{"id":71,"date":"2023-06-22T15:41:46","date_gmt":"2023-06-22T15:41:46","guid":{"rendered":"https:\/\/accord-prostata.se\/hcp\/?page_id=71"},"modified":"2025-09-16T11:32:26","modified_gmt":"2025-09-16T11:32:26","slug":"fragor-och-svar","status":"publish","type":"page","link":"https:\/\/accord-prostata.se\/hcp\/fragor-och-svar\/","title":{"rendered":"FAQ"},"content":{"rendered":"\n<div class=\"wp-block-custom-blocks-container block-container block-container--full-width block-container--align-middle  has-none-background-color\"><div class=\"block-container--background-image\" style=\"background-image:url(https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2023\/06\/grey-background.webp);opacity:1\"><\/div>\n<div class=\"wp-block-columns has-2-columns\">\n<div class=\"wp-block-column\">\n<h1 class=\"wp-block-heading has-white-color has-text-color\" id=\"fragor-och-svar\"><strong>Fr\u00e5gor och svar<\/strong><\/h1>\n\n\n\n<p class=\"has-white-color has-text-color wp-block-paragraph\">H\u00e4r hittar du svaren p\u00e5 n\u00e5gra vanliga fr\u00e5gor om ORGOVYX<sup>\u00ae<\/sup>.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column\" id=\"glove\">\n\n<div class=\"responsive-image--container\">\n  <img decoding=\"async\" src=\"https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2023\/06\/faq-glasses-desktop.webp\" \n       class=\"responsive-image\" \n       alt=\"Gloves\" \n       loading=\"lazy\"       srcset=\"https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2023\/06\/faq-glasses-desktop-480x208.webp 480w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2023\/06\/faq-glasses-desktop-960x416.webp 782w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2023\/06\/faq-glasses-desktop-960x416.webp 1366w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2023\/06\/faq-glasses-desktop.webp 2048w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2023\/06\/faq-glasses-desktop.webp 2500w\"\n       sizes=\"(max-width: 2500px) 100vw, 2500px\">\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-container block-container block-container--full-width block-container--align-top  block-container--border-left has-signal-yellow-background-color\">\n<div class=\"wp-block-columns has-2-columns\">\n<div class=\"wp-block-column\" style=\"flex-basis:80%\">\n<div class=\"spacer\"><\/div>\n\n\n<h2 class=\"wp-block-heading\" id=\"om-orgovyx\">Om ORGOVYX<sup>\u00ae<\/sup><\/h2>\n\n\n\n<div class=\"wp-block-custom-blocks-accordion block-accordion--group\">\n<div class=\"block-accordion--group---menu block-tab--group---menu block-all--group---button\">\n    <div class=\"block-accordion--group---menu----symbol\"><\/div>\n  <button type=\"button\" class=\"block-accordion--group---menu----heading block-tab--group---menu----heading\">Vad \u00e4r ORGOVYX<sup>\u00ae<\/sup> och vad \u00e4r indikationen f\u00f6r anv\u00e4ndning?<\/button>\n<\/div>\n\n\n<div class=\"wp-block-column block-accordion--group---content  block-all--group---content\">\n<p class=\"wp-block-paragraph\">ORGOVYX<sup>\u00ae<\/sup> (relugolix) \u00e4r en gonadotropinfris\u00e4ttande hormonreceptorantagonist som \u00e4r indicerad f\u00f6r behandling av vuxna patienter med avancerad, hormonk\u00e4nslig prostatacancer.<sup>1<\/sup><\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-accordion block-accordion--group\">\n<div class=\"block-accordion--group---menu block-tab--group---menu block-all--group---button\">\n    <div class=\"block-accordion--group---menu----symbol\"><\/div>\n  <button type=\"button\" class=\"block-accordion--group---menu----heading block-tab--group---menu----heading\">Har ORGOVYX<sup>\u00ae<\/sup> utv\u00e4rderats av n\u00e5gra vetenskapliga f\u00f6reningar?<\/button>\n<\/div>\n\n\n<div class=\"wp-block-column block-accordion--group---content  block-all--group---content\">\n<p class=\"wp-block-paragraph\">ORGOVYX<sup>\u00ae<\/sup> har utv\u00e4rderats av flera olika vetenskapliga f\u00f6reningar som en behandling f\u00f6r prostatacancer, inklusive:<sup>2\u20134<\/sup><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The European Society for Medical Oncology (ESMO)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Relugolix fick 4 ESMO-MCBS (Magnitude of Clinical Benefit Scale) po\u00e4ng av 5.<sup>2<\/sup> Ett ESMO-MCBS po\u00e4ng p\u00e5 4 anses kunna vara betydelefullt f\u00f6r subventionsans\u00f6kningar.