3 Pregnane X Receptor (PXR). Kh\u00f4ng lo\u1ea1i b\u1ecf nguy c\u01a1 gi\u1ea3m n\u1ed3ng \u0111\u1ed9 v\u00e0 th\u1eddi gian ti\u1ebfp x\u00fac c\u1ee7a hormon ng\u1eeba thai khi d\u00f9ng \u0111\u1ed3ng th\u1eddi.<\/p>\r\n<p><strong>4.9 Qu\u00e1 li\u1ec1u v\u00e0 x\u1eed tr\u00ed:<\/strong><\/p>\r\n<p>Trong c\u00e1c nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng \u0111\u00e3 c\u00f3 m\u1ed9t s\u1ed1 \u00edt b\u1ec7nh nh\u00e2n d\u00f9ng TAGRISSO li\u1ec1u h\u00e0ng ng\u00e0y l\u00ean \u0111\u1ebfn 240 mg m\u00e0 kh\u00f4ng ghi nh\u1eadn \u0111\u1ed9c t\u00ednh gi\u1edbi h\u1ea1n li\u1ec1u (dose limiting toxicities). Tr\u00ean c\u00e1c nghi\u00ean c\u1ee9u n\u00e0y, b\u1ec7nh nh\u00e2n d\u00f9ng TAGRISSO v\u1edbi li\u1ec1u h\u00e0ng ng\u00e0y 160 mg v\u00e0 240 mg \u0111\u00e3 ghi nh\u1eadn c\u00f3 s\u1ef1 t\u0103ng t\u1ea7n su\u1ea5t v\u00e0 m\u1ee9c \u0111\u1ed9 tr\u1ea7m tr\u1ecdng c\u00e1c ph\u1ea3n \u1ee9ng ngo\u1ea1i \u00fd \u0111i\u1ec3n h\u00ecnh g\u00e2y ra do EGFR TKI (ch\u1ee7 y\u1ebfu l\u00e0 ti\u00eau ch\u1ea3y v\u00e0 n\u1ed5i m\u1ea9n da) so v\u1edbi m\u1ee9c li\u1ec1u 80 mg. R\u1ea5t \u00edt kinh nghi\u1ec7m v\u1ec1 qu\u00e1 li\u1ec1u ng\u1eabu nhi\u00ean tr\u00ean ng\u01b0\u1eddi. T\u1ea5t c\u1ea3 c\u00e1c tr\u01b0\u1eddng h\u1ee3p \u0111\u1ec1u x\u1ea3y ra ri\u00eang l\u1ebb l\u00e0 do b\u1ec7nh nh\u00e2n sai s\u00f3t khi d\u00f9ng thu\u1ed1c m\u00e0 kh\u00f4ng g\u1eb7p b\u1ea5t k\u1ef3 h\u1eadu qu\u1ea3 l\u00e2m s\u00e0ng n\u00e0o.<\/p>\r\n<p>Kh\u00f4ng c\u00f3 x\u1eed tr\u00ed \u0111\u1eb7c bi\u1ec7t trong tr\u01b0\u1eddng h\u1ee3p qu\u00e1 li\u1ec1u TAGRISSO. Khi nghi ng\u1edd qu\u00e1 li\u1ec1u, n\u00ean ng\u01b0ng d\u00f9ng TAGRISSO v\u00e0 b\u1eaft \u0111\u1ea7u x\u1eed tr\u00ed tri\u1ec7u ch\u1ee9ng.<\/p>\r\n<p><script src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-5528370293090692\" async=\"\" crossorigin=\"anonymous\"><\/script><ins class=\"adsbygoogle\" style=\"display: block; text-align: center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-5528370293090692\" data-ad-slot=\"8909623906\"><\/ins><script> (adsbygoogle = window.adsbygoogle || []).push({}); <\/script><\/p>\r\n<p><strong>5. C\u01a1 ch\u1ebf t\u00e1c d\u1ee5ng c\u1ee7a thu\u1ed1c :<\/strong><\/p>\r\n<p><strong>5.1. D\u01b0\u1ee3c l\u1ef1c h\u1ecdc:<\/strong><\/p>\r\n<p><em>T\u00e1c \u0111\u1ed9ng v\u1ec1 d\u01b0\u1ee3c l\u1ef1c:<\/em> C\u00e1c nghi\u00ean c\u1ee9u in vitro \u0111\u00e3 cho th\u1ea5y osimertinib c\u00f3 t\u00e1c \u0111\u1ed9ng \u1ee9c ch\u1ebf hi\u1ec7u qu\u1ea3 cao th\u1ee5 th\u1ec3 EGFR b\u1eb1ng c\u00e1c b\u01b0\u1edbc \u0111i\u1ec1u tr\u1ecb c\u00e1c t\u1ebf b\u00e0o ung th\u01b0 ph\u1ed5i kh\u00f4ng ph\u1ea3i t\u1ebf b\u00e0o nh\u1ecf c\u00f3 \u0111\u1ed9t bi\u1ebfn T790M v\u00e0 \u0111\u1ed9t bi\u1ebfn EGFRm nh\u1ea1y c\u1ea3m tr\u00ean l\u00e2m s\u00e0ng (x\u00e9t nghi\u1ec7m phospho-EGFR cho th\u1ea5y IC50s r\u00f5 r\u1ec7t t\u1eeb 6nM \u0111\u1ebfn 54nM). \u0110i\u1ec1u n\u00e0y d\u1eabn \u0111\u1ebfn \u1ee9c ch\u1ebf s\u1ef1 ph\u00e1t tri\u1ec3n c\u1ee7a t\u1ebf b\u00e0o trong khi cho th\u1ea5y \u00edt c\u00f3 t\u00e1c \u0111\u1ed9ng \u0111\u00e1ng k\u1ec3 tr\u00ean EGFR c\u1ee7a c\u00e1c t\u1ebf b\u00e0o kh\u00f4ng c\u00f3 \u0111\u1ed9t bi\u1ebfn (wild-type cell lines) (x\u00e9t nghi\u1ec7m phospho-EGFR cho th\u1ea5y IC50s r\u00f5 r\u1ec7t t\u1eeb 480nM \u0111\u1ebfn 1,8\u03bcM). Khi d\u00f9ng osimertinib \u0111\u01b0\u1eddng u\u1ed1ng in vivo l\u00e0m cho kh\u1ed1i u co l\u1ea1i \u1edf c\u1ea3 m\u1eabu kh\u1ed1i u gh\u00e9p ngo\u1ea1i lai v\u00e0 bi\u1ebfn \u0111\u1ed5i gen tr\u00ean ph\u1ed5i chu\u1ed9t c\u00f3 t\u1ebf b\u00e0o ung th\u01b0 ph\u1ed5i kh\u00f4ng t\u1ebf b\u00e0o nh\u1ecf c\u00f3 \u0111\u1ed9t bi\u1ebfn EGFRm v\u00e0 T790M.<\/p>\r\n<p><em>\u0110i\u1ec7n sinh l\u00fd h\u1ecdc tr\u00ean tim:<\/em> Kh\u1ea3 n\u0103ng k\u00e9o d\u00e0i kho\u1ea3ng QTc khi d\u00f9ng TAGRISSO \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 tr\u00ean 210 b\u1ec7nh nh\u00e2n \u0111ang d\u00f9ng osimertinib 80 mg\/ng\u00e0y trong nghi\u00ean c\u1ee9u AURA2. C\u00e1c gi\u00e1 tr\u1ecb ECG \u0111\u00e3 \u0111\u01b0\u1ee3c thu th\u1eadp sau khi d\u00f9ng 1 li\u1ec1u osimertinib v\u00e0 khi thu\u1ed1c \u0111\u00e3 n\u1ed3ng \u0111\u1ed9 h\u1eb1ng \u0111\u1ecbnh \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 t\u00e1c \u0111\u1ed9ng c\u1ee7a osimertinib tr\u00ean kho\u1ea3ng QTc. Ph\u00e2n t\u00edch d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc d\u1ef1 \u0111o\u00e1n kh\u1ea3 n\u0103ng k\u00e9o d\u00e0i kho\u1ea3ng QTc li\u00ean quan \u0111\u00ean thu\u1ed1c l\u00e0 14 mili gi\u00e2y \u1edf li\u1ec1u 80 mg v\u1edbi tr\u1ecb s\u1ed1 gi\u1edbi h\u1ea1n tr\u00ean l\u00e0 16 mili gi\u00e2y (\u0111\u1ed9 tin c\u1eady 90% CI).<\/p>\r\n<p><em>Hi\u1ec7u qu\u1ea3 v\u00e0 an to\u00e0n tr\u00ean l\u00e2m s\u00e0ng<\/em><\/p>\r\n<p>B\u1ec7nh nh\u00e2n ung th\u01b0 ph\u1ed5i kh\u00f4ng t\u1ebf b\u00e0o nh\u1ecf (NSCLC) c\u00f3 \u0111\u1ed9t bi\u1ebfn T790M tr\u01b0\u1edbc khi \u0111i\u1ec1u tr\u1ecb &#8211; nghi\u00ean c\u1ee9u AURA3<\/p>\r\n<p>Hi\u1ec7u qu\u1ea3 v\u00e0 t\u00ednh an to\u00e0n c\u1ee7a TAGRISSO trong vi\u1ec7c \u0111i\u1ec1u tr\u1ecb b\u1ec7nh nh\u00e2n ung th\u01b0 ph\u1ed5i kh\u00f4ng t\u1ebf b\u00e0o nh\u1ecf (NSCLC) giai \u0111o\u1ea1n ti\u1ebfn tri\u1ec3n t\u1ea1i ch\u1ed7 hay di c\u0103n, c\u00f3 \u0111\u1ed9t bi\u1ebfn T790M khi b\u1ec7nh ti\u1ebfn tri\u1ec3n ho\u1eb7c sau khi \u0111i\u1ec1u tr\u1ecb b\u1eb1ng EGFR TKI \u0111\u00e3 \u0111\u01b0\u1ee3c ch\u1ee9ng minh trong nghi\u00ean c\u1ee9u pha 3 ng\u1eabu nhi\u00ean, nh\u00e3n m\u1edf, c\u00f3 \u0111\u1ed1i ch\u1ee9ng (AURA3). T\u1ea5t c\u1ea3 b\u1ec7nh nh\u00e2n ph\u1ea3i c\u00f3 \u0111\u1ed9t bi\u1ebfn EGFR T790M d\u01b0\u01a1ng t\u00ednh \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh qua x\u00e9t nghi\u1ec7m \u0111\u1ed9t bi\u1ebfn EGFR cobas th\u1ef1c hi\u1ec7n t\u1ea1i ph\u00f2ng th\u00ed nghi\u1ec7m ch\u00ednh tr\u01b0\u1edbc khi \u0111\u01b0a v\u00e0o \u0111i\u1ec1u tr\u1ecb. T\u00ecnh tr\u1ea1ng \u0111\u1ed9t bi\u1ebfn T790M c\u0169ng \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 qua vi\u1ec7c th\u00e1o xo\u1eafn c\u00e1c DNA kh\u1ed1i u trong tu\u1ea7n ho\u00e0n (ctDNA) l\u1ea5y t\u1eeb m\u1eabu huy\u1ebft t\u01b0\u01a1ng trong khi s\u00e0ng l\u1ecdc. M\u1ee5c ti\u00eau ch\u00ednh \u0111\u00e1nh gi\u00e1 hi\u1ec7u qu\u1ea3 l\u00e0 th\u1eddi gian s\u1ed1ng kh\u00f4ng b\u1ec7nh ti\u1ebfn tri\u1ec3n (PFS) theo \u0111\u00e1nh gi\u00e1 c\u1ee7a nghi\u00ean c\u1ee9u vi\u00ean. C\u00e1c m\u1ee5c ti\u00eau \u0111o l\u01b0\u1eddng hi\u1ec7u qu\u1ea3 b\u1ed5 sung bao g\u1ed3m t\u1ef7 l\u1ec7 \u0111\u00e1p \u1ee9ng kh\u00e1ch quan (objective response rate &#8211; ORR), th\u1eddi gian \u0111\u00e1p \u1ee9ng (DoR) v\u00e0 th\u1eddi gian s\u1ed1ng c\u00f2n to\u00e0n b\u1ed9 (OS) theo \u0111\u00e1nh gi\u00e1 c\u1ee7a nghi\u00ean c\u1ee9u vi\u00ean.