{"id":18,"date":"2023-05-22T12:07:02","date_gmt":"2023-05-22T12:07:02","guid":{"rendered":"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/?page_id=18"},"modified":"2025-12-15T13:11:23","modified_gmt":"2025-12-15T13:11:23","slug":"safety","status":"publish","type":"page","link":"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/safety\/","title":{"rendered":"Safety"},"content":{"rendered":"<div id=\"acf-block-6903814540127\" class=\"hero hero-roctavian\">\n    <div class=\"hero-background-image hero-background-image-desktop\" style=\"background-image: url(https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2025\/11\/safety-scaled-e1763394087670.png?v=1.49);\"><\/div>\n    <div class=\"hero-background-image hero-background-image-mobile\" style=\"background-image: url(https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2025\/11\/HCP_2.0-SAFETY\u20134-YEAR-DATA_MOBILE_.png?v=1.49);\"><\/div>\n    <div class=\"overlay\"><\/div>\n\n    <div class=\"hero-content\">\n        <div class=\"title-area\">\n                            <h1>SAFETY PROFILE FOR ROCTAVIAN\n<\/h1>\n                                <\/div>\t\t\n                    <div class=\"text-area\">\n                <div class=\"text-area-content\">\n                                        <div class=\"text\">\n                        <p>Want to hear firsthand experiences from patients dosed with ROCTAVIAN?<\/p>\n                    <\/div>\n                                                                <div class=\"cta\">\n                                                                                    <p><a class=\"button button-arrow\" href=\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/patient-stories\/\" target=\"_self\">Watch now <\/a><\/p>\n                        <\/div>\n                                    <\/div>\n            <\/div>\n                            <div class=\"image-caption\">\n                <p class=\"p1\">Andrew W., dosed with ROCTAVIAN in 2018 as part of a clinical trial.<\/p>\n            <\/div>\n\n            <div class=\"additional-caption\">\n                            <\/div>\n            <\/div>\n<\/div>\n\n\n<div id=\"Adverse-events\" class=\"block wrapped-content block-tight-bottom\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-646bf94af22e2\" class=\"block-wysiwyg\">\n            <h2>Safety profile of ROCTAVIAN after 5 years<sup>1,2<\/sup><\/h2>\n<ul>\n<li>The safety of ROCTAVIAN was evaluated in 134 patients in the Phase 3 study (112 rollover and 22 directly enrolled)<\/li>\n<li>Long-term safety continues to be evaluated in the long-term follow-up study<\/li>\n<\/ul>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"Symptom-table\" 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-646f47f6d5a2c\" class=\"block-wysiwyg\">\n            <h2>Contraindictions<\/h2>\n<p>Patients with active infections, either acute (such as acute respiratory infections or acute hepatitis) or uncontrolled chronic (such as chronic active hepatitis B). Patients with known significant hepatic fibrosis (stage 3 or 4 on the Batts-Ludwig scale or equivalent), or cirrhosis, and patients with known hypersensitivity to mannitol.<\/p>\n<p>&nbsp;<\/p>\n    <\/div>\n\n<div id=\"acf-block-67486d3494606\" class=\"block-wysiwyg\">\n            <h2>Select Warnings and Precautions<\/h2>\n<p><strong>Infusion-related reactions<\/strong> including hypersensitivity reactions and anaphylaxis, have occurred. Monitor during and for at least 3 hours after ROCTAVIAN administration. Administer ROCTAVIAN in a setting where personnel and equipment are immediately available to treat infusion-related reactions. Discontinue infusion for anaphylaxis.<\/p>\n<p><strong>Hepatotoxicity:<\/strong> Monitor ALT. The majority of patients treated with ROCTAVIAN experienced ALT elevations and required corticosteroids for ALT elevation. Assess patient\u2019s ability to receive corticosteroids and\/or other immunosuppressive therapy that may be required for an extended period.<\/p>\n<p><strong>Monitor for Factor VIII<\/strong> activity and Factor VIII inhibitors.<\/p>\n<p><strong>Malignancy:<\/strong> Monitor for hepatocellular malignancy in patients with risk factors for hepatocellular carcinoma (eg, hepatitis B or C, nonalcoholic fatty liver disease, chronic alcohol consumption, nonalcoholic steatohepatitis, advanced age). Perform regular liver ultrasound (eg, annually) and alpha-fetoprotein testing following administration.<\/p>\n<p>The safety of ROCTAVIAN was evaluated in 134 patients in the Phase 3 study (112 rollover and 22 directly enrolled). Long-term safety continues to be evaluated in the long term follow-up study. Below please see the most common adverse events for patients treated with ROCTAVIAN.