Kepivance® (palifermin) is a human keratinocyte growth factor (KGF) produced by recombinant DNA technology in Escherichia coli (E coli). Kepivance® is a water-soluble, 140 amino acid protein with a molecular weight of 16.3 kilodaltons. It differs from endogenous human KGF in that the first 23 N-terminal amino acids have been deleted to improve protein stability.

Kepivance® is supplied as a sterile, white, preservative-free, lyophilized powder for IV injection after reconstitution with 1.2 mL of Sterile Water for Injection, USP. Reconstitution yields a clear, colorless solution of Kepivance® (5 mg/mL) with a pH of 6.5. Each single-use vial of Kepivance® contains 6.25 mg palifermin, 50 mg mannitol, 25 mg sucrose, 1.94 mg L-histidine, and 0.13 mg polysorbate 20 (0.01% w/v).

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