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).
Kepivance is a mucocutaneous epithelial human growth factor indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy requiring hematopoietic stem cell support. Kepivance is indicated as supportive care for preparative regimens predicted to result in ≥ WHO Grade 3 mucositis in the majority of patients.
Limitations of Use
The safety and efficacy of Kepivance have not been established in patients with non-hematologic malignancies [see Warnings and Precautions (5.1
Kepivance is not recommended for use with melphalan 200 mg/m2 as a conditioning regimen [See Clinical Studies].
Published Studies Related to Kepivance (Palifermin)
Palifermin reduces severe mucositis in definitive chemoradiotherapy of locally advanced head and neck cancer: a randomized, placebo-controlled study. [2011.07.10]
PURPOSE: Oral mucositis (OM) is a debilitating toxicity of chemoradiotherapy for head and neck cancer (HNC). This randomized, placebo-controlled, double-blind study evaluated the efficacy and safety of palifermin to reduce OM associated with definitive chemoradiotherapy for locally advanced HNC... CONCLUSION: Although palifermin reduced severe functional OM, its role in the management of locally advanced HNC during chemoradiotherapy remains to be elucidated.
Palifermin decreases severe oral mucositis of patients undergoing postoperative radiochemotherapy for head and neck cancer: a randomized, placebo-controlled trial. [2011.07.10]
PURPOSE: Radiochemotherapy of head and neck cancer causes severe mucositis in most patients. We investigated whether palifermin reduces this debilitating sequela... CONCLUSION: Palifermin reduced the occurrence of severe oral mucositis in patients with head and neck cancer undergoing postoperative radiochemotherapy. Additional clinical exploration of palifermin with postoperative radiochemotherapy would be useful.
Single-dose palifermin prevents severe oral mucositis during multicycle chemotherapy in patients with cancer: a randomized trial. [2010.09.21]
BACKGROUND: Mucositis can be a serious complication of cancer treatment. Palifermin reduces mucositis when given in multiple doses to patients undergoing hematopoietic stem-cell transplantation. OBJECTIVE: To evaluate the efficacy of palifermin given as a single dose before each cycle in patients receiving multicycle chemotherapy... CONCLUSION: A single dose of palifermin before each cycle reduced the incidence and severity of mucositis. The drug was generally well tolerated, but most patients experienced thickening of oral mucosa. Further investigation is needed to determine whether palifermin use will facilitate greater adherence to chemotherapy regimens by reducing mucositis.
Gut protection by palifermin during autologous haematopoietic SCT. [2009.05]
Conditioning therapy in connection with haematopoietic SCT (HSCT) induces a disruption of the intestinal barrier function facilitating the permeation of bacteria and endotoxin through the bowel wall with subsequent increased risk of septicaemia and a worsening of GVHD in the allogeneic setting.
Long-term follow-up of a phase I/II randomized, placebo-controlled trial of palifermin to prevent graft-versus-host disease (GVHD) after related donor allogeneic hematopoietic cell transplantation (HCT). [2008.09]
We previously conducted a randomized, double-blind, placebo-controlled study conducted from 2000 to 2003 of palifermin, a recombinant human keratinocyte growth factor, dosed from 240 microg/kg to 720 microg/kg, in 100 allogeneic hematopoietic stem cell transplantation (HCT) recipients... We conclude that the benefits of palifermin appear primarily to be limited to ameliorating mucotoxicity when given to allogeneic HCT recipients.
Clinical Trials Related to Kepivance (Palifermin)
Palifermin After Haploidentical PBSCT [Not yet recruiting]
This is a double blind, placebo controlled clinical trial, where patients with an advanced
form of blood cancer are treated with haploidentical allogeneic peripheral blood progenitor
cell (PBPC) transplant after which they are randomised to receive either placebo or a
keratinocyte growth factor (Palifermin or Kepivance®).
The function of Kepivance® is to stimulate the growth of epithelial cells. This drug has
also been suggested to have an ability to help improve the reconstitution, or development,
of the immune system after the transplantation.