<sup>5<\/sup><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The European Association of Urology (EAU)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">I EAUs behandlingsriktlinjer f\u00f6r prostatacancer \u00e4r relugolix en antagonist till luteiniserande hormonfris\u00e4ttande hormon (LHRH) och ett behandlingsalternativ vid behandling av hormonk\u00e4nslig prostatacancer.<sup>3<\/sup>&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The National Comprehensive Cancer Network (NCCN)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">I de uppdaterade NCCN Clinical Practice Guidelines for Prostate Cancer beskrivs ORGOVYX\u00ae som ett behandlingsalternativ f\u00f6r androgen deprivationsterapi (ADT) vid&nbsp; kastrationsnaiv prostatacancer.<sup>4*<\/sup>&nbsp;<\/p>\n\n\n\n<p class=\"has-small-print-font-size wp-block-paragraph\">Med termen &#8220;kastrationsnaiv&#8221; definieras patienter som inte har behandlats med ADT och de som inte st\u00e5r p\u00e5 ADT vid tiden f\u00f6r progression.<sup>4<\/sup><\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-accordion block-accordion--group\">\n<div class=\"block-accordion--group---menu block-tab--group---menu block-all--group---button\">\n    <div class=\"block-accordion--group---menu----symbol\"><\/div>\n  <button type=\"button\" class=\"block-accordion--group---menu----heading block-tab--group---menu----heading\">Vilken aktiv substans inneh\u00e5ller ORGOVYX<sup>\u00ae<\/sup>?<\/button>\n<\/div>\n\n\n<div class=\"wp-block-column block-accordion--group---content  block-all--group---content\">\n<p class=\"wp-block-paragraph\">ORGOVYX<sup>\u00ae<\/sup> inneh\u00e5ller den aktiva substansen relugolix. Varje ORGOVYX<sup>\u00ae<\/sup> filmdragerad tablett inneh\u00e5ller 120 mg relugolix.<sup>1<\/sup><\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-accordion block-accordion--group\">\n<div class=\"block-accordion--group---menu block-tab--group---menu block-all--group---button\">\n    <div class=\"block-accordion--group---menu----symbol\"><\/div>\n  <button type=\"button\" class=\"block-accordion--group---menu----heading block-tab--group---menu----heading\">Hur administreras ORGOVYX<sup>\u00ae<\/sup> och vilken \u00e4r den rekommenderade doseringen?<\/button>\n<\/div>\n\n\n<div class=\"wp-block-column block-accordion--group---content  block-all--group---content\">\n<p class=\"wp-block-paragraph\">ORGOVYX<sup>\u00ae<\/sup> administreras oralt. Det \u00e4r viktigt att informera patienterna om att de ska sv\u00e4lja tabletterna hela. Tabletten kan tas med eller utan mat tillsammans med v\u00e4tska.<sup>1<\/sup><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Behandlingen ska inledas med en laddningsdos p\u00e5 360 mg (tre tabletter) den f\u00f6rsta dagen, f\u00f6ljt av en dos p\u00e5 120 mg (en tablett) en g\u00e5ng dagligen, ungef\u00e4r vid samma tid varje dag.<sup>1<\/sup><\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-accordion block-accordion--group\">\n<div class=\"block-accordion--group---menu block-tab--group---menu block-all--group---button\">\n    <div class=\"block-accordion--group---menu----symbol\"><\/div>\n  <button type=\"button\" class=\"block-accordion--group---menu----heading block-tab--group---menu----heading\">Vad \u00e4r verkningsmekanismen f\u00f6r ORGOVYX<sup>\u00ae<\/sup>?<\/button>\n<\/div>\n\n\n<div class=\"wp-block-column block-accordion--group---content  block-all--group---content\">\n<p class=\"wp-block-paragraph\">ORGOVYX<sup>\u00ae<\/sup> (relugolix) \u00e4r en icke-peptid GnRH-antagonist som kompetitivt binder till GnRH-receptorer i fr\u00e4mre hypofysen och d\u00e4rigenom f\u00f6rhindrar naturligt GnRH fr\u00e5n att binda och stimulera ins\u00f6ndring av luteiniserande hormon (LH) och follikelstimulerande hormon (FSH). Som ett resultat minskar produktionen av testosteron i testiklarna.<sup>1<\/sup>\u00a0<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Behandlingen med ORGOVYX<sup>\u00ae<\/sup> \u00e4r inte f\u00f6rknippad med en initial testosteron\u00f6kning (\u201duppflamning\u201d) och f\u00f6rhindrar d\u00e4rmed en del potentiella kliniska symtom.<sup>1<\/sup><\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-accordion block-accordion--group\">\n<div class=\"block-accordion--group---menu block-tab--group---menu block-all--group---button\">\n    <div class=\"block-accordion--group---menu----symbol\"><\/div>\n  <button type=\"button\" class=\"block-accordion--group---menu----heading block-tab--group---menu----heading\">Hur ska jag \u00f6vervaka patienter som tar ORGOVYX<sup>\u00ae<\/sup>?