{"id":300,"date":"2022-09-26T23:05:58","date_gmt":"2022-09-26T23:05:58","guid":{"rendered":"https:\/\/naglazymehcp-dev-001.azurewebsites.net\/en-us\/naglazyme\/?page_id=300"},"modified":"2023-04-26T13:56:25","modified_gmt":"2023-04-26T13:56:25","slug":"infuse-naglazyme","status":"publish","type":"page","link":"https:\/\/hcp.biomarin.com\/en-us\/naglazyme\/infuse-naglazyme\/","title":{"rendered":"Infuse NAGLAZYME"},"content":{"rendered":"<div id=\"acf-block-6429eb03d4bf4\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-6429eb03d4c9d\" class=\"block-wysiwyg\">\n            <h1>Infuse NAGLAZYME<sup>\u00ae<\/sup> (galsulfase)<\/h1>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-6429eb03d4ccb\" class=\"block single-video\" 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\/662863369\" style=\"background-image: url(https:\/\/hcp.biomarin.com\/en-us\/naglazyme\/wp-content\/uploads\/sites\/2\/2022\/10\/vlcsnap-2022-10-04-14h43m14s253.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: Administering the NAGLAZYME (galsulfase) infusion \n<\/h2>\n\t\t\t\t\t\t\t\t                    <div class=\"supporting-text\">\n                        <p>Weekly NAGLAZYME treatment is life-long and compliance is critically important. However, venipuncture can be a painful procedure and can cause much anxiety in patients, especially children. Watch our video to learn how to make the treatment more comfortable. <\/p>\n\t\t\t\t    <\/div>\n                \t\t\t\t\t\t\t\t    <p class=\"duration\">09:44<\/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-6429eb03d4cdc\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-6429eb03d4d05\" class=\"block-wysiwyg\">\n            <h2>Equipment setup<\/h2>\n<p>Following are the steps for setting up the equipment for infusing NAGLAZYME. If you are using plain saline as a primary line, connect the NAGLAZYME tubing at the port closest to the patient.<\/p>\n<ol>\n<li>Prime the IV tubing with NAGLAZYME solution<\/li>\n<li>Attach a 0.2-\u03bcm in\u2010line filter to the end of the tubing and slowly prime the filter<\/li>\n<li>Prime tubing and filter SLOWLY to prevent foaming<\/li>\n<li>Be sure the drug administration tubing and filter are primed with drug solution (not plain saline). This will ensure that the correct volume is delivered in the first hour of infusion<\/li>\n<\/ol>\n<h2>Infusion rate<\/h2>\n<p>Use an infusion pump for NAGLAZYME administration.<\/p>\n<p>Infuse the total volume of NAGLAZYME solution over no less than 4 hours as follows:<\/p>\n<ul>\n<li>2.5% of the total NAGLAZYME solution volume in the first hour<\/li>\n<li>97.5% of the total volume over the next 3 hours<\/li>\n<\/ul>\n<h3>Infusion rate examples<\/h3>\n<p><strong>For 250-mL volume:<\/strong><br \/>\n6 mL\/hour for the first hour. If the infusion is well tolerated, the infusion rate can be increased to 80 mL\/hour for approximately 3 hours.<\/p>\n<p><strong>For 120-mL volume:<\/strong><br \/>\n3 mL\/hour for the first hour. If the infusion is well tolerated, the infusion rate can be increased to 39 mL\/hour for approximately 3 hours.<\/p>\n<p>Note: Patients and families often ask if the infusion can be administered in a shorter amount of time. For maximum safety and efficacy, do not administer NAGLAZYME at a faster rate than recommended.<\/p>\n    <\/div>\n\n<div id=\"acf-block-6429eb03d4d37\" class=\"block-wysiwyg\">\n            <h2>Patient monitoring during NAGLAZYME infusion<\/h2>\n<h3>What to monitor<\/h3>\n<p>Monitor vital signs:<\/p>\n<ul>\n<li>Prior to infusion<\/li>\n<li>Every hour during the infusion especially after increases in infusion rate<\/li>\n<li>At infusion completion<\/li>\n<li>Prior to discharge<\/li>\n<\/ul>\n<h3>What to look for<\/h3>\n<p>When monitoring vital signs, look for signs of infusion\u2010associated reactions (IARs), such as:<\/p>\n<ul>\n<li>Increase or decrease in heart rate<\/li>\n<li>Increase or decrease in respiratory rate<\/li>\n<li>Decrease in oxygen saturation (pulse oximetry)<\/li>\n<li>Increase or decrease in temperature<\/li>\n<\/ul>\n<p>Other mild reactions (including shivering, rashes, or swelling of the lips) may progress rapidly if not treated.