<\/p>\r\n<p>B\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c ph\u00e2n nh\u00f3m ng\u1eabu nhi\u00ean d\u00f9ng thu\u1ed1c theo t\u1ef7 l\u1ec7 2:1, t\u01b0\u01a1ng \u1ee9ng l\u00e0 d\u00f9ng TAGRISSO (n=279) ho\u1eb7c h\u00f3a tr\u1ecb b\u1ed9 \u0111\u00f4i c\u00f3 platinum (n=140). Vi\u1ec7c d\u00f9ng thu\u1ed1c \u0111\u01b0\u1ee3c ph\u00e2n ng\u1eabu nhi\u00ean theo ch\u1ee7ng t\u1ed9c (ch\u00e2u \u00c1 v\u00e0 kh\u00f4ng ph\u1ea3i ch\u00e2u \u00c1). B\u1ec7nh nh\u00e2n \u1edf nh\u00e1nh TAGRISSO d\u00f9ng li\u1ec1u 80 mg u\u1ed1ng m\u1ed9t l\u1ea7n\/ng\u00e0y cho \u0111\u1ebfn khi kh\u00f4ng dung n\u1ea1p v\u1edbi \u0111i\u1ec1u tr\u1ecb, ho\u1eb7c nghi\u00ean c\u1ee9u vi\u00ean x\u00e1c \u0111\u1ecbnh r\u1eb1ng c\u00e1c b\u1ec7nh nh\u00e2n kh\u00f4ng c\u00f2n l\u1ee3i \u00edch l\u00e2m s\u00e0ng. H\u00f3a tr\u1ecb g\u1ed3m pemetrexed 500 mg\/m2 v\u1edbi carboplatin AUC5 ho\u1eb7c pemetrexed 500 mg\/m2 v\u1edbi cisplatin 75 mg\/m2) v\u00e0o ng\u00e0y 1 c\u1ee7a m\u1ed7i chu k\u1ef3 21 ng\u00e0y cho \u0111\u1ebfn 6 chu k\u1ef3. B\u1ec7nh nh\u00e2n kh\u00f4ng ti\u1ebfn tri\u1ec3n b\u1ec7nh sau b\u1ed1n chu k\u1ef3 h\u00f3a tr\u1ecb li\u1ec7u c\u00f3 platinum nh\u01b0 tr\u00ean c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb duy tr\u00ec b\u1eb1ng pemetrexed (pemetrexed 500 mg\/m2 v\u00e0o ng\u00e0y 1 c\u1ee7a m\u1ed7i chu k\u1ef3 21 ng\u00e0y). Nh\u1eefng b\u1ec7nh nh\u00e2n trong nh\u00e1nh h\u00f3a tr\u1ecb c\u00f3 b\u1ec7nh ti\u1ebfn tri\u1ec3n tr\u00ean ch\u1ea9n \u0111o\u00e1n h\u00ecnh \u1ea3nh (theo nghi\u00ean c\u1ee9u vi\u00ean v\u00e0 \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh qua ch\u1ea9n \u0111o\u00e1n h\u00ecnh \u1ea3nh \u0111\u1ed9c l\u1eadp) s\u1ebd c\u00f3 c\u01a1 h\u1ed9i \u0111\u01b0\u1ee3c b\u1eaft \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb b\u1eb1ng TAGRISSO.<\/p>\r\n<p>C\u00e1c \u0111\u1eb7c t\u00ednh c\u01a1 b\u1ea3n v\u1ec1 nh\u00e2n tr\u1eafc h\u1ecdc v\u00e0 b\u1ec7nh l\u00fd c\u1ee7a d\u00e2n s\u1ed1 nghi\u00ean c\u1ee9u l\u00e0 tu\u1ed5i trung v\u1ecb 62 tu\u1ed5i, b\u1ec7nh nh\u00e2n \u2265 75 tu\u1ed5i (15%), ph\u1ee5 n\u1eef (64%), ng\u01b0\u1eddi da tr\u1eafng (32%), ch\u1ee7ng t\u1ed9c Ch\u00e2u \u00c1 (65%), kh\u00f4ng h\u00fat thu\u1ed1c (68%), 100% b\u1ec7nh nh\u00e2n c\u00f3 tr\u1ecb s\u1ed1 th\u1ec3 tr\u1ea1ng theo WHO l\u00e0 0 ho\u1eb7c 1. C\u00f3 54% b\u1ec7nh nh\u00e2n \u0111\u00e3 b\u1ecb di c\u0103n t\u1ea1ng ngo\u00e0i l\u1ed3ng ng\u1ef1c (extra-thoracic visceral metastases), trong \u0111\u00f3 c\u00f3 34% b\u1ecb di c\u0103n n\u00e3o (CNS metastases) (\u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh qua sang th\u01b0\u01a1ng th\u1ea7n kinh trung \u01b0\u01a1ng \u1edf m\u1ee9c c\u01a1 b\u1ea3n, ti\u1ec1n s\u1eed y khoa, v\u00e0\/ho\u1eb7c ph\u1eabu thu\u1eadt tr\u01b0\u1edbc \u0111\u00f3, v\u00e0\/ho\u1eb7c x\u1ea1 tr\u1ecb tr\u01b0\u1edbc khi di c\u0103n n\u00e3o) v\u00e0 23% di c\u0103n gan. C\u00f3 41% b\u1ec7nh nh\u00e2n b\u1ecb di c\u0103n x\u01b0\u01a1ng.<\/p>\r\n<p>Nghi\u00ean c\u1ee9u AURA3 cho th\u1ea5y c\u00f3 c\u1ea3i thi\u1ec7n \u0111\u00e1ng k\u1ec3 c\u00f3 \u00fd ngh\u0129a th\u1ed1ng k\u00ea v\u1ec1 PFS tr\u00ean nh\u00e1nh b\u1ec7nh nh\u00e2n \u0111i\u1ec1u tr\u1ecb b\u1eb1ng TAGRISSO so v\u1edbi nh\u00e1nh d\u00f9ng h\u00f3a tr\u1ecb. B\u1ea3ng 1 t\u00f3m t\u1eaft k\u1ebft qu\u1ea3 v\u1ec1 hi\u1ec7u qu\u1ea3 c\u1ee7a nghi\u00ean c\u1ee9u AURA3 theo \u0111\u00e1nh gi\u00e1 t\u1eeb nghi\u00ean c\u1ee9u vi\u00ean v\u00e0 H\u00ecnh 1 tr\u00ecnh b\u00e0y \u0111\u1ed3 th\u1ecb \u0111\u01b0\u1eddng cong Kaplan-Meier \u0111\u1ed1i v\u1edbi PFS. D\u1eef li\u1ec7u s\u1ed1ng c\u00f2n to\u00e0n b\u1ed9 ch\u01b0a \u0111\u01b0\u1ee3c ho\u00e0n thi\u1ec7n t\u1ea1i th\u1eddi \u0111i\u1ec3m ph\u00e2n t\u00edch OS ban \u0111\u1ea7u n\u00e0y.<\/p>\r\n<p>&#8211; xem B\u1ea3ng 1 &amp; H\u00ecnh 1.<\/p>\r\n<p><img loading=\"lazy\" decoding=\"async\" width=\"1442\" height=\"1423\" class=\"wp-image-7813\" src=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-554.png\" alt=\"Image from Drug Label Content\" srcset=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-554.png 1442w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-554-300x296.png 300w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-554-768x758.png 768w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-554-1024x1011.png 1024w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-554-60x60.png 60w\" sizes=\"auto, (max-width: 1442px) 100vw, 1442px\" \/><\/p>\r\n<p><img loading=\"lazy\" decoding=\"async\" width=\"1709\" height=\"1131\" class=\"wp-image-7814\" src=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-555.png\" alt=\"Image from Drug Label Content\" srcset=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-555.png 1709w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-555-300x199.png 300w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-555-768x508.png 768w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-555-1024x678.png 1024w\" sizes=\"auto, (max-width: 1709px) 100vw, 1709px\" \/><\/p>\r\n<p>Ph\u00e2n t\u00edch \u0111\u1ed9 nh\u1ea1y \u0111\u1ed1i v\u1edbi PFS \u0111\u01b0\u1ee3c H\u1ed9i \u0111\u1ed3ng \u0111\u1ed9c l\u1eadp th\u1ea9m \u0111\u1ecbnh m\u00f9 (BICR) th\u1ef1c hi\u1ec7n \u0111\u00e3 cho th\u1ea5y PFS \u0111\u1ea1t \u0111\u01b0\u1ee3c trung v\u1ecb l\u00e0 11,0 th\u00e1ng \u1edf nh\u00e1nh TAGRISSO so v\u1edbi 4,2 th\u00e1ng \u1edf nh\u00e1nh h\u00f3a tr\u1ecb. Ph\u00e2n t\u00edch n\u00e0y cho th\u1ea5y hi\u1ec7u qu\u1ea3 \u0111i\u1ec1u tr\u1ecb ph\u00f9 h\u1ee3p v\u1edbi \u0111\u00e1nh gi\u00e1 c\u1ee7a nghi\u00ean c\u1ee9u vi\u00ean (HR 0,28; 95% CI: 0,20; 0,38).