{"id":6976,"date":"2025-10-24T18:10:30","date_gmt":"2025-10-24T18:10:30","guid":{"rendered":"https:\/\/www.roctavian.com\/en-us\/?page_id=6976"},"modified":"2025-11-21T14:34:54","modified_gmt":"2025-11-21T14:34:54","slug":"risks-and-benefits","status":"publish","type":"page","link":"https:\/\/www.roctavian.com\/en-us\/risks-and-benefits\/","title":{"rendered":"Risks and Benefits"},"content":{"rendered":"<div id=\"acf-block-68fbc0a870e5c\" class=\"hero hero-roctavian\">\n\t<div class=\"hero-background-image hero-background-image-desktop\" style=\"background-image: url(https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/11\/1.4-Risks-and-benefits-of-ROCTAVIAN-Hero-DESKTOP.png?v=0.113);\"><\/div>\n\t<div class=\"hero-background-image hero-background-image-mobile\" style=\"background-image: url(https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/11\/1.4-Risks-and-Benefits-of-ROCTAVIAN-MOBILE_420-x-200_11_19.png?v=0.113);\"><\/div>\n\t<div class=\"overlay\"><\/div>\n\n\t<div class=\"hero-content\">\n\t\t<div class=\"title-area\">\n\t\t\t                <h1>RISKS AND BENEFITS OF ROCTAVIAN\n<\/h1>\n            \t\t\t\t\t<\/div>\t\t\n                    <div class=\"text-area\">\n                <div class=\"text-area-content\">\n                                        <div class=\"text\">\n                        <p>Looking for a treatment<br \/>\ncenter nearest you?<\/p>\n                    <\/div>\n                                                                <div class=\"cta\">\n                                                                                    <p><a class=\"button\" href=\"https:\/\/www.roctavian.com\/en-us\/doctor-finder\/\" target=\"_self\">SEARCH NOW<\/a><\/p>\n                        <\/div>\n                                    <\/div>\n            <\/div>\n                            <div class=\"image-caption\">\n                <p>David N. received ROCTAVIAN in 2024.<\/p>\n            <\/div>\n\n            <div class=\"additional-caption\">\n                            <\/div>\n        \t<\/div>\n<\/div>\n    <div class=\"hero-footer hero-footer-roctavian\">\n        <div class=\"wrapper\">\n            <div class=\"inner-wrapper\">\n                <p>The safety profile of ROCTAVIAN is based on 5 years of data<\/p>\n            <\/div>\n        <\/div>\n    <\/div>\n\n\n<div id=\"side-fx--LB\" class=\"block wrapped-content bg-band block-zero-top\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-68fbcccab0a4b\" class=\"block-wysiwyg\">\n            <p>The most common side effects of ROCTAVIAN are:<\/p>\n<ul>\n<li>Nausea (32.1%)<\/li>\n<li>Fatigue (15.7%)<\/li>\n<li>Infusion-related reactions (9%)<\/li>\n<li>Headaches (7.5%)<\/li>\n<li>Vomiting (6%)<\/li>\n<li>Abdominal pain (6%)<\/li>\n<li>Elevated liver enzyme levels that were temporary, asymptomatic, and low grade (82.8% experienced ALT levels above the upper limit of normal)<\/li>\n<\/ul>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"benefits-WT\" class=\"block wrapped-content block-zero-bottom\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-68fbcda6b4a81\" class=\"block-wysiwyg\">\n            <h2>What are benefits of ROCTAVIAN?<\/h2>\n<ul>\n<li>ROCTAVIAN <strong>treats the underlying cause<\/strong> of severe hemophilia A by potentially helping you make your own Factor VIII*<\/li>\n<li>ROCTAVIAN is a one-time infusion that may provide <strong>years of freedom from continuous prophylaxis<\/strong><\/li>\n<li>ROCTAVIAN has been studied in the longest and largest gene therapy clinical study in severe hemophilia A\u2014now with <strong>5 years of clinical data<\/strong><sup>\u2020<\/sup>\n<ul>\n<li>ROCTAVIAN has helped most people achieve 5 years of durable bleed control<\/li>\n<li>Safety data have been collected through 5 years<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><small><br \/>\n*Individual Factor VIII levels produced and durability of levels reached can vary. ROCTAVIAN did not work for everyone. Some patients did not respond to treatment or lost response to treatment.<br \/>\n<sup>\u2020<\/sup>At FDA approval, ROCTAVIAN had the longest and largest Phase 3 clinical study for gene therapy in severe hemophilia A.<\/small><\/p>\n    <\/div>\n\n<figure id=\"acf-block-690a0b3a3b6e0\">\n    <div class=\"image image-rounded image-align-left\">\n                    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/11\/Screenshot-2025-11-04-at-13.50.06-e1763033622336.png?v=0.113\" alt=\"\" \/>            <\/div>\n    <\/figure>\n        <\/div>\n    <\/div>\n<\/div>\n\n\n<p id=\"Blue-Line\"><\/p>\n\n\n<div id=\"what-else-WT\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-68fbd03249277\" class=\"block-wysiwyg\">\n            <h2>What else should I know about ROCTAVIAN?