Quick answers
- What is Palifermin used for?
- The FDA-approved label (Kepivance, Swedish Orphan Biovitrum AB (publ), December 17, 2025) says: “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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Palifermin have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Palifermin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Palifermin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Palifermin?
- 1 company lists prescription products of Palifermin in the FDA NDC Directory, including Swedish Orphan Biovitrum AB (publ).
What Palifermin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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. …
— FDA label: Kepivance, Swedish Orphan Biovitrum AB (publ), effective December 17, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Kepivance |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Swedish Orphan Biovitrum AB (publ)1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA125103 KEPIVANCE | Biovitrum Ab | December 15, 2004 | 11, latest July 27, 2023 2023: Labeling · 2019: Labeling · 2016: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2643434, 2643436 |
|---|---|
| SPL set ID of the quoted label | 426f6e64-2c20-4a61-6d65-7320426f6e64 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA125103 |
| Active ingredients (FDA) | PALIFERMIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Kepivance, Swedish Orphan Biovitrum AB (publ), effective December 17, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →