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| Preparation and Storage |
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Kepivance® is supplied as a sterile, white, preservative-free,
lyophilized powder containing 6.25 mg of palifermin in a single-dose vial.
It must be reconstituted with 1.2 mL of Sterile Water for Injection, USP (not supplied) and is
provided in a dispensing pack containing 6 single-dose vials.1
Do not use Kepivance® beyond the date stamped on the vial label.1
Kepivance® lyophilized powder should only be reconstituted with Sterile Water
for Injection, USP (not supplied). Kepivance® should be reconstituted aseptically
by slowly injecting 1.2 mL of Sterile Water for Injection, USP (not supplied) to yield
a final concentration of 5 mg/mL. The contents should be swirled gently during dissolution.
Do not shake or vigorously agitate the vial.1
Generally, dissolution of Kepivance® takes less
than 3 minutes.1
PROTECT Kepivance® FROM LIGHT.1
The reconstituted solution contains no preservatives and is intended
for single use only. Following reconstitution, it is recommended
that the product be used immediately. If not used immediately, the reconstituted
solution of Kepivance® may be stored
refrigerated in its carton at 2° to 8°C (36° to 46°F) for
up to 24 hours. Prior to injection, Kepivance® may be allowed to reach
room temperature for a maximum of 1 hour but should be protected
from light. Discard Kepivance®
left at room temperature for more than 1 hour. Do not freeze
the reconstituted solution.1
The reconstituted solution should be clear and colorless. Visually inspect the solution
for discoloration and particulate matter before administration. Kepivance® should not be administered
if discoloration or particulates are observed.1
DO NOT FILTER the reconstituted
solution during preparation or administration.1
Kepivance® should only be administered by intravenous bolus injection.
If heparin is used to maintain an IV line, saline should be used to rinse the line
prior to and after administration of Kepivance® since Kepivance® has been shown to bind to heparin in vitro.1
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Kepivance® (palifermin) prescribing information. |
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ABOUT ORAL MUCOSITIS
ABOUT KEPIVANCE®
TOOLS AND RESOURCES
FOR NURSES
FOR PHARMACISTS
IMPORTANT PRODUCT SAFETY INFORMATION
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