<\/button>\n<\/div>\n\n\n<div class=\"wp-block-column block-accordion--group---content  block-all--group---content\">\n<p class=\"wp-block-paragraph\">D\u00e4r det \u00e4r kliniskt l\u00e4mpligt rekommenderas att:<sup>1<\/sup><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Leverfunktionen \u00f6vervakas hos patienter med k\u00e4nda eller misst\u00e4nkta leversjukdomar under behandlingen<\/li>\n\n\n\n<li>Effekten av ORGOVYX<sup>\u00ae<\/sup> \u00f6vervakas med hj\u00e4lp av kliniska parametrar och serumniv\u00e5er av prostataspecifikt antigen (PSA)<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n<div class=\"spacer\"><\/div>\n\n\n<h2 class=\"wp-block-heading\" id=\"sakerhet\">S\u00e4kerhet<\/h2>\n\n\n\n<div class=\"wp-block-custom-blocks-accordion block-accordion--group\">\n<div class=\"block-accordion--group---menu block-tab--group---menu block-all--group---button\">\n    <div class=\"block-accordion--group---menu----symbol\"><\/div>\n  <button type=\"button\" class=\"block-accordion--group---menu----heading block-tab--group---menu----heading\">Finns det n\u00e5gon risk f\u00f6r symptomatisk &#8220;flare&#8221; efter att ha tagit ORGOVYX<sup>\u00ae<\/sup>?<\/button>\n<\/div>\n\n\n<div class=\"wp-block-column block-accordion--group---content  block-all--group---content\">\n<p class=\"wp-block-paragraph\">Behandling med ORGOVYX<sup>\u00ae<\/sup> \u00e4r inte f\u00f6rknippad med de initiala \u00f6kningarna av FSH- och LH-koncentrationer och den efterf\u00f6ljande testosteron\u00f6kningen (&#8220;surge&#8221; som kan ge &#8220;symtomatiskt flare&#8221;) som observerats vid initiering av behandling med en LHRH-analog.<sup>1<\/sup> D\u00e4rf\u00f6r \u00e4r det on\u00f6digt att l\u00e4gga till en antiandrogen som &#8220;flareprofylax&#8221; n\u00e4r man initierar patienter p\u00e5 ORGOVYX<sup>\u00ae<\/sup>-behandling.<sup>1<\/sup><\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-accordion block-accordion--group\">\n<div class=\"block-accordion--group---menu block-tab--group---menu block-all--group---button\">\n    <div class=\"block-accordion--group---menu----symbol\"><\/div>\n  <button type=\"button\" class=\"block-accordion--group---menu----heading block-tab--group---menu----heading\">Vilka biverkningar kan vara f\u00f6rknippade med behandling med ORGOVYX<sup>\u00ae<\/sup>?<\/button>\n<\/div>\n\n\n<div class=\"wp-block-column block-accordion--group---content  block-all--group---content\">\n<p class=\"wp-block-paragraph\">De vanligaste observerade biverkningarna som upplevs under behandling med ORGOVYX<sup>\u00ae<\/sup> \u00e4r fysiologiska effekter av testosteronsuppression, inklusive v\u00e4rmevallningar (54 %), muskuloskeletal sm\u00e4rta (30 %) och tr\u00f6tthet (26 %). Andra mycket vanliga biverkningar \u00e4r diarr\u00e9 och f\u00f6rstoppning (12 % vardera).<sup>1<\/sup><\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-accordion block-accordion--group\">\n<div class=\"block-accordion--group---menu block-tab--group---menu block-all--group---button\">\n    <div class=\"block-accordion--group---menu----symbol\"><\/div>\n  <button type=\"button\" class=\"block-accordion--group---menu----heading block-tab--group---menu----heading\">Vilka \u00e4r kontraindikationerna f\u00f6r ORGOVYX<sup>\u00ae<\/sup>?<\/button>\n<\/div>\n\n\n<div class=\"wp-block-column block-accordion--group---content  block-all--group---content\">\n<p class=\"wp-block-paragraph\">ORGOVYX<sup>\u00ae<\/sup> \u00e4r kontraindicerat hos patienter med \u00f6verk\u00e4nslighet mot den aktiva substansen eller mot n\u00e5got av f\u00f6ljande hj\u00e4lp\u00e4mnen:<sup>1<\/sup><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Mannitol (E421)<\/li>\n\n\n\n<li>Natriumst\u00e4rkelseglykolat (E468)<\/li>\n\n\n\n<li>Hydroxipropylcellulosa (E463)<\/li>\n\n\n\n<li>Magnesiumstearat (E572)<\/li>\n\n\n\n<li>Hypromellos (E464)<\/li>\n\n\n\n<li>Titandioxid (E171)<\/li>\n\n\n\n<li>R\u00f6d j\u00e4rnoxid (E172)<\/li>\n\n\n\n<li>Karnaubavax (E903)<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-accordion block-accordion--group\">\n<div class=\"block-accordion--group---menu block-tab--group---menu block-all--group---button\">\n    <div class=\"block-accordion--group---menu----symbol\"><\/div>\n  <button type=\"button\" class=\"block-accordion--group---menu----heading block-tab--group---menu----heading\">Vilka l\u00e4kemedelsinteraktioner b\u00f6r man t\u00e4nka p\u00e5 vid f\u00f6rskrivning av ORGOVYX<sup>\u00ae<\/sup>?