- Medicine Name: Palynziq
- Generic Name: Pegvaliase-pqpz
- Dosage Form & Strength: Injection: 2.5 mg/0.5 mL, 10 mg/0.5 mL, & 20 mg/mL in a single-dose
- Manufactured By: BioMarin Pharmaceutical Inc.
Palynziq is a phenylalanine (Phe)-metabolizing enzyme used to reduce blood Phe concentrations in adult patients with phenylketonuria (PKU) who have uncontrolled blood Phe concentrations greater than 600 micromol/L on existing management.
Recommended Dosage: Therapy with Palynziq injection should be managed by a health specialist experienced in the management of PKU. Baseline blood phenylalanine concentration needs to be obtained prior to initiating therapy.
The recommended injection sites for Palynziq are: the front middle of thighs and the abdomen at least 2 inches (5 centimeters) away from the navel. In case a caregiver is giving Palynziq, the top of the buttocks and the back of the upper arms can also be considered.
Induction: The recommended initial induction dosage for medicine Palynziq is 2.5 mg administered subcutaneously once weekly for 4 weeks. The initial dose needs to be administered under the supervision of a health specialist.
Titration: Titrate the dosage of Palynziq injection in a step-wise manner, depending on tolerability, over at least five weeks, to achieve a dosage of 20 mg subcutaneously once daily.
Maintenance: Therapeutic response may not be achieved until the respective patient is titrated to a useful maintenance dosage of Pegvaliase-pqpz. Consider the lowest and tolerated dosage of Pegvaliase-pqpz.
Assess patient tolerability, blood phenylalanine concentrations, and dietary protein and phenylalanine intake throughout the therapy.
Individualize the maintenance dosage of Palynziq to achieve blood phenylalanine control (blood phenylalanine concentrations ≤ 600 micromol/L), taking into account patient tolerability to Palynziq and dietary protein intake.
Maintain the Palynziq dosage at 20 mg once in a day for at least 24 weeks. Consider increasing the dosage to 40 mg once in a day in those who have been on Palynziq 20 mg once in a day continuously for at least 24 weeks without achieving blood phenylalanine control. Consider increasing the dosage to a maximum of 60 mg once in a day in those who have been on 40 mg once in day continuously for at least 16 weeks without achieving blood phenylalanine control.
Missed Dose: If a dose of Palynziq is missed, instruct patients to take their very next dose as scheduled and to not take a couple of doses of Palynziq to make up for the missed dose.
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