<\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-6482ee51034d4\" class=\"block wrapped-content bg-band bg-band-white block-zero-top block-zero-bottom\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-674424076bf8b\" class=\"block-wysiwyg\">\n            <h4 class=\"purple-text\" style=\"text-align: center\">Adverse reactions in \u22655% of patients treated with ROCTAVIAN through 5 years<sup>1<\/sup><\/h4>\n    <\/div>\n\n\n<figure class=\"wp-block-table is-style-regular\"><table class=\"has-white-background-color has-background\"><thead><tr><th class=\"has-text-align-left\" data-align=\"left\" rowspan=\"2\"><br><br><strong>Adverse Reactions<\/strong><\/th><th colspan=\"2\"><strong>Number of Patients (%)<br><\/strong>N=134<\/th><\/tr><tr><th><strong>All grades<\/strong><\/th><th><strong>\u2265Grade 3<\/strong><\/th><\/tr><\/thead><tbody><tr><th class=\"has-text-align-left\" data-align=\"left\" colspan=\"3\"><strong>Nervous system disorders<\/strong><\/th><\/tr><tr><td class=\"has-text-align-left\" data-align=\"left\">Headache<\/td><td>10 (7.5%)<\/td><td>0 (0%)<\/td><\/tr><tr><th class=\"has-text-align-left\" data-align=\"left\" colspan=\"3\">Gastrointestinal disorders<\/th><\/tr><tr><td class=\"has-text-align-left\" data-align=\"left\">Nausea<\/td><td>43 (32.1%)<\/td><td>0 (0%)<\/td><\/tr><tr><td class=\"has-text-align-left\" data-align=\"left\">Vomiting<\/td><td>8 (6.0%)<\/td><td>0 (0%)<\/td><\/tr><tr><td class=\"has-text-align-left\" data-align=\"left\">Abdominal pain*<\/td><td>8 (6.0%)<\/td><td>0 (0%)<\/td><\/tr><tr><th class=\"has-text-align-left\" data-align=\"left\" colspan=\"3\">General disorders and administration site conditions<\/th><\/tr><tr><td class=\"has-text-align-left\" data-align=\"left\">Fatigue<small><sup><small><sup>\u2020<\/sup><\/small><\/sup><\/small><\/td><td>21 (15.7%)<\/td><td>0 (0%)<\/td><\/tr><tr><td class=\"has-text-align-left\" data-align=\"left\">Infusion-related reactions<small><sup><small><sup>\u2021<\/sup><\/small><\/sup><\/small><\/td><td>12 (9.0%)<\/td><td>N\/A<small><sup>\u00a7<\/sup><\/small><\/td><\/tr><\/tbody><\/table><figcaption class=\"wp-element-caption\"><br><small>*Includes abdominal discomfort, abdominal distension, abdominal tenderness, and abdominal pain upper.<sup>2<\/sup> <\/small><br><small><sup><small><sup>\u2020<\/sup><\/small><\/sup>Includes fatigue, lethargy, and malaise.<sup>2<\/sup> <\/small><br><small><sup><small><sup>\u2021<\/sup><\/small><\/sup>Infusion-related reactions are not under a specific system organ class and include multiple symptoms that occurred during or within 6 hours after the end of infusion.<sup>2<\/sup><\/small><br><small><sup>\u00a7<\/sup><\/small>Data cannot be updated following identical analysis used in the USPI, as they were based on FDA review and comments. Incidence of Grade \u22653 infusion-related<br>reactions not available under the 5-year analysis of available, valid data.<\/figcaption><\/figure>\n\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-64c21744b2fdb\" class=\"block wrapped-content bg-band block-tight-top block-zero-bottom\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-64c21744b3041\" class=\"block-wysiwyg\">\n            <h2 style=\"text-align: center\">Most ALT elevations occurred in the first 26 weeks post-infusion and were asymptomatic<\/h2>\n<ul>\n<li class=\"p1\">ALT elevations were generally transient and resolved with temporary corticosteroids. The median duration (range) of treatment with corticosteroids in response to ALT elevations was 35 weeks (3, 120 weeks)<\/li>\n<li class=\"p1\">Since Year 2, no corticosteroids have been initiated to treat ALT elevations in the study<br \/>\n<!-- \/wp:table --><\/li>\n<\/ul>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"Laboratory-abnormalities\" class=\"block wrapped-content bg-band block-zero-top block-zero-bottom block-remove-top-padding\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-646f47f6d5cdb\" class=\"block-wysiwyg\">\n            <h4 class=\"purple-text\" style=\"text-align: center\"><strong>Laboratory abnormalities (\u226510%) in patients treated with ROCTAVIAN through 5 years (N=134)<sup>1<\/sup><\/strong><\/h4>\n    <\/div>\n\n\n<figure class=\"wp-block-table is-style-regular\"><table class=\"has-white-background-color has-background has-fixed-layout\"><tbody><tr><td><strong>ALT Increases &gt;ULN<\/strong><\/td><td>111 (82.8%)<\/td><\/tr><tr><td><strong>AST Increases &gt;ULN<\/strong><\/td><td>97 (72.4%)<\/td><\/tr><tr><td><strong>LDH Increases &gt;ULN<\/strong><\/td><td>80 (59.7%)<\/td><\/tr><tr><td><strong>Blood CPK Increases<\/strong> <strong>&gt;ULN<\/strong><\/td><td>68 (50.7%)<\/td><\/tr><tr><td><strong>Factor VIII Activity Levels &gt;ULN<\/strong>*<\/td><td>38 (28.4%)<\/td><\/tr><tr><td><strong>GGT Increases &gt;ULN <\/strong><\/td><td>28 (20.9%)<\/td><\/tr><tr><td><strong>Bilirubin Increases &gt;ULN <\/strong><\/td><td>20 (14.9%)<\/td><\/tr><\/tbody><\/table><figcaption class=\"wp-element-caption\"><small>ALT=alanine aminotransferase; AST=aspartate aminotransferase; CPK=creatine phosphokinase; GGT=gamma-glutamyl transferase; LDH=lactate dehydrogenase;<br>ULN=upper limit of normal.