{"id":65,"date":"2022-11-28T20:55:16","date_gmt":"2022-11-28T20:55:16","guid":{"rendered":"https:\/\/hcp.biomarin.com\/en-us\/voxzogo2\/?page_id=65"},"modified":"2024-09-09T21:29:31","modified_gmt":"2024-09-09T21:29:31","slug":"safety-data","status":"publish","type":"page","link":"https:\/\/hcp.biomarin.com\/en-us\/voxzogo\/safety-data\/","title":{"rendered":"VOXZOGO Safety"},"content":{"rendered":"
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The safety of VOXZOGO has been rigorously evaluated<\/h1>\n

Adverse reactions reported in the 1-year phase 3 study are consistent with those seen in the long-term safety study.1,2<\/sup><\/h3>\n <\/div>\n\n
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\n \"adverse <\/div>\n <\/figure>\n\n
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*Includes adverse reactions occurring more frequently in the VOXZOGO arm and with a risk difference of \u22655% (ie, difference of >2 subjects) between treatment arms.<\/small>
\n\u2020<\/sup>Injection site reactions occurring more frequently in VOXZOGO-treated subjects than placebo.<\/small>
\n\u2021<\/sup>Includes the preferred terms: gastroenteritis and gastroenteritis, viral.<\/small>
\n\u00a7<\/sup>Includes the preferred terms: dizziness, presyncope, procedural dizziness, and vertigo.<\/small>
\n||<\/sup>Includes the preferred terms: fatigue, lethargy, and malaise.<\/small><\/p>\n <\/div>\n <\/div>\n <\/div>\n<\/div>\n\n

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97% of children given VOXZOGO (58\/60) remained on treatment during the phase 3 pivotal clinical trial1,3<\/sup><\/h2>\n

One patient discontinued due to pain and one discontinued due to anxiety with injections.<\/p>\n <\/div>\n <\/div>\n <\/div>\n<\/div>\n\n

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Overall safety profile in patients <5 years was similar to that seen in older pediatric patients1<\/sup><\/h2>\n
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  • The safety of VOXZOGO in patients <5 years was evaluated in a 52-week randomized, placebo controlled, double-blind study1<\/sup><\/li>\n
  • The most common adverse reactions (>10%) reported in pediatric patients <5 years were injection site reactions (86%) and rash (28%)1<\/sup><\/li>\n<\/ul>\n <\/div>\n <\/div>\n <\/div>\n<\/div>\n\n
    \n\t
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    Transient decreases in blood pressure1<\/sup><\/h2>\n

    In the phase 3 study of children aged 5 to 15 years, the median time to onset of events from injection was 31 minutes (range, 18-120 minutes)1<\/sup><\/p>\n <\/div>\n \n

    \n \n \n \n \n
    \n
    \n \"VOXZOGO <\/div>\n <\/figure>\n <\/div>\n \t\t<\/div>\n\t<\/div>\n<\/div>\n\n
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    • 2 of 60 VOXZOGO-treated patients (3%) each had one symptomatic episode of blood-pressure decrease with vomiting and\/or dizziness, compared with 0 of 61 patients (0%) on placebo1<\/sup><\/li>\n
    • 8 of 60 patients (13%) taking VOXZOGO had a total of 11 events, compared with 3 of 61 patients (5%) on placebo, who had 3 events1,3,<\/sup>*<\/li>\n
    • Changes in blood pressure were identified predominantly during periods of frequent vital signs monitoring at clinical visits after dosing over 1 year of treatment1<\/sup><\/li>\n
    • No clinically significant cardiovascular changes were observed\n
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      • 14 of 60 VOXZOGO-treated patients (23%) reported post-dose decreases in systolic blood pressure <70 mm Hg (+2x age), compared with 15 of 61 (25% on placebo)3<\/sup><\/li>\n
      • 10 of 60 VOXZOGO-treated patients (17%) reported post-dose decreases in diastolic blood pressure <40 mm Hg, compared with 6 of 61 (10%) on placebo3<\/sup><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n <\/div>\n <\/div>\n <\/div>\n<\/div>\n\n
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        \n\t\t \t\t\t

        References:\n<\/h4>\n\t\t\t\t\t\t
          \n
        1. VOXZOGO [package insert]. Novato, CA: BioMarin Pharmaceutical Inc; 2023.\n<\/span><\/li>\n
        2. Savarirayan R, Tofts L, Irving M, et al. Safe and persistent growth-promoting effects of vosoritide in children with achondroplasia: 2-year results from an open-label, phase 3 extension study. Genet Med<\/em>. 2021;23(12):2443-2447. doi:10.1038\/s41436-021-01287-7\n<\/span><\/li>\n
        3. Savarirayan R, Tofts L, Irving M, et al. Once-daily, subcutaneous vosoritide therapy in children with achondroplasia: a randomised, double-blind, phase 3, placebo-controlled, multicentre trial. Lancet<\/em>. 2020;396(10252):684-692. doi:10.1016\/S0140-6736(20)31541-5\n<\/span><\/li>\n <\/ol>\n\t\t\t\t\t<\/div>\n\t<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":4,"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":"\nSafety | VOXZOGO\u00ae (vosoritide) HCP<\/title>\n<meta name=\"description\" content=\"VOXZOGO safety has been evaluated in multiple clinical trials. 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