PALIFERMIN

PALIFERMIN (pal-i-fur'men) Kepivance Classifications: biologic response modifier; keratinocyte growth factor; cytokine; Therapeutic: biologic response modifier; keratinocyte growth factor Pregnancy Category: C

Availability

6.25 mg powder for injection

Action

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.

Therapeutic Effect

Palifermin reduces the incidence of severe oral mucositis that interferes with food consumption in the cancer patient.

Uses

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.

Contraindications

Hypersensitivity to Escherichia coli–derived protein, palifermin; nonhematologic malignancies; within 24 h of chemotherapy; pregnancy (category C). Safe use in children not established.

Cautious Use

Use contraception for females of childbearing age; lactation.

Route & Dosage

Oral Mucositis Adult: IV 60 mcg/kg/d for 3 d before and 3 d after myelotoxic therapy  Premyelotoxic therapy: Final dose should be given 24–48 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.

Administration

Intravenous Do not give within 24 h before/after or during myelotoxic chemotherapy. 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.

• 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.

Adverse Effects (≥5%)

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: Proteinuria.

Interactions

Drug: Administration of palifermin within 24 h of myelotoxic chemotherapy increases the severity and duration of oral mucositis.

Pharmacokinetics

Distribution: Extravascular distribution. Half-Life: 4.5 h.

Nursing Implications

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.

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Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug