Prescription medicine
Palifermin Brand names: Kepivance
Palifermin (Kepivance) is a prescription medicine with an FDA approval on record since 2004. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the palifermin FDA label on DailyMed (effective December 17, 2025, Swedish Orphan Biovitrum AB (publ)); the BLA 125103 record on Drugs@FDA; every palifermin label on DailyMed.
Highlights of the record
FDA label of December 17, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageKepivance 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.
Forms and strengths
- 5.16 mg/1.2ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- December 15, 2004 Kepivance, Biovitrum Ab; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 389 through July 30, 2026
What is palifermin used for?
From the label: indications and usageKepivance 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. […]
FDA pharmacologic class: Mucocutaneous Epithelial Cell Growth Factor.
Source: FDA drug label (KEPIVANCE), Swedish Orphan Biovitrum AB (publ), effective December 17, 2025 (SPL set 426f6e64-2c20-4a61-6d65-7320426f6e64), via openFDA; the full label on DailyMed
Is there a generic for palifermin (Kepivance)?
No generic palifermin is approved (Drugs@FDA, October 8, 2026).
- 2004 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the palifermin label say about other medicines?
The palifermin label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Heparin | drug interactions | Heparin increases systemic exposure; flush intravenous line between heparin and Kepivance. ( 7 ) Do not administer within 24 hours of myelotoxic chemotherapy. |
Source: FDA drug label (KEPIVANCE), Swedish Orphan Biovitrum AB (publ), effective December 17, 2025 (SPL set 426f6e64-2c20-4a61-6d65-7320426f6e64), via openFDA; the full label on DailyMed
What do FAERS reports show for palifermin?
The FDA Adverse Event Reporting System holds 389 reports that list palifermin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 67 are coded as a death and 153 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Palifermin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other