SPL Set ID: 6e566303-d93a-4130-b764-25749829aa95

Pegloticase is a uric acid specific enzyme which is a PEGylated product that consists of recombinant modified mammalian urate oxidase (uricase) produced by a genetically modified strain of Escherichia coli. Uricase is covalently conjugated to monomethoxypoly (ethylene glycol) [mPEG] (10 kDa molecular weight). The cDNA coding for uricase is based on mammalian sequences. Each uricase subunit has a molecular weight of approximately 34 kDa per subunit. The average molecular weight of pegloticase (tetrameric enzyme conjugated to mPEG) is approximately 540 kDa. Ready-to-Use KRYSTEXXA (pegloticase) injection 8 mg/50 mL (0.16 mg/mL) single-dose vial is supplied as a sterile, preservative-free, clear and colorless solution intended for intravenous infusion and does not require further dilution. Each 8 mg/50 mL (0.16 mg/mL) single-dose vial contains 50 mL of deliverable volume including 8 mg of uricase protein (conjugated to 24 mg of 10 kDa mPEG), Disodium Hydrogen Phosphate Heptahydrate (109 mg), Sodium Chloride (438.5 mg), Sodium Dihydrogen Phosphate Monohydrate (13mg), and Water for Injection to deliver 8 mg of pegloticase (as uricase protein). To-be-Diluted KRYSTEXXA (pegloticase) injection 8 mg/mL single-dose vial is supplied as a sterile, preservative-free, clear and colorless solution intended for intravenous infusion after dilution. KRYSTEXXA (pegloticase) concentrations are expressed as concentrations of uricase protein. Each 8 mg/mL single-dose vial contains 1 mL of deliverable volume including 8 mg of uricase protein (conjugated to 24 mg of 10 kDa mPEG), Disodium Hydrogen Phosphate Dihydrate (2.18 mg), Sodium Chloride (8.77 mg), Sodium Dihydrogen Phosphate Dihydrate (0.43 mg), and Water for Injection to deliver 8 mg of pegloticase (as uricase protein).