ACMG recommends maintaining blood Phe levels below 360 μmol/L (6 mg/dL) for patients with PKU2

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Get started todaySignificant blood Phe reduction is possible with PALYNZIQ1

A Phe-restricted diet* is not required in conjunction with PALYNZIQ. The majority of patients were not on a Phe-restricted diet* prior to and during the study.1
- 57% (149 of 261) were taking medical food and 16% (41 of 261) were on a Phe-restricted diet

A cross-sectional analysis showed that 66% (57 of 86) of patients had blood Phe levels ≤360 µmol/L at 24 months, and 50% (43 of 86) of the patients had blood Phe levels ≤120 µmol/L at 24 months.1

The majority of patients (89/118) achieved blood Phe levels ≤360 µmol/L, with 50% of them achieving this level by 10 months in the study.1,3

Frequency of hypersensitivity reactions decreased over time from induction/titration to maintenance phases, despite increasing dose.1,4
- 10% (29 of 285) of patients experienced a total of 42 anaphylaxis episodes1
- Most common adverse reactions (at least 20% in either treatment phase) were: injection site reactions, arthralgia, hypersensitivity reactions, headache, generalized skin reactions lasting at least 14 days, nausea, abdominal pain, vomiting, cough, oropharyngeal pain, pruritus, diarrhea, nasal congestion, fatigue, dizziness, and anxiety1
A Phe-restricted diet is defined as >75% of protein intake from medical food.1
References: 1. PALYNZIQ [package insert]. Novato, CA: BioMarin Pharmaceutical Inc; 2020. 2. Vockley J, Andersson HC, Antshel KM, et al; for the American College of Medical Genetics and Genomics Therapeutic Committee. Phenylalanine hydroxylase deficiency: diagnosis and management guideline. Genet Med. 2014;16(2):188-200. 3. Data on file. BioMarin Pharmaceutical Inc. 4. Gupta S, Lau K, Harding CO, et al. Association of immune response with efficacy and safety outcomes in adults with phenylketonuria administered pegvaliase in phase 3 clinical trials. EBioMedicine. 2018;37:366-373.