Palifermin
Also known as: AMG-162, FGF7 recombinant, Kepivance, KGF analog, KGF‑1, recombinant human keratinocyte growth factor, rHuKGF
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Summary
Palifermin (brand name Kepivance) is a recombinant human keratinocyte growth factor approved to decrease the incidence and duration of severe oral mucositis in patients undergoing high‑dose chemotherapy and radiation for hematologic malignancies.
Mechanism of Action
Binds to FGFR2b on epithelial cells, activating downstream signaling that promotes cell proliferation, differentiation, and mucosal barrier protection, thereby reducing oral mucositis.
Routes of Administration
Goals & Uses
- Reduction of total parenteral nutrition requirementNutritional SupportModerate
- Reduction of opioid analgesic use in mucositisPain ManagementModerate
- Accelerate mucosal healingSupportive CareModerate
- Reduction of severe oral mucositisOncology Supportive CareHigh
- Mucosal protection during conditioning regimensOncology Supportive CareHigh
- Reduce oral mucositis severitySupportive OncologyHigh
Contraindications
- Uncontrolled malignancy with potential KGF‑driven growthOncologyModerate
- Hypersensitivity to paliferminAllergyHigh
- Administration within 24 hours of chemotherapy or radiationDrug Treatment InteractionHigh
- Hypersensitivity to palifermin or E. coli-derived proteinsAllergy/immunologyHigh
- Non-hematologic malignanciesOncologyHigh
Adverse Effects
- EdemaFluid BalanceCommonSwelling from fluid retention
- Rash / erythemaSkinCommon
- Taste alterationSensoryCommon
- Elevated serum amylase and lipaseLaboratoryCommon
- Edema (periorbital, peripheral)VascularUncommon
- ArthralgiaMusculoskeletalCommonJoint pain
- Skin rash / erythemaDermatologicCommon
- Oral/perioral dysesthesiaNeurologic/localCommon
- Potential tumor growth stimulationOncologic RiskUnknown
- Elevated serum creatinineRenal / LaboratoryRare
Drug Interactions
- HeparinModerate
- Other growth factors (e.g., G-CSF)Low
- Myeloablative chemotherapy agentsHigh
Population Constraints
- Pediatric patientsAgeRelative
- Pediatric patients (<1 year)AgeAbsolute
- Pregnant or breastfeeding womenReproductiveRelative
- Pregnant womenReproductiveRelative
- Patients with solid tumors or non-hematologic cancersOncologyRelative
- Renal or hepatic impairmentOrgan DysfunctionRelative
Regulatory Status
- European UnionApprovedApproved: Prevention of oral mucositis associated with high‑dose chemotherapy and radiotherapyMarketing authorization granted by EMA.
- United StatesApprovedApproved: Prevention of severe oral mucositis in patients receiving myelotoxic therapy for hematologic malignanciesApproved by FDA in 2004.
- United KingdomApprovedApproved: Reduction of oral mucositis in patients undergoing intensive chemo‑radiotherapy for blood cancersAuthorized by MHRA.
FDA‑approved (2004). Contraindicated in patients with known hypersensitivity to palifermin or any formulation component.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Palifermin?
Palifermin (brand name Kepivance) is a recombinant human keratinocyte growth factor approved to decrease the incidence and duration of severe oral mucositis in patients undergoing high‑dose chemotherapy and radiation for hematologic malignancies.
What is Palifermin used for?
Palifermin is educationally associated with: Reduction of total parenteral nutrition requirement, Reduction of opioid analgesic use in mucositis, Accelerate mucosal healing, Reduction of severe oral mucositis, Mucosal protection during conditioning regimens, Reduce oral mucositis severity. Educational only — not medical advice.
How is Palifermin administered?
Recorded routes of administration: Intravenous.
What are the potential side effects of Palifermin?
Reported adverse effects include: Edema, Rash / erythema, Taste alteration, Elevated serum amylase and lipase, Edema (periorbital, peripheral), Arthralgia, Skin rash / erythema, Oral/perioral dysesthesia, Potential tumor growth stimulation, Elevated serum creatinine. This list is not exhaustive — consult a qualified clinician.
Who should avoid Palifermin?
Recorded contraindications: Uncontrolled malignancy with potential KGF‑driven growth, Hypersensitivity to palifermin, Administration within 24 hours of chemotherapy or radiation, Hypersensitivity to palifermin or E. coli-derived proteins, Non-hematologic malignancies. Consult a qualified clinician before use.