Clinical data
AHFS/ Monograph
MedlinePlus a605017
Routes of
intravenous bolus injection
ATC code V03AF08 (WHO)
CAS Number 162394-19-6 YesY
DrugBank DB00039 YesY
ChemSpider none
UNII QMS40680K6 YesY
ECHA InfoCard 100.118.147
Chemical and physical data
Formula C721H1142N202O204S9
Molar mass 16192.7 g/mol
 NYesY (what is this?)  (verify)

Palifermin (trade name Kepivance, marketed by Biovitrum) is a truncated human recombinant keratinocyte growth factor (KGF)[1] produced in Escherichia coli. KGF stimulates the growth of cells that line the surface of the mouth and intestinal tract.[2]

Therapeutic use(s)

When patients with blood cancers (leukemia and lymphoma) receive high dose chemotherapy and radiation therapy to undergo bone marrow transplantation, they usually get severe oral mucositis.[3] Palifermin reduces the incidence and duration of severe oral mucositis[4][5] by protecting those cells and stimulating the growth of new epithelial cells to build up the mucosal barrier.

Palifermin is also being studied in the prevention and treatment of oral mucositis and dysphagia (difficulty swallowing) in other types of cancer.[2]

Drug target/mechanism of action

Keratinocyte growth factor (KGF) resides in the family of fibroblast growth factor (FGF). The drug’s target is the KGF receptor. Through the binding of this drug to the aforementioned receptor, Palifermin stimulates epithelial cell proliferation, differentiation, and upregulation of cytoprotective mechanisms to reduce the symptoms of oral mucositis.[6]

Side effects

Common side effects often seen in conjunction with the use of Palifermin include, but are not limited to:

  • Swelling
  • Pain (including joint pain)
  • Increase in blood pancreas enzymes
  • Increased blood pressure
  • Proteinuria

Some of the more serious side effects can be seen below:

  • Difficulty breathing
  • Changes in cutaneous or mucous membrane appearance/feel (redness/rash, swelling, itching, change in color or thickness of tongue, changes in taste)
  • Fever[6]


Palifermin is administered via intravenous bolus injection. The drug comes as a lyophilized powder that must be reconstituted with sterile water for injection before it may be administered. It is given for three days before, and three days after chemotherapy is undergone. However, it is important that the drug is not administered within 24 hours of the actual chemotherapy process. This drug is most commonly dosed in a hospital setting, but can be taken at home as per specific instructions regarding preparation and storage from a doctor. The recommended dosage consists of 60 µg/kg/day.[6]

Drug interactions

Co-administration of Palifermin with Heparin should be avoided. Drug interactions with Heparin include a significantly increased systemic exposure to Palifermin. Avoid administration of Palifermin within 24 hours of myeltoxic chemotherapy, as this could result in increased oral mucositis.[6]

Pre-clinical trials

Toxicology studies

Toxicology studies were conducted by use of animal models, utilizing a variety of species, including mice, rats, and monkeys. Singles doses in rats and monkeys were given up to 30,000 and 50,000 micrograms/kg, respectively. Daily doses of 1,000 and 300 micrograms/kg, respectively, were given to rats and monkeys for 28 consecutive days. Toxic effects noted included exaggerated pharmacological effects of the drug, such as hyperkeratosis of skin and tongue and goblet cell hyperplasia in the GI tract. It was noted that the rats were more sensitive to these effects than the monkeys. Induced genetic abnormality assays including microchromosome reverse mutation and E. coli mutagenicity assays were completed using mice. There were no genotoxic effects noted from this study.[7]

Clinical trials

Phase I

Phase II

Phase III


Palifermin costs approximately 5,000 euros (423,760 Indian rupee) per treatment for a 70 kg patient.[10]

Annual sales

The worldwide profits for years the 2008–2011 are provided below.


  1. Beaven AW, Shea TC (September 2007). "The effect of palifermin on chemotherapyand radiation therapy-induced mucositis: a review of the current literature". Support Cancer Ther. 4 (4): 188–97. doi:10.3816/SCT.2007.n.014. PMID 18632516.
  2. 1 2 Kepivance entry in the public domain NCI Dictionary of Cancer Terms
  3. Blijlevens N, Sonis S (May 2007). "Palifermin (recombinant keratinocyte growth factor-1): a pleiotropic growth factor with multiple biological activities in preventing chemotherapy- and radiotherapy-induced mucositis". Ann. Oncol. 18 (5): 817–26. doi:10.1093/annonc/mdl332. PMID 17030544.
  4. Spielberger R, Stiff P, Bensinger W, et al. (December 2004). "Palifermin for oral mucositis after intensive therapy for hematologic cancers". N. Engl. J. Med. 351 (25): 2590–8. doi:10.1056/NEJMoa040125. PMID 15602019.
  5. McDonnell AM, Lenz KL (January 2007). "Palifermin: role in the prevention of chemotherapy- and radiation-induced mucositis". Ann Pharmacother. 41 (1): 86–94. doi:10.1345/aph.1G473. PMID 17190850.
  6. 1 2 3 4 "Kepivance (Palifermin) Drug". RxList. June 2013.
  7. "Pharmacology Review(s)". Food and Drug Administration: 1–4. 2004.
  8. "Clinical Pharmacology and Biopharmaceutics Review". Food and Drug Administration: 51–58. November 2004.
  9. 1 2 "Statistical Review(s)". Food and Drug Administration: 1–5. December 2004.
  10. NEW DRUGS in TRANSPLANTATION, EBMT Meeting, France, March 2007 C. PAILLET, Pharmacist, Pharm D. C. RENZULLO, Pharmacist, Pharm D. Edouard Herriot Hospital, Lyon, FRANCE
  11. Biovitrum (2011). "Biovitrum Full Year Report" (PDF): 1–15.
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