<\/h2>\n<p><strong>ROCTAVIAN works in the liver,<\/strong> so maintaining a healthy lifestyle before and after your infusion is important<\/p>\n<ul>\n<li>Your doctor will perform routine blood tests to check your liver health<\/li>\n<li>To help keep your liver healthy, do not drink alcohol for the first year after your ROCTAVIAN infusion<\/li>\n<li>Talk to your doctor before taking any medicines, herbal products, or supplements<\/li>\n<\/ul>\n<p>For 6 months after administration of ROCTAVIAN, men of reproductive potential and their female partners must prevent or postpone pregnancy using an effective form of contraception.<\/p>\n<p><strong>You should not take ROCTAVIAN if you:<\/strong><\/p>\n<ul>\n<li>Have an active infection or a long-term infection that is not controlled by the medicines you take<\/li>\n<li>Have scarring of the liver (significant liver fibrosis or cirrhosis)<\/li>\n<li>Are allergic to mannitol (an inactive ingredient in ROCTAVIAN)<\/li>\n<\/ul>\n<p class=\"p1\">ROCTAVIAN is not intended for administration in women or children.<\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-68fbd1de50598\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<figure id=\"acf-block-6911ec69722d9\">\n    <div class=\"image image-rounded image-natural-size image-align-center\">\n                    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/11\/3.0-REFERING_question-icon-e1762179972404.png?v=0.113\" alt=\"\" \/>            <\/div>\n    <\/figure>\n\n<div id=\"acf-block-68fbd1de50711\" class=\"block-wysiwyg\">\n            <h2 style=\"text-align: center\">Get the conversation started<\/h2>\n<p>If you think you may be ready for ROCTAVIAN, here are a few things you may want to discuss with your doctor:<\/p>\n<ul>\n<li>How could ROCTAVIAN help me?<\/li>\n<li><a href=\"https:\/\/www.roctavian.com\/en-us\/am-i-ready-for-roctavian\/\">Am I ready for ROCTAVIAN?<\/a><\/li>\n<li>Can I stop prophylaxis completely after receiving ROCTAVIAN?<\/li>\n<li>I\u2019m interested in a one-time ROCTAVIAN infusion because ____.<\/li>\n<\/ul>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"dis-guide-LB\" class=\"block call-to-action call-to-action-no-overlay light-cta block-tight-top block-tight-bottom\">\n    <div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t\t<div class=\"box\" style=\"background-image: url(https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/10\/lb-bg-OW-1024x404.jpg);\">\n\t\t\t\t<div class=\"overlay\"><\/div>\n\t\t\t\t<div class=\"cta-content\">\n\t\t\t\t    \t\t\t\t\t<div class=\"cta-content-main\">\n                        <div class=\"content-block\">\n\t\t\t\t\t        \t\t\t\t\t        \t\t\t\t\t\t        <h2 class=\"h3\">This Discussion Guide may help the conversation with your doctor\n<\/h2>\n\t\t\t\t\t\t    \t\t\t\t\t\t    \t\t\t\t\t    <\/div>\n\t\t\t\t\t                                <div class=\"content-block\">\n                                <p><a class=\"button button-ghost\" href=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2024\/10\/roctavian-questions-discussion-guide.pdf?v=0.113\" target=\"_blank\">Download<\/a><\/p>\n                            <\/div>\n\t\t\t\t\t                        <\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"acf-block-6911ed5da511b\" class=\"block call-to-action patient-story-cta\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n            <div class=\"box\" style=\"background-image: url(https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/11\/2.2_Is_it_Time_for_ROCTAVIAN\u2013DESKTOP-1024x235.png);\">\n                <div class=\"story-cta-inner\">z\n                                    <p class=\"quote\">Since my ROCTAVIAN infusion, I don\u2019t have <br> to dose up before I do something. I can just go.<\/p>\n                \n                                    <p class=\"citation\">\u2014 Andrew S., received ROCTAVIAN in <br> 2018 as part of a clinical study<\/p>\n                \n                                    <img decoding=\"async\" class=\"mobile-image\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/11\/Mask-Group-2.png?v=0.113\" alt=\"\" \/>                \n                                    <a href=\"https:\/\/www.roctavian.com\/en-us\/roctavian-stories\/#Andrew-S\" class=\"button\">Watch Andrew&#8217;s Story<\/a>\n                                <\/div>\n            <\/div>\n        <\/div>\n    <\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":10,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-6976","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Risks and Benefits | ROCTAVIAN\u00ae (valoctocogene roxaparvovec-rvox)<\/title>\n<meta name=\"description\" content=\"Learn the risks and benefits of treatment with one-time ROCTAVIAN and what you need to know to start a conversation with your doctor. See Full Prescribing &amp; Safety Information.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.roctavian.com\/en-us\/risks-and-benefits\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Risks and Benefits | ROCTAVIAN\u00ae (valoctocogene roxaparvovec-rvox)\" \/>\n<meta property=\"og:description\" content=\"Learn the risks and benefits of treatment with one-time ROCTAVIAN and what you need to know to start a conversation with your doctor. See Full Prescribing &amp; Safety Information.