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 (Kepivance) is a recombinant keratinocyte growth factor approved as a prescription drug for the prevention and treatment of oral mucositis in patients receiving intensive chemotherapy and hematopoietic stem cell transplantation. It belongs to the growth‑factor family and is administered intravenously to stimulate the repair of oral mucosal epithelium, thereby reducing the severity of mucosal injury caused by cancer therapy.
Mechanism of Action
Palifermin is an analog of human keratinocyte growth factor (FGF7). It binds to the fibroblast growth factor receptor 2b (FGFR2b) expressed on epithelial cells of the oral mucosa, activating downstream signaling that promotes cell proliferation, differentiation, and survival. This cellular response accelerates mucosal healing and enhances resistance to the cytotoxic damage produced by chemotherapy or radiotherapy.
What the Research Shows
Systematic reviews of clinical trials have identified palifermin as one of several agents with activity against chemotherapy‑ or radiotherapy‑induced oral mucositis. Randomised studies in adult patients undergoing high‑dose chemotherapy and stem‑cell transplantation reported a relative risk reduction of severe mucositis (RR 0.81, 95% CI 0.69–0.95). Guidelines for pediatric oncology cite the same data but note that adverse events limit routine use in children. Recent literature also lists palifermin alongside other pharmacologic and non‑pharmacologic strategies, emphasizing that while it shows benefit, it is not universally adopted as first‑line therapy.
Reported Benefits
Evidence from randomised trials demonstrates that palifermin reduces the incidence and severity of oral mucositis in adults receiving intensive chemotherapy, with an approximate 19% relative risk reduction for severe lesions. Its growth‑factor action directly targets epithelial repair, offering a mechanistic advantage over purely symptomatic treatments. Guidelines recognise it as an effective option when mucositis risk is high, such as in hematopoietic stem‑cell transplant regimens.
Limitations of the Evidence
The supportive data are largely confined to adult transplant populations; pediatric studies report limited feasibility and a higher incidence of adverse effects, leading to recommendations against routine use in children. Direct comparisons with other interventions (cryotherapy, photobiomodulation, benzydamine) are sparse, so the relative advantage of palifermin remains uncertain. Cost, availability, and the need for intravenous administration also constrain broader adoption.
Safety Considerations
Clinical reports note that palifermin can cause adverse events, including skin rash, erythema, and taste alterations, with some pediatric trials flagging safety concerns. Monitoring for these effects is advised, especially when used in combination with high‑dose chemotherapy. No severe life‑threatening toxicity has been highlighted in the cited literature, but clinicians should remain vigilant and weigh benefits against potential side‑effects.
How It Is Administered
Palifermin is supplied for intravenous infusion, typically given as a short infusion before the start of the chemotherapy or conditioning regimen for stem‑cell transplantation. The formulation is a sterile solution intended for single‑use vials; dosing schedules follow the prescribing information approved for the indication of oral mucositis prevention.
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
- Journal ArticleHighDaugėlaitė G, et al.2019-01-01T00:00:00.000000Z
- Journal ArticleModerateWu Y, et al.2025-01-01T00:00:00.000000Z
- Journal ArticleModerateColella G, et al.2023-01-01T00:00:00.000000Z
- Journal ArticleModeratePatel P, et al.2021-01-01T00:00:00.000000Z
Frequently Asked Questions
What type of cancer patients can receive palifermin?
Palifermin is approved for adults undergoing high‑dose chemotherapy and hematopoietic stem‑cell transplantation, where the risk of severe oral mucositis is high. It is not routinely recommended for pediatric patients because of safety concerns.
How does palifermin differ from symptomatic mouthwashes?
Unlike mouthwashes that provide temporary relief, palifermin is a growth factor that stimulates epithelial cell growth and repair, aiming to prevent or lessen mucosal injury rather than merely soothing symptoms.
Are there any non‑drug alternatives for mucositis prevention?
Evidence supports cryotherapy, photobiomodulation (low‑level laser), and benzydamine mouthwash as effective, low‑cost measures. These are often used when palifermin is unavailable, contraindicated, or in pediatric settings.
What side effects should patients be aware of?
Commonly reported effects include skin rash, redness, and altered taste. While severe toxicity is rare, clinicians monitor patients for these reactions and adjust therapy if necessary.
Is palifermin given as a single dose or multiple doses?
The approved regimen involves multiple intravenous infusions administered on consecutive days before the chemotherapy or conditioning phase, following the dosing schedule outlined in the product label.
What is Palifermin?
Palifermin (Kepivance) is a recombinant keratinocyte growth factor approved as a prescription drug for the prevention and treatment of oral mucositis in patients receiving intensive chemotherapy and hematopoietic stem cell transplantation. It belongs to the growth‑factor family and is administered intravenously to stimulate the repair of oral mucosal epithelium, thereby reducing the severity of mucosal injury caused by cancer therapy.
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.