Source: FDA, National Drug Code (US) Revision Year: 2020
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 mLprefilled 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). |
| Dosage Forms and Strengths |
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Palynziq is a clear to slightly opalescent, colorless to pale yellow solution available as follows:
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| How Supplied | |||||||||
|---|---|---|---|---|---|---|---|---|---|
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Palynziq (pegvaliase-pqpz) injection is supplied as a preservative-free, sterile, clear to slightly opalescent, colorless to pale yellow solution. All dosage strengths of Palynziq are provided in a 1 mL glass syringe with a 26 gauge, 0.5 inch needle. Each carton contains 1 or 10 trays with single-dose prefilled syringe(s), Prescribing Information, Medication Guide, and Instructions for Use. The following packaging configurations are available. Table 6. Palynziq Packaging Configurations:
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| Drug | Countries | |
|---|---|---|
| PALYNZIQ | Austria, Estonia, France, Croatia, Ireland, Italy, Japan, Lithuania, Poland, United States |
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