<\/small><br>*Patients with 1 or more instances of Factor VIII activity levels &gt;150 IU\/dL (ULN of the one-stage assay used).<sup>2<\/sup><\/figcaption><\/figure>\n\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-6744224804c26\" class=\"block wrapped-content bg-band bg-band-white block-tight-top block-zero-bottom block-remove-bottom-padding\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-6744224804c49\" class=\"block-wysiwyg\">\n            <h2>Routine follow-ups keep your patients on track<\/h2>\n<ul>\n<li>Monitor ALT elevations weekly for at least 26 weeks following administration of ROCTAVIAN<\/li>\n<li>See the ROCTAVIAN Prescribing Information for complete monitoring schedule and guidance<\/li>\n<\/ul>\n<p>Find out <a href=\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/starting-patients\/\">why follow-ups are important<\/a>.<\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-6744801be1b40\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-6744801be1b91\" class=\"block-wysiwyg\">\n            <h2>In the clinical study<sup>2<\/sup>:<\/h2>\n    <\/div>\n\n<figure id=\"acf-block-674858d6a8ff0\">\n    <div class=\"image image-responsive image-rounded image-align-left\">\n                    <div class=\"image-desktop\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2025\/11\/Group-8122.png?v=1.49\" alt=\"\" \/>\t\t\t<\/div>\n\t\t\t<div class=\"image-mobile\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2025\/11\/Zero-e1764004758435.png?v=1.49\" alt=\"\" \/>\t\t\t<\/div>\n            <\/div>\n    <\/figure>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-6912155b84d89\" class=\"block single-stacked-video\" data-muted-autoplay=\"false\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n            \n                            <h2 class=\"h3\">\u201cSeeing my factor levels at those weekly appointments gave me the confidence that ROCTAVIAN gene therapy was working for me.\u201d\n<\/h2>\n                                        <div class=\"supporting-text\">\n                    <h5>\u2014Andrew S., dosed with ROCTAVIAN in 2018 as part of a clinical trial<\/h5>\n                <\/div>\n                        \n            <div class=\"video-poster\">\n                <a class=\"modal-video permitted\" href=\"https:\/\/player.vimeo.com\/video\/1016018735\" style=\"background-image: url(https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2025\/10\/2.0_Safety_Andrew_S.png?v=1.49);\">Play<\/a>\n            <\/div>\n            \n                            <p><a class=\"button\" href=\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/patient-stories\/#acf-block-69021303457cf\" target=\"_self\">Watch his story<\/a><\/p>            \n                    <\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"acf-block-646bfc7f049bf\" class=\"block call-to-action dark-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=\"\">\n\t\t\t\t<div class=\"overlay\"><\/div>\n\t\t\t\t<div class=\"cta-content\">\n\t\t\t\t                            <div class=\"cta-image\">\n                            <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2023\/05\/5.3_Connect-icon-750x750.png\" alt=\"\" \/>                        <\/div>\n                    \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\">How to test for eligibility for ROCTAVIAN?\n<\/h2>\n\t\t\t\t\t\t    \t\t\t\t\t\t    \t\t\t\t\t\t        <p>See the simple steps to identify patients eligible for treatment.<\/p>\n\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 button-arrow\" href=\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/starting-patients\/\" target=\"_self\">SEE ELIGIBILITY STEPS<\/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-691214ca19861\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-691214ca19883\" class=\"block-wysiwyg\">\n            <p><small><strong>References:<br \/>\n1.<\/small><\/strong> Data on file. BioMarin Pharmaceutical Inc.; 2025. <strong>2.<\/strong> ROCTAVIAN\u00ae (valoctocogene roxaparvovec-rvox). Prescribing information. BioMarin International, Ltd.; 2023.<\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"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-18","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Safety Profile | ROCTAVIAN\u00ae (valoctocogene roxaparvovec-rvox) for Healthcare Professionals<\/title>\n<meta name=\"description\" content=\"Review safety data for ROCTAVIAN\u00ae (valoctocogene roxaparvovec-rvox) which includes important information on tolerability, hepatic reactions, and adverse reactions\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" 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