<\/p>\r\n<p>C\u1ea3i thi\u1ec7n c\u00f3 \u00fd ngh\u0129a v\u1ec1 m\u1eb7t l\u00e2m s\u00e0ng \u0111\u1ed1i v\u1edbi PFS v\u1edbi t\u1ef7 s\u1ed1 r\u1ee7i ro HRs &lt; 0,50 c\u00f3 l\u1ee3i cho nh\u00e1nh b\u1ec7nh nh\u00e2n d\u00f9ng TAGRISSO so v\u1edbi nh\u00e1nh h\u00f3a tr\u1ecb, ghi nh\u1eadn n\u00e0y l\u00e0 nh\u1ea5t qu\u00e1n trong t\u1ea5t c\u1ea3 c\u00e1c ph\u00e2n nh\u00f3m x\u00e1c \u0111\u1ecbnh tr\u01b0\u1edbc \u0111\u00e3 ph\u00e2n t\u00edch, bao g\u1ed3m c\u1ea3 ch\u1ee7ng t\u1ed9c, tu\u1ed5i t\u00e1c, gi\u1edbi t\u00ednh, ti\u1ec1n s\u1eed h\u00fat thu\u1ed1c v\u00e0 \u0111\u1ed9t bi\u1ebfn EGFR (\u0111\u1ed9t bi\u1ebfn m\u1ea5t \u0111o\u1ea1n \u1edf Exon 19 v\u00e0 \u0111\u1ed9t bi\u1ebfn \u0111i\u1ec3m L858R).<\/p>\r\n<p><em>D\u1eef li\u1ec7u v\u1ec1 hi\u1ec7u qu\u1ea3 tr\u00ean b\u1ec7nh nh\u00e2n di c\u0103n n\u00e3o trong nghi\u00ean c\u1ee9u AURA3<\/em><\/p>\r\n<p>B\u1ec7nh nh\u00e2n \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n \u0111\u1ec3 \u0111\u01b0\u1ee3c ch\u1ecdn ng\u1eabu nhi\u00ean v\u00e0o nghi\u00ean c\u1ee9u l\u00e0 b\u1ec7nh nh\u00e2n c\u00f3 di c\u0103n n\u00e3o \u1ed5n \u0111\u1ecbnh, kh\u00f4ng tri\u1ec7u ch\u1ee9ng, kh\u00f4ng \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh d\u00f9ng corticosteroids trong t\u1ed1i thi\u1ec3u l\u00e0 4 tu\u1ea7n tr\u01b0\u1edbc khi b\u1eaft \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb. B\u1ea3ng 2 t\u00f3m t\u1eaft \u0111\u00e1nh gi\u00e1 c\u1ee7a BICR v\u1ec1 hi\u1ec7u qu\u1ea3 tr\u00ean h\u1ec7 th\u1ea7n kinh trung \u01b0\u01a1ng c\u0103n c\u1ee9 theo ti\u00eau chu\u1ea9n RECIST v1.1 tr\u00ean 116 b\u1ec7nh nh\u00e2n (chi\u1ebfm t\u1ef7 l\u1ec7 28%) \u0111\u00e3 x\u00e1c \u0111\u1ecbnh l\u00e0 di c\u0103n h\u1ec7 th\u1ea7n kinh trung \u01b0\u01a1ng b\u1eb1ng ph\u01b0\u01a1ng ti\u1ec7n ch\u1ea9n \u0111o\u00e1n h\u00ecnh \u1ea3nh s\u1ecd n\u00e3o t\u1ea1i th\u1eddi \u0111i\u1ec3m tham gia nghi\u00ean c\u1ee9u trong t\u1ed5ng s\u1ed1 419 b\u1ec7nh nh\u00e2n.<\/p>\r\n<p>&#8211; xem B\u1ea3ng 2.<\/p>\r\n<p><img loading=\"lazy\" decoding=\"async\" width=\"1442\" height=\"1407\" class=\"wp-image-7815\" src=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-556.png\" alt=\"Image from Drug Label Content\" srcset=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-556.png 1442w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-556-300x293.png 300w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-556-768x749.png 768w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-556-1024x999.png 1024w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-556-60x60.png 60w\" sizes=\"auto, (max-width: 1442px) 100vw, 1442px\" \/><\/p>\r\n<p>AURA3 c\u00f3 \u0111\u1ecbnh tr\u01b0\u1edbc vi\u1ec7c \u0111\u00e1nh gi\u00e1 PFS cho ph\u00e2n nh\u00f3m c\u00f3 di c\u0103n tr\u00ean h\u1ec7 th\u1ea7n kinh trung \u01b0\u01a1ng \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh t\u1ea1i \u0111\u1ea7u v\u00e0o c\u1ee7a nghi\u00ean c\u1ee9u, th\u1ec3 hi\u1ec7n \u1edf H\u00ecnh 2.<\/p>\r\n<p>&#8211; xem H\u00ecnh 2.<\/p>\r\n<p><img loading=\"lazy\" decoding=\"async\" width=\"2043\" height=\"1135\" class=\"wp-image-7816\" src=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-557.png\" alt=\"Image from Drug Label Content\" srcset=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-557.png 2043w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-557-300x167.png 300w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-557-768x427.png 768w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-557-1024x569.png 1024w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-557-450x250.png 450w\" sizes=\"auto, (max-width: 2043px) 100vw, 2043px\" \/><\/p>\r\n<p>AURA3 cho th\u1ea5y s\u1ef1 c\u1ea3i thi\u1ec7n \u0111\u00e1ng k\u1ec3 c\u00f3 \u00fd ngh\u0129a th\u1ed1ng k\u00ea v\u1ec1 PFS tr\u00ean b\u1ec7nh nh\u00e2n d\u00f9ng TAGRISSO so v\u1edbi b\u1ec7nh nh\u00e2n d\u00f9ng h\u00f3a tr\u1ecb b\u1ea5t k\u1ec3 t\u00ecnh tr\u1ea1ng di c\u0103n h\u1ec7 th\u1ea7n kinh trung \u01b0\u01a1ng t\u1ea1i th\u1eddi \u0111i\u1ec3m tham gia nghi\u00ean c\u1ee9u.<\/p>\r\n<p>K\u1ebft qu\u1ea3 do b\u1ec7nh nh\u00e2n ghi nh\u1eadn: C\u00e1c tri\u1ec7u ch\u1ee9ng do b\u1ec7nh nh\u00e2n b\u00e1o c\u00e1o (patient-reported symptoms) v\u00e0 ch\u1ea5t l\u01b0\u1ee3ng cu\u1ed9c s\u1ed1ng li\u00ean quan \u0111\u1ebfn s\u1ee9c kh\u1ecfe (health-related quality of life &#8211; HRQL) \u0111\u00e3 \u0111\u01b0\u1ee3c thu th\u1eadp qua thi\u1ebft b\u1ecb \u0111i\u1ec7n t\u1eed b\u1eb1ng c\u00e1ch s\u1eed d\u1ee5ng b\u1ea3ng c\u00e2u h\u1ecfi EORTC QLQ-C30 v\u00e0 b\u1ea3ng c\u00e2u h\u1ecfi chuy\u00ean bi\u1ec7t v\u1ec1 ung th\u01b0 ph\u1ed5i (EORTC QLQ-LC13). B\u1ea3ng c\u00e2u h\u1ecfi LC13 ban \u0111\u1ea7u \u0111\u01b0\u1ee3c d\u00f9ng m\u1ed9t l\u1ea7n m\u1ed9t tu\u1ea7n trong 6 tu\u1ea7n \u0111\u1ea7u ti\u00ean, sau \u0111\u00f3 m\u1ed7i 3 tu\u1ea7n tr\u01b0\u1edbc v\u00e0 sau khi b\u1ec7nh ti\u1ebfn tri\u1ec3n. B\u1ea3ng c\u00e2u h\u1ecfi C30 \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 m\u1ed7i 6 tu\u1ea7n tr\u01b0\u1edbc v\u00e0 sau khi b\u1ec7nh ti\u1ebfn tri\u1ec3n.<\/p>\r\n<p><em>Ph\u00e2n t\u00edch c\u00e1c tri\u1ec7u ch\u1ee9ng ung th\u01b0 ph\u1ed5i ch\u00ednh<\/em><\/p>\r\n<p>TAGRISSO l\u00e0m c\u1ea3i thi\u1ec7n c\u00e1c tri\u1ec7u ch\u1ee9ng ung th\u01b0 ph\u1ed5i do b\u1ec7nh nh\u00e2n b\u00e1o c\u00e1o so v\u1edbi h\u00f3a tr\u1ecb qua s\u1ef1 kh\u00e1c bi\u1ec7t c\u00f3 \u00fd ngh\u0129a th\u1ed1ng k\u00ea v\u1ec1 s\u1ef1 thay \u0111\u1ed5i \u0111\u00e1ng k\u1ec3 so v\u1edbi ban \u0111\u1ea7u tr\u00ean to\u00e0n b\u1ed9 th\u1eddi gian t\u1eeb khi ph\u00e2n nh\u00f3m ng\u1eabu nhi\u00ean cho \u0111\u1ebfn 6 th\u00e1ng \u0111\u1ed1i v\u1edbi 5 tri\u1ec7u ch\u1ee9ng ch\u00ednh \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh tr\u01b0\u1edbc (ch\u00e1n \u0103n, ho, \u0111au ng\u1ef1c, kh\u00f3 th\u1edf v\u00e0 m\u1ec7t m\u1ecfi) \u0111\u01b0\u1ee3c th\u1ec3 hi\u1ec7n trong B\u1ea3ng 3.<\/p>\r\n<p>&#8211; xem B\u1ea3ng 3.