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Palifermin

Pronunciation

(pal ee FER min)

Index Terms

  • AMJ 9701
  • Keratinocyte Growth Factor, Recombinant Human
  • rhKGF
  • rhu Keratinocyte Growth Factor
  • rHu-KGF

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous [preservative free]:

Kepivance: 6.25 mg (1 ea)

Brand Names: U.S.

  • Kepivance

Pharmacologic Category

  • Chemoprotective Agent
  • Keratinocyte Growth Factor

Pharmacology

Palifermin is a recombinant keratinocyte growth factor (KGF) produced in E. coli. Endogenous KGF is produced by mesenchymal cells in response to epithelial tissue injury. KGF binds to the KGF receptor resulting in proliferation, differentiation and migration of epithelial cells in multiple tissues, including (but not limited to) the tongue, buccal mucosa, esophagus, and salivary gland.

Onset of Action

Epithelial cell proliferation (dose-dependent): 48 hours

Half-Life Elimination

4.5 hours (range: 3.3 to 5.7 