The hypothesis is that the patients T-cell dependent humoral immune response to recall
antigen (PrevenarTM) will be higher in in palifermin treated patients than in the placebo
Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer [Recruiting]
RATIONALE: Growth factors, such as palifermin, may prevent chronic graft-versus-host disease
caused by donor stem cell transplant.
PURPOSE: This randomized clinical trial studies palifermin in preventing chronic
graft-versus-host disease in patients who have undergone donor stem cell transplant for
A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Subjects With Acute Leukemias Undergoing HSCT [Recruiting]
20010133 is an open-label, dose escalation study in pediatric patients with acute leukemias
receiving myelotoxic therapy (high dose etoposide, cyclophosphamide and total body
irradiation [TBI]) followed by hematopoietic stem cell transplant (HSCT). The study will
evaluate the safety and pharmacokinetics of palifermin in pediatric patients. Three doses
(40 μg/kg/day, 60 μg/kg/day, and 80 μg/kg/day) are be evaluated in each age group (1 to 2, 3
to 11, and 12 to 16 years, respectively) using a conventional dose escalation design.
Palifermin is administered for 3 consecutive days (Day - 10 to Day -8, respectively) before
the start of the conditioning regimen and for 3 consecutive days (Day 0 to Day +2) following
HSCT. Patients will be enrolled simultaneously to each age group to identify a safe, well
tolerated, efficacious dose in each age group. Patients will also be followed for secondary
malignancies, progression-free survival (PFS) and overall survival (OS) for a maximum of 10
Dose Escalation Study Of Palifermin in Pediatric Research Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation [Recruiting]
Mucositis is a well-known complication of both autologous and allogeneic hematopoietic stem
cell transplantation (HSCT). Many who suffer this disorder require total parental nutrition
and intravenous narcotics for pain control. Palifermin (Kepivance[TM]) is a human
keratinocyte growth factor that is produced by recombinant DNA technology in E. coli.
Palifermin is a FDA-approved, commercially available pharmacologic agent that is
manufactured by Amgen. As keratinocyte growth factor receptors have been found within the
epithelium of gastric mucosa, the use of palifermin has been proven to decrease the
frequency and duration of severe mucositis in adult studies. Whereas the appropriate dosing
regimen has been determined for adults at 60mcg/kg/day, the dosing of palifermin has not
been established in the pediatric setting. This initial pediatric study of palifermin will
determine the maximum tolerated dose, evaluating the use of this agent at three dose levels,
below, at, and above the recommended adult dose. Non-hematologic, life-threatening NCI
grade IV or grade V toxicities definitely related to the administration of palifermin from
the first infusion until day +6 after HSCT (post palifermin administration day +3) will
comprise the safety endpoints of the study.
The study is designed to evaluate palifermin at 3 dose levels. The study population will be
recipients of either a matched family member donor or matched unrelated donor HSCT. The
pharmacokinetics of palifermin at each dose level will be described to help determine the
appropriate dose for future studies, which will evaluate efficacy
Busulfan, Melphalan, and Fludarabine With Peri-transplant Palifermin, Followed by a T-Cell Depleted Hematopoietic Stem Cell Transplant From HLA Matched or Mismatched Related or Unrelated Donors in Patients With Advanced Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) [Recruiting]
The purpose of this study is to find out how good the addition of Palifermin to the
conditioning regimen for a T cell depleted allogeneic stem cell transplant is at lowering
the fatal infectious complications associated with the transplant. The conditioning regimen
is the treatment given before transplantation and will include busulfan, melphalan,
fludarabine, and anti-thymocyte globulin (ATG). An earlier study at this institution showed
that the same conditioning regimen without Palifermin and the same type of transplant was
safe and able to cure patients with MDS/AML. However, the success rate was lowered by fatal
infectious complications happening after the transplant. The new part of this study is the
addition of Palifermin before and after administration of the pre-transplant treatments to
lower these complications. The purpose of this study is also to find out the possible bad
side effects of this new regimen.