<\/p>\r\n<p><img loading=\"lazy\" decoding=\"async\" width=\"2186\" height=\"511\" class=\"wp-image-7817\" src=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-558.png\" alt=\"Image from Drug Label Content\" srcset=\"https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-558.png 2186w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-558-300x70.png 300w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-558-768x180.png 768w, https:\/\/pharmog.com\/wp\/wp-content\/uploads\/2019\/04\/image-from-drug-label-content-558-1024x239.png 1024w\" sizes=\"auto, (max-width: 2186px) 100vw, 2186px\" \/><\/p>\r\n<p>Gi\u00e1 tr\u1ecb trung b\u00ecnh hi\u1ec7u ch\u1ec9nh v\u00e0 s\u1ef1 kh\u00e1c bi\u1ec7t \u01b0\u1edbc t\u00ednh \u0111\u01b0\u1ee3c thu th\u1eadp t\u1eeb ph\u00e9p ph\u00e2n t\u00edch theo \u0110\u00e1nh gi\u00e1 l\u1eb7p l\u1ea1i m\u00f4 h\u00ecnh h\u1ed7n h\u1ee3p (Mixed Model Repeated Measures &#8211; MMRM). M\u00f4 h\u00ecnh n\u00e0y bao g\u1ed3m b\u1ec7nh nh\u00e2n, \u0111i\u1ec1u tr\u1ecb, l\u1ea7n th\u0103m kh\u00e1m, t\u01b0\u01a1ng t\u00e1c gi\u1eefa \u0111i\u1ec1u tr\u1ecb theo s\u1ed1 l\u1ea7n th\u0103m kh\u00e1m, \u0111i\u1ec3m s\u1ed1 tri\u1ec7u ch\u1ee9ng c\u01a1 b\u1ea3n, t\u01b0\u01a1ng t\u00e1c gi\u1eefa s\u1ed1 tri\u1ec7u ch\u1ee9ng c\u01a1 b\u1ea3n theo s\u1ed1 l\u1ea7n th\u0103m kh\u00e1m v\u00e0 s\u1eed d\u1ee5ng ma tr\u1eadn ph\u01b0\u01a1ng sai kh\u00f4ng c\u1ea5u tr\u00fac.<\/p>\r\n<p>Ch\u1ea5t l\u01b0\u1ee3ng cu\u1ed9c s\u1ed1ng li\u00ean quan \u0111\u1ebfn s\u1ee9c kh\u1ecfe (HRQL) v\u00e0 ph\u00e2n t\u00edch c\u1ea3i thi\u1ec7n ch\u1ee9c n\u0103ng th\u1ec3 ch\u1ea5t (physical functioning improvement analysis): B\u1ec7nh nh\u00e2n d\u00f9ng TAGRISSO c\u00f3 c\u01a1 h\u1ed9i l\u1edbn h\u01a1n \u0111\u00e1ng k\u1ec3 \u0111\u1ea1t \u0111\u01b0\u1ee3c s\u1ef1 c\u1ea3i thi\u1ec7n c\u00f3 \u00fd ngh\u0129a l\u00e2m s\u00e0ng l\u1edbn h\u01a1n ho\u1eb7c b\u1eb1ng 10 \u0111i\u1ec3m v\u1ec1 t\u00ecnh tr\u1ea1ng s\u1ee9c kh\u1ecfe to\u00e0n c\u1ea7u v\u00e0 ch\u1ee9c n\u0103ng th\u1ec3 ch\u1ea5t theo B\u1ea3ng c\u00e2u h\u1ecfi EORTC C30 so v\u1edbi h\u00f3a tr\u1ecb li\u1ec7u trong th\u1eddi gian nghi\u00ean c\u1ee9u. T\u1ef7 su\u1ea5t ch\u00eanh (OR) c\u1ee7a t\u00ecnh tr\u1ea1ng s\u1ee9c kh\u1ecfe to\u00e0n c\u1ea7u l\u00e0: 2,11 (95% CI 1,24; 3,67; p=0,007); T\u1ef7 su\u1ea5t ch\u00eanh (OR) c\u1ee7a ch\u1ee9c n\u0103ng th\u1ec3 ch\u1ea5t l\u00e0: 2,79 (95% CI 1,50; 5,46; p=0,002).<\/p>\r\n<p>B\u1ec7nh nh\u00e2n ung th\u01b0 ph\u1ed5i kh\u00f4ng t\u1ebf b\u00e0o nh\u1ecf (NSCLC) c\u00f3 \u0111\u1ed9t bi\u1ebfn T790M tr\u01b0\u1edbc khi \u0111i\u1ec1u tr\u1ecb &#8211; trong nghi\u00ean c\u1ee9u AURAex v\u00e0 AURA2<\/p>\r\n<p>C\u00e1c nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng 2 nh\u00e1nh ri\u00eang l\u1ebb, nh\u00e3n m\u1edf g\u1ed3m nghi\u00ean c\u1ee9u \u0111o\u00e0n h\u1ec7 m\u1edf r\u1ed9ng pha 2 (AURAex (n=201)) v\u00e0 nghi\u00ean c\u1ee9u pha 2 (AURA2 (n=210)) \u0111\u00e3 \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n tr\u00ean b\u1ec7nh nh\u00e2n ung th\u01b0 ph\u1ed5i c\u00f3 \u0111\u1ed9t bi\u1ebfn EGFR T790M v\u00e0 b\u1ec7nh ti\u1ebfn tri\u1ec3n sau m\u1ed9t ho\u1eb7c nhi\u1ec1u li\u1ec7u ph\u00e1p \u0111i\u1ec1u tr\u1ecb to\u00e0n th\u00e2n tr\u01b0\u1edbc \u0111\u00e2y, k\u1ec3 c\u1ea3 li\u1ec7u ph\u00e1p EGFR TKI. To\u00e0n b\u1ed9 b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u ph\u1ea3i c\u00f3 \u0111\u1ed9t bi\u1ebfn EGFR T790M d\u01b0\u01a1ng t\u00ednh \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh qua x\u00e9t nghi\u1ec7m \u0111\u1ed9t bi\u1ebfn EGFR \u0111o b\u1eb1ng h\u1ec7 th\u1ed1ng cobas trong ph\u00f2ng x\u00e9t nghi\u1ec7m trung t\u00e2m tr\u01b0\u1edbc khi \u0111\u01b0a v\u00e0o \u0111i\u1ec1u tr\u1ecb. T\u00ecnh tr\u1ea1ng \u0111\u1ed9t bi\u1ebfn T790M c\u0169ng \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 b\u1eb1ng c\u00e1ch \u0111\u00e1nh gi\u00e1 h\u1ed3i c\u1ee9u ctDNA tr\u00edch xu\u1ea5t t\u1eeb m\u1eabu huy\u1ebft t\u01b0\u01a1ng thu th\u1eadp trong khi s\u00e0ng l\u1ecdc. To\u00e0n b\u1ed9 b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c cho d\u00f9ng TAGRISSO v\u1edbi li\u1ec1u 80 mg, 1 l\u1ea7n\/ng\u00e0y. M\u1ee5c ti\u00eau ch\u00ednh \u0111\u00e1nh gi\u00e1 hi\u1ec7u qu\u1ea3 c\u1ee7a hai nghi\u00ean c\u1ee9u n\u00e0y l\u00e0 t\u1ef7 l\u1ec7 \u0111\u00e1p \u1ee9ng kh\u00e1ch quan (Objective response rate \u2013 ORR) theo ti\u00eau chu\u1ea9n RECIST v1.1 b\u1edfi BICR. M\u1ee5c ti\u00eau ph\u1ee5 \u0111o l\u01b0\u1eddng hi\u1ec7u qu\u1ea3 bao g\u1ed3m th\u1eddi gian \u0111\u00e1p \u1ee9ng (Duration of Response &#8211; DoR) v\u00e0 th\u1eddi gian s\u1ed1ng kh\u00f4ng b\u1ec7nh ti\u1ebfn tri\u1ec3n (Progression-Free Survival &#8211; PFS).<\/p>\r\n<p>\u0110\u1eb7c \u0111i\u1ec3m c\u01a1 b\u1ea3n c\u1ee7a d\u00e2n s\u1ed1 nghi\u00ean c\u1ee9u t\u1ed5ng th\u1ec3 (AURAex v\u00e0 AURA2) nh\u01b0 sau: \u0111\u1ed9 tu\u1ed5i trung v\u1ecb 63 n\u0103m, b\u1ec7nh nh\u00e2n \u2265 75 tu\u1ed5i (13%), ph\u1ee5 n\u1eef (68%), ng\u01b0\u1eddi da tr\u1eafng (36%), ch\u00e2u \u00c1 (60%). To\u00e0n b\u1ed9 b\u1ec7nh nh\u00e2n \u0111\u1ec1u \u0111\u01b0\u1ee3c nh\u1eadn \u00edt nh\u1ea5t l\u00e0 \u0111i\u1ec1u tr\u1ecb b\u01b0\u1edbc 1 tr\u01b0\u1edbc khi \u0111\u01b0a v\u00e0o nghi\u00ean c\u1ee9u. Ba m\u01b0\u01a1i m\u1ed1t ph\u1ea7n tr\u0103m (31%) (N=129) \u0111\u00e3 nh\u1eadn \u0111i\u1ec1u tr\u1ecb b\u01b0\u1edbc 1 tr\u01b0\u1edbc khi \u0111i\u1ec1u tr\u1ecb (b\u1eb1ng EGFR-TKI), 69% (N=282) \u0111\u00e3 nh\u1eadn \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u01b0\u1edbc 2 ho\u1eb7c nhi\u1ec1u h\u01a1n. B\u1ea3y m\u01b0\u01a1i hai ph\u1ea7n tr\u0103m (72%) b\u1ec7nh nh\u00e2n l\u00e0 ng\u01b0\u1eddi kh\u00f4ng h\u00fat thu\u1ed1c, 100% b\u1ec7nh nh\u00e2n c\u00f3 ch\u1ec9 s\u1ed1 th\u1ec3 tr\u1ea1ng theo T\u1ed5 ch\u1ee9c Y t\u1ebf Th\u1ebf gi\u1edbi (WHO) l\u00e0 0 ho\u1eb7c 1. N\u0103m m\u01b0\u01a1i ch\u00edn ph\u1ea7n tr\u0103m (59%) b\u1ec7nh nh\u00e2n \u0111\u00e3 c\u00f3 di c\u0103n t\u1ea1ng ngo\u00e0i l\u1ed3ng ng\u1ef1c, trong \u0111\u00f3 c\u00f3 39% b\u1ec7nh nh\u00e2n b\u1ecb di c\u0103n tr\u00ean h\u1ec7 th\u1ea7n kinh trung \u01b0\u01a1ng (CNS) (\u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh b\u1edfi sang th\u01b0\u01a1ng tr\u00ean th\u1ea7n kinh trung \u01b0\u01a1ng so v\u1edbi tr\u1ecb s\u1ed1 c\u01a1 b\u1ea3n, ti\u1ec1n s\u1eed y khoa, v\u00e0\/ho\u1eb7c ph\u1eabu thu\u1eadt tr\u01b0\u1edbc \u0111\u00f3 v\u00e0\/ho\u1eb7c x\u1ea1 tr\u1ecb tr\u01b0\u1edbc khi di c\u0103n CNS) v\u00e0 29% c\u00f3 di c\u0103n gan. B\u1ed1n m\u01b0\u01a1i b\u1ea3y ph\u1ea7n tr\u0103m (47%) b\u1ec7nh nh\u00e2n c\u00f3 b\u1ec7nh di c\u0103n x\u01b0\u01a1ng. Th\u1eddi gian theo d\u00f5i trung v\u1ecb \u0111\u1ed1i v\u1edbi PFS l\u00e0 12,6 th\u00e1ng.