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| Pharmacodynamics of Kepivance® |
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Epithelial cell proliferation was assessed by Ki67 immunohistochemical staining in healthy subjects. A 3-fold or greater increase in Ki67 staining was observed in buccal biopsies from 3 of 6 healthy subjects given Kepivance® at 40 mcg/kg/day IV for 3 days, when measured 24 hours after the third dose. Dose-dependent epithelial cell proliferation was observed in healthy subjects given single IV doses of 120 to 250 mcg/kg
48 hours post-dosing.1
The reported increase in cellular proliferation was based on increased epithelial thickness in buccal biopsies (Figure 1 & 2).2 Furthermore, markers of cellular proliferation (Ki67 and mitotic figures) measured in the buccal biopsies at baseline (pre-Kepivance® administration) and at 24, 48, and 72 hours post-dosing with Kepivance® were highest at 48 hours, and remained elevated compared with baseline at 72 hours post-dosing.3
Figure 1. Biological Activity of Human Buccal Mucosa - Pre-Kepivance® H & E3
Degeneration and thinning of epithelium
H & E = hematoxylin and eosin
Data on file.
Figure 2. Biological Activity of Human Buccal Mucosa - 24 Hrs Post-Kepivance® (40 mcg/kg/d for 3 days) H & E3
Increased thickness of epithelium;
increased basal-cell proliferation
H & E = hematoxylin and eosin
Data on file.
| 1 |
Kepivance® (palifermin) prescribing information.
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| 2 |
Farrell CL, Rex KL, Chen JN, et al. The effects of keratinocyte growth factor in preclinical models of mucositis. Cell Prolif. 2002;35(suppl 1):78-85. |
| 3 |
Data on file. |
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ABOUT ORAL MUCOSITIS
ABOUT KEPIVANCE®
TOOLS AND RESOURCES
FOR NURSES
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IMPORTANT PRODUCT SAFETY INFORMATION
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