"A new consumer-friendly form ( is now available for making reports to MedWatch, the Food and Drug Administration's (FDA) on-line system for collecting information about serious problems with drugs, medical devices and other FDA-"...
(palifermin) for Injection, for Intravenous Use
Kepivance (palifermin) is a truncated human KGF produced by recombinant 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 use vial of Kepivance contains palifermin (6.25 mg),with L histidine (1.94 mg), mannitol (50 mg), polysorbate 20 (0.13 mg or 0.01% w/v), and sucrose (25 mg).
What are the possible side effects of palifermin (Kepivance)?
If you experience any of the following serious side effects from palifermin, seek emergency medical attention or contact your doctor immediately:
- breathing problems;
- skin and mucus membrane side effects such as rash, redness, swelling, itching, unusual sensations in the mouth, tongue color change, tongue thickening and changes in taste.
Other common side effects include:
- joint pain;
- increases in blood pancreas enzymes;
- increased blood pressure; or
- protein in the...
Last reviewed on RxList: 6/14/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Kepivance Information
Report Problems to the Food and Drug Administration
Find out what women really need.