Kepivance® (palifermin) for injection is currently unavailable due to a regulatory delay, according to the Food and Drug Administration (FDA).
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. It is also approved as supportive care for preparative regimens predicted to result in WHO grade 3 or greater mucositis in the majority of patients.
The current shortage affects both the 3-pack (NDC 66658-112-03) and 6-pack (NDC 66658-112-06) presentations. The product is expected to be available again in October 2023.
- US Food and Drug Administration. FDA Drug Shortages. Accessed February 13, 2023. https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Palifermin+%28Kepivance%29+Lyophilized+Powder+for+Injection&st=c&tab=tabs-4&panels=0.
- Kepivance. Package insert. Stockholm, Sweden. Sobi; 2019. Accessed February 13, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125103s176lbl.pdf.