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| Pharmacokinetics |
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The pharmacokinetics of Kepivance® were studied in healthy subjects and patients with hematologic
malignancies. After single IV doses of 20 to 250 mcg/kg (healthy subjects) and 60 mcg/kg (cancer patients),
Kepivance® concentrations declined rapidly (over 95% decrease) in the first 30 minutes post-dose. A slight
increase or plateau in concentration occurred at approximately 1 to 4 hours, followed by a terminal decline phase.
Kepivance® exhibited linear pharmacokinetics with extravascular distribution.
On average, total body clearance (CL) appeared to be 2- to
4-fold higher,
and volume of distribution at steady state (Vss) to be 2-fold higher in
cancer patients compared
with healthy subjects after a 60 mcg/kg single
dose of Kepivance®. The elimination half-life was similar between
healthy
subjects and cancer patients (average 4.5 hours with a range of 3.3 to 5.7 hours).
No accumulation of
Kepivance® occurred after 3 consecutive daily doses of
20 and 40 mcg/kg in healthy volunteers or 60 mcg/kg in cancer patients.1
| 1 |
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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