Palifermin

Palifermin (Kepivance)

Class & Mechanism

  • Recombinant human keratinocyte growth factor (KGF, FGF7 analog)
  • Binds KGF receptor (FGFR2b) on epithelial cells → stimulates proliferation, differentiation, and protection of epithelial cells.
  • Reduces incidence and duration of severe oral mucositis in patients receiving myeloablative conditioning (esp. with TBI) for hematopoietic stem cell transplantation.

Indications

  • FDA-approved:
    • Prevention and treatment of severe oral mucositis in hematologic malignancy patients undergoing myeloablative therapy with TBI + HSCT.
  • Not approved in solid tumors (concerns that stimulating epithelial growth could promote tumor growth in epithelial cancers).

Dosing (Adults)

  • 60 mcg/kg IV once daily
  • Admin schedule:
    • 3 consecutive daily doses before conditioning regimen (last dose >24 h before conditioning chemo/TBI)
    • 3 consecutive daily doses after HSCT (at least 24 h after conditioning is complete)
    • Total: 6 doses
  • IV bolus injection over 15–30 seconds.

Avoid giving palifermin within 24 h before, during, or after cytotoxic chemotherapy/TBI → risk of worsening mucositis (epithelial proliferation).

Adverse Effects

  • Generally well tolerated.
  • Common (>30%): rash, erythema, edema, tongue thickening, taste alteration, mouth/tongue discoloration.
  • Less common: arthralgia, fever, pruritus, paresthesia.
  • Transient ↑ serum amylase/lipase (pancreatic enzyme elevation).

Clinical Benefits

  • Reduces incidence, severity, and duration of WHO grade 3–4 oral mucositis.
  • Decreases need for parenteral nutrition and opioid analgesics.
  • Improves patient quality of life during HSCT.

Pharmacist Considerations

  • Dosing based on actual body weight.
  • Timing critical: never administer within 24 h of cytotoxic therapy or TBI.
  • Monitor mucositis severity, pain control, and nutritional support needs.
  • Monitor amylase/lipase (rare pancreatitis).
  • Educate patients: skin rash and tongue changes are expected and reversible.

Limitations

  • Costly biologic agent (limits routine use).
  • Evidence strongest in HSCT with TBI-based regimens; benefit less consistent in chemo-only conditioning.
  • Not for solid tumors due to theoretical tumor growth stimulation.
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