<\/button>\n<\/div>\n\n\n<div class=\"wp-block-column block-accordion--group---content  block-all--group---content\">\n<p class=\"wp-block-paragraph\"><br>Samtidig administrering av ORGOVYX<sup>\u00ae<\/sup> och perorala P-gp-h\u00e4mmare rekommenderas inte. Om samtidig anv\u00e4ndning \u00e4r n\u00f6dv\u00e4ndig, ska ORGOVYX<sup>\u00ae<\/sup> tas f\u00f6rst, och den perorala P-gp-h\u00e4mmaren tas 6 timmar d\u00e4refter. Patienten ska ocks\u00e5 kontrolleras oftare avseende biverkningar.<sup>1<\/sup><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Behandlingen med ORGOVYX<sup>\u00ae<\/sup> kan avbrytas i upp till 2 veckor f\u00f6r en kort behandlingskur med P-gp-h\u00e4mmare. Om behandlingen med ORGOVYX<sup>\u00ae<\/sup> avbryts i mer \u00e4n 7 dagar, ska administreringen av ORGOVYX<sup>\u00ae<\/sup> \u00e5terupptas med en laddningsdos p\u00e5 360 mg den f\u00f6rsta dagen, f\u00f6ljt av 120 mg en g\u00e5ng dagligen.<sup>1<\/sup><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Samtidig administrering av ORGOVYX<sup>\u00ae<\/sup> och kombinerade av P-gp- och starka CYP3A-inducerare rekommenderas inte. Om samtidig administrering \u00e4r n\u00f6dv\u00e4ndig, ska ORGOVYX<sup>\u00ae<\/sup>-dosen h\u00f6jas till 240 mg en g\u00e5ng dagligen. Den rekommenderade 120 mg dosen av ORGOVYX<sup>\u00ae<\/sup> ska \u00e5terupptas en g\u00e5ng dagligen efter det att behandlingen med kombinationen av P-gp- och starka CYP3A-inducerare har satts ut.<sup>1<\/sup><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Se den fullst\u00e4ndiga <span style=\"text-decoration: underline;color:#00b3db\"><a href=\"https:\/\/www.fass.se\/LIF\/product?userType=0&amp;nplId=20210308000013&amp;docType=6\">produktresum\u00e9n<\/a><\/span> f\u00f6r en fullst\u00e4ndig lista \u00f6ver potentiella l\u00e4kemedelsinteraktioner.<\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-accordion block-accordion--group\">\n<div class=\"block-accordion--group---menu block-tab--group---menu block-all--group---button\">\n    <div class=\"block-accordion--group---menu----symbol\"><\/div>\n  <button type=\"button\" class=\"block-accordion--group---menu----heading block-tab--group---menu----heading\">Kr\u00e4vs det n\u00e5gra dosjusteringar i s\u00e4rskilda populationer?<\/button>\n<\/div>\n\n\n<div class=\"wp-block-column block-accordion--group---content  block-all--group---content\">\n<p class=\"wp-block-paragraph\">ORGOVYX<sup>\u00ae<\/sup> kr\u00e4ver ingen dosjustering f\u00f6r \u00e4ldre patienter eller patienter med l\u00e4tt\/m\u00e5ttligt nedsatt njur- eller leverfunktion. F\u00f6rsiktighet \u00e4r dock befogad hos patienter med gravt nedsatt njurfunktion.<sup>1<\/sup><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u00d6vervakning av leverfunktionen hos patienter med k\u00e4nd eller misst\u00e4nkt leversjukdom rekommenderas under behandlingen. Farmakokinetiken f\u00f6r relugolix hos patienter med gravt nedsatt leverfunktion har inte utv\u00e4rderats.<sup>1<\/sup><\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-accordion block-accordion--group\">\n<div class=\"block-accordion--group---menu block-tab--group---menu block-all--group---button\">\n    <div class=\"block-accordion--group---menu----symbol\"><\/div>\n  <button type=\"button\" class=\"block-accordion--group---menu----heading block-tab--group---menu----heading\">Vilken bed\u00f6mning b\u00f6r jag g\u00f6ra innan jag p\u00e5b\u00f6rjar behandling med ORGOVYX<sup>\u00ae<\/sup> f\u00f6r en patient?<\/button>\n<\/div>\n\n\n<div class=\"wp-block-column block-accordion--group---content  block-all--group---content\">\n<p class=\"wp-block-paragraph\">Innan behandling med ORGOVYX<sup>\u00ae<\/sup> p\u00e5b\u00f6rjas med patienter b\u00f6r du bed\u00f6ma riskfaktorer f\u00f6r kardiovaskul\u00e4r sjukdom och bent\u00e4thet hos alla patienter.<sup>1<\/sup><\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"spacer\"><\/div>\n\n\n<h2 class=\"wp-block-heading\" id=\"kliniska-data\">Kliniska data<\/h2>\n\n\n\n<div class=\"wp-block-custom-blocks-accordion block-accordion--group\">\n<div class=\"block-accordion--group---menu block-tab--group---menu block-all--group---button\">\n    <div class=\"block-accordion--group---menu----symbol\"><\/div>\n  <button type=\"button\" class=\"block-accordion--group---menu----heading block-tab--group---menu----heading\">Har effekt och s\u00e4kerhet av ORGOVYX<sup>\u00ae<\/sup> utv\u00e4rderats i n\u00e5gra kliniska pr\u00f6vningar?<\/button>\n<\/div>\n\n\n<div class=\"wp-block-column block-accordion--group---content  block-all--group---content\">\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.nejm.org\/doi\/10.1056\/NEJMoa2004325\">HERO-studien<\/a> var en multinationell, randomiserad, \u00f6ppen fas 3-studie f\u00f6r att utv\u00e4rdera effekt och s\u00e4kerhet av ORGOVYX<sup>\u00ae<\/sup>, j\u00e4mf\u00f6rt med leuprorelin, hos m\u00e4n med avancerad prostatacancer.