{"id":416,"date":"2023-05-22T23:55:51","date_gmt":"2023-05-22T23:55:51","guid":{"rendered":"https:\/\/roctavianhcp-dev-001.azurewebsites.net\/en-us-new\/roctavian\/?page_id=416"},"modified":"2023-12-21T09:52:51","modified_gmt":"2023-12-21T09:52:51","slug":"follow-up","status":"publish","type":"page","link":"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/follow-up\/","title":{"rendered":"Follow-up"},"content":{"rendered":"<div id=\"acf-block-64b8093c07a1f\" class=\"simple-hero\">\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\/2023\/07\/1.1_Hero_Why-ROCTAVIAN@2x-2000x302.png);\"><\/div>\n\t    <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\/2023\/07\/1.1_Hero_Why-ROCTAVIAN@2x-2000x302.png);\"><\/div>\n        <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\t\t\t\t\t\t    <h1>Follow-up\n<\/h1>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"**\" class=\"block wrapped-content block-tight-bottom\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-646cb7a22e15d\" class=\"block-wysiwyg\">\n            <h2>The ROCTAVIAN follow-up plan<sup>1<\/sup><\/h2>\n    <\/div>\n\n<figure id=\"acf-block-646cf1705d5f9\">\n    <div class=\"image image-rounded\">\n                    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/wp-content\/uploads\/sites\/3\/2023\/07\/4.2_FollowupNEW.png?v=1.7\" alt=\"\" \/>            <\/div>\n    <\/figure>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-646cb7a22e1e8\" class=\"block wrapped-content block-tight-top\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-646cb7a22e26a\" class=\"block-wysiwyg\">\n            <ul>\n<li>A baseline assessment of liver function should be recorded<\/li>\n<li>Monitor ALT weekly for at least the first 6 months, and institute corticosteroid treatment in response to ALT elevations as required. Continue to monitor ALT until it returns to baseline. Monitor Factor VIII activity levels, since ALT elevation may be accompanied by a decrease in Factor VIII activity<\/li>\n<li>Consider more frequent monitoring in patients with Factor VIII activity levels \u22645 IU\/dL and evidence of bleeding, taking into account the stability of Factor VIII levels since their previous measurement<\/li>\n<li>Weekly monitoring is recommended, and is clinically indicated, during corticosteroid tapering<sup>1<\/sup><\/li>\n<li>Note: Agents that may reduce or increase the plasma concentration of corticosteroids (eg, agents that induce or inhibit cytochrome P450 3A4) can decrease the efficacy of the corticosteroid regimen or increase their side effects<\/li>\n<\/ul>\n<p>*Monitoring of ALT should be accompanied by monitoring of AST and CPK, to rule out alternative causes for ALT elevations (including potentially hepatotoxic medications or agents, alcohol consumption, or strenuous exercise).<\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"Managing-hepatic-reactions\" 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-646cb7a22e2f6\" class=\"block-wysiwyg\">\n            <h2>Managing hepatic reactions<\/h2>\n    <\/div>\n\n<figure id=\"acf-block-646cf1705d70e\">\n    <div class=\"image image-responsive image-rounded\">\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\/2023\/07\/MicrosoftTeams-image-2241-002.png?v=1.7\" 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\/2023\/07\/MicrosoftTeams-image-231.png?v=1.7\" alt=\"\" \/>\t\t\t<\/div>\n            <\/div>\n    <\/figure>\n\n<div id=\"acf-block-646f881e7b4b7\" class=\"block-wysiwyg\">\n            <h4><strong>ALT levels \u22651.5 x baseline or above the ULN<sup>1<\/sup><\/strong><\/h4>\n<ul>\n<li>Consider corticosteroid treatment using the schedule above<\/li>\n<li>Patients should be evaluated for alternative causality (including potential hepatotoxic medications or agents, alcohol consumption, or strenuous exercise)<\/li>\n<li>Consider repeating ALT laboratory testing within 24 to 48 hours and, if clinically indicated, perform additional tests to exclude alternative etiologies. In the absence of an alternative cause for the ALT elevation, a corticosteroid regimen should be promptly initiated<\/li>\n<li>If ALT continues to rise or has not