The first injection must be performed under the supervision of a healthcare provider.1
*Additional time may be required prior to each dosage escalation based on patient tolerability.
†Individualize treatment to the lowest effective and tolerated dosage. 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 once daily continuous treatment for at least 16 weeks. The first injection must be performed under the supervision of a healthcare provider.1
‡Discontinue PALYNZIQ in patients who have not achieved an adequate response after 16 weeks of continuous treatment at the maximum dosage of 60 mg once daily. The interpretation of ‘adequate response’ is left up to the discretion of the healthcare provider.
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.