<sup>6<\/sup><\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-accordion block-accordion--group\">\n<div class=\"block-accordion--group---menu block-tab--group---menu block-all--group---button\">\n    <div class=\"block-accordion--group---menu----symbol\"><\/div>\n  <button type=\"button\" class=\"block-accordion--group---menu----heading block-tab--group---menu----heading\">Vilka var inskrivningskriterierna f\u00f6r HERO-studien?<\/button>\n<\/div>\n\n\n<div class=\"wp-block-column block-accordion--group---content  block-all--group---content\">\n<p class=\"wp-block-paragraph\">Patienter var l\u00e4mpliga om de var \u226518 \u00e5r, hade histologiskt eller cytologiskt bekr\u00e4ftad adenokarcinom i prostatan och var l\u00e4mpliga att f\u00e5 kontinuerlig ADT i minst ett \u00e5r.<sup>6<\/sup><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Deltagande patienter hade en av tre kliniska sjukdomspresentationer:<sup>6<\/sup><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Tecken p\u00e5 biokemiskt eller kliniskt \u00e5terfall efter lokal prim\u00e4r intervention med kurativ avsikt (50,2 %)<\/li>\n\n\n\n<li>Nydiagnostiserad androgenk\u00e4nslig metastaserad sjukdom (22,7 %)<\/li>\n\n\n\n<li>Avancerad lokaliserad sjukdom \u00e4r inte l\u00e4mplig f\u00f6r prim\u00e4r intervention med botande avsikt (27,1 %)<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Patienter med allvarliga kardiovaskul\u00e4ra biverkningar inom 6 m\u00e5nader innan studien p\u00e5b\u00f6rjades exkluderades.<sup>6<\/sup><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">F\u00f6r fullst\u00e4ndiga inklusionsskriterier, klicka <a href=\"https:\/\/www.nejm.org\/doi\/10.1056\/NEJMoa2004325\">h\u00e4r<\/a> f\u00f6r att se studieprotokollet f\u00f6r HERO-studien.<\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-accordion block-accordion--group\">\n<div class=\"block-accordion--group---menu block-tab--group---menu block-all--group---button\">\n    <div class=\"block-accordion--group---menu----symbol\"><\/div>\n  <button type=\"button\" class=\"block-accordion--group---menu----heading block-tab--group---menu----heading\">Varf\u00f6r anv\u00e4ndes leuprorelin som j\u00e4mf\u00f6relsel\u00e4kemedel i HERO-studien?<\/button>\n<\/div>\n\n\n<div class=\"wp-block-column block-accordion--group---content  block-all--group---content\">\n<p class=\"wp-block-paragraph\">Leuprorelin valdes som komparator i HERO-studien eftersom den ans\u00e5ngs vara standardbehandling n\u00e4r studien plenerades \u00e5r 2016. Enligt den Europeiska l\u00e4kemedelsmyndigheten (EMA) \u00e4r leuprorelin ett rekommenderat behandlingsalternativ och d\u00e4rmed acceptabelt som komparator i studien.<sup>7<\/sup><\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-accordion block-accordion--group\">\n<div class=\"block-accordion--group---menu block-tab--group---menu block-all--group---button\">\n    <div class=\"block-accordion--group---menu----symbol\"><\/div>\n  <button type=\"button\" class=\"block-accordion--group---menu----heading block-tab--group---menu----heading\">Vad var det prim\u00e4ra effektm\u00e5ttet i HERO-studien?<\/button>\n<\/div>\n\n\n<div class=\"wp-block-column block-accordion--group---content  block-all--group---content\">\n<p class=\"wp-block-paragraph\">Det prim\u00e4ra effektm\u00e5ttet var den ih\u00e5llande kastrationsfrekvensen, definierad som den kumulativa sannolikheten f\u00f6r testosteronsuppression till &lt;50 ng\/dl under mottagande av studiel\u00e4kemedel fr\u00e5n dag 29 till och med vecka 48.<sup>6<\/sup><\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-accordion block-accordion--group\">\n<div class=\"block-accordion--group---menu block-tab--group---menu block-all--group---button\">\n    <div class=\"block-accordion--group---menu----symbol\"><\/div>\n  <button type=\"button\" class=\"block-accordion--group---menu----heading block-tab--group---menu----heading\">Vilka var de viktigaste sekund\u00e4ra effektm\u00e5tten i HERO-studien?