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.roctavian.com\/en-us\/risks-and-benefits\/\" \/>\n<meta property=\"og:site_name\" content=\"BioMarin Roctavian Patient EN-US\" \/>\n<meta property=\"article:modified_time\" content=\"2025-11-21T14:34:54+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.roctavian.com\/en-us\/risks-and-benefits\/\",\"url\":\"https:\/\/www.roctavian.com\/en-us\/risks-and-benefits\/\",\"name\":\"Risks and Benefits | ROCTAVIAN\u00ae (valoctocogene roxaparvovec-rvox)\",\"isPartOf\":{\"@id\":\"https:\/\/www.roctavian.com\/en-us\/#website\"},\"datePublished\":\"2025-10-24T18:10:30+00:00\",\"dateModified\":\"2025-11-21T14:34:54+00:00\",\"description\":\"Learn the risks and benefits of treatment with one-time ROCTAVIAN and what you need to know to start a conversation with your doctor. See Full Prescribing & Safety Information.\",\"breadcrumb\":{\"@id\":\"https:\/\/www.roctavian.com\/en-us\/risks-and-benefits\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.roctavian.com\/en-us\/risks-and-benefits\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.roctavian.com\/en-us\/risks-and-benefits\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.roctavian.com\/en-us\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Risks and Benefits\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.roctavian.com\/en-us\/#website\",\"url\":\"https:\/\/www.roctavian.com\/en-us\/\",\"name\":\"ROCTAVIANTM (valoctocogene roxaparvovec-rvox) Gene Therapy Treatment for Hemophilia\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.roctavian.com\/en-us\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Risks and Benefits | ROCTAVIAN\u00ae (valoctocogene roxaparvovec-rvox)","description":"Learn the risks and benefits of treatment with one-time ROCTAVIAN and what you need to know to start a conversation with your doctor. See Full Prescribing & Safety Information.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.roctavian.com\/en-us\/risks-and-benefits\/","og_locale":"en_US","og_type":"article","og_title":"Risks and Benefits | ROCTAVIAN\u00ae (valoctocogene roxaparvovec-rvox)","og_description":"Learn the risks and benefits of treatment with one-time ROCTAVIAN and what you need to know to start a conversation with your doctor. See Full Prescribing & Safety Information.","og_url":"https:\/\/www.roctavian.com\/en-us\/risks-and-benefits\/","og_site_name":"BioMarin Roctavian Patient EN-US","article_modified_time":"2025-11-21T14:34:54+00:00","twitter_card":"summary_large_image","schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.roctavian.com\/en-us\/risks-and-benefits\/","url":"https:\/\/www.roctavian.com\/en-us\/risks-and-benefits\/","name":"Risks and Benefits | ROCTAVIAN\u00ae (valoctocogene roxaparvovec-rvox)","isPartOf":{"@id":"https:\/\/www.roctavian.com\/en-us\/#website"},"datePublished":"2025-10-24T18:10:30+00:00","dateModified":"2025-11-21T14:34:54+00:00","description":"Learn the risks and benefits of treatment with one-time ROCTAVIAN and what you need to know to start a conversation with your doctor. See Full Prescribing & Safety Information.","breadcrumb":{"@id":"https:\/\/www.roctavian.com\/en-us\/risks-and-benefits\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.roctavian.com\/en-us\/risks-and-benefits\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.roctavian.com\/en-us\/risks-and-benefits\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.roctavian.com\/en-us\/"},{"@type":"ListItem","position":2,"name":"Risks and Benefits"}]},{"@type":"WebSite","@id":"https:\/\/www.roctavian.com\/en-us\/#website","url":"https:\/\/www.roctavian.com\/en-us\/","name":"ROCTAVIANTM (valoctocogene roxaparvovec-rvox) Gene Therapy Treatment for Hemophilia","description":"","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.roctavian.com\/en-us\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"}]}},"_links":{"self":[{"href":"https:\/\/www.roctavian.com\/en-us\/wp-json\/wp\/v2\/pages\/6976","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.roctavian.com\/en-us\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.roctavian.com\/en-us\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.roctavian.com\/en-us\/wp-json\/wp\/v2\/users\/10"}],"replies":[{"embeddable":true,"href":"https:\/\/www.roctavian.com\/en-us\/wp-json\/wp\/v2\/comments?post=6976"}],"version-history":[{"count":57,"href":"https:\/\/www.roctavian.com\/en-us\/wp-json\/wp\/v2\/pages\/6976\/revisions"}],"predecessor-version":[{"id":8283,"href":"https:\/\/www.roctavian.com\/en-us\/wp-json\/wp\/v2\/pages\/6976\/revisions\/8283"}],"wp:attachment":[{"href":"https:\/\/www.roctavian.com\/en-us\/wp-json\/wp\/v2\/media?parent=6976"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}