pegvaliase - Medications

Pegvaliase-pqpz is a phenylalanine-metabolizing enzyme that is composed of recombinant phenylalanine ammonia lyase (rAvPAL) conjugated to N-hydroxysuccinimide (NHS)-methoxypolyethylene glycol (PEG). rAvPAL is manufactured in Escherichia coli bacteria transformed with a plasmid containing the phenylalanine ammonia lyase (PAL) gene derived from Anabaena variabilis . During the rAvPAL manufacturing process, fermentation is carried out in nutrient medium containing the antibiotic kanamycin. However, kanamycin is cleared in the manufacturing process and is not detectable in the final product. rAvPAL is a homotetrameric protein with a molecular weight of 62 kD per monomer. To produce pegvaliase-pqpz, an average of nine (9) 20 kD PEG molecules are covalently bound (or conjugated) to each monomer of rAvPAL. The total molecular weight of pegvaliase‑pqpz (rAvPAL‑PEG) is approximately 1000 kD. Palynziq (pegvaliase‑pqpz) injection, intended for subcutaneous injection, is a clear to slightly opalescent, colorless to pale yellow, sterile, preservative-free solution and is formulated at pH 6.6 to 7.4. Palynziq is provided in a single-dose prefilled syringe and is available in three dosage strengths: 2.5 mg/0.5 mL, 10 mg/0.5 mL, and 20 mg/mL. Palynziq contents for each dosage strength are summarized in Table 4. Table 4: Contents of Palynziq Strength Total Contents per Prefilled Syringe Palynziq 2.5 mg/0.5 mL prefilled syringe 2.5 mg pegvaliase-pqpz (expressed as the amount of rAvPAL conjugated to 7.25 mg of 20 kD PEG in 0.5 mL Water for Injection, USP) and contains the following inactive ingredients: sodium chloride (for tonicity adjustment), trans-cinnamic acid (0.07 mg), and tromethamine and tromethamine hydrochloride (for pH adjustment). Palynziq 10 mg/0.5 mL prefilled syringe 10 mg pegvaliase-pqpz (expressed as the amount of rAvPAL conjugated to 29 mg of 20 kD PEG in 0.5 mL Water for Injection, USP) and contains the following inactive ingredients: sodium chloride (for tonicity adjustment), trans-cinnamic acid (0.07 mg), and tromethamine and tromethamine hydrochloride (for pH adjustment). Palynziq 20 mg/mL prefilled syringe 20 mg pegvaliase-pqpz (expressed as the amount of rAvPAL conjugated to 58 mg of 20 kD PEG in 1 mL Water for Injection, USP) and contains the following inactive ingredients: sodium chloride (for tonicity adjustment), trans-cinnamic acid (0.15 mg), and tromethamine and tromethamine hydrochloride (for pH adjustment).