Palifermin

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Palifermin
Names
Trade namesKepivance
Clinical data
Drug classKeratinocyte growth factor (KGF)[1][2]
Main usesInflamation of the mouth caused by chemotherapy[1]
Side effectsJoint pain, numbness, swelling, redness, pancreas inflammation[1]
Routes of
use
Intravenous bolus injection
Typical dose60 μg/kg/day[1]
External links
AHFS/Drugs.comMonograph
US NLMPalifermin
MedlinePlusa605017
Chemical and physical data
FormulaC721H1142N202O204S9
Molar mass16192.82 g·mol−1
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Palifermin, sold under the brand name Kepivance, is a medication used to treat inflamation of the mouth caused by chemotherapy.[1] Specifically it is used for blood cancers receiving high dose chemotherapy as part of autologous stem-cell transplantation.[3] It is given by injection into a vein.[1] It should not be given within 24 hours of chemotherapy.[1]

Common side effects include joint pain, numbness, swelling, redness, and pancreas inflammation.[1] Other concerns include increased growth of certain cancers.[1] It is a manufactured form of keratinocyte growth factor (KGF).[1][2]

Palifermin was approved for medical use in 2004.[1] While it was approved in Europe in 2005, this approval was subsequently withdrawn.[4] Use is not approved in Canada as of 2021.[5] In the United States a course of six doses cost about 17,700 USD as of 2021.[6]

Medical uses

When people with blood cancers (leukemia and lymphoma) receive high dose chemotherapy and radiation therapy to undergo bone marrow transplantation, they often get severe mucositis in the mouth.[7] Palifermin reduces the incidence and duration of severe mucositis[8][9] by protecting those cells and stimulating the growth of new epithelial cells to build up the mucosal barrier.

Dosage

The typical dose is 60 μg/kg/day.[10]

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.

Side effects

Common side effects often seen in conjunction with the use of palifermin include:

  • 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[10]

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 myelotoxic chemotherapy, as this could result in increased oral mucositis.[10]

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.[10]

Society and culture

Costs

Palifermin costs approximately 5,000 euros (423,760 Indian rupee) per treatment for a 70 kg patient.[11]

Sales

The worldwide profits for years the 2008–2011 are:

  • 2008: $5.7 million
  • 2009: $109.9 million
  • 2010: $94.8 million
  • 2011: $77.9 million[12]

Research

Palifermin is also being studied in the prevention and treatment of oral mucositis and difficulty swallowing in other types of cancer.[13]

Phase III

  • Study 2000162 (Randomized, double-blind, placebo-controlled). Intended to evaluate Palifermin efficacy in reducing oral mucositis in subjects with hematologic malignancy undergoing chemotherapy with autologous peripheral blood progenitor cell transplantation. Patients were administered with 3 daily, consecutive IV doses (or placebo) of Palifermin (60 micrograms/kg) before chemotherapy and Filgrastim (60 micrograms/kg) was administered after transplantation for three days consecutively. Efficacy was demonstrated in the drug versus the placebo.[14]

References

  1. 1.00 1.01 1.02 1.03 1.04 1.05 1.06 1.07 1.08 1.09 1.10 "Palifermin Monograph for Professionals". Drugs.com. Retrieved 22 October 2021.
  2. 2.0 2.1 Beaven AW, Shea TC (September 2007). "The effect of palifermin on chemotherapyand radiation therapy-induced mucositis: a review of the current literature". Supportive Cancer Therapy. 4 (4): 188–97. doi:10.3816/SCT.2007.n.014. PMID 18632516.
  3. "DailyMed - KEPIVANCE- palifermin injection, powder, lyophilized, for solution". dailymed.nlm.nih.gov. Retrieved 24 October 2021.
  4. "Kepivance". Retrieved 22 October 2021.
  5. Government of Canada, Health Canada (25 April 2012). "Drug Product Database Online Query". health-products.canada.ca. Retrieved 24 October 2021.
  6. "Kepivance Prices, Coupons & Patient Assistance Programs". Drugs.com. Retrieved 22 October 2021.
  7. 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.
  8. 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.
  9. 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. S2CID 11280180.[permanent dead link]
  10. 10.0 10.1 10.2 10.3 "Kepivance (Palifermin) Drug". RxList. June 2013.
  11. NEW DRUGS in TRANSPLANTATION Archived 2006-08-11 at WebCite, EBMT Meeting, France, March 2007 C. PAILLET, Pharmacist, Pharm D. C. RENZULLO, Pharmacist, Pharm D. Edouard Herriot Hospital, Lyon, FRANCE
  12. Biovitrum (2011). "Biovitrum Full Year Report" (PDF): 1–15. Cite journal requires |journal= (help)
  13. Kepivance entry in the public domain NCI Dictionary of Cancer Terms
  14. "Statistical Review(s)". Food and Drug Administration: 1–5. December 2004.

External links

External sites:
Identifiers: