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palifermin

V03AF08

Forms & Strengths

Lyophilized powder for injection: 6.25 mg single-use vial

Adult Dosing

60 mcg/kg/day IV bolus for 3 consecutive days before and 3 consecutive days after myelotoxic therapy (total 6 doses)
Administer first 3 doses prior to conditioning regimen; administer first post-transplantation dose within 24 hours after hematopoietic stem cell support

Pediatric Dosing

Safety and efficacy not established in pediatric patients
Pharmacokinetics and dosing studied in pediatric patients with hematologic malignancies undergoing HSCT, but adult dosing (60 mcg/kg/day) is often referenced off-label

Indications

Decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy requiring hematopoietic stem cell support

Mechanism of Action

Human recombinant keratinocyte growth factor (KGF)
Binds to KGF receptors on epithelial cells, resulting in proliferation, differentiation, and migration of epithelial cells in the oral cavity and GI tract

Contraindications

Known hypersensitivity to palifermin or Escherichia coli-derived proteins

Adverse Reactions

Rash, erythema, and pruritus
Edema and peripheral edema
Oral paresthesia, tongue thickening, and tongue discoloration
Arthralgia
Elevated serum amylase and lipase

Drug Interactions

May bind to heparin; flush IV lines with saline before and after administration if heparin is used
Potential to stimulate proliferation of epithelial-derived malignancies (theoretical concern, though studies show no clear increase in relapse rates)

Curated Content: Needs Vetting Before Put to Clinical Use