palifermin

palifermin

Kepivance

Pharmacologic class: Keratinocyte growth factor (KGF) (rDNA origin)

Therapeutic class: Biologic and immunologic agent

Pregnancy risk category C

Action

Produced by recombinant DNA technology in Escherichia coli; binds to KGF receptor on cell surface, resulting in epithelial cell proliferation, differentiation, and migration

Availability

Powder for injection (lyophilized): 6.25 mg in single-use vials

⊘Indications and dosages

➣ To decrease incidence and duration of severe oral mucositis in patients with hematologic malignancies who are receiving myelotoxic therapy requiring hematopoietic stem cell support

Adults: 60 mcg/kg/day I.V. bolus injection for 3 consecutive days before and 3 consecutive days after myelotoxic therapy, for a total of six doses. Give first three doses before myelotoxic therapy, with third dose given 24 to 48 hours before such therapy. Administer last three doses after myelotoxic therapy, with first of these given after (but on same day of) hematopoietic stem cell infusion and at least 4 days after most recent palifermin dose.

Contraindications

• Hypersensitivity to drug, its components, or E. coli-derived proteins

Precautions

Use cautiously in:
• patients with nonhematologic cancers
• elderly patients
• pregnant or breastfeeding patients
• children (safety and efficacy not established).

Administration

• Reconstitute powder with 1.2 ml sterile water for injection to yield final concentration of 5 mg/ml.
☞ Swirl vial gently during dissolution; don't shake or vigorously agitate.
• Don't filter reconstituted solution during preparation or administration.
• Use immediately (within 1 hour) after reconstituting; protect from light.
• When heparin is used to maintain I.V. line, use normal saline solution to rinse line before and after palifermin administration.
• Administer by I.V. bolus injection.
• Don't give within 24 hours before, during infusion of, or within 24 hours after myelotoxic chemotherapy.

Route	Onset	Peak	Duration
I.V.	Unknown	Unknown	Unknown

Adverse reactions

CNS: dysesthesia

CV: hypertension

EENT: tongue discoloration or thickening

Musculoskeletal: pain, arthralgias

Skin: rash, pruritus, skin toxicities, erythema

Other: altered taste, edema, fever

Interactions

Drug-drug. Heparin: possible binding

Drug-diagnostic tests. Amylase, lipase: increased

Patient monitoring

• Monitor serum amylase and lipase levels frequently.

Patient teaching

• Instruct patient to report adverse reactions, including rash, itching, skin redness, swelling, discolored tongue, and altered taste.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs and tests mentioned above.