Source: FDA, National Drug Code (US) Revision Year: 2020
KRYSTEXXA (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.
KRYSTEXXA is intended for intravenous infusion.
KRYSTEXXA is a sterile, clear, colorless solution containing 8 mg/mL pegloticase in phosphate-buffered saline.
KRYSTEXXA (pegloticase) concentrations are expressed as concentrations of uricase protein. Each mL of KRYSTEXXA contains 8 mg of uricase protein (conjugated to 24 mg of 10 kDa mPEG), 2.18 mg Disodium Hydrogen Phosphate Dihydrate (Na2HPO4∙2H2O), 8.77 mg Sodium Chloride (NaCl), 0.43 mg Sodium Dihydrogen Phosphate Dihydrate (NaH2PO4∙2H2O), and Water for Injection to deliver 8 mg of pegloticase (as uricase protein).
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KRYSTEXXA is a clear, colorless, sterile 8 mg/mL solution of pegloticase in a 2 mL single-dose vial, expressed as amounts of uricase protein. KRYSTEXXA must be diluted prior to use. |
| How Supplied |
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KRYSTEXXA is supplied as a clear, colorless, sterile solution in phosphate buffered saline intended for intravenous infusion after dilution. KRYSTEXXA is supplied in a single-dose 2 mL glass vial with a Teflon coated (latex-free) rubber injection stopper to deliver KRYSTEXXA as 8 mg of uricase protein in 1 mL volume. NDC# 75987-080-10 |
| Drug | Countries | |
|---|---|---|
| KRYSTEXXA | Estonia, Lithuania, United States |
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