{"id":2916,"date":"2022-09-04T17:58:18","date_gmt":"2022-09-04T17:58:18","guid":{"rendered":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/?page_id=2916"},"modified":"2026-04-15T10:58:40","modified_gmt":"2026-04-15T10:58:40","slug":"dosing-administration","status":"publish","type":"page","link":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/dosing-administration\/","title":{"rendered":"Dosing & Administration"},"content":{"rendered":"
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DOSING CAN BE
\nADAPTED BASED ON
\nPATIENT RESPONSE1<\/sup><\/span>\n<\/h1>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n\n
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Patients can self-inject PALYNZIQ\u00ae<\/sup> (pegvaliase-pqpz) at home<\/h2>\n

PALYNZIQ is a daily, at-home subcutaneous injection for PKU. It\u2019s available in prefilled syringes at 3 different dosage strengths.1<\/sup><\/p>\n <\/div>\n\n

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Dosing is gradually increased to help reach an optimal dose based on tolerability, Phe levels, and dietary protein intake. The first injection must be performed under the supervision of a healthcare provider to monitor for signs of anaphylaxis.1<\/sup><\/p>\n

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PALYNZIQ should be increased to the next dose if the patient does not achieve a response during the recommended titration period.1<\/sup><\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/blockquote>\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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Dosage can be decreased after efficacy is achieved2<\/sup><\/h2>\n <\/div>\n\n
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The majority of adults who achieved a Phe level \u2264120 \u00b5mol\/L did so by following the recommended dosing schedule.1,3<\/sup><\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/blockquote>\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\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n

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See storage instructions for PALYNZIQ\n<\/h2>\n <\/div>\n
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Storage instructions for PALYNZIQ1<\/sup><\/h3>\n
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  • PALYNZIQ is supplied in a prefilled syringe and is not<\/em> autoinjectable1<\/sup><\/li>\n
  • Refrigerate PALYNZIQ at 36\u00ba F (2\u00ba C)<\/strong> to 46\u00ba F (8\u00ba C)<\/strong> in the original carton to protect from light1<\/sup><\/li>\n
  • PALYNZIQ can be safely stored in the original carton at room temperature between 68\u00ba F (20\u00ba C)<\/strong> and 77\u00ba F (25\u00ba C)<\/strong> for up to 30 days1<\/sup>\n
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    • On the carton, patients should record the date that they remove PALYNZIQ from the refrigerator<\/li>\n
    • Do not re-refrigerate once stored at room temperature<\/li>\n<\/ul>\n<\/li>\n
    • PALYNZIQ maintenance doses can be individualized based on patient tolerability, Phe levels, and dietary needs1<\/sup><\/li>\n<\/ul>\n \n <\/div>\n <\/div>\n \t\t<\/div>\n\t<\/div>\n<\/div>\n <\/div>\n <\/div>\n <\/div>\n\n
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      *Additional time may be required prior to each dosage based on patient tolerability.1<\/sup>
      \n\u2020<\/sup>Individualize treatment to the lowest effective and tolerable dose. Consider increasing to 40 mg once daily in patients who have not achieved a response with 20 mg once daily continuous treatment for at least 24 weeks. Consider increasing to a maximum of 60 mg once daily in patients who have not achieved a response with 40 mg continuous treatment for at least 16 weeks.1<\/sup>
      \n\u2021<\/sup>Discontinue PALYNZIQ in patients who have not achieved an adequate response after 16 weeks of continuous treatment at the maximum dose of 60 mg once daily.1<\/sup>
      \n\u00a7<\/sup>Based on real-world evidence from an extended follow-up sample of 483 patients with 12 months or more between the first dispense of their maximum prescribed dose and last dispense.2<\/sup><\/p>\n

       <\/p>\n

      References: 1.<\/strong> PALYNZIQ package insert. Novato, CA: BioMarin Pharmaceutical Inc; February 2026. 2.<\/strong> Lah M, Cook K, Gomes DA, et al. Real-world treatment, dosing, and discontinuation patterns among patients treated with pegvaliase for phenylketonuria: evidence from dispensing data. Mol Genet Metab Rep<\/em>. 2022;33:100918. doi:10.1016\/j.ymgmr.2022.100918 3.<\/strong> Data on file. BioMarin Pharmaceutical Inc.<\/p>\n <\/div>\n <\/div>\n <\/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":""},"class_list":["post-2916","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nPALYNZIQ\u00ae Dosing & Administration | Recommended Schedule<\/title>\n<meta name=\"description\" content=\"Review the stepwise dosing schedule from induction and titration to maintenance.\" \/>\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\/palynziq\/dosing-administration\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" 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