improved after 2 weeks, increase the corticosteroid dose up to a maximum of 1.2 mg\/kg, after ruling out alternative causes for ALT elevation<\/li>\n<li>Taper corticosteroids after ALT levels reach baseline. The taper may be individualized based on the trend of ALT decline, the patient\u2019s medical condition, corticosteroid tolerance, and adverse reactions to corticosteroid therapy<\/li>\n<\/ul>\n<h4><strong>Corticosteroids after Year 1<sup>1<\/sup><\/strong><\/h4>\n<ul>\n<li>There is limited information regarding the benefit of starting a new corticosteroid course after the first year of ROCTAVIAN administration<\/li>\n<\/ul>\n<h4><strong>Monitoring during corticosteroids<sup>1<\/sup><\/strong><\/h4>\n<ul>\n<li>Monitor for and manage adverse reactions from corticosteroid use<\/li>\n<li>During corticosteroid treatment, monitor hepatic status and Factor VIII activity at least weekly<\/li>\n<\/ul>\n<h4><strong>Alternative immunosuppressants<sup>1<\/sup><\/strong><\/h4>\n<ul>\n<li>Other immunosuppressive therapies (eg, tacrolimus, mycophenolate mofetil) may be considered if corticosteroids are contraindicated, ineffective, or there are adverse events secondary to corticosteroid use necessitating discontinuation<\/li>\n<\/ul>\n<p>*Prednisone or equivalent dose of another corticosteroid.<\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"Post-infusion-bleed-management\" 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-646cb7a22e413\" class=\"block-wysiwyg\">\n            <h2>Post-infusion bleed management<\/h2>\n<h3>Manage your patient\u2019s use of hemostatic agents following ROCTAVIAN<sup>1<\/sup><\/h3>\n<ul>\n<li>Monitoring the patient&#8217;s Factor VIII activity level will indicate how well the patient is responding to ROCTAVIAN and allow you to assess the potential need for treatment with Factor VIII concentrates or hemostatic agents<\/li>\n<li>Not all patients respond to ROCTAVIAN. Counsel patients, as necessary, on when they may need to re-instate prophylactic use of Factor VIII concentrates\/hemostatic agents<\/li>\n<li>Advise patients on tapering Factor VIII concentrates\/hemostatic agents and, as necessary, on whether and how to continue or re-start their use, and on actions in case of invasive procedures, surgery, trauma, or bleeds and, currently, it is not possible to predict who will respond to treatment and how long treatment response will continue<\/li>\n<\/ul>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-646cc12ae8b6a\" class=\"block call-to-action\">\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\/5.2_FAQs-icon-750x750.png\" alt=\"Two speech bubbles in a circle; one has a question mark in it. The other contains an ellipses\" \/>                        <\/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\">One-to-one support\n<\/h2>\n\t\t\t\t\t\t    \t\t\t\t\t\t    \t\t\t\t\t\t        <p>BioMarin RareConnections\u2122 can assist you and your patients throughout their treatment journey<\/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\/treatment-support\/\" target=\"_self\">Get Help<\/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-646cc12aea4f0\" class=\"block references\">\n    <div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t    \t\t\t    <h4>Reference:\n<\/h4>\n\t\t\t\t\t\t                <ol>\n                                                                                                                        <li><span>ROCTAVIAN\u2122 (valoctocogene roxaparvovec-rvox). Prescribing Information. BioMarin Pharmaceutical Inc.; 2023\n<\/span><\/li>\n                                                            <\/ol>\n\t\t\t\t\t<\/div>\n\t<\/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":""},"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Follow-up | ROCTAVIAN\u2122 (valoctocogene roxaparvovec-rvox) for Healthcare Professionals<\/title>\n<meta name=\"description\" content=\"The follow-up monitoring schedule for ROCTAVIAN\u2122 (valoctocogene roxaparvovec-rvox) is an important part of treatment success\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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