{"id":5506,"date":"2024-09-26T16:51:48","date_gmt":"2024-09-26T16:51:48","guid":{"rendered":"https:\/\/www.roctavian.com\/en-us\/?page_id=5506"},"modified":"2025-11-20T08:30:07","modified_gmt":"2025-11-20T08:30:07","slug":"safety","status":"publish","type":"page","link":"https:\/\/www.roctavian.com\/en-us\/safety\/","title":{"rendered":"SAFETY"},"content":{"rendered":"<div id=\"acf-block-6903814540127\" 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\/1.2-Safety-Hero-\u2013-DESKTOP-2-e1762376752914.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\/1.2-Safety-\u2013-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>SAFETY PROFILE 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>Have additional questions about ROCTAVIAN?<\/p>\n                    <\/div>\n                                                                <div class=\"cta\">\n                                                                                    <p><a class=\"button button-arrow\" href=\"https:\/\/www.roctavian.com\/en-us\/connect-with-us\/\" target=\"_self\">Connect with us<\/a><\/p>\n                        <\/div>\n                                    <\/div>\n            <\/div>\n                            <div class=\"image-caption\">\n                <p>Lorenzo V. received ROCTAVIAN in 2019 as part of a clinical study.<\/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>Safety data have been collected through 5 years<\/p>\n            <\/div>\n        <\/div>\n    <\/div>\n\n\n<div id=\"Intro--WT\" class=\"block wrapped-content block-tight-top\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-68fb968c18a30\" class=\"block-wysiwyg\">\n            <p>When considering any new treatment, it\u2019s common to have questions. Read on to learn more about ROCTAVIAN safety information.<\/p>\n<ul>\n<li>The safety profile of ROCTAVIAN was evaluated in a clinical study, with 5 years of data so far<\/li>\n<li>The study included 134 people with severe hemophilia A<\/li>\n<ul>\n<li>112 people whose data were collected for at least 6 months before their infusion (rollover population)<\/li>\n<li>22 people who immediately received their infusion (directly enrolled population)<\/li>\n<\/ul>\n<li>Long-term safety continues to be studied, and data will be collected for years<\/li>\n<li>Patients should not take ROCTAVIAN if they have an active infection or if they have a long-term infection that is not controlled by the medicines they take; have scarring of the liver (significant liver fibrosis or cirrhosis); or are allergic to mannitol (an inactive ingredient in ROCTAVIAN)<\/li>\n<\/ul>\n<p>Learn more about <a href=\"https:\/\/www.roctavian.com\/en-us\/roctavian-results\/\">ROCTAVIAN study results<\/a>, including improved bleed control and infusion-reduction data.<\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"Zero-graphic-LB\" class=\"block wrapped-content bg-band\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<figure id=\"acf-block-690a613e8f406\">\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:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/11\/Group-8365.png?v=0.113\" alt=\"\" \/>\t\t\t<\/div>\n\t\t\t<div class=\"image-mobile\">\n\t\t\t    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/11\/zero-mob.png?v=0.113\" alt=\"\" \/>\t\t\t<\/div>\n            <\/div>\n    <\/figure>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"warnings-WT\" class=\"block cards cards-3-col 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    <h2>Select Warnings and Precautions\n<\/h2>\n\t\t\t\t\t\t\t\t\t\t\t\t    <p>Before receiving ROCTAVIAN, there are a few things you should know and some precautions that you and your healthcare team will need to take.<\/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-68fb98d86b76f\" class=\"card card-inner-image card-inner-image-small card-bg-white\" data-muted-autoplay=\"false\">\n        <div class=\"card-content\">\n                    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/11\/warnings-precautions-03.png?v=0.113\" alt=\"\" \/>                            <h2>Your doctor will monitor your liver health\n<\/h2>\n        \n                                                                                                            <ul>\n<li>Before and regularly following administration of ROCTAVIAN, your doctor will perform blood tests to check your liver health. Make sure you obtain these blood tests during the specified time your doctor instructs you to<\/li>\n<li>Based on your liver test results, you may need to take corticosteroids or another medicine for a period of time (several months or longer) to help decrease liver enzyme levels, which may cause side effects while you receive them<\/li>\n<li>Talk to your doctor about these side effects and what you need to do to maintain your liver health<\/li>\n<\/ul>\n                                                                                    <\/div>\n<\/div>\n\n<div id=\"acf-block-68fb98d86b807\" class=\"card card-inner-image card-inner-image-small card-bg-white\" data-muted-autoplay=\"false\">\n        <div class=\"card-content\">\n                    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/11\/warnings-precautions-01.png?v=0.113\" alt=\"\" \/>                            <h2>Tell your doctor if you experience side effects*\n<\/h2>\n        \n                                                                                                            <ul>\n<li>During and in the hours following the infusion, tell your doctor or nurse immediately about any<br \/>\nsymptoms you experience, including hives