{"id":598,"date":"2023-05-23T13:38:34","date_gmt":"2023-05-23T13:38:34","guid":{"rendered":"https:\/\/roctavianhcp-dev-001.azurewebsites.net\/en-us-new\/roctavian\/?page_id=598"},"modified":"2023-12-21T09:52:36","modified_gmt":"2023-12-21T09:52:36","slug":"faq","status":"publish","type":"page","link":"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/faq\/","title":{"rendered":"FAQ"},"content":{"rendered":"
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FAQs<\/h2>\n <\/div>\n <\/div>\n <\/div>\n<\/div>\n\n
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How does ROCTAVIAN work?\n<\/h2>\n <\/div>\n
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ROCTAVIAN is an adeno-associated virus serotype 5 (AAV5) gene therapy that is designed to help the body to produce Factor VIII on its own.1<\/sup> Find out more in How ROCTAVIAN Works<\/a>.<\/p>\n <\/div>\n <\/div>\n

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Is my patient eligible for ROCTAVIAN?\n<\/h2>\n <\/div>\n
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There are many different considerations that go into patient eligibility. See all of the eligibility criteria in Eligibility & Steps to Treatment<\/a>.<\/p>\n <\/div>\n <\/div>\n

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How do I get my patient started on ROCTAVIAN?\n<\/h2>\n <\/div>\n
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Some of the first steps to treatment are ordering the AAV5 DetectCDxTM<\/sup> companion diagnostic and enrolling your patients in BioMarin RareConnectionsTM<\/sup> patient support services. Learn more in Eligibility<\/a>.<\/p>\n

AAV5 DetectCDx\u2122 is a trademark of ARUP Laboratories.<\/small><\/p>\n <\/div>\n <\/div>\n

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What are the ABR results over three years?\n<\/h2>\n <\/div>\n
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The efficacy of ROCTAVIAN has been studied in patients for over 3 years.1<\/sup> See the Efficacy<\/a> data. Individual Factor VIII activity levels produced and durability reached may vary.<\/p>\n <\/div>\n <\/div>\n

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Can ROCTAVIAN help patients maintain Factor VIII activity levels?\n<\/h2>\n <\/div>\n
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Factor VIII activity levels were one of several measurements of efficacy determined in the ROCTAVIAN clinical trials. Find out more in Efficacy<\/a>.<\/p>\n <\/div>\n <\/div>\n

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How long has ROCTAVIAN been studied?\n<\/h2>\n <\/div>\n
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Patients first received ROCTAVIAN in the GENEr8-1 study, the longest and largest gene therapy Phase 3 clinical trial for severe hemophilia A, in 2017.2<\/sup> Learn more about the Study Design<\/a>.<\/p>\n <\/div>\n <\/div>\n

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What are the most common adverse reactions\/side effects experienced with ROCTAVIAN?\n<\/h2>\n <\/div>\n
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The most common adverse reactions (\u22655%) to ROCTAVIAN were nausea, fatigue, headache, infusion-related reactions, vomiting, and abdominal pain.\u00a0See more information in Safety Profile<\/a>.<\/p>\n <\/div>\n <\/div>\n

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What is the name of the ROCTAVIAN support program?\n<\/h2>\n <\/div>\n
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A one-time gene therapy deserves personalized product and education support. BioMarin RareConnectionsTM<\/sup> provides patients and hemophilia treatment centers with personalized product support throughout the ROCTAVIAN journey. Visit the Treatment Support<\/a> page to find out more.<\/p>\n <\/div>\n <\/div>\n \t\t<\/div>\n\t<\/div>\n<\/div>\n\n

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Connect with us\n<\/h2>\n\t\t\t\t\t\t \t\t\t\t\t\t \t\t\t\t\t\t

Still have questions? <\/p>\n\t\t\t\t\t\t \t\t\t\t\t <\/div>\n\t\t\t\t\t

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Let us know<\/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

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References:\n<\/h4>\n\t\t\t\t\t\t
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  1. ROCTAVIAN\u2122 (valoctocogene roxaparvovec-rvox). Prescribing Information. BioMarin Pharmaceutical Inc.; 2023.\n<\/span><\/li>\n
  2. Ozelo MC, Mahlangu J, Pasi KJ, et al. Valoctocogene roxaparvovec gene therapy for hemophilia A. N Engl J Med.<\/em> 2022;386(11):1013-1025.\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":"\nFrequently Asked Questions | ROCTAVIAN\u2122 (valoctocogene roxaparvovec-rvox) for Healthcare Professionals<\/title>\n<meta name=\"description\" content=\"Answers to some of the most frequently asked questions about ROCTAVIAN\u2122 (valoctocogene roxaparvovec-rvox), the only one-time gene therapy for the treatment of severe hemophilia A\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/hcp.biomarin.com\/en-us\/roctavian\/faq\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta 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