SPL Set ID: 426f6e64-2c20-4a61-6d65-7320426f6e64

1 drug(s) with this SPL Set ID

Open DailyMed details

KEPIVANCE PALIFERMIN
(PALIFERMIN) 5.16 mg Injection
SWEDISH ORPHAN BIOVITRUM AB (PUBL) FDA Rx Only

Kepivance (palifermin) is a truncated human KGF produced by recominant DNA technology in 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 intravenous 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-dose vial of Kepivance contains palifermin (5.16 mg),with L histidine (1.60 mg), mannitol (41 mg), polysorbate 20 (0.11 mg or 0.01% w/v), and sucrose (21 mg).

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