<\/p>\r\n<p>Trong 411 b\u1ec7nh nh\u00e2n c\u00f3 \u0111\u1ed9t bi\u1ebfn EGFR T790M d\u01b0\u01a1ng t\u00ednh tr\u01b0\u1edbc khi \u0111i\u1ec1u tr\u1ecb, tr\u1ecb s\u1ed1 ORR t\u1ed5ng qu\u00e1t theo \u0111\u00e1nh gi\u00e1 c\u1ee7a BICR l\u00e0 66% (95% CI: 61; 71). \u1ede b\u1ec7nh nh\u00e2n c\u00f3 \u0111\u00e1p \u1ee9ng \u0111\u00e3 \u0111\u01b0\u1ee3c x\u00e1c nh\u1eadn b\u1edfi BICR, DOR trung v\u1ecb l\u00e0 12,5 th\u00e1ng (95% CI: 11,1; NE). ORR theo BICR trong AURAex v\u00e0 AURA2 t\u01b0\u01a1ng \u1ee9ng l\u00e0 62% (95% CI: 55; 68) v\u00e0 70% (95% CI: 63; 77). PFS trung v\u1ecb l\u00e0 11,0 th\u00e1ng; 95% CI (9,6; 12,4).<\/p>\r\n<p>T\u1ef7 l\u1ec7 \u0111\u00e1p \u1ee9ng kh\u00e1ch quan theo BICR \u0111\u00e3 \u0111\u01b0\u1ee3c ghi nh\u1eadn l\u00e0 tr\u00ean 50% \u1edf t\u1ea5t c\u1ea3 c\u00e1c ph\u00e2n nh\u00f3m ph\u00e2n t\u00edch \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh tr\u01b0\u1edbc, bao g\u1ed3m c\u00e1c li\u1ec7u ph\u00e1p \u0111i\u1ec1u tr\u1ecb, ch\u1ee7ng t\u1ed9c, tu\u1ed5i t\u00e1c v\u00e0 khu v\u1ef1c.<\/p>\r\n<p>Khi \u0111\u00e1nh gi\u00e1 \u0111\u00e1p \u1ee9ng tr\u00ean to\u00e0n b\u1ed9 d\u00e2n s\u1ed1, 85% (223\/262) \u0111\u01b0\u1ee3c ghi nh\u1eadn l\u00e0 c\u00f3 \u0111\u00e1p \u1ee9ng t\u1ea1i th\u1eddi \u0111i\u1ec3m r\u00e0 so\u00e1t \u0111\u1ea7u ti\u00ean (6 tu\u1ea7n); 94% (247\/262) ghi nh\u1eadn d\u1eef li\u1ec7u \u0111\u00e1p \u1ee9ng t\u1ea1i th\u1eddi \u0111i\u1ec3m r\u00e0 so\u00e1t th\u1ee9 hai (12 tu\u1ea7n).<\/p>\r\n<p><em>D\u1eef li\u1ec7u hi\u1ec7u qu\u1ea3 tr\u00ean b\u1ec7nh nh\u00e2n di c\u0103n CNS trong c\u00e1c nghi\u00ean c\u1ee9u pha 2 (AURAex v\u00e0 AURA2)<\/em><\/p>\r\n<p>\u0110\u00e1nh gi\u00e1 c\u1ee7a BICR v\u1ec1 hi\u1ec7u qu\u1ea3 CNS theo ti\u00eau chu\u1ea9n RECIST v 1.1 \u0111\u00e3 \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n trong m\u1ed9t ph\u00e2n nh\u00f3m g\u1ed3m 50 b\u1ec7nh nh\u00e2n (trong t\u1ed5ng s\u1ed1 411 b\u1ec7nh nh\u00e2n) \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh c\u00f3 di c\u0103n CNS \u0111o \u0111\u01b0\u1ee3c tr\u00ean h\u00ecnh \u1ea3nh scan n\u00e3o. T\u1ef7 l\u1ec7 \u0111\u00e1p \u1ee9ng kh\u00e1ch quan (ORR) tr\u00ean CNS l\u00e0 54% (27\/50 b\u1ec7nh nh\u00e2n; 95% CI: 39,3; 68,2) \u0111\u01b0\u1ee3c quan s\u00e1t, trong \u0111\u00f3 c\u00f3 12% \u0111\u00e1p \u1ee9ng ho\u00e0n to\u00e0n.<\/p>\r\n<p>C\u00e1c nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng \u0111\u00e3 kh\u00f4ng \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh \u0111\u1ed1i v\u1edbi b\u1ec7nh nh\u00e2n NSCLC c\u00f3 \u0111\u1ed9t bi\u1ebfn EGFR T790M ngay t\u1eeb \u0111\u1ea7u (de novo EGFR T790M).<\/p>\r\n<p>Tr\u1ebb em: T\u00ednh an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a TAGRISSO \u1edf tr\u1ebb em v\u00e0 tr\u1ebb v\u1ecb th\u00e0nh ni\u00ean &lt; 18 tu\u1ed5i ch\u01b0a \u0111\u01b0\u1ee3c thi\u1ebft l\u1eadp. Hi\u1ec7n ch\u01b0a c\u00f3 d\u1eef li\u1ec7u.<\/p>\r\n<p><strong><em>C\u01a1 ch\u1ebf t\u00e1c d\u1ee5ng: <\/em><\/strong><\/p>\r\n<p>Osimertinib l\u00e0 ch\u1ea5t \u1ee9c ch\u1ebf Tyrosine Kinase (TKI). \u0110\u00e2y l\u00e0 ch\u1ea5t \u1ee9c ch\u1ebf kh\u00f4ng thu\u1eadn ngh\u1ecbch th\u1ee5 th\u1ec3 y\u1ebfu t\u1ed1 ph\u00e1t tri\u1ec3n bi\u1ec3u b\u00ec (Epidermal Growth Factor Receptors &#8211; EGFRs) c\u00f3 \u0111\u1ed9t bi\u1ebfn nh\u1ea1y c\u1ea3m (EGFRm) v\u00e0 \u0111\u1ed9t bi\u1ebfn T790M \u0111\u1ec1 kh\u00e1ng v\u1edbi TKI.<\/p>\r\n<p><strong>[XEM T\u1ea0I \u0110\u00c2Y]<\/strong><\/p>\r\n<p><strong>5.2. D\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc:<\/strong><\/p>\r\n<p>C\u00e1c tham s\u1ed1 d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u1ee7a osimertinib \u0111\u01b0\u1ee3c x\u00e1c l\u1eadp tr\u00ean ng\u01b0\u1eddi kh\u1ecfe m\u1ea1nh v\u00e0 b\u1ec7nh nh\u00e2n ung th\u01b0 ph\u1ed5i kh\u00f4ng t\u1ebf b\u00e0o nh\u1ecf (NSCLC). D\u1ef1a tr\u00ean ph\u00e2n t\u00edch v\u1ec1 d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc trong d\u00e2n s\u1ed1 nghi\u00ean c\u1ee9u, \u0111\u1ed9 thanh th\u1ea3i huy\u1ebft t\u01b0\u01a1ng bi\u1ec3u ki\u1ebfn c\u1ee7a osimertinib l\u00e0 14,2 L\/gi\u1edd, th\u1ec3 t\u00edch ph\u00e2n b\u1ed1 bi\u1ec3u ki\u1ebfn l\u00e0 997 L v\u00e0 th\u1eddi gian b\u00e1n th\u1ea3i pha cu\u1ed1i kho\u1ea3ng 48 gi\u1edd. AUC v\u00e0 Cmax t\u0103ng t\u1ef7 l\u1ec7 theo li\u1ec1u \u1edf m\u1ee9c li\u1ec1u t\u1eeb 20 \u0111\u00ean 240 mg. Khi d\u00f9ng osimertinib ng\u00e0y 1 l\u1ea7n l\u00e0m t\u0103ng t\u00edch l\u0169y kho\u1ea3ng 3 l\u1ea7n v\u1edbi m\u1ee9c ti\u1ebfp x\u00fac h\u1eb1ng \u0111\u1ecbnh \u0111\u1ea1t \u0111\u01b0\u1ee3c sau 15 ng\u00e0y d\u00f9ng thu\u1ed1c. \u1ede tr\u1ea1ng th\u00e1i h\u1eb1ng \u0111\u1ecbnh, n\u1ed3ng \u0111\u1ed9 thu\u1ed1c trong huy\u1ebft t\u01b0\u01a1ng tu\u1ea7n ho\u00e0n duy tr\u00ec m\u1ed9t c\u00e1ch \u0111i\u1ec3n h\u00ecnh \u1edf m\u1ee9c g\u1ea5p 1,6 l\u1ea7n trong kho\u00e0ng 24 gi\u1edd d\u00f9ng thu\u1ed1c.