or other rashes, itching, sneezing, coughing, difficulty breathing, runny nose, watery eyes, tingling throat, nausea (feeling sick), diarrhea, low blood pressure, rapid heartbeat, light-headedness (near-fainting), fever, chills, or shivering<\/li>\n<li>Talk to your doctor about what to do if you experience any side effects after you have your infusion<\/li>\n<\/ul>\n                                                                                    <\/div>\n<\/div>\n\n<div id=\"acf-block-68fb98d86b86f\" class=\"card card-inner-image card-inner-image-small card-bg-white\" data-muted-autoplay=\"false\">\n        <div class=\"card-content\">\n                    <img decoding=\"async\" class=\"\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/11\/warnings-precautions-02.png?v=0.113\" alt=\"\" \/>                            <h2>Other considerations\n<\/h2>\n        \n                                                                                                            <ul>\n<li>ROCTAVIAN can insert itself into the DNA of human body cells. The effect that insertion may have on those cells is unknown, but such events may contribute to a theoretical risk of cancer<\/li>\n<li>There have been no reported cases of cancer caused by treatment with ROCTAVIAN<\/li>\n<li>Your doctor may perform regular monitoring if you have pre-existing risk factors for developing liver cancer. In the event of cancer, your doctor may send a sample to BioMarin Pharmaceutical Inc. for further testing<\/li>\n<\/ul>\n                                                                                    <\/div>\n<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"warn-note-WT\" class=\"block wrapped-content block-tight-top block-zero-bottom\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-68fb9b114f616\" class=\"block-wysiwyg\">\n            <p><small>*The most common adverse reactions (\u22655%) to ROCTAVIAN in the Phase 3 clinical study were nausea (32.1%), fatigue (15.7%), infusion-related reactions (9%), headache (7.5%), vomiting (6%), and abdominal pain (6%).<\/small><\/p>\n    <\/div>\n\n<figure id=\"acf-block-690a62a7cb6be\">\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<div id=\"side-fx--WT\" class=\"block cards cards-3-col\">\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    <h2>What are the most common side effects with ROCTAVIAN?\n<\/h2>\n\t\t\t\t\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-68fb9d6fcddd8\" class=\"card card-bg-white\" data-muted-autoplay=\"false\">\n        <div class=\"card-content\">\n                \n                                                                                                            <ul>\n<li>Nausea<\/li>\n<li>Fatigue<\/li>\n<li>Infusion-related reactions<\/li>\n<\/ul>\n                                                                                    <\/div>\n<\/div>\n\n<div id=\"acf-block-68fb9d6fcde4f\" class=\"card card-bg-white\" data-muted-autoplay=\"false\">\n        <div class=\"card-content\">\n                \n                                                                                                            <ul>\n<li>Headache<\/li>\n<li>Vomiting<\/li>\n<li>Abdominal pain<\/li>\n<\/ul>\n                                                                                    <\/div>\n<\/div>\n\n<div id=\"acf-block-68fb9d6fcdebf\" class=\"card card-bg-white\" data-muted-autoplay=\"false\">\n        <div class=\"card-content\">\n                \n                                                                                                            <ul>\n<li>Changes to laboratory results from blood tests that measure your liver health and other ways your body is responding to ROCTAVIAN<\/li>\n<\/ul>\n                                                                                    <\/div>\n<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"acf-block-690bbbb40c3ab\" 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\/10\/Callout-1-1024x266.png);\">\n                <div class=\"story-cta-inner\">z\n                                    <p class=\"quote\">For about 6 months post-infusion, I had weekly blood tests to make sure that all the levels of my liver were looking good and healthy.<\/p>\n                \n                                    <p class=\"citation\">\u2014 Dave N., received ROCTAVIAN in 2024<\/p>\n                \n                                    <img decoding=\"async\" class=\"mobile-image\" src=\"https:\/\/www.roctavian.com\/en-us\/wp-content\/uploads\/sites\/5\/2025\/11\/dave-story-mobile.png?v=0.113\" alt=\"\" \/>                \n                                    <a href=\"https:\/\/www.roctavian.com\/en-us\/roctavian-stories\/#dave-N\" class=\"button\">WATCH DAVE&#8217;S STORY<\/a>\n                                <\/div>\n            <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"am-i-elig..\" class=\"block call-to-action call-to-action-no-overlay light-cta\">\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\">Are you ready to move forward with ROCTAVIAN?\n<\/h2>\n\t\t\t\t\t\t    \t\t\t\t\t\t    \t\t\t\t\t\t        <p>Learn how doctors can confirm eligibility with simple blood tests.<\/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\" href=\"https:\/\/www.roctavian.com\/en-us\/am-i-ready-for-roctavian\/\" target=\"_self\">AM I ELIGIBLE?<\/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>","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-5506","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 &amp; Side Effects | ROCTAVIAN\u00ae 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