{"id":294,"date":"2022-09-26T23:03:53","date_gmt":"2022-09-26T23:03:53","guid":{"rendered":"https:\/\/naglazymehcp-dev-001.azurewebsites.net\/en-us\/naglazyme\/?page_id=294"},"modified":"2023-04-19T16:29:07","modified_gmt":"2023-04-19T16:29:07","slug":"prepare-naglazyme","status":"publish","type":"page","link":"https:\/\/hcp.biomarin.com\/en-us\/naglazyme\/prepare-naglazyme\/","title":{"rendered":"Prepare NAGLAZYME"},"content":{"rendered":"<div id=\"acf-block-6429bdafc05b1\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-6429bdafc062e\" class=\"block-wysiwyg\">\n            <h1>Prepare NAGLAZYME<sup>\u00ae<\/sup> (galsulfase)<\/h1>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-6429bdafc0659\" class=\"block single-video block-tight-top block-tight-bottom\" data-muted-autoplay=\"false\">\n    <div class=\"wrapper\">\n\t\t<div class=\"video-poster\">\n\t\t\t<a class=\"modal-video permitted\" href=\"https:\/\/player.vimeo.com\/video\/662862938\" style=\"background-image: url(https:\/\/hcp.biomarin.com\/en-us\/naglazyme\/wp-content\/uploads\/sites\/2\/2022\/10\/vlcsnap-2022-10-04-14h12m07s476.png?v=0.33);\">Play<\/a>\n\t\t<\/div>\n\t\t<div class=\"video-details\">\n\t\t\t<div class=\"video-details-inner\">\n\t\t\t    \t\t\t\t    <h2 class=\"h3\">View video: Preparing NEGLAZYME<sup>\u00ae<\/sup>(galsulfase) for infusion\n<\/h2>\n\t\t\t\t\t\t\t\t                    <div class=\"supporting-text\">\n                        <p>NEGLAZYME is supplied as 5ml single use vials. Examine each vial before using. The solution should be clear to slightly opalescent and colorless to pale yellow. <strong>Do not use if the solution is discolored<\/strong>.<\/p>\n\t\t\t\t    <\/div>\n                \t\t\t\t\t\t\t\t    <p class=\"duration\">03:12<\/p>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"acf-block-6429bdafc0673\" 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-6429bdafc0693\" class=\"block-wysiwyg\">\n            <h2>Dose preparation<sup>1<\/sup><\/h2>\n<p>The recommended dose of NAGLAZYME<sup>\u00ae<\/sup> (galsulfase) is 1 mg\/kg of body weight administered once weekly as an IV infusion over <strong>no less than 4 hours<\/strong>. Calculate the patient\u2019s NAGLAZYME dose as follows:<\/p>\n<ul>\n<li>Determine the number of vials needed using the 2\u2010step algorithm below<\/li>\n<li>Round up to the next whole vial<\/li>\n<li>Remove the required number of vials from the refrigerator and allow them to reach room temperature\n<ul class=\"child_list\">\n<li>Do not allow vials to remain at room temperature longer than 24 hours prior to dilution. Do not heat or microwave vials<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h2>NAGLAZYME dosing algorithm<sup>1<\/sup><\/h2>\n    <\/div>\n\n<figure id=\"acf-block-6429bdafc06b2\">\n    <div class=\"image image-align-left\">\n                    <img decoding=\"async\" class=\"\" src=\"https:\/\/hcp.biomarin.com\/en-us\/naglazyme\/wp-content\/uploads\/sites\/2\/2022\/10\/dosing-algorithm.png?v=0.33\" alt=\"dosing algorithm\" \/>            <\/div>\n    <\/figure>\n\n<div id=\"acf-block-6429bdafc08b8\" class=\"block-wysiwyg\">\n            <p>Before withdrawing NAGLAZYME from the vial, visually inspect each vial for particulate matter and discoloration.<\/p>\n<p>The solution should be clear to slightly opalescent and colorless to pale yellow. Some translucency may be present in the solution. Do not use if the solution is discolored or if there is particulate matter in the solution. Do not freeze or shake vial.<sup>1<\/sup><\/p>\n<h2>Calculate total infusion volume<\/h2>\n<p>All MPS VI study patients, including those with weights as low as 14 kg, were infused using 250-mL total volume.<\/p>\n<p>Consider using a 100\u2010mL infusion bag for patients who are<sup>1<\/sup>:<\/p>\n<ul>\n<li>20 kg and under<\/li>\n<li>Susceptible to fluid overload due to pulmonary disease, cardiac valvular disease, or congestive heart failure<\/li>\n<\/ul>\n<h2>Prepare the NAGLAZYME infusion<\/h2>\n<p>For a 250\u2010mL infusion bag:<\/p>\n<ul>\n<li>Withdraw and discard a volume of the 0.9% Sodium Chloride Injection, USP, bag, equal to the volume of NAGLAZYME to be added<\/li>\n<\/ul>\n<p>For a 100\u2010mL infusion bag:<\/p>\n<ul>\n<li>Withdrawing and discarding of dose volume is not necessary<\/li>\n<li>Add the dose volume directly to the infusion bag<\/li>\n<\/ul>\n<p>Using an 18\u2010gauge non\u2010filter needle, slowly withdraw the calculated dose of NAGLAZYME from the appropriate number of vials, using caution to avoid excessive agitation, bubbles, and foaming.<\/p>\n<p>Slowly add the NAGLAZYME to the 0.9% Sodium Chloride Injection, USP, bag, angling the needle tip.<\/p>\n<p>Gently rotate the infusion bag to mix\u2014do not shake. Agitation may denature NAGLAZYME, rendering it biologically inactive. Therefore:<\/p>\n<ul>\n<li>Use care to avoid agitation of the solution<\/li>\n<li>Do not use a filter needle<\/li>\n<li>Do not shake the solution<\/li>\n<li>Do not use a pneumatic tube delivery system<\/li>\n<li>Do not use Volutrol or Buretrol straight IV tubing<\/li>\n<li>Avoid agitation<\/li>\n<\/ul>\n<p>Label the infusion bag per your institution\u2019s policy. Do not mix NAGLAZYME with other medicinal products.<sup>1<\/sup><\/p>\n<p>NAGLAZYME does not contain any preservatives; therefore, after dilution with saline in the infusion bag, any unused product or waste material should be discarded and disposed of in accordance with local requirements.<sup>1<\/sup><\/p>\n<p><a class=\"nxt_page\" href=\"https:\/\/hcp.biomarin.com\/en-us\/naglazyme\/infuse-naglazyme\/\">Step 4: Infuse NAGLAZYME \u00bb<\/a><\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-6429bdafc08ec\" 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> NAGLAZYME [package insert]. Novato, CA: BioMarin Pharmaceutical Inc; 2019.\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":""},"class_list":["post-294","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>Naglazyme HCP | Prepare Naglazyme<\/title>\n<meta name=\"description\" content=\"The recommended dose of NAGLAZYME is 1 mg\/kg of body weight, administered once weekly as an IV infusion over no less than 4 hours.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link 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