<\/button>\n<\/div>\n\n\n<div class=\"wp-block-column block-accordion--group---content  block-all--group---content\">\n<p class=\"wp-block-paragraph\">Viktiga sekund\u00e4ra effektm\u00e5tt inkluderade:<sup>6<\/sup><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Icke-underl\u00e4gsenhet av ORGOVYX<sup>\u00ae<\/sup> j\u00e4mf\u00f6rt med leuprorelin med avseende p\u00e5 bibeh\u00e5llen kastrationshastighet med en icke-underl\u00e4gsenhetsmarginal p\u00e5 \u221210 procentenheter&nbsp;<\/li>\n\n\n\n<li>Den kumulativa sannolikheten f\u00f6r testosteronsuppression till &lt;50 ng\/dL p\u00e5 dag 4 och dag 15 &#8211; Andelen patienter med ett PSA-svar (&gt;50 % minskning) p\u00e5 dag 15 med bekr\u00e4ftelse p\u00e5 dag 29&nbsp;<\/li>\n\n\n\n<li>Den djupg\u00e5ende kastrationsgraden (definierad som den kumulativa sannolikheten f\u00f6r testosteronsuppression till &lt;20 ng\/dL) p\u00e5 dag 15&nbsp;<\/li>\n\n\n\n<li>FSH-niv\u00e5 i slutet av vecka 24<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-accordion block-accordion--group\">\n<div class=\"block-accordion--group---menu block-tab--group---menu block-all--group---button\">\n    <div class=\"block-accordion--group---menu----symbol\"><\/div>\n  <button type=\"button\" class=\"block-accordion--group---menu----heading block-tab--group---menu----heading\">Vilka biverkningar rapporterades i HERO-studien?<\/button>\n<\/div>\n\n\n<div class=\"wp-block-column block-accordion--group---content  block-all--group---content\">\n<p class=\"wp-block-paragraph\">Den totala incidensen av biverkningar var densamma i alla behandlingsgrupper.<sup>6<\/sup><br>De vanligaste observerade biverkningarna under behandling med ORGOVYX<sup>\u00ae<\/sup> (\u226510 % incidens) inkluderar:<sup>6<\/sup><\/p>\n\n\n\n<figure id=\"faq-table\" class=\"wp-block-table\"><table><thead><tr><th class=\"has-text-align-center\" data-align=\"center\">Biverkningar*<\/th><th class=\"has-text-align-center\" data-align=\"center\">ORGOVYX<sup>\u00ae<\/sup> (n=622)<\/th><th class=\"has-text-align-center\" data-align=\"center\">Leuprorelin (n=308)<\/th><\/tr><\/thead><tbody><tr><td class=\"has-text-align-center\" data-align=\"center\">V\u00e4rmevallningar<\/td><td class=\"has-text-align-center\" data-align=\"center\">338 (54,3 %)<\/td><td class=\"has-text-align-center\" data-align=\"center\">159 (51,6 %)<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">Tr\u00f6tthet<\/td><td class=\"has-text-align-center\" data-align=\"center\">134 (21,5 %)<\/td><td class=\"has-text-align-center\" data-align=\"center\">57 (18,5 %)<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">F\u00f6rstoppning<\/td><td class=\"has-text-align-center\" data-align=\"center\">76 (12,2 %)<\/td><td class=\"has-text-align-center\" data-align=\"center\">30 (9,7 %)<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">Diarr\u00e9<\/td><td class=\"has-text-align-center\" data-align=\"center\">76 (12,2 %)<\/td><td class=\"has-text-align-center\" data-align=\"center\">21 (6,8 %)<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">Artralgi<\/td><td class=\"has-text-align-center\" data-align=\"center\">75 (12,1 %)<\/td><td class=\"has-text-align-center\" data-align=\"center\">28 (9,1 %)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"has-small-print-font-size wp-block-paragraph\">*Biverkningar i alla grader.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Diarr\u00e9 rapporterades hos en h\u00f6gre andel av patienterna i ORGOVYX-gruppen<sup>\u00ae<\/sup> (12,2 %) \u00e4n i leuprorelin-gruppen (6,8 %).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Alla fall av diarr\u00e9 var lindriga eller m\u00e5ttliga (grad 1 eller grad 2) och ingen patient avbr\u00f6t diarr\u00e9n p\u00e5 grund av diarr\u00e9.<sup>6<\/sup><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ingen signifikant skillnad mellan behandlingsgrupperna observerades i incidensen av \u00f6kningar av niv\u00e5er av leveraminotransferaser som var minst 3 g\u00e5nger den \u00f6vre gr\u00e4nsen f\u00f6r det normala intervallet (1,4 % i ORGOVYX-gruppen<sup>\u00ae<\/sup> och 1,3 % i leuprorelin-gruppen).<sup>6<\/sup><\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-accordion block-accordion--group\">\n<div class=\"block-accordion--group---menu block-tab--group---menu block-all--group---button\">\n    <div class=\"block-accordion--group---menu----symbol\"><\/div>\n  <button type=\"button\" class=\"block-accordion--group---menu----heading block-tab--group---menu----heading\">Vilka allvarliga kardiovaskul\u00e4ra biverkningar rapporterades i HERO-studien?