<\/p>\n<h3>Be prepared for IARs<\/h3>\n<p>The first IARs occurred as late as 146 weeks in the clinical studies. Therefore it is important that:<\/p>\n<ul>\n<li>A physician be available or accessible by phone or pager<\/li>\n<li>The patient be monitored closely for IAR signs and symptoms<\/li>\n<li>Emergency procedures be in place in the event a severe IAR occurs<\/li>\n<li>Patients and\/or parents be educated and encouraged to report IAR symptoms\n<ul class=\"child_list\">\n<li>This is especially important for parents of younger patients who may not be able to self\u2010report IAR symptoms<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n    <\/div>\n\n<div id=\"acf-block-6429eb03d4d73\" class=\"block-wysiwyg\">\n            <h2>NAGLAZYME IARs<sup>1,2<\/sup><\/h2>\n<ul>\n<li>IARs occurred in 33 of 59 patients treated with NAGLAZYME\n<ul class=\"child_list\">\n<li>Initial reactions occurred as early as week 1 and as late as week 146<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li>The most frequent serious adverse events related to the use of NAGLAZYME occurred during infusions and included laryngeal edema, apnea, pyrexia, urticaria, respiratory distress, angioedema, and anaphylactoid reaction<\/li>\n<\/ul>\n<ul>\n<li>Severe symptoms included urticaria, chest pain, rash, dyspnea, apnea, laryngeal edema, and conjunctivitis<\/li>\n<li>The most common symptoms of IARs included:\n<ul class=\"child_list\">\n<li>Pyrexia, chills, rash, urticaria, dyspnea, nausea, vomiting, pruritus, erythema, abdominal pain, hypertension, and headache<\/li>\n<li>Respiratory distress, chest pain, hypotension, angioedema, conjunctivitis, tremor, and cough were also reported<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li>Because of the potential for IARs, patients should receive antihistamines with or without antipyretics prior to infusion\n<ul class=\"child_list\">\n<li>Despite these measures, 23 of 33 patients experienced recurrent IARs<\/li>\n<\/ul>\n<\/li>\n<li>Symptoms typically abated with slowing or interruption of infusion and additional antihistamines, antipyretics, and occasionally steroids<\/li>\n<\/ul>\n<h3>Special safety considerations for patients with airway obstruction<\/h3>\n<ul>\n<li>Patients with highly compromised upper airway disease warrant close monitoring during infusions<\/li>\n<li>Sleep apnea is common in MPS VI patients and antihistamine pretreatment may increase the risk of apneic episodes<\/li>\n<li>Caution should be exercised when administering prophylactic antihistamines as patients may have airway difficulty during deep sleep<\/li>\n<li>Use of continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) during infusion should be considered in patients with sleep apnea who are using positive airway pressure machines<\/li>\n<li>Evaluation of airway patency should be considered prior to initiation of treatment due to the increased risk of sleep apnea<\/li>\n<\/ul>\n    <\/div>\n\n<div id=\"acf-block-6429eb03d4da9\" class=\"block-wysiwyg\">\n            <h2>Manage IARs<\/h2>\n<h3>If an IAR occurs, stop the infusion promptly. Then:<\/h3>\n<ul>\n<li>Assess and appropriately manage the patient\u2019s symptoms<\/li>\n<li>Consider administration of additional antihistamines, antipyretics, and possibly corticosteroids<\/li>\n<\/ul>\n<p>If symptoms subside, consider restarting the infusion at a slower rate (eg, half the rate at which the IAR occurred).