PALYNZIQ® (pegvaliase-pqpz) Injection is self-administered subcutaneously at home. It’s available in prefilled syringes at 3 different dosage strengths.1
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
*Additional time may be required prior to each dosage based on patient tolerability.
†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.
‡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.
PALYNZIQ should be increased to the next dose if the patient does not achieve a response during the recommended titration period.1
§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
The majority of patients who achieved a Phe level ≤120 µmol/L did so by following the recommended dosing schedule.3
References: 1. PALYNZIQ [package insert]. Novato, CA: BioMarin Pharmaceutical Inc; 2020. 2. 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. 2022;33:100918. doi:10.1016/j.ymgmr.2022.100918 3. Data on file. BioMarin Pharmaceutical Inc.
BOXED WARNING: RISK OF ANAPHYLAXIS
WARNINGS AND PRECAUTIONS
Anaphylaxis
Other Hypersensitivity Reactions
ADVERSE REACTIONS
Blood Phenylalanine Monitoring and Diet
DRUG INTERACTIONS
Effect of PALYNZIQ on Other PEGylated Products
USE IN SPECIFIC POPULATIONS
Pregnancy and Lactation
Pediatric Use
Geriatric Use
You are encouraged to report suspected adverse reactions to BioMarin at 1-866-906-6100, or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information, with Boxed Warning for risk of anaphylaxis, and Medication Guide here.
INDICATION
PALYNZIQ is a phenylalanine (Phe)-metabolizing enzyme indicated to reduce blood Phe concentrations in adult patients with phenylketonuria who have uncontrolled blood Phe concentrations greater than 600 micromol/L on existing management.