PALYNZIQ is a daily at-home subcutaneous injection available in 3 different dosage strengths to help patients achieve their blood Phe goals1,2
- PALYNZIQ® (pegvaliase-pqpz) Injection is supplied in a prefilled syringe1
- Not auto-injectable
- PALYNZIQ should be refrigerated at 36°F (2°C) to 46°F (8°C) in the original carton to protect from light1
- PALYNZIQ can be safely stored in the original carton at room temperature between 68°F (20°C) to 77°F (25°C) for up to 30 days1
- On the carton, patients should record the date that they remove PALYNZIQ from the refrigerator
- Do not re-refrigerate once stored at room temperature
- PALYNZIQ doses can be individualized based on patient tolerability, blood Phe, and dietary needs1
PALYNZIQ dosage is gradually increased to help reach an optimal dose based on patient tolerability, blood Phe levels, and protein intake1
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.
In clinical trials, the majority of patients (89/118) achieved blood Phe levels ≤360 µmol/L. Of those who achieved ≤360 µmol/L following the titration schedule (58/118)2:
- 50% (29/58) achieved ≤360 µmol/L on a 20 mg dose
- 38% (22/58) achieved ≤360 µmol/L on a 40 mg dose
- 12% (7/58) achieved ≤360 µmol/L on a 60 mg dose
References: 1. PALYNZIQ [package insert]. Novato, CA: BioMarin Pharmaceutical Inc; 2020. 2. PALYNZIQ [instructions for use]. Novato, CA: BioMarin Pharmaceutical Inc; 2020.