Palifermin

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 in the setting of autologous 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. Kepivance was not effective in decreasing the incidence of severe mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of allogeneic hematopoietic stem cell support. Kepivance is not recommended for use with melphalan 200 mg/m 2 as a conditioning regimen.

KGF is an endogenous protein in the fibroblast growth factor (FGF) family that binds to the KGF receptor. Binding of KGF to its receptor has been reported to result in proliferation, differentiation, and migration of epithelial cells. The KGF receptor, one of four receptors in the FGF family, has been reported to be present on epithelial cells in many tissues examined including the tongue, buccal mucosa, esophagus, stomach, intestine, salivary gland, lung, liver, pancreas, kidney, bladder, mammary gland, skin (hair follicles and sebaceous gland), and the lens of the eye. The KGF receptor has been reported to not be present on cells of the hematopoietic lineage. Endogenous KGF is produced by mesenchymal cells and is upregulated in response to epithelial tissue injury.

Administer as an intravenous bolus injection at a dose of 60 mcg/kg/day for 3 consecutive days before and 3 consecutive days after myelotoxic therapy for a total of 6 doses. Administer the first 3 doses prior to myelotoxic therapy with the third dose 24 to 48 hours before myelotoxic therapy. Administer the last 3 doses after myelotoxic therapy is complete with the first of these doses on the day of hematopoietic stem cell infusion after the infusion is completed, and at least 7 days after the most recent administration of Kepivance

None None

Potential for stimulation of tumor growth — Kepivance is not indicated for non-hematologic tumors. The effects of Kepivance on stimulation of keratinocyte growth factor (KGF) receptor-expressing, non-hematopoietic tumors in patients are not known

Most common adverse reactions (incidence ≥20% and 5%≥placebo) are rash, fever, elevated serum amylase, pruritus, erythema, and edema

In vitro and in vivo data showed that palifermin interacts with unfractionated as well as low molecular weight heparins with no noticeable effect on the pharmacodynamics of either drug. If heparin is used to maintain an intravenous line, rinse the line with saline prior to and after Kepivance administration. Do not administer Kepivance 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. Heparin increases systemic exposure, flush intravenous line between heparin and Kepivance. Do not administer within 24 hours of myelotoxic chemotherapy.

Store Kepivance vials in the dispensing pack in its carton refrigerated at 2° to 8°C (36° to 46°F) until time of use. Protect from light.