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

Therapeutic class: Biologic and immunologic agent

Pregnancy risk category C


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


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.


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


Use cautiously in:

• patients with nonhematologic cancers

• use with melphalan 200 mg/m2 as a conditioning regimen (not recommended)

• elderly patients

• pregnant or breastfeeding patients

• children (safety and efficacy not established).


• 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.

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


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.

McGraw-Hill Nurse's Drug Handbook, 7th Ed. Copyright © 2013 by The McGraw-Hill Companies, Inc. All rights reserved


(pa-liff-er-min) ,


(trade name)


Therapeutic: cytoprotective agents
Pharmacologic: keratinocyte growth factors
Pregnancy Category: C


To decrease incidence/duration of severe oral mucositis (at least WHO grade 3) associated with myelotoxic therapy in patients requiring stem cell support for hematologic malignancies.


Enhances proliferation of epithelial cells.

Therapeutic effects

Decreased incidence/duration of mucositis.


Absorption: IV administration results in complete bioavailability.
Distribution: Distributes into extravascular space.
Metabolism and Excretion: Unknown.
Half-life: 4.5 hr.

Time/action profile (levels)

IVunknownend of doseunknown


Contraindicated in: Hypersensitivity to palifermin or other E. coli-derived proteins.
Use Cautiously in: Obstetric: Use only if maternal benefit outweighs fetal risk; Lactation / Pediatric: Safety not established.

Adverse Reactions/Side Effects


  • skin toxicity (most frequent)


  • oral toxicity (most frequent)


  • ↑ amylase
  • ↑ lipase


  • arthralgia (most frequent)


  • dysesthesia (most frequent)


Drug-Drug interaction

Binds to and inactivates heparin (flush tubing between use).Administration within 24 hr after myelotoxic therapy (chemotherapy/radiation) ↑ severity and duration of mucositis.


Intravenous (Adults) 60 mcg/kg/day for 3 days before and 3 days after myelotoxic therapy.


Powder for injection: 6.25 mg/vial

Nursing implications

Nursing assessment

  • Assess level of oral mucositis prior to and periodically during therapy.
  • Lab Test Considerations: May cause ↑ serum lipase and amylase; usually reversible.
    • May cause proteinuria.

Potential Nursing Diagnoses

Acute pain (Indications)
Impairedoral mucous membrane (Indications)


  • Do not administer palifermin within 24 hr before, during infusion, or 24 hr after infusion of myelotoxic chemotherapy.
    • Administer doses for 3 consecutive days before (third dose 24–48 hr prior to chemotherapy) and 3 consecutive days after myelotoxic chemotherapy (fourth dose on same day as hematopoietic stem cells infusion after infusion is completed and at least 4 days after most recent palifermin administration) for a total of 6 doses.
  • Intravenous Administration
  • pH: No Data.
  • Diluent: Reconstitute palifermin powder by slowly injecting 1.2 mL of sterile water for injection aseptically.Concentration: 5 mg/mL. Swirl gently; do not shake or vigorously agitate. Solution should be clear and colorless; do not administer solution that is discolored or contains particulate matter. Dissolution usually takes less than 3 minutes. Administer immediately after reconstitution or refrigerate and administer within 24 hr. Do not freeze. Allow to reach room temperature for up to 1 hr. Protect from light. Discard palifermin after expiration date or if left at room temperature for more than 1 hr.
  • Rate: Administer via bolus injection. Do not use a filter.
  • Y-Site Incompatibility: heparin. If heparin solution is used to maintain IV line, flush with 0.9% NaCl prior to and after use of palifermin.

Patient/Family Teaching

  • Explain the purpose of palifermin to patient.
  • Inform patient of evidence of tumor growth and stimulation in cell culture and animal models.
  • Advise patient to notify health care professional if rash, erythema, edema, pruritus, oral/perioral dysesthesia (tongue discoloration, tongue thickening, alteration of taste) occur.

Evaluation/Desired Outcomes

  • Decrease in incidence and duration of oral mucositis in patients receiving myelotoxic therapy requiring hematopoietic stem cell support.
Drug Guide, © 2015 Farlex and Partners
References in periodicals archive ?
The keratinocyte growth factor (palifermin) was approved by the US Food and Drug Administration (FDA) to prevent mucositis (7).
Palifermin (recombinant keratinocyte growth factor-1): A pleiotropic growth factor with multiple biological activities in preventing chemotherapy- and radiotherapy-induced mucositis.
Use of palifermin for the prevention of high-dose methotrexate-induced oral mucositis.
Schneider et al., "Palifermin reduces severe mucositis in definitive chemoradiotherapy of locally advanced head and neck cancer: a randomized, placebo-controlled study," Journal of Clinical Oncology, vol.
At present, palifermin (recombinant keratinocyte growth factor-1) has shown to reduce the complications associated with cancer treatment related oral mucositis [21], although several others are in the drug discovery pipeline [22, 23].
There is some example of novel intervention that possibly will improve outcomes for specific populations but consequence in raised costs including $1,000 per contrast-enhanced magnetic resonance imaging screening, which is 10 times the cost of screening mammography in breast cancer [25]; $48,000 per patient per year for the use of intensity-modulated radiation therapy to treat prostate cancer; $1,800 per positronemission tomography scan for cancer staging [23,4]; $1,800 per month for gefitinib (Iressa) for the treatment of lung cancer; $50,000 per patient per year for trastuzumab (Herceptin) in the treatment of HER2-positive breast cancer [16,8] and more than $8,000 for a 6-day course of palifermin (Kepivance) in the treatment of oral mucositis.
O palifermin e um fator de crescimento de queratinocitos recombinante, aprovado na Europa e recentemente nos Estados Unidos, para a reducao e incidencia da mucosite oral em malignidades hematologicas.
More recently, the successful development of a recombinant human keratinocyte growth factor (KGF-1, palifermin) significantly reduces the severity and duration of severe OM.
The ONS Putting Evidence Into Practice materials recommend the following prevention strategies: (a) a regular oral care protocol that includes patient education; (b) palifermin, a keratinocyte growth factor, in patients receiving high-dose chemotherapy, radiation, and allogeneic or autologous stem cell transplantion (it is not indicated for Abby's regimen); or (c) cryotherapy (ice chips) for patients receiving melphalan or bolus 5-FU because of their short half-lives (this has not been studied for Abby's regimen).
KGF (palifermin): Keratinocytes are cells that secrete proteins which are important components of epithelial cells.