{"id":7224,"date":"2025-06-17T13:01:57","date_gmt":"2025-06-17T13:01:57","guid":{"rendered":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/?page_id=7224"},"modified":"2026-04-15T11:04:00","modified_gmt":"2026-04-15T11:04:00","slug":"resources-rems","status":"publish","type":"page","link":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/resources-rems\/","title":{"rendered":"PALYNZIQ REMs"},"content":{"rendered":"<div id=\"acf-block-68516acba761b\" class=\"wrapper hero-wrapper\">\n    <div class=\"hero hero-no-overlay hero-wide-half\">\n                <div class=\"overlay\"><\/div>\n        <div class=\"wrapper\">\n            <div class=\"inner-wrapper\">\n                <div class=\"hero-content\">\n                    \n                                                                                    <h1>WHAT IS THE PALYNZIQ RISK EVALUATION AND MITIGATION STRATEGY <span class=\"alt\">(REMS)<\/span>?\n<\/h1>\n                                                                                                <\/div>\n            <\/div>\n        <\/div>\n    <\/div>\n    <\/div>\n\n<div id=\"acf-block-68516acba783e\" class=\"block wrapped-content block-tight-top block-zero-bottom\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-68516acba796f\" class=\"block-wysiwyg\">\n            <ul>\n<li><strong>A REMS is required<\/strong> by the FDA to ensure that the benefits of therapy outweigh the risks<\/li>\n<li><strong>The goal of the PALYNZIQ<sup>\u00ae<\/sup> (pegvaliase-pqpz) Injection REMS program<\/strong> is to mitigate the risk of anaphylaxis<sup>1<\/sup><\/li>\n<\/ul>\n    <\/div>\n        <\/div>\n    <\/div>\n        <\/div>\n\n<div id=\"acf-block-68516acba7b53\" class=\"block cards cards-2-col block-tight-top block-tight-bottom\">\n\t<div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t\t<div class=\"cards-title\">\n\t\t\t    \t\t\t\t\t\t\t<\/div>\n\t\t\t<div class=\"cards-wrapper\">\n\t\t\t    \n<div id=\"acf-block-68516acba8098\" class=\"card card-fixed-button\" data-muted-autoplay=\"false\">\n    \t    \n\n                    <img decoding=\"async\" class=\"card-image\" src=\"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/wp-content\/uploads\/sites\/3\/2025\/06\/stethoscope2.png?v=0.136\" alt=\"Healthcare provider enrolling in PALYNZIQ\u00ae REMS program to ensure safe PKU treatment. REMS enrollment process for PALYNZIQ\u00ae providers and patients.\" \/>        \n\t    <div class=\"card-content\">\n                \n                                                                                                            <h3 style=\"text-align: left\">Enroll yourself<\/h3>\n<ul>\n<li>Read the full Prescribing Information for PALYNZIQ<\/li>\n<li>Read the REMS Prescriber Guide<\/li>\n<li>Read the REMS Program Overview<\/li>\n<li>Complete the REMS Prescriber Knowledge Assessment<\/li>\n<li>Sign the REMS Prescriber Enrollment Form<\/li>\n<\/ul>\n                                                                                                                                                                                                                                                                        \n                                                                                        <\/div>\n                                <div class=\"card-actions\">\n                            \n                            <p><a class=\"button button-arrow\" href=\"https:\/\/www.palynziqrems.com\/#Main\" target=\"_blank\">Enroll now<\/a><\/p>\n                                                                                    <\/div>\n<\/div>\n\n<div id=\"acf-block-68516acba8110\" class=\"card card-fixed-button\" data-muted-autoplay=\"false\">\n    \t    \n\n                    <img decoding=\"async\" class=\"card-image\" src=\"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/wp-content\/uploads\/sites\/3\/2025\/06\/REMS-PAGE-ICONS_checklist.png?v=0.136\" alt=\"\" \/>        \n\t    <div class=\"card-content\">\n                \n                                                                                                            <h3 style=\"text-align: left\">Enroll each patient<\/h3>\n<ul>\n<li>Counsel your patient on the risks associated with PALYNZIQ, including the risk of anaphylaxis and the need for autoinjectable epinephrine\n<ul>\n<li>Prescribe autoinjectable epinephrine, and instruct patients on how to use it and to carry it with them at all times<\/li>\n<\/ul>\n<\/li>\n<li>Review the following with your patient:\n<ul>\n<li>REMS Patient Guide<\/li>\n<li>REMS Wallet Card<\/li>\n<li>REMS Safety Video<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n                                                                                                                                                                                                                                                                        \n                                                                                        <\/div>\n                                <div class=\"card-actions\">\n                            \n                            <p><a class=\"button button-arrow\" href=\"https:\/\/www.palynziqrems.com\" target=\"_blank\">Click here to view REMS resources<\/a><\/p>\n                                                                                    <\/div>\n<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"acf-block-69b93360313c3\" class=\"block boxed-content block-tight-top boxed-content-white\">\n\t<div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t\t<div class=\"box\">\n\t\t\t\t\t\t\t\t\n<div id=\"acf-block-69b9336031483\" class=\"block-wysiwyg\">\n            <p>Visit <a href=\"https:\/\/www.palynziqrems.com\/#Main\" target=\"_blank\" rel=\"noopener\">PALYNZIQREMS.com<\/a> or submit signed completed forms by fax or mail to PALYNZIQ REMS:<\/p>\n<p><strong>Phone:<\/strong> 1-855-758-REMS (1-855-758-7367)<br \/>\n<strong>Fax:<\/strong> 1-866-713-8421<br \/>\n<strong>PALYNZIQ REMS, 200 Pinecrest Plaza, Morgantown, <\/strong><strong>WV 26505<\/strong><\/p>\n<p><a class=\"button button-arrow\" href=\"https:\/\/www.palynziqrems.com\/#Main\" target=\"_blank\" rel=\"noopener\">Visit PALYNZIQREMS.com to enroll<\/a><\/p>\n    <\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div id=\"acf-block-686fb6253d167\" class=\"block wrapped-content bg-band bg-band-gradient block-zero-bottom\">\n    <div class=\"wrapper\">\n        <div class=\"inner-wrapper\">\n                \n<div id=\"acf-block-686fb6253d2cc\" class=\"block-wysiwyg references\">\n            <p><small><strong>Reference: 1.<\/strong> PALYNZIQ package insert. Novato, CA: BioMarin Pharmaceutical Inc; February 2026.<\/small><\/p>\n    <\/div>\n        <\/div>\n    <\/div>\n        <\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":5,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"template-full-gradient-bg-page.php","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-7224","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>PALYNZIQ\u00ae REMS Program | Enrollment<\/title>\n<meta name=\"description\" content=\"Learn about the PALYNZIQ\u00ae Risk Evaluation and Mitigation Strategy (REMS) and get enrolled.\" \/>\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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