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| Precautions |
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The safety and efficacy of Kepivance® have not been established in patients with nonhematologic
malignancies. The effects of Kepivance® on stimulation of KGF receptorexpressing,
non-hematopoietic tumors in
patients are not known. Kepivance® has been
shown to enhance the growth
of human epithelial tumor cell lines in vitro and to increase
the rate of tumor
cell line growth in a human carcinoma xenograft model.1
Patients should be informed of the possible adverse effects of Kepivance® , including
muco-cutaneous adverse effects. These include rash, erythema, edema, pruritus,
oral/perioral dysesthesia, tongue discoloration, tongue thickening, and alteration of taste.
Patients should be instructed to report these adverse effects, or any other adverse
reactions, to the prescribing physician.
The safety and efficacy of Kepivance® have not been established in patients with nonhematologic
malignancies. Patients should be informed of the evidence of tumor growth
and stimulation in cell culture and in animal models of non-hematopoietic human tumors.1
No formal drug-drug interaction studies have been conducted for Kepivance® with drugs
that may be used in the intended patient population. Kepivance® has been shown to bind
to heparin in vitro. Therefore, if heparin is used to maintain an IV line, saline should be
used to rinse the line prior to and after Kepivance® administration.
Kepivance® should not be administered within 24 hours before, during infusion of, or
within 24 hours after administration of myelotoxic chemotherapy.
In a clinical trial,
administration of Kepivance® within 24 hours of chemotherapy resulted in increased
severity and duration of oral mucositis.1
Carcinogenicity: The carcinogenic potential of Kepivance® has not been evaluated in
long-term animal studies.
Mutagenicity: No clastogenic or mutagenic effects of Kepivance® were observed in the
Ames or mammalian chromosomal aberration assays; however, such studies are generally
not informative for biological products.
Impairment of Fertility: When Kepivance® was administered intravenously daily to
male and female rats prior to and during mating, reproductive performance, fertility, and
sperm assessment parameters were not affected at doses up to 100 mcg/kg/day. Systemic
toxicity (clinical signs of toxicity and/or body weight effects), decreased epididymal
sperm counts, and increased post-implantation loss were observed at doses
≥ 300 mcg/kg/day (5-fold higher than the recommended human dose). Increased preimplantation
loss and a decreased fertility index were observed at a Kepivance® dose of
1,000 mcg/kg/day.1
Kepivance® has been shown to be embryotoxic in rabbits and rats when given in doses
that are 2.5 and 8 times the human dose, respectively.
Increased post-implantation loss and decreased fetal body weights were observed when
Kepivance® was administered to pregnant rabbits from days 6 to 18 of gestation at IV
doses ≥ 150 mcg/kg/day (2.5-fold higher than the recommended human dose). However,
treatment with these doses was also associated with maternal toxicity (clinical signs and
reductions in body weight gain/food consumption). No evidence of developmental
toxicity was observed in rabbits at doses up to 60 mcg/kg/day.
Increased post-implantation loss, decreased fetal body weight and/or increased skeletal
variations were observed when Kepivance® was administered to pregnant rats from days
6 to 17 or 19 of gestation at IV doses 500 mcg/kg/day (> 8-fold higher than the
recommended human dose). Treatment with these doses was also frequently associated
with maternal toxicity (clinical signs and body weight effects). No evidence of
developmental toxicity was observed in rats at doses up to 300 mcg/kg/day.
There are no adequate and well-controlled studies in pregnant women. Kepivance®
should be used during pregnancy only if the potential benefit to the mother justifies the
potential risk to the fetus.1
It is not known whether Kepivance® is excreted in human milk. Because many drugs are
excreted in human milk caution should be exercised when Kepivance® is administered
to a nursing woman.1
The safety and effectiveness of Kepivance® in pediatric patients have not been
established.1
Clinical studies of Kepivance® did not include sufficient numbers of subjects age 65
years and over to determine whether they respond differently from younger subjects.
Among 409 patients with hematologic malignancies who received Kepivance® in clinical
studies, 9 (2%) were age 65. 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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