Classifications: biologic response modifier; keratinocyte growth factor; cytokine; Therapeutic: biologic response modifier; keratinocyte growth factor
Pregnancy Category: C
6.25 mg powder for injection
Naturally occurring keratinocyte growth factor (KGF) is produced and regulated in response to epithelial tissue injury.
Binding of KGF to its receptors in epithelial cells results in proliferation, differentiation, and repair of injury to epithelial
cells. Palifermin is a synthetic form of KCG; thus it enhances replacement of injured cells.
Palifermin reduces the incidence of severe oral mucositis that interferes with food consumption in the cancer patient.
Reduction of the incidence and duration of severe oral mucositis in patients with hematologic malignancies who are receiving
myelotoxic therapy requiring hematopoietic stem cell support.
Hypersensitivity to Escherichia coliderived protein, palifermin; nonhematologic malignancies; within 24 h of chemotherapy; pregnancy (category C). Safe
use in children not established.
Use contraception for females of childbearing age; lactation.
Route & Dosage
Adult: IV 60 mcg/kg/d for 3 d before and 3 d after myelotoxic therapy Premyelotoxic therapy: Final dose should be given 2448 h before therapy. Postmyelotoxic therapy: First dose should be given after but on the same day of hematopoietic stem cell infusion, and at least 4 d after the most
recent administration of palifermin.
PREPARE: Direct: Reconstitute powder with 1.2 mL sterile water to yield 5 mg/mL. Gently swirl to dissolve but do not shake. Powder will dissolve
in about 3 min. Should be used immediately.
ADMINISTER: Direct: Give as a bolus dose. If heparin is used to maintain the IV line, flush before/after with NS. If diluted solution was refrigerated,
may warm to room temperature for up to 1 h but protect from light.
INCOMPATIBILITIES Y-site: Heparin.
Body as a Whole: Edema, fever, pain. CNS: Dysesthesia. GI: Mouth/tongue thickness or discoloration, taste alterations. Metabolic: Elevated serum amylase, elevated serum lipase. Musculoskeletal: Arthralgia. Skin: Erythema, pruritus, rash. Urogenital:
- Store powder vial at 2°8° C (36°46° F). Protect from light. If needed, may store reconstituted
solution refrigerated for up to 24 h. Discard any reconstituted solution left at room temperature for longer than 1 h.
of palifermin within 24 h of myelotoxic chemotherapy
increases the severity and duration of oral mucositis.
Extravascular distribution. Half-Life:
Assessment & Drug Effects
- Monitor for improvement in mucositis.
- Monitor for S&S of oral toxicities and skin toxicities.
Patient & Family Education
- Report any of the following to a health care provider: alteration of taste, discoloration or enlargement of the tongue,
lack of sensation around the mouth, skin rash, itching, or edema.