{"id":4754,"date":"2025-07-17T13:55:01","date_gmt":"2025-07-17T13:55:01","guid":{"rendered":"https:\/\/medical.biomarin.com\/en-us\/?page_id=4754"},"modified":"2026-01-07T19:44:52","modified_gmt":"2026-01-07T19:44:52","slug":"valoctocogene-roxaparvovec-safety","status":"publish","type":"page","link":"https:\/\/medical.biomarin.com\/en-us\/hemophilia-a\/valoctocogene-roxaparvovec-safety\/","title":{"rendered":"Valoctocogene roxaparvovec safety"},"content":{"rendered":"<div id=\"acf-block-6454fb1ae9df6\" class=\"hero hero-no-overlay hero-small-title hero-large-first-para\">\n            <div class=\"hero-background-image hero-background-image-desktop\" style=\"background-image: url(https:\/\/medical.biomarin.com\/en-us\/wp-content\/uploads\/sites\/2\/2025\/10\/Program-banner-drop.png?v=1.20);\"><\/div>\n\t    <div class=\"hero-background-image hero-background-image-mobile\" style=\"background-image: url(https:\/\/medical.biomarin.com\/en-us\/wp-content\/uploads\/sites\/2\/2025\/10\/Program-banner-drop.png?v=1.20);\"><\/div>\n    \t<div class=\"overlay\"><\/div>\n\t<div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t\t<div class=\"hero-content\">\n\t\t\t    \t\t\t        <ul class=\"breadcrumb\">\n\t\t\t            \t\t\t                                                                        <li><a href=\"https:\/\/medical.biomarin.com\/en-us\/hemophilia-a\/\">Hemophilia A<\/a><\/li>\n                            \t\t\t                                                                        <li>Valoctocogene roxaparvovec safety<\/li>\n                            \t\t\t            \t\t\t        <\/ul>\n\t\t\t    \t\t\t\t\t\t\t\t\t\t\t\t    <h1>BioMarin&#x2019;s enduring commitment to communicate safety information on valoctocogene roxaparvovec\n<\/h1>\n\t\t\t\t\t\t\t\t\t\t\t\t\n                <p class=\"inline-buttons\">\n                                                        <\/p>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n\n<div id=\"acf-block-64550f6fb06de\" class=\"block wrapped-content block-tight-bottom\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-64550f6fb0856\" class=\"block-wysiwyg\">\n            <p><strong>The purpose of this site is to provide a global source of safety information from clinical trials&#xA0;and real-world data for healthcare professionals.&#xA0; This site will provide periodic updates on specific safety data that is of clinical interest. This site is NOT inclusive of all safety information including adverse events and\/or risks associated with valoctocogene roxaparvovec treatment.&#xA0; It is NOT a source for real-time reporting of adverse events or real-time information of safety events.<\/strong><\/p>\n<p>Safety information provided on this site is from published manuscripts, congress oral presentations, posters, and abstracts.&#xA0; Data may vary based on the source, please refer to your local country product label for the full safety profile.<\/p>\n<p>BioMarin continues to monitor long term safety via ongoing clinical studies, post approval studies, and ongoing registries.&#xA0; BioMarin will continue to provide safety and efficacy updates at relevant congresses through oral presentations, posters, and abstracts.<\/p>\n<p>The website was last updated March 2024 and may not reflect all available information. Please reach out to Medical Information for additional information.<\/p>\n<p>To date,&#xA0;valoctocogene roxaparvovec has been administered to more than 160 clinical participants with some having received an infusion 7 years ago.&#xA0;Please see the clinical trial program on the BioMarinMedical.com Hemophilia A Page for more information.<\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-6455078341332\" class=\"block cards cards-4-col bg-band block-zero-top block-tight-bottom\">\n\t<div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t\t<div class=\"cards-title\">\n\t\t\t    \t\t\t\t\t\t\t\t    <p><b>Select Safety information provided below represents key safety areas of clinical interest with regards to <\/b><b>valoctocogene<\/b> <b>roxaparvovec<\/b><b> treatment.&#xA0; <\/b><\/p>\n<p><b>Click on each area for additional information. <\/b><\/p>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t<div class=\"cards-wrapper\">\n\t\t\t    \n<div id=\"acf-block-64550f6fb111d\" class=\"card card-fixed-button\" data-muted-autoplay=\"false\">\n        <div class=\"card-content\">\n                            <h4>Liver Health\n<\/h4>\n        \n                                                                                                                                                                                                                                                                                                                                                                                    \n                                                                                        <\/div>\n                                <div class=\"card-actions\">\n                            \n                            <p><a class=\"button button-arrow\" href=\"https:\/\/medical.biomarin.com\/en-us\/valoctocogene-roxaparvovec-safety\/liver-health\/\" target=\"_self\">See more<\/a><\/p>\n                                                                                    <\/div>\n<\/div>\n\n<div id=\"acf-block-64550783413a3\" class=\"card card-fixed-button\" data-muted-autoplay=\"false\">\n        <div class=\"card-content\">\n                            <h4>Malignancy (vector integration)\n<\/h4>\n        \n                                                                                                                                                                                                                                                                                                                                                                                    \n                                                                                        <\/div>\n                                <div class=\"card-actions\">\n                            \n                            <p><a class=\"button button-arrow\" href=\"https:\/\/medical.biomarin.com\/en-us\/valoctocogene-roxaparvovec-safety\/malignancy-vector-integration\/\" target=\"_self\">See more<\/a><\/p>\n                                                                                    <\/div>\n<\/div>\n\n<div id=\"acf-block-645507834140f\" class=\"card card-fixed-button\" data-muted-autoplay=\"false\">\n        <div class=\"card-content\">\n                            <h4>Thromboembolism\n<\/h4>\n        \n                                                                                                                                                                                                                                                                                                                                                                                    \n                                                                                        <\/div>\n                                <div class=\"card-actions\">\n                            \n                            <p><a class=\"button button-arrow\" href=\"https:\/\/medical.biomarin.com\/en-us\/valoctocogene-roxaparvovec-safety\/thromboembolism\/\" target=\"_self\">See more<\/a><\/p>\n                                                                                    <\/div>\n<\/div>\n\n<div id=\"acf-block-6455078341481\" class=\"card card-fixed-button\" data-muted-autoplay=\"false\">\n        <div class=\"card-content\">\n                            <h4>FVIII Inhibitor Development\n<\/h4>\n        \n                                                                                                                                                                                                                                                                                                                                                                                    \n                                                                                        <\/div>\n                                <div class=\"card-actions\">\n                            \n                            <p><a class=\"button button-arrow\" href=\"https:\/\/medical.biomarin.com\/en-us\/valoctocogene-roxaparvovec-safety\/fviii-inhibitor-development-summary\/\" target=\"_self\">See more<\/a><\/p>\n                                                                                    <\/div>\n<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"congress-component?\" class=\"block wrapped-content block-tight-top block-tight-bottom\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-6455078341693\" class=\"block-wysiwyg\">\n            <h3>Recent Congress Posters and Presentations that contain updates on safety information<\/h3>\n<p><a href=\"https:\/\/medical.biomarin.com\/en-us\/hemophilia-a-congress-posters-and-presentations\/\">Access posters and presentations from recent congresses.<\/a> All displayed posters and presentations are protected by copyright and are intended for individual use only. Please Note: Poster content may be unavailable or delayed. This could be due to copyright or embargo guidelines. You may check back later or contact <a href=\"mailto:medinfo@bmrn.com\" target=\"_blank\" rel=\"noopener\">medinfo@bmrn.com<\/a> or complete a request form to inquire about this specific material.<\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-646b472c062fb\" class=\"block featured-resources-listing\">\n\t<div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n            \t\t\t                <article class=\"resource resource-prescribing-information\">\n                                            <p class=\"resource-type\">Prescribing Information<\/p>\n                                        <div class=\"box prescribing-information\">\n                                                    <h2 class=\"resource-flag\">valoctocogene roxaparovec Product Labels<\/h2>\n                                                                            <p>This site focuses on specific safety data that is of clinical interest and is not inclusive of all adverse events and is not a source for real-time reporting of adverse events and safety information. Please refer to the product label for full safety profile.<\/p>\n                                                <ul>\n                                                                                                                                                                                                                                                                                                <li><a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cder\/daf\/index.cfm\" target=\"_blank\">Prescribing Information\n<\/a><\/li>\n                                                                                    <\/ul>\n                    <\/div>\n                <\/article>\n                        \t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"acf-block-6488a1c86d563\" class=\"block wrapped-content block-tight-top\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-6488a1c86d6bd\" class=\"block-wysiwyg\">\n            <p>You may report adverse events to BioMarin at&#xA0;<a href=\"mailto:drugsafety@bmrn.com\" target=\"_blank\" rel=\"noopener noreferrer\">drugsafety@bmrn.com<\/a>. You are encouraged to report negative adverse events of prescription drugs to the FDA. Visit&#xA0;<a href=\"http:\/\/www.fda.giv\/medwatch\" target=\"_blank\" rel=\"noopener noreferrer\">www.fda.gov\/medwatch<\/a>, or call <a href=\"tel:1-800-FDA-1088\">1-800-FDA-1088<\/a>.