PALYNZIQ® Dosing & Administration

PALYNZIQ® Injection is a daily at-home subcutaneous injection available in 3 dosage strengths1

PALYNZIQ® is available in 3 different dosage strengths:1

  • 2.5 mg/0.5 mL single-dose prefilled syringe (white)
  • 10 mg/0.5 mL single-dose prefilled syringe (green)
  • 20 mg/mL single-dose prefilled syringe (blue)
 
  • PALYNZIQ® is supplied in a prefilled syringe intended for use as a single at-home subcutaneous injection1
  • PALYNZIQ® should be refrigerated at 2ºC to 8ºC1
  • PALYNZIQ® can be safely stored at room temperature in the original carton for up to 30 days1
    • Do not re-refrigerate once stored at room temperature (below 25°C)
    • Do not freeze

Recommended dosing regimen

  • There are 3 phases to the recommended dosing regimen for PALYNZIQ®: induction, titration, and maintenance1
  • The maximum daily dose of PALYNZIQ® is 60 mg1

The first injection must be performed under the supervision of a healthcare provider and patients must be closely observed for at least 1 hour following injection. Prior to self-injection, the patient's competency with self-administration must be confirmed.1

Additional time may be required between dose escalations based on patient tolerability.1

Individualise treatment achieve blood Phe levels of 120–600 µmol/L. Consider increasing to a maximum of 60 mg subcutaneously once daily in patients who have not achieved a response after at least 16 weeks of continuous treatment with 40 mg subcutaneously once daily.1

Therapeutic dosage is based on patient tolerability, blood Phe concentrations, and dietary Phe intake1

In clinical trials, consistent dietary Phe intake was recommended until therapeutic dosage was achieved2

  • Before initiating treatment, blood Phe levels must be obtained. Monitoring of blood phenylalanine level is recommended once a month1
  • Dietary Phe intake should remain consistent until a maintenance dosage is established1
  • Most patients were not on a Phe-restricted diet prior to and during the trials2
    • Patients’ total protein intake remained relatively stable throughout treatment, while dietary Phe intake increased2
  • If blood Phe levels are below 30 µmol/L, dietary protein intake should be increased to appropriate levels, and then, if needed, the dosage of PALYNZIQ® should be reduced1

A 20% reduction in blood Phe considered the first sign of response in clinical trials3

  • Treatment may be continued to reach individualised Phe targets once this threshold is met, based on patient tolerability1

References: 1. PALYNZIQ® Summary of Product Characteristics. 2. Thomas J et al. Mol Genet Metab 2018;124(1):27–38. 3. Harding CO et al. Mol Genet Metab 2018;124(1):20–26.