<\/p>\n<h3>Subsequent infusions may be managed with:<\/h3>\n<ul>\n<li>A slower rate of infusion<\/li>\n<li>Additional prophylactic antihistamines<\/li>\n<li>Antipyretics<\/li>\n<li>Possibly prophylactic corticosteroids<\/li>\n<\/ul>\n<p>The physician should evaluate the risks and benefits of readministering NAGLAZYME following a severe hypersensitivity or anaphylactic reaction.<\/p>\n<p><strong>Note: Caution should be exercised if epinephrine use is being considered in patients with MPS VI, due to increased prevalence of coronary artery disease.<\/strong><\/p>\n<p>Please see Important Safety Information below and <a href=\"https:\/\/hcp.biomarin.com\/en-us\/naglazyme\/wp-content\/uploads\/sites\/2\/2022\/09\/NaglazymePrescribingInformation.pdf?v=0.39\" target=\"_blank\" rel=\"noopener\">full Prescribing Information<\/a> for more information.<\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-6429eb03d4dd3\" class=\"block single-video\" 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\/662863369#t=3m11s\" style=\"background-image: url(https:\/\/hcp.biomarin.com\/en-us\/naglazyme\/wp-content\/uploads\/sites\/2\/2022\/10\/vlcsnap-2022-10-04-20h54m43s843.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: Managing infusion reactions\n<\/h2>\n\t\t\t\t\t\t\t\t                    <div class=\"supporting-text\">\n                        <p><strong>Potential Reactions<\/strong><\/p>\n<ul>\n<li>Decrease in oxygen saturation<\/li>\n<li>Increase or decrease in heart rate<\/li>\n<li>Increase or decrease in respiratory rate<\/li>\n<li>Increase or decrease in body temperature<\/li>\n<\/ul>\n<p>Other mild reactions may include shivering, rashes, or swelling of the lips.<\/p>\n\t\t\t\t    <\/div>\n                \t\t\t\t\t\t\t\t    <p class=\"duration\">09:44<\/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-6429eb03d4de1\" class=\"block wrapped-content\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-6429eb03d4df8\" class=\"block-wysiwyg\">\n            <h2>Postinfusion procedures<\/h2>\n<h3>After the infusion is complete:<\/h3>\n<ul>\n<li>Run normal saline to clear NAGLAZYME solution from tubing<\/li>\n<li>Obtain postinfusion vital signs<\/li>\n<li>Observe the patient for a postinfusion period specified by the treating physician<\/li>\n<li>Discard and dispose of infusion\u2010related materials in accordance with your institutional policies<\/li>\n<\/ul>\n<p><a href=\"https:\/\/hcp.biomarin.com\/en-us\/naglazyme\/dosing-and-infusion\/downloadable-infusion-resources\/\" rel=\"noopener\">Downloadable infusion resources for you and your patients \u00bb<\/a><\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<div id=\"acf-block-6429eb03d4e15\" 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                                                                                                                                                <li><span>Data on file. BioMarin Pharmaceutical Inc.\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-300","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Naglazyme HCP | Infuse Naglazyme<\/title>\n<meta name=\"description\" content=\"NAGLAZYME\u00ae (galsulfase) is indicated for patients with mucopolysaccharidosis VI (MPS VI; Maroteaux-Lamy syndrome)\" \/>\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\/naglazyme\/infuse-naglazyme\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Naglazyme HCP | Infuse Naglazyme\" \/>\n<meta property=\"og:description\" content=\"NAGLAZYME\u00ae (galsulfase) is indicated for patients with mucopolysaccharidosis VI (MPS VI; 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