<\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"parent":4701,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-4754","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>Valoctocogene roxaparvovec safety | BioMarin Medical<\/title>\n<meta name=\"description\" content=\"BioMarin\u2019s enduring commitment to communicate safety information on valoctocogene roxaparvovec\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/medical.biomarin.com\/en-us\/hemophilia-a\/valoctocogene-roxaparvovec-safety\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Valoctocogene roxaparvovec safety | BioMarin Medical\" \/>\n<meta property=\"og:description\" content=\"BioMarin\u2019s enduring commitment to communicate safety information on valoctocogene roxaparvovec\" \/>\n<meta property=\"og:url\" content=\"https:\/\/medical.biomarin.com\/en-us\/hemophilia-a\/valoctocogene-roxaparvovec-safety\/\" \/>\n<meta property=\"og:site_name\" content=\"BioMarin Medical\" \/>\n<meta property=\"article:modified_time\" content=\"2026-01-07T19:44:52+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:\/\/medical.biomarin.com\/en-us\/hemophilia-a\/valoctocogene-roxaparvovec-safety\/\",\"url\":\"https:\/\/medical.biomarin.com\/en-us\/hemophilia-a\/valoctocogene-roxaparvovec-safety\/\",\"name\":\"Valoctocogene roxaparvovec safety | BioMarin Medical\",\"isPartOf\":{\"@id\":\"https:\/\/medical.biomarin.com\/en-us\/#website\"},\"datePublished\":\"2025-07-17T13:55:01+00:00\",\"dateModified\":\"2026-01-07T19:44:52+00:00\",\"description\":\"BioMarin\u2019s enduring commitment to communicate safety information on valoctocogene roxaparvovec\",\"breadcrumb\":{\"@id\":\"https:\/\/medical.biomarin.com\/en-us\/hemophilia-a\/valoctocogene-roxaparvovec-safety\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/medical.biomarin.com\/en-us\/hemophilia-a\/valoctocogene-roxaparvovec-safety\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/medical.biomarin.com\/en-us\/hemophilia-a\/valoctocogene-roxaparvovec-safety\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/medical.biomarin.com\/en-us\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Hemophilia A\",\"item\":\"https:\/\/medical.biomarin.com\/en-us\/hemophilia-a\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Valoctocogene roxaparvovec safety\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/medical.biomarin.com\/en-us\/#website\",\"url\":\"https:\/\/medical.biomarin.com\/en-us\/\",\"name\":\"BioMarin Medical\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/medical.biomarin.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":"Valoctocogene roxaparvovec safety | BioMarin Medical","description":"BioMarin\u2019s enduring commitment to communicate safety information on valoctocogene roxaparvovec","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:\/\/medical.biomarin.com\/en-us\/hemophilia-a\/valoctocogene-roxaparvovec-safety\/","og_locale":"en_US","og_type":"article","og_title":"Valoctocogene roxaparvovec safety | BioMarin Medical","og_description":"BioMarin\u2019s enduring commitment to communicate safety information on valoctocogene roxaparvovec","og_url":"https:\/\/medical.biomarin.com\/en-us\/hemophilia-a\/valoctocogene-roxaparvovec-safety\/","og_site_name":"BioMarin Medical","article_modified_time":"2026-01-07T19:44:52+00:00","twitter_card":"summary_large_image","schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/medical.biomarin.com\/en-us\/hemophilia-a\/valoctocogene-roxaparvovec-safety\/","url":"https:\/\/medical.biomarin.com\/en-us\/hemophilia-a\/valoctocogene-roxaparvovec-safety\/","name":"Valoctocogene roxaparvovec safety | BioMarin Medical","isPartOf":{"@id":"https:\/\/medical.biomarin.com\/en-us\/#website"},"datePublished":"2025-07-17T13:55:01+00:00","dateModified":"2026-01-07T19:44:52+00:00","description":"BioMarin\u2019s enduring commitment to communicate safety information on valoctocogene roxaparvovec","breadcrumb":{"@id":"https:\/\/medical.biomarin.com\/en-us\/hemophilia-a\/valoctocogene-roxaparvovec-safety\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/medical.biomarin.com\/en-us\/hemophilia-a\/valoctocogene-roxaparvovec-safety\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/medical.biomarin.com\/en-us\/hemophilia-a\/valoctocogene-roxaparvovec-safety\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/medical.biomarin.com\/en-us\/"},{"@type":"ListItem","position":2,"name":"Hemophilia A","item":"https:\/\/medical.biomarin.com\/en-us\/hemophilia-a\/"},{"@type":"ListItem","position":3,"name":"Valoctocogene roxaparvovec safety"}]},{"@type":"WebSite","@id":"https:\/\/medical.biomarin.com\/en-us\/#website","url":"https:\/\/medical.biomarin.com\/en-us\/","name":"BioMarin Medical","description":"","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/medical.biomarin.com\/en-us\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"}]}},"_links":{"self":[{"href":"https:\/\/medical.biomarin.com\/en-us\/wp-json\/wp\/v2\/pages\/4754","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medical.biomarin.com\/en-us\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/medical.biomarin.com\/en-us\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/medical.biomarin.com\/en-us\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/medical.biomarin.com\/en-us\/wp-json\/wp\/v2\/comments?post=4754"}],"version-history":[{"count":5,"href":"https:\/\/medical.biomarin.com\/en-us\/wp-json\/wp\/v2\/pages\/4754\/revisions"}],"predecessor-version":[{"id":6277,"href":"https:\/\/medical.biomarin.com\/en-us\/wp-json\/wp\/v2\/pages\/4754\/revisions\/6277"}],"up":[{"embeddable":true,"href":"https:\/\/medical.biomarin.com\/en-us\/wp-json\/wp\/v2\/pages\/4701"}],"wp:attachment":[{"href":"https:\/\/medical.biomarin.com\/en-us\/wp-json\/wp\/v2\/media?parent=4754"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}