<\/p>\r\n<p><em>H\u1ea5p thu:<\/em> Sau khi d\u00f9ng TAGRISSO \u0111\u01b0\u1eddng u\u1ed1ng, n\u1ed3ng \u0111\u1ed9 \u0111\u1ec9nh c\u1ee7a osimertinib trong huy\u1ebft t\u01b0\u01a1ng \u0111\u1ea1t \u0111\u01b0\u1ee3c \u1edf kho\u1ea3ng th\u1eddi gian tmax trung v\u1ecb (min-max) l\u00e0 6 gi\u1edd (3-24 gi\u1edd), v\u1edbi m\u1ed9t v\u00e0i \u0111\u1ec9nh \u0111\u00e3 \u0111\u01b0\u1ee3c ghi nh\u1eadn trong 24 gi\u1edd \u0111\u1ea7u ti\u00ean tr\u00ean m\u1ed9t s\u1ed1 b\u1ec7nh nh\u00e2n. \u0110\u1ed9 sinh kh\u1ea3 d\u1ee5ng tuy\u1ec7t \u0111\u1ed1i c\u1ee7a TAGRISSO ch\u01b0a \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh. D\u1ef1a tr\u00ean m\u1ed9t nghi\u00ean c\u1ee9u d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc l\u00e2m s\u00e0ng tr\u00ean b\u1ec7nh nh\u00e2n t\u1ea1i m\u1ee9c li\u1ec1u 80 mg, th\u1ee9c \u0103n kh\u00f4ng l\u00e0m thay \u0111\u1ed5i sinh kh\u1ea3 d\u1ee5ng osimertinib \u0111\u1ebfn m\u1ed9t m\u1ee9c \u0111\u1ed9 c\u00f3 \u00fd ngh\u0129a l\u00e2m s\u00e0ng. (AUC t\u0103ng 6% (90% CI -5, 19) v\u00e0 Cmax gi\u1ea3m 7% (90% CI -19, 6)). \u1ede ng\u01b0\u1eddi t\u00ecnh nguy\u1ec7n kh\u1ecfe m\u1ea1nh d\u00f9ng 1 vi\u00ean 80 mg m\u00e0 pH d\u1ea1 d\u00e0y \u0111\u00e3 \u0111\u01b0\u1ee3c n\u00e2ng l\u00ean do d\u00f9ng li\u1ec1u omeprazole trong 5 ng\u00e0y, n\u1ed3ng \u0111\u1ed9 v\u00e0 th\u1eddi gian ti\u1ebfp x\u00fac c\u1ee7a osimertinib \u0111\u00e3 kh\u00f4ng b\u1ecb \u1ea3nh h\u01b0\u1edfng (AUC v\u00e0 Cmax t\u0103ng t\u01b0\u01a1ng \u1ee9ng l\u00e0 7% v\u00e0 2%) v\u1edbi 90% CI v\u1ec1 t\u1ef7 l\u1ec7 ti\u1ebfp x\u00fac n\u1eb1m trong gi\u1edbi h\u1ea1n 80-125%.<\/p>\r\n<p><em>Ph\u00e2n b\u1ed1:<\/em> Th\u1ec3 t\u00edch ph\u00e2n b\u1ed1 trung v\u1ecb \u01b0\u1edbc t\u00ednh tr\u00ean d\u00e2n s\u1ed1 nghi\u00ean c\u1ee9u c\u1ee7a osimertinib \u1edf tr\u1ea1ng th\u00e1i h\u1eb1ng \u0111\u1ecbnh (Vss\/F) l\u00e0 997 L cho th\u1ea5y thu\u1ed1c ph\u00e2n ph\u1ed1i r\u1ed9ng r\u00e3i v\u00e0o c\u00e1c m\u00f4. Kh\u00f4ng th\u1ec3 \u0111o m\u1ee9c g\u1eafn k\u1ebft protein trong huy\u1ebft t\u01b0\u01a1ng v\u00ec kh\u00f4ng \u1ed5n \u0111\u1ecbnh, tuy nhi\u00ean theo c\u00e1c \u0111\u1eb7c t\u00ednh l\u00fd h\u00f3a c\u1ee7a osimertinib, m\u1ee9c g\u1eafn k\u1ebft v\u1edbi protein huy\u1ebft t\u01b0\u01a1ng c\u00f3 l\u1ebd l\u00e0 r\u1ea5t cao. Osimertinib c\u0169ng \u0111\u00e3 \u0111\u01b0\u1ee3c ch\u1ee9ng t\u1ecf g\u1eafn k\u1ebft t\u01b0\u01a1ng \u0111\u01b0\u01a1ng v\u1edbi protein huy\u1ebft t\u01b0\u01a1ng \u1edf chu\u1ed9t v\u00e0 \u1edf ng\u01b0\u1eddi, albumin huy\u1ebft thanh c\u1ee7a ng\u01b0\u1eddi v\u00e0 chu\u1ed9t v\u00e0 t\u1ebf b\u00e0o gan ng\u01b0\u1eddi.<\/p>\r\n<p><em>Bi\u1ebfn \u0111\u1ed5i sinh h\u1ecdc<\/em><\/p>\r\n<p>Nghi\u00ean c\u1ee9u in vitro cho th\u1ea5y osimertinib \u0111\u01b0\u1ee3c chuy\u1ec3n h\u00f3a ch\u1ee7 y\u1ebfu b\u1edfi CYP3A4 v\u00e0 CYP3A5. Qu\u00e1 tr\u00ecnh chuy\u1ec3n h\u00f3a qua CYP3A4 c\u00f3 th\u1ec3 l\u00e0 \u0111\u01b0\u1eddng chuy\u1ec3n h\u00f3a ph\u1ee5. \u0110\u01b0\u1eddng chuy\u1ec3n h\u00f3a thay th\u1ebf c\u00f3 th\u1ec3 t\u1ed3n t\u1ea1i nh\u01b0ng ch\u01b0a \u0111\u01b0\u1ee3c m\u00f4 t\u1ea3 \u0111\u1ea7y \u0111\u1ee7. D\u1ef1a tr\u00ean c\u00e1c nghi\u00ean c\u1ee9u trong \u1ed1ng nghi\u1ec7m in vitro, 2 ch\u1ea5t chuy\u1ec3n h\u00f3a c\u00f3 ho\u1ea1t t\u00ednh d\u01b0\u1ee3c l\u00fd (AZ7550 v\u00e0 AZ5104) sau \u0111\u00f3 \u0111\u00e3 \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh trong huy\u1ebft t\u01b0\u01a1ng trong nghi\u00ean c\u1ee9u ti\u1ec1n l\u00e2m s\u00e0ng v\u00e0 \u1edf ng\u01b0\u1eddi sau m\u1ed9t li\u1ec1u u\u1ed1ng v\u1edbi osimertinib; AZ7550 cho th\u1ea5y d\u01b0\u1ee3c l\u1ef1c t\u01b0\u01a1ng t\u1ef1 v\u1edbi TAGRISSO trong khi AZ5104 cho th\u1ea5y hi\u1ec7u qu\u1ea3 m\u1ea1nh h\u01a1n tr\u00ean EGFR \u1edf c\u1ea3 hai th\u1ec3 \u0111\u1ed9t bi\u1ebfn v\u00e0 kh\u00f4ng \u0111\u1ed9t bi\u1ebfn (type wide). C\u1ea3 hai ch\u1ea5t chuy\u1ec3n h\u00f3a xu\u1ea5t hi\u1ec7n t\u1eeb t\u1eeb trong huy\u1ebft t\u01b0\u01a1ng sau khi b\u1ec7nh nh\u00e2n u\u1ed1ng TAGRISSO, v\u1edbi tmax b\u00ecnh qu\u00e2n (min-max) \u0111\u1ed1i v\u1edbi c\u00e1c ch\u1ea5t chuy\u1ec3n h\u00f3a AZ7550 v\u00e0 AZ5104 t\u01b0\u01a1ng \u1ee9ng l\u00e0 24 gi\u1edd (4-72 gi\u1edd) v\u00e0 24 gi\u1edd (6-72 gi\u1edd). Trong huy\u1ebft t\u01b0\u01a1ng ng\u01b0\u1eddi, osimertinib chi\u1ebfm 0,8%, v\u1edbi 2 ch\u1ea5t chuy\u1ec3n h\u00f3a ph\u00e2n b\u1ed1 l\u00e0 0,08% v\u00e0 0,07% t\u1ed5ng s\u1ed1 ph\u00f3ng x\u1ea1 v\u1edbi ph\u1ea7n l\u1edbn c\u00e1c ch\u1ea5t ph\u00f3ng x\u1ea1 g\u1eafn k\u1ebft t\u01b0\u01a1ng \u0111\u01b0\u01a1ng v\u1edbi protein huy\u1ebft t\u01b0\u01a1ng. Vi\u1ec7c ti\u1ebfp x\u00fac trung b\u00ecnh h\u00ecnh h\u1ecdc c\u1ee7a c\u1ea3 hai AZ5104 v\u00e0 AZ7550, d\u1ef1a tr\u00ean AUC, x\u1ea5p x\u1ec9 10% m\u1ee9c ti\u1ebfp x\u00fac c\u1ee7a osimertinib khi \u1edf tr\u1ea1ng th\u00e1i \u1ed5n \u0111\u1ecbnh.<\/p>\r\n<p>\u0110\u01b0\u1eddng chuy\u1ec3n h\u00f3a ch\u00ednh c\u1ee7a osimertinib l\u00e0 qua oxy h\u00f3a v\u00e0 kh\u1eed alkyl h\u00f3a. C\u00f3 \u00edt nh\u1ea5t 12 th\u00e0nh ph\u1ea7n \u0111\u00e3 \u0111\u01b0\u1ee3c quan s\u00e1t th\u1ea5y trong n\u01b0\u1edbc ti\u1ec3u g\u1ed9p v\u00e0 m\u1eabu ph\u00e2n \u1edf ng\u01b0\u1eddi v\u1edbi 5 th\u00e0nh ph\u1ea7n chi\u1ebfm &gt; 1% li\u1ec1u m\u00e0 trong \u0111\u00f3 osimertinib d\u1ea1ng kh\u00f4ng \u0111\u1ed5i, AZ5104 v\u00e0 AZ7550, chi\u1ebfm kho\u1ea3ng 1,9; 6,6 v\u00e0 2,7% li\u1ec1u trong khi s\u1ea3n ph\u1ea9m c\u1ed9ng cysteinyl kh\u00e9p (M21) v\u00e0 m\u1ed9t ch\u1ea5t chuy\u1ec3n h\u00f3a ch\u01b0a r\u00f5 (M25) chi\u1ebfm t\u1ef7 l\u1ec7 t\u01b0\u01a1ng \u1ee9ng l\u00e0 1,5% v\u00e0 1,9% li\u1ec1u.<\/p>\r\n<p>D\u1ef1a tr\u00ean c\u00e1c nghi\u00ean c\u1ee9u in vitro, osimertinib l\u00e0 m\u1ed9t ch\u1ea5t \u1ee9c ch\u1ebf c\u1ea1nh tranh c\u1ee7a CYP 3A4\/5 nh\u01b0ng kh\u00f4ng \u1ee9c ch\u1ebf CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6 v\u00e0 2E1 \u1edf c\u00e1c n\u1ed3ng \u0111\u1ed9 c\u00f3 li\u00ean quan v\u1ec1 m\u1eb7t l\u00e2m s\u00e0ng. D\u1ef1a tr\u00ean c\u00e1c nghi\u00ean c\u1ee9u in vitro, osimertinib kh\u00f4ng ph\u1ea3i l\u00e0 m\u1ed9t ch\u1ea5t \u1ee9c ch\u1ebf UGT1A1 v\u00e0 UGT2B7 \u1edf n\u1ed3ng \u0111\u1ed9 l\u00e2m s\u00e0ng c\u00f3 li\u00ean quan \u0111\u1ebfn gan. UGT1A1 c\u00f3 th\u1ec3 g\u00e2y ra \u1ee9c ch\u1ebf tr\u00ean ru\u1ed9t nh\u01b0ng t\u00e1c \u0111\u1ed9ng l\u00e2m s\u00e0ng ch\u01b0a \u0111\u01b0\u1ee3c bi\u1ebft.<\/p>\r\n<p><em>Th\u1ea3i tr\u1eeb:<\/em> Sau khi u\u1ed1ng m\u1ed9t li\u1ec1u duy nh\u1ea5t 20 mg, 67,8% li\u1ec1u \u0111\u00e3 \u0111\u01b0\u1ee3c ph\u00e1t hi\u1ec7n trong ph\u00e2n (1,2% \u1edf d\u1ea1ng kh\u00f4ng \u0111\u1ed5i), trong khi 14,2% li\u1ec1u d\u00f9ng (0,8% \u1edf d\u1ea1ng kh\u00f4ng \u0111\u1ed5i) \u0111\u00e3 \u0111\u01b0\u1ee3c t\u00ecm th\u1ea5y trong n\u01b0\u1edbc ti\u1ec3u sau 84 ng\u00e0y k\u1ec3 t\u1eeb ng\u00e0y thu m\u1eabu. Osimertinib kh\u00f4ng \u0111\u1ed5i chi\u1ebfm kho\u1ea3ng 2% c\u1ee7a qu\u00e1 tr\u00ecnh th\u1ea3i tr\u1eeb v\u1edbi 0,8% trong n\u01b0\u1edbc ti\u1ec3u v\u00e0 1,2% trong ph\u00e2n.