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Pegvaliase Dosage

Medically reviewed by Drugs.com. Last updated on Jun 1, 2023.

Applies to the following strengths: 2.5 mg/0.5 mL; 20 mg/mL; 10 mg/0.5 mL

Usual Adult Dose for Phenylketonuria

INDUCTION: 2.5 mg subcutaneously once a week for 4 weeks

RECOMMENDED TITRATION SCHEDULE:
Week 1: 2.5 mg subcutaneously twice a week
Week 2: 10 mg subcutaneously once a week
Week 3: 10 mg subcutaneously twice a week
Week 4: 10 mg subcutaneously four times a week
Week 5: 10 mg subcutaneously once a day
Week 6: 20 mg subcutaneously once a day
MAINTENANCE DOSE: 20 to 60 mg subcutaneously once a day; maintenance dose should be individualized to achieve blood phenylalanine control (blood phenylalanine concentrations less than or equal to 600 micromol/L)
MAXIMUM DOSE:

Comments:

Use: To reduce blood phenylalanine concentrations in patients with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

PREMEDICATION:


FOR READMINISTRATION FOLLOWING ANAPHYLAXIS:

Phenylalanine Concentration Below 30 micromol/L:

Blood Level Monitoring:

Diet:

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for Palynziq. It includes element to assure safe use and an implementation system. For additional information: www.accessdata.fda.gov/scripts/cder/rems/index.cfm

US BOXED WARNING: RISK OF ANAPHYLAXIS


CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:


Missed dose: If a dose is missed, take next dose as scheduled; do not take 2 doses to make-up for the missed dose

Storage requirements:

General:

Monitoring:

Patient advice:

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.