<\/button>\n<\/div>\n\n\n<div class=\"wp-block-column block-accordion--group---content  block-all--group---content\">\n<p class=\"wp-block-paragraph\">I en f\u00f6rspecificerad s\u00e4kerhetsanalys definierades allvarliga kardiovaskul\u00e4ra h\u00e4ndelser som icke-fatal hj\u00e4rtinfarkt, icke-fatal stroke och d\u00f6d oavsett orsak. Efter 48 veckors behandling var incidensen av allvarliga kardiovaskul\u00e4ra biverkningar (MACE) 2,9 % (exakt 95 % KI, 1,7\u20134,5) i ORGOVYX-gruppen<sup>\u00ae<\/sup> och 6,2 % (exakt 95 % KI, 3,8\u20139,5) i leuprorelingruppen.<sup>6<\/sup><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Kaplan\u2013Meier uppskattningar av incidensen \u00f6verensst\u00e4mde med en 54 % l\u00e4gre risk (HR, 0,46; 95 % KI, 0,24\u20130,88) i ORGOVYX-gruppen<sup>\u00ae<\/sup> \u00e4n i leuprorelingruppen (analys ej specificerad).<sup>6<\/sup><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">I subgruppen av patienter med en rapporterad anamnes av dessa h\u00e4ndelser var incidensen av MACE under mottagandet av pr\u00f6vningsl\u00e4kemedlet 3,6 % (3 av 84 patienter) i ORGOVYX-gruppen<sup>\u00ae<\/sup> (analys ej specificerad) och 17,8 % (8 av 45 patienter) i leuprorelingruppen, vilket indikerar att oddsen f\u00f6r att f\u00e5 en h\u00e4ndelse var 4,8 g\u00e5nger s\u00e5 h\u00f6ga med leuprorelin som med ORGOVYX<sup>\u00ae<\/sup>.<sup>6<\/sup><\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-accordion block-accordion--group\">\n<div class=\"block-accordion--group---menu block-tab--group---menu block-all--group---button\">\n    <div class=\"block-accordion--group---menu----symbol\"><\/div>\n  <button type=\"button\" class=\"block-accordion--group---menu----heading block-tab--group---menu----heading\">Var kan jag l\u00e4sa mer om HERO-studien?<\/button>\n<\/div>\n\n\n<div class=\"wp-block-column block-accordion--group---content  block-all--group---content\">\n<p class=\"wp-block-paragraph\">Klicka <a href=\"https:\/\/www.nejm.org\/doi\/10.1056\/NEJMoa2004325\">h\u00e4r<\/a> f\u00f6r att se HERO-studien.<\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"spacer\"><\/div>\n\n\n<h2 class=\"wp-block-heading\" id=\"annan-information\">Annan information<\/h2>\n\n\n\n<div class=\"wp-block-custom-blocks-accordion block-accordion--group\">\n<div class=\"block-accordion--group---menu block-tab--group---menu block-all--group---button\">\n    <div class=\"block-accordion--group---menu----symbol\"><\/div>\n  <button type=\"button\" class=\"block-accordion--group---menu----heading block-tab--group---menu----heading\">Vilka utbildningsresurser finns tillg\u00e4ngliga f\u00f6r att l\u00e4ra sig mer om ORGOVYX<sup>\u00ae<\/sup>?<\/button>\n<\/div>\n\n\n<div class=\"wp-block-column block-accordion--group---content  block-all--group---content\">\n<p class=\"wp-block-paragraph\">Utbildningsmaterial f\u00f6r h\u00e4lso- och sjukv\u00e5rdspersonal finns <a href=\"https:\/\/accord-prostata.se\/hcp\/utbildning-och-material\/\">h\u00e4r<\/a>.<\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"spacer\"><\/div><\/div>\n\n\n\n<div class=\"wp-block-column\">\n\n<div class=\"responsive-image--container\">\n  <img decoding=\"async\" src=\"https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2023\/06\/pocket-watch-faq.webp\" \n       class=\"responsive-image\" \n       alt=\"\" \n       loading=\"lazy\"       srcset=\"https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2023\/06\/pocket-watch-faq-mobile-480x331.webp 480w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2023\/06\/pocket-watch-faq-mobile-960x662.webp 782w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2023\/06\/pocket-watch-faq-mobile-960x662.webp 1366w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2023\/06\/pocket-watch-faq.webp 2048w, \n               https:\/\/accord-prostata.se\/hcp\/wp-content\/uploads\/sites\/2\/2023\/06\/pocket-watch-faq.webp 2500w\"\n       sizes=\"(max-width: 2500px) 100vw, 2500px\">\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-container block-container block-container--full-width block-container--align-top  has-iris-background-color\">\n<div class=\"wp-block-columns has-1-columns\">\n<div class=\"wp-block-column\">\n<h3 class=\"wp-block-heading has-white-color has-text-color\" id=\"om-du-vill-ha-mer-information-om-orgovyx-vanligen-kontakta-din-lokala-accord-representant\">Om du vill ha mer information om ORGOVYX<sup>\u00ae<\/sup>, v\u00e4nligen kontakta din lokala Accord-representant.