More than 350 patients over 10 years participated in the extensive clinical trial program that established efficacy, safety, and dosing regimen of PALYNZIQ® (pegvaliase-pqpz) Injection.1,2
*Patients were randomized 2:1 to either continue their randomized dosage of PALYNZIQ (20 mg or 40 mg once daily) or receive matching placebo.
Baseline patient demographics included patients with significantly elevated blood Phe levels >1200 µmol/L (20 mg/dL).3
ITT, intent-to-treat.
*A Phe-restricted diet is defined as >75% of protein intake from medical food.2
†The US recommendation for total protein intake from natural food is 0.8 g/kg for adults, which equals 56 g/day for a 70 kg person.1
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.