{"id":45,"date":"2022-08-17T13:23:53","date_gmt":"2022-08-17T13:23:53","guid":{"rendered":"https:\/\/hcp.biomarin.com\/en-us\/vimizim\/?page_id=45"},"modified":"2026-03-18T11:26:54","modified_gmt":"2026-03-18T11:26:54","slug":"vimizim-safety-and-tolerability","status":"publish","type":"page","link":"https:\/\/hcp.biomarin.com\/en-us\/vimizim\/vimizim-safety-and-tolerability\/","title":{"rendered":"Safety"},"content":{"rendered":"<div id=\"acf-block-643e7247b6d20\" class=\"page-header\">         \n            \n        <div class=\"header-image\" style=\"background-image: url(https:\/\/hcp.biomarin.com\/en-us\/vimizim\/wp-content\/uploads\/sites\/2\/2022\/09\/fanny.png?v=0.46)\"><\/div>\n     \n    <div class=\"header-content\">\n                    <h1>VIMIZIM<sup>\u00ae<\/sup> (elosulfase alfa) safety profile and tolerability<sup>1<\/sup><\/h1>\n            <\/div>\n<\/div>\n\n<div id=\"acf-block-643e7247b70f4\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-643e7247b7274\" class=\"block-wysiwyg\">\n            <h2>The most common adverse reactions that occurred were pyrexia, vomiting, headache, nausea, abdominal pain, chills, and fatigue<sup>1<\/sup><\/h2>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-643e7247b72db\" class=\"block split-content equal-bias content-align-top bottom-border\" data-muted-autoplay=\"false\">\n\t<div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t                                                                <div class=\"content-block first-block\">\n                                                                                                <ul>\n<li>Serious and severe reactions were associated with VIMIZIM, including hypersensitivity reactions as well as life-threatening allergic reactions<sup>1<\/sup><\/li>\n<li>Anaphylaxis occurred during infusions and up to 3 hours after infusions<sup>1<\/sup><\/li>\n<li>176 patients aged 5 to 57 were enrolled in the 24-week phase 3 pivotal study<sup>1,2<\/sup><\/li>\n<li>Acute reactions requiring intervention were managed by<sup>1<\/sup>\n<ul>\n<li>Temporarily slowing or stopping the infusion<\/li>\n<li>Administering additional antihistamines, antipyretics, and\/or corticosteroids<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n                                                                                    <\/div>\n                    \n                                            <div class=\"content-block second-block\">\n                                                                                                                                                                                                                                                                                    \n                                    \n                                                                                                                \n                                    \n                                    <figure>\n                                        <div class=\"image image-rounded\">\n                                                                                            <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/vimizim\/wp-content\/uploads\/sites\/2\/2026\/03\/7077330_004_US_Website_Content_Vimizim_HCP_Table_Update_v2-1900x1539.png\" alt=\"\" \/>                                                                                    <\/div>\n                                                                            <\/figure>\n                                                                                    <\/div>\n                                                \t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"acf-block-643e7247b7309\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-643e7247b733a\" class=\"block-wysiwyg\">\n            <h2>VIMIZIM safety and tolerability<sup>1<\/sup><\/h2>\n<p class=\"p1\">Life-threatening hypersensitivity reactions, including anaphylaxis, have been reported in patients treated with enzyme replacement therapies, including VIMIZIM; consider the risks and benefits of readministering VIMIZIM following a severe reaction<sup>1<\/sup><\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-643e7247b7369\" class=\"block cards cards-2-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\t\t\t<\/div>\n\t\t\t<div class=\"cards-wrapper\">\n\t\t\t    \n<div id=\"acf-block-643e7247b7399\" class=\"card\" data-muted-autoplay=\"false\">\n        <div class=\"card-content\">\n                            <h4>44 of 235 (18.7%) patients experienced hypersensitivity reactions<sup>1<\/sup>\n<\/h4>\n        \n                                                                                                            <ul>\n<li>Frequent symptoms of hypersensitivity reactions (occurring in more than 2 patients) included anaphylactic reactions, urticaria, peripheral edema, cough, dyspnea, and flushing<\/li>\n<li>Hypersensitivity reactions have occurred as early as 30 minutes from the start of infusion but as late as 6 days after infusion<\/li>\n<\/ul>\n                                                                                    <\/div>\n<\/div>\n\n<div id=\"acf-block-643e7247b73b4\" class=\"card\" data-muted-autoplay=\"false\">\n        <div class=\"card-content\">\n                            <h4>18 of 235 (7.7%) patients experienced signs and symptoms consistent with anaphylaxis (see boxed warning)<sup>1<\/sup>\n<\/h4>\n        \n                                                                                                            <ul>\n<li>Cases of anaphylaxis have occurred as early as 30 minutes from the start of infusion and up to 3 hours after infusion; anaphylaxis occurred as late into treatment as the 47th infusion<\/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-643e7247b73bf\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-643e7247b73e7\" class=\"block-wysiwyg\">\n            <h2>VIMIZIM long-term safety and tolerability<sup>3<\/sup><\/h2>\n<h3>VIMIZIM demonstrated a consistent safety profile from baseline to 120 weeks<sup>3<\/sup><\/h3>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-643e7247b8f61\" class=\"block split-content equal-bias content-align-top bottom-border\" data-muted-autoplay=\"false\">\n\t<div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t                                                                <div class=\"content-block first-block\">\n                                                                                                <h4>No new serious adverse events were observed in long-term extension study<sup>3<\/sup><\/h4>\n<ul>\n<li>173 of 176 patients enrolled in the 24-week phase 3 study continued into the 120-week extension study<\/li>\n<li>The most common adverse reactions were injection-associated and were managed with symptomatic treatment and\/or modification of infusion rate<sup>3<\/sup><\/li>\n<li>In the VIMIZIM 2 mg\/kg\/wk group (who received 120 weeks of drug), the rate of drug discontinuation due to adverse events was 1.8%<sup>3<\/sup><\/li>\n<\/ul>\n                                                                                    <\/div>\n                    \n                                            <div class=\"content-block second-block\">\n                                                                                                                                                                                                                                                                                    \n                                    \n                                                                                                                \n                                    \n                                    <figure>\n                                        <div class=\"image image-rounded\">\n                                                                                            <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/vimizim\/wp-content\/uploads\/sites\/2\/2022\/08\/AE2.png?v=0.46\" alt=\"\" \/>                                                                                    <\/div>\n                                                                                    <figcaption><p><small>AE, adverse event; PBO, placebo; QOW, once every other week; QW, once a week; SAE, serious adverse event<\/small><\/p>\n<\/figcaption>\n                                                                            <\/figure>\n                                                                                    <\/div>\n                                                \t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"acf-block-643e7247b8fc2\" class=\"block boxed-content top-border boxed-content-white\">\n\t<div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t\t<div class=\"box\">\n\t\t\t\t\t\t\t\t\n<div id=\"acf-block-643e7247b8fe1\" class=\"image-text-block\">\n        <div class=\"content-block\">\n                                                    <p><a class=\"button button-text button-arrow\" href=\"https:\/\/hcp.biomarin.com\/en-us\/vimizim\/vimizim-dosing\/\" target=\"_self\">Find out how VIMIZIM is administered <\/a><\/p>\n                        <\/div>\n<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"acf-block-643e7247b9004\" class=\"block references\">\n    <div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t    \t\t\t    <h4>References:\n<\/h4>\n\t\t\t\t\t\t                <ol>\n                                                                                                                        <li><span>VIMIZIM [package insert]. Novato, CA: BioMarin Pharmaceutical Inc; 2025.\n<\/span><\/li>\n                                                                                                                                                <li><span>Hendriksz CJ, Burton B, Fleming TR, et al. Efficacy and safety of enzyme replacement therapy with BMN 110 (elosulfase alfa) for Morquio A syndrome (mucopolysaccharidosis IVA): a phase 3 randomised placebo-controlled study. <em>J Inherit Metab Dis<\/em>. 2014;37(6):979-990.\n<\/span><\/li>\n                                                                                                                                                <li><span>Hendriksz CJ, Parini R, AlSayed MD, et al. Long-term endurance and safety of elosulfase alfa enzyme replacement therapy in patients with Morquio A syndrome. <em>Mol Genet Metab<\/em>. 2016;119(1-2):131-143.\n<\/span><\/li>\n                                                            <\/ol>\n\t\t\t\t\t<\/div>\n\t<\/div>\n<\/div>\n\n","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-45","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>VIMIZIM\u00ae (elosulfase alfa) | Safety<\/title>\n<meta name=\"description\" content=\"The most common adverse reactions that occurred with VIMIZIM - elosulfase alfa - were pyrexia, vomiting, headache, nausea, abdominal pain, chills, and fatigue. 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