{"id":7101,"date":"2025-06-12T09:18:09","date_gmt":"2025-06-12T09:18:09","guid":{"rendered":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/?page_id=7101"},"modified":"2025-11-17T19:16:43","modified_gmt":"2025-11-17T19:16:43","slug":"trial-results-safety","status":"publish","type":"page","link":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/trial-results-safety\/","title":{"rendered":"Safety Data"},"content":{"rendered":"
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PALYNZIQ IS
\nBACKED BY A
\nWELL-ESTABLISHED
\nSAFETY PROFILE<\/span>\n<\/h1>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n\n
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Anaphylaxis has been reported after administration of PALYNZIQ®<\/sup> (pegvaliase-pqpz) Injection and may occur at any time during treatment1<\/sup><\/h2>\n

Hypersensitivity reactions other than anaphylaxis were reported in 72% (204\/285) of patients. Management should be based on the severity of the reaction, recurrence, and clinical judgment, and may include dosage adjustment, temporary drug interruption, or treatment with antihistamines, antipyretics, and\/or corticosteroids.1<\/sup><\/p>\n

Of all patients, only 1 in 10 experienced anaphylaxis, with all episodes resolving without sequelae1<\/sup><\/h2>\n <\/div>\n\n
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Serious injection site infections, including abscess, cellulitis, necrosis, and ulcers, have been reported.<\/h2>\n

Remind patients and caregivers about the importance of using aseptic injection techniques and rotating injection sites with each dose.<\/p>\n

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The majority of adverse reactions during the induction\/titration phase were mild to moderate in severity1,2<\/sup><\/h2>\n <\/div>\n\n
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15% of patients (44 of 285) discontinued treatment due to an adverse event1<\/sup><\/h3>\n

The most common adverse reactions leading to discontinuation were hypersensitivity reactions (6%)<\/strong>, including anaphylaxis (3%)<\/strong>, angioedema (1%)<\/strong>, arthralgia (4%)<\/strong>, generalized skin reactions<\/strong> lasting at least 14 days (2%)<\/strong>, and injection site reactions (1%)<\/strong>.1<\/sup><\/p>\n

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Effective management of the most common adverse reactions is possible with1<\/sup>:<\/h3>\n