<\/h3>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-container block-container block-container--full-width block-container--align-top  block-container--spacer-top has-ocean-background-color\">\n<div class=\"wp-block-columns has-2-columns\">\n<div class=\"wp-block-column\">\n<h5 class=\"wp-block-heading has-white-color has-text-color\" id=\"referenser\"><strong>Referenser<\/strong><\/h5>\n\n\n\n<ol class=\"wp-block-list has-white-color has-text-color has-link-color wp-elements-bff0a9cb8a6ad535fe16d0d3dda9d818\">\n<li>ORGOVYX<sup>\u00ae<\/sup> Produktresum\u00e9<\/li>\n\n\n\n<li>European Society for Medical Oncology. Relugolix. Available at: <a href=\"https:\/\/www.esmo.org\/guidelines\/esmo-mcbs\/esmo-mcbs-for-solid-tumours\/esmo-mcbs-scorecards\/scorecard-321-1\">https:\/\/www.esmo.org\/guidelines\/esmo-mcbs\/esmo-mcbs-for-solid-tumours\/esmo-mcbs-scorecards\/scorecard-321-1<\/a> (\u00c5tkomst december 2024).&nbsp;<\/li>\n\n\n\n<li>European Association of Urology. Prostate Cancer. Available at: <a href=\"https:\/\/uroweb.org\/guidelines\/prostate-cancer\/chapter\/quality-of-life-outcomes-in-prostate-cancer\">https:\/\/uroweb.org\/guidelines\/prostate-cancer\/chapter\/quality-of-life-outcomes-in-prostate-cancer<\/a> (\u00c5tkomst december 2024).&nbsp;<\/li>\n\n\n\n<li>NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines<sup>\u00ae<\/sup>) Prostate Cancer. Available at: <a href=\"https:\/\/www.nccn.org\/professionals\/physician_gls\/pdf\/prostate.pdf\">https:\/\/www.nccn.org\/professionals\/physician_gls\/pdf\/prostate.pdf<\/a> (\u00c5tkomst december 2024).&nbsp;<\/li>\n\n\n\n<li>European Society for Medical Oncology. ESMO-MCBS Evaluation Forms. Available at: <a href=\"https:\/\/www.esmo.org\/guidelines\/esmo-mcbs-esmo-mcbs-for-solid-tumours\/esmo-mcbs-evaluation-forms\">https:\/\/www.esmo.org\/guidelines\/esmo-mcbs-esmo-mcbs-for-solid-tumours\/esmo-mcbs-evaluation-forms<\/a> (\u00c5tkomst december 2024).<\/li>\n\n\n\n<li>Shore ND, <em>et al. N Engl J Med<\/em>. 2020;382(4):2187\u20132196.<\/li>\n\n\n\n<li>European Medicines Agency. 2022. Assessment Report. Available at: <a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/assessment-report\/orgovyx-epar-public-assessment-report_en.pdf\">https:\/\/www.ema.europa.eu\/en\/documents\/assessment-report\/orgovyx-epar-public-assessment-report_en.pdf<\/a> (\u00c5tkomst december 2024).<\/li>\n<\/ol>\n<\/div>\n\n\n\n<div class=\"wp-block-column\">\n<h5 class=\"wp-block-heading has-white-color has-text-color\" id=\"akronymer\"><strong>Akronymer<\/strong><\/h5>\n\n\n\n<p class=\"has-white-color has-text-color wp-block-paragraph\"><strong>ADT<\/strong>, Androgen deprivationsterapi.<br><strong>CI<\/strong>, konfidensintervall.<br><strong>CYP<\/strong>, cytokrom P450.<br><strong>EAU<\/strong>, European Association of Urology.<br><strong>EMA<\/strong>, European Medicines Agency.<br><strong>ESMO<\/strong>, European Society for Medical Oncology.<br><strong>GB<\/strong> (Great Britain), Storbritannien.<br><strong>HR<\/strong>, hazardkvot.<br><strong>HTA<\/strong>, Health Technology Assessment.<br><strong>FSH<\/strong>, follikelstimulerande hormon.<br><strong>LH<\/strong>, luteiniserande hormon.<br><strong>LHRH<\/strong>, luteiniserande hormonfris\u00e4ttande hormon.<br><strong>MACE<\/strong>, Major Adverse Cardiovascular Events.<br><strong>MCBS<\/strong>, Magnitude of Clinical Benefit Scale.<br><strong>NCCN<\/strong>, National Comprehensive Cancer Network.<br><strong>P-gp<\/strong>, P-glykoprotein.<br><strong>PSA<\/strong>, prostataspecifikt antigen.<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-custom-blocks-container block-container block-container--full-width block-container--align-top  block-container--spacer-bottom has-ocean-background-color\">\n<div class=\"wp-block-columns has-1-columns\">\n<div class=\"wp-block-column\">\n<div class=\"adverse-event-reporting--container\">\n  <div class=\"adverse-event-reporting--container---box\">\n    <p><span style=\"color:black\">\u25bc<\/span> Detta l\u00e4kemedel \u00e4r f\u00f6rem\u00e5l f\u00f6r ut\u00f6kad \u00f6vervakning. F\u00f6r fullst\u00e4ndig SPC Orgovyx klicka <a href=\"https:\/\/www.fass.se\/LIF\/product?userType=0&amp;nplId=20210308000013&amp;docType=6\">h\u00e4r<\/a>.<\/p>\n  <\/div>\n<\/div><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-columns has-1-columns\">\n<div class=\"wp-block-column\">\n<p class=\"has-text-align-right has-white-color has-text-color has-small-print-font-size wp-block-paragraph\">SE-Onc-Org-01461 | Senast uppdaterad december 2024<\/p>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":2,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-71","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Fr\u00e5gor och svar | ORGOVYX\u00ae | F\u00f6r h\u00e4lso- och 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