Palifermin

Summary

Palifermin (Kepivance) is a recombinant truncated form of human KGF/FGF7 approved for reducing the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy requiring hematopoietic stem cell support. It is administered intravenously before and after conditioning regimens.

Mechanism of Action

Recombinant human keratinocyte growth factor (KGF) that binds to KGF receptors on epithelial cells, stimulating proliferation, differentiation, and migration of epithelial cells, particularly in the gastrointestinal tract and oral mucosa, thereby reducing the incidence and severity of mucositis.

Routes of Administration

Goals & Uses

• Reduction of total parenteral nutrition requirementNutritional SupportModerate
• Reduction of opioid analgesic use in mucositisPain ManagementModerate
• Reduction of severe oral mucositisOncology Supportive CareHigh
• Mucosal protection during conditioning regimensOncology Supportive CareHigh

Contraindications

• 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
• Elevated serum amylase and lipaseLaboratoryCommon
• ArthralgiaMusculoskeletalCommonJoint pain
• Skin rash / erythemaDermatologicCommon
• Oral/perioral dysesthesiaNeurologic/localCommon
• Potential tumor growth stimulationOncologic RiskUnknown

Drug Interactions

• HeparinModerate
• Myeloablative chemotherapy agentsHigh

Population Constraints

• Pediatric patientsAgeRelative
• Pregnant womenReproductiveRelative
• Patients with solid tumors or non-hematologic cancersOncologyRelative
• Renal or hepatic impairmentOrgan DysfunctionRelative

Regulatory Status

• European UnionApprovedApproved: Reduction of incidence and duration of severe oral mucositis in patients with haematological malignancies receiving myeloablative therapy with haematopoietic stem cell supportEMA approved; marketed as Kepivance; centralized procedure.
• United StatesApprovedApproved: Reduction of incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy requiring hematopoietic stem cell supportFDA approved December 2004; BLA 125103; marketed as Kepivance.
• United KingdomApprovedApproved: Reduction of incidence and duration of severe oral mucositis in haematological malignancy patients undergoing myeloablative therapy with haematopoietic stem cell supportApproved via EMA mutual recognition prior to Brexit; post-Brexit status maintained under MHRA.

FDA approved in December 2004 (BLA 125103) for reduction of severe oral mucositis in hematologic malignancy patients undergoing hematopoietic stem cell transplantation. EMA approved under the brand name Kepivance. Not indicated for solid tumors due to potential for stimulating epithelial tumor growth.

Evidence & Sources

No sources recorded yet.