<\/p>\r\n<p><em>T\u01b0\u01a1ng t\u00e1c v\u1edbi protein v\u1eadn chuy\u1ec3n: <\/em>C\u00e1c nghi\u00ean c\u1ee9u in vitro cho th\u1ea5y osimertinib kh\u00f4ng ph\u1ea3i l\u00e0 ch\u1ea5t n\u1ec1n c\u1ee7a OATP1B1 v\u00e0 OATP1B3. In vitro, osimertinib kh\u00f4ng \u1ee9c ch\u1ebf OAT1, OAT3, OATP1B1, OATP1B3 v\u00e0 MATE2K \u1edf c\u00e1c n\u1ed3ng \u0111\u1ed9 c\u00f3 li\u00ean quan v\u1ec1 l\u00e2m s\u00e0ng. Tuy nhi\u00ean, kh\u00f4ng th\u1ec3 lo\u1ea1i tr\u1eeb t\u01b0\u01a1ng t\u00e1c v\u1edbi ch\u1ea5t n\u1ec1n MATE1 v\u00e0 OCT2.<\/p>\r\n<p><em>T\u00e1c \u0111\u1ed9ng c\u1ee7a osimertinib tr\u00ean P-gp v\u00e0 BCRP<\/em>: D\u1ef1a tr\u00ean c\u00e1c nghi\u00ean c\u1ee9u in vitro, osimertinib l\u00e0 m\u1ed9t ch\u1ea5t n\u1ec1n c\u1ee7a P-glycoprotein v\u00e0 protein kh\u00e1ng ung th\u01b0 v\u00fa (BCRP), nh\u01b0ng c\u00f3 l\u1ebd kh\u00f4ng g\u00e2y t\u01b0\u01a1ng t\u00e1c thu\u1ed1c tr\u00ean l\u00e2m s\u00e0ng v\u1edbi c\u00e1c thu\u1ed1c kh\u00e1c do osimertinib t\u1ea1i c\u00e1c m\u1ee9c li\u1ec1u l\u00e2m s\u00e0ng. D\u1ef1a tr\u00ean d\u1eef li\u1ec7u in vitro, osimertinib l\u00e0 m\u1ed9t ch\u1ea5t \u1ee9c ch\u1ebf BCRP v\u00e0 P-gp. Ch\u01b0a nghi\u00ean c\u1ee9u c\u00e1c t\u01b0\u01a1ng t\u00e1c \u0111i\u1ec1u bi\u1ebfn qua men PXR kh\u00e1c v\u1edbi CYP3A4 (xem ph\u1ea7n &#8221;T\u01b0\u01a1ng t\u00e1c&#8221;).<\/p>\r\n<p><em>Tr\u00ean c\u00e1c nh\u00f3m d\u00e2n s\u1ed1 \u0111\u1eb7c bi\u1ec7t:<\/em> Trong m\u1ed9t ph\u00e2n t\u00edch d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc tr\u00ean d\u00e2n s\u1ed1 nghi\u00ean c\u1ee9u (n=1088), kh\u00f4ng x\u00e1c \u0111\u1ecbnh m\u1ed1i li\u00ean h\u1ec7 c\u00f3 \u00fd ngh\u0129a l\u00e2m s\u00e0ng gi\u1eefa m\u1ee9c ti\u1ebfp x\u00fac \u1edf tr\u1ea1ng th\u00e1i h\u1eb1ng \u0111\u1ecbnh \u0111\u01b0\u1ee3c d\u1ef1 \u0111o\u00e1n (AUCss) v\u00e0 tu\u1ed5i t\u00e1c c\u1ee7a b\u1ec7nh nh\u00e2n (25-91 tu\u1ed5i), gi\u1edbi t\u00ednh (n\u1eef 65%), ch\u1ee7ng t\u1ed9c (bao g\u1ed3m da tr\u1eafng, ch\u1ee7ng t\u1ed9c ch\u00e2u \u00c1, Nh\u1eadt B\u1ea3n, Trung Qu\u1ed1c v\u00e0 b\u1ec7nh nh\u00e2n kh\u00f4ng ph\u1ea3i da tr\u1eafng v\u00e0 kh\u00f4ng thu\u1ed9c ch\u1ee7ng t\u1ed9c ch\u00e2u \u00c1) v\u00e0 t\u00ecnh tr\u1ea1ng h\u00fat thu\u1ed1c (ng\u01b0\u1eddi hi\u1ec7n t\u1ea1i h\u00fat thu\u1ed1c n=27, ng\u01b0\u1eddi t\u1eebng h\u00fat thu\u1ed1c n=329). Ph\u00e2n t\u00edch d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc tr\u00ean d\u00e2n s\u1ed1 nghi\u00ean c\u1ee9u cho th\u1ea5y tr\u1ecdng l\u01b0\u1ee3ng c\u01a1 th\u1ec3 l\u00e0 m\u1ed9t bi\u1ebfn \u0111\u1ed9c l\u1eadp (covariate) \u0111\u00e1ng k\u1ec3 v\u1edbi AUCss osimertinib d\u1ef1 ki\u1ebfn theo tr\u1ecdng l\u01b0\u1ee3ng c\u01a1 th\u1ec3 t\u1eeb 89kg \u0111\u1ebfn 43kg (\u0111i\u1ec3m ph\u00e2n v\u1ecb (quantiles) 95% \u0111\u1ebfn 5%) \u0111\u00e3 thay \u0111\u1ed5i \u00edt h\u01a1n 20% khi so s\u00e1nh v\u1edbi c\u00e1c AUCss theo tr\u1ecdng l\u01b0\u1ee3ng c\u01a1 th\u1ec3 trung v\u1ecb l\u00e0 60kg. Xem x\u00e9t c\u00e1c \u0111i\u1ec3m t\u1eeb nh\u1ecf nh\u1ea5t \u0111\u1ebfn cao nh\u1ea5t c\u1ee7a tr\u1ecdng l\u01b0\u1ee3ng c\u01a1 th\u1ec3 (t\u1eeb &lt; 43kg \u0111\u1ebfn &gt; 89kg), t\u1ef7 l\u1ec7 ch\u1ea5t chuy\u1ec3n h\u00f3a AZ5104 dao \u0111\u1ed9ng t\u1eeb 11,8% xu\u1ed1ng c\u00f2n 9,6% trong khi \u0111\u1ed1i v\u1edbi AZ7550, t\u1ef7 l\u1ec7 n\u00e0y dao \u0111\u1ed9ng t\u01b0\u01a1ng \u1ee9ng t\u1eeb 12,8% xu\u1ed1ng c\u00f2n 8,1%. D\u1ef1a tr\u00ean m\u1ed9t ph\u00e2n t\u00edch d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc d\u00e2n s\u1ed1, albumin huy\u1ebft thanh \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh l\u00e0 m\u1ed9t bi\u1ebfn \u0111\u1ed9c l\u1eadp (covariate) \u0111\u00e1ng k\u1ec3 v\u1edbi AUCss osimertinib d\u1ef1 ki\u1ebfn thay \u0111\u1ed5i t\u1eeb -15% \u0111\u1ebfn +30% theo m\u1ee9c albumin t\u01b0\u01a1ng \u1ee9ng t\u1eeb 29 \u0111\u1ebfn 46 g\/L (\u0111i\u1ec3m ph\u00e2n v\u1ecb (quantiles) 95% \u0111\u1ebfn 5%) khi so s\u00e1nh v\u1edbi AUCss \u1edf m\u1ee9c albumin trung v\u1ecb c\u0103n b\u1ea3n 39 g\/L. Nh\u1eefng thay \u0111\u1ed5i v\u1ec1 m\u1ee9c ti\u1ebfp x\u00fac n\u00e0y do tr\u1ecdng l\u01b0\u1ee3ng c\u01a1 th\u1ec3 ho\u1eb7c s\u1ef1 kh\u00e1c bi\u1ec7t albumin c\u01a1 b\u1ea3n kh\u00f4ng \u0111\u01b0\u1ee3c xem l\u00e0 c\u00f3 li\u00ean quan v\u1ec1 l\u00e2m s\u00e0ng.<\/p>\r\n<p><em>B\u1ec7nh nh\u00e2n suy gi\u1ea3m ch\u1ee9c n\u0103ng gan:<\/em> Osimertinib \u0111\u01b0\u1ee3c th\u1ea3i tr\u1eeb ch\u1ee7 y\u1ebfu qua gan, v\u00e0 do \u0111\u00f3, b\u1ec7nh nh\u00e2n suy gan c\u00f3 th\u1ec3 t\u0103ng m\u1ee9c ti\u1ebfp x\u00fac. Ch\u01b0a \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh th\u1eed nghi\u1ec7m d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc tr\u00ean ng\u01b0\u1eddi suy gan. D\u1ef1a tr\u00ean ph\u00e2n t\u00edch d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc d\u00e2n s\u1ed1, kh\u00f4ng c\u00f3 m\u1ed1i quan h\u1ec7 gi\u1eefa c\u00e1c d\u1ea5u ch\u1ec9 c\u1ee7a ch\u1ee9c n\u0103ng gan (ALT, AST, bilirubin) v\u00e0 m\u1ee9c ti\u1ebfp x\u00fac osimertinib. C\u00e1c d\u1ea5u ch\u1ec9 c\u1ee7a ch\u1ee9c n\u0103ng gan (albumin huy\u1ebft thanh) cho th\u1ea5y c\u00f3 t\u00e1c \u0111\u1ed9ng tr\u00ean d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u1ee7a osimertinib. C\u00e1c nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n \u0111\u00e3 lo\u1ea1i tr\u1eeb b\u1ec7nh nh\u00e2n c\u00f3 AST ho\u1eb7c ALT &gt; 2,5 l\u1ea7n gi\u1edbi h\u1ea1n tr\u00ean c\u1ee7a b\u00ecnh th\u01b0\u1eddng (ULN), ho\u1eb7c n\u1ebfu do b\u1ec7nh \u00e1c t\u00ednh ti\u1ec1m \u1ea9n, \u0111\u00e3 lo\u1ea1i tr\u1eeb b\u1ec7nh nh\u00e2n c\u00f3 AST ho\u1eb7c ALT &gt; 5,0xULN ho\u1eb7c v\u1edbi bilirubin to\u00e0n ph\u1ea7n &gt; 1,5xULN. D\u1ef1a tr\u00ean ph\u00e2n t\u00edch d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc c\u1ee7a 104 b\u1ec7nh nh\u00e2n suy gan nh\u1eb9, 8 b\u1ec7nh nh\u00e2n suy gan trung b\u00ecnh v\u00e0 972 b\u1ec7nh nh\u00e2n c\u00f3 ch\u1ee9c n\u0103ng gan b\u00ecnh th\u01b0\u1eddng, m\u1ee9c osimertinib l\u00e0 t\u01b0\u01a1ng t\u1ef1 nhau. C\u00f3 \u00edt d\u1eef li\u1ec7u c\u00f3 s\u1eb5n tr\u00ean b\u1ec7nh nh\u00e2n suy gan n\u1eb7ng (xem ph\u1ea7n &#8221;Li\u1ec1u l\u01b0\u1ee3ng v\u00e0 C\u00e1ch d\u00f9ng&#8221;).<\/p>\r\n<p><em>B\u1ec7nh nh\u00e2n suy gi\u1ea3m ch\u1ee9c n\u0103ng th\u1eadn<\/em>: Ch\u01b0a ti\u1ebfn h\u00e0nh nghi\u00ean c\u1ee9u d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc tr\u00ean b\u1ec7nh nh\u00e2n suy th\u1eadn. D\u1ef1a tr\u00ean ph\u00e2n t\u00edch d\u01b0\u1ee3c \u0111\u1ed9ng d\u00e2n s\u1ed1 c\u1ee7a 471 b\u1ec7nh nh\u00e2n suy th\u1eadn nh\u1eb9 (CLcr 60 \u0111\u1ebfn &lt; 90mL\/ph\u00fat), 208 b\u1ec7nh nh\u00e2n suy th\u1eadn v\u1eeba (CLcr 30 \u0111\u1ebfn &lt; 60mL\/ph\u00fat), 5 b\u1ec7nh nh\u00e2n suy th\u1eadn n\u1eb7ng (CLcr 15 \u0111\u1ebfn &lt; 30mL\/ph\u00fat) v\u00e0 402 b\u1ec7nh nh\u00e2n c\u00f3 ch\u1ee9c n\u0103ng th\u1eadn b\u00ecnh th\u01b0\u1eddng (l\u1edbn h\u01a1n ho\u1eb7c b\u1eb1ng 90mL\/ph\u00fat), m\u1ee9c ti\u1ebfp x\u00fac osimertinib l\u00e0 t\u01b0\u01a1ng t\u1ef1 nhau. T\u00ecnh tr\u1ea1ng suy th\u1eadn n\u1eb7ng c\u00f3 th\u1ec3 \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn th\u1ea3i tr\u1eeb c\u00e1c thu\u1ed1c th\u1ea3i tr\u1eeb qua \u0111\u01b0\u1eddng th\u1eadn. C\u00e1c th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng n\u00e0y kh\u00f4ng bao g\u1ed3m b\u1ec7nh nh\u00e2n c\u00f3 CLcr &lt; 15mL\/ph\u00fat.<\/p>\r\n<p><strong>5.3 Gi\u1ea3i th\u00edch: <\/strong><\/p>\r\n<p>Ch\u01b0a c\u00f3 th\u00f4ng tin. \u0110ang c\u1eadp nh\u1eadt.<\/p>\r\n<p><strong>5.4 Thay th\u1ebf thu\u1ed1c : <\/strong><\/p>\r\n<p>Ch\u01b0a c\u00f3 th\u00f4ng tin. \u0110ang c\u1eadp nh\u1eadt.<\/p>\r\n<p><strong><em>*L\u01b0u \u00fd:<\/em><\/strong><\/p>\r\n<p><strong><em>C\u00e1c th\u00f4ng tin v\u1ec1 thu\u1ed1c tr\u00ean Pharmog.com ch\u1ec9 mang t\u00ednh ch\u1ea5t tham kh\u1ea3o &#8211; Khi d\u00f9ng thu\u1ed1c c\u1ea7n tuy\u1ec7t \u0111\u1ed1i tu\u00e2n theo theo h\u01b0\u1edbng d\u1eabn c\u1ee7a B\u00e1c s\u0129 <\/em><\/strong><\/p>\r\n<p><strong><em>Ch\u00fang t\u00f4i kh\u00f4ng ch\u1ecbu tr\u00e1ch nhi\u1ec7m v\u1ec1 b\u1ea5t c\u1ee9 h\u1eadu qu\u1ea3 n\u00e0o x\u1ea3y ra do t\u1ef1 \u00fd d\u00f9ng thu\u1ed1c d\u1ef1a theo c\u00e1c th\u00f4ng tin tr\u00ean Pharmog.com<\/em><\/strong><\/p>\r\n<p><script src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-5528370293090692\" async=\"\" crossorigin=\"anonymous\"><\/script><ins class=\"adsbygoogle\" style=\"display: block; text-align: center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-5528370293090692\" data-ad-slot=\"8909623906\"><\/ins><script> (adsbygoogle = window.adsbygoogle || []).push({}); <\/script><\/p>\r\n<p><strong>6. Ph\u1ea7n th\u00f4ng tin k\u00e8m theo c\u1ee7a thu\u1ed1c:<\/strong><\/p>\r\n<p><strong>6.1. Danh m\u1ee5c t\u00e1 d\u01b0\u1ee3c:<\/strong><\/p>\r\n<p>Nh\u00e2n vi\u00ean: Mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, sodium stearyl fumarate.<\/p>\r\n<p>L\u1edbp bao: Polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, oxide s\u1eaft v\u00e0ng (E172), oxide s\u1eaft \u0111\u1ecf (E172), oxide s\u1eaft \u0111en (E172).<\/p>\r\n<p><strong>6.2. T\u01b0\u01a1ng k\u1ef5 :<\/strong><\/p>\r\n<p>Kh\u00f4ng \u00e1p d\u1ee5ng.<\/p>\r\n<p><strong>6.3. B\u1ea3o qu\u1ea3n: <\/strong><\/p>\r\n<p>N\u01a1i kh\u00f4, tr\u00e1nh \u00e1nh s\u00e1ng, nhi\u1ec7t \u0111\u1ed9 d\u01b0\u1edbi 30\u00b0C.<\/p>\r\n<p><strong>6.4. Th\u00f4ng tin kh\u00e1c :<\/strong><\/p>\r\n<p>Kh\u00f4ng c\u00f3.<\/p>\r\n<p><strong>6.5 T\u00e0i li\u1ec7u tham kh\u1ea3o:<\/strong><\/p>\r\n<p>D\u01b0\u1ee3c Th\u01b0 Qu\u1ed1c Gia Vi\u1ec7t Nam<\/p>\r\n<p>Ho\u1eb7c HDSD Thu\u1ed1c.<\/p>\r\n<p><strong>7. Ng\u01b0\u1eddi \u0111\u0103ng t\u1ea3i \/T\u00e1c gi\u1ea3:<\/strong><\/p>\r\n<p>B\u00e0i vi\u1ebft \u0111\u01b0\u1ee3c s\u01b0u t\u1ea7m ho\u1eb7c vi\u1ebft b\u1edfi: <a href=\"https:\/\/pharmog.com\/wp\/thong-tin-tac-gia-bac-sy-do-my-linh\/\">B\u00e1c s\u0129 nhi khoa &#8211; \u0110\u1ed7 M\u1ef9 Linh.<\/a><\/p>\r\n<p>Ki\u1ec3m duy\u1ec7t , hi\u1ec7u \u0111\u00ednh v\u00e0 \u0111\u0103ng t\u1ea3i: <a href=\"https:\/\/pharmog.com\/wp\/thong-tin-ve-pharmog-team\/\">PHARMOG TEAM<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Thu\u1ed1c Tagrisso l\u00e0 thu\u1ed1c g\u00ec ? D\u01b0\u1edbi \u0111\u00e2y l\u00e0 n\u1ed9i dung t\u1edd h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng g\u1ed1c c\u1ee7a Thu\u1ed1c Tagrisso (Th\u00f4ng tin bao g\u1ed3m li\u1ec1u d\u00f9ng, c\u00e1ch d\u00f9ng, ch\u1ec9 \u0111\u1ecbnh, ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh, th\u1eadn tr\u1ecdng, d\u01b0\u1ee3c l\u00fd&#8230;) 1. T\u00ean ho\u1ea1t ch\u1ea5t v\u00e0 bi\u1ec7t d\u01b0\u1ee3c: Ho\u1ea1t ch\u1ea5t : Osimertinib mesylate Ph\u00e2n lo\u1ea1i: Thu\u1ed1c ch\u1ed1ng ung th\u01b0, [&hellip;]<\/p>\n","protected":false},"author":8612,"featured_media":11504,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"default","ast-site-content-layout":"","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[370],"tags":[1043],"class_list":["post-7809","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-biet-duoc-goc","tag-osimertinib"],"_links":{"self":[{"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/posts\/7809","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/users\/8612"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/comments?post=7809"}],"version-history":[{"count":4,"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/posts\/7809\/revisions"}],"predecessor-version":[{"id":51960,"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/posts\/7809\/revisions\/51960"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/media\/11504"}],"wp:attachment":[{"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/media?parent=7809"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/categories?post=7809"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmog.com\/wp\/wp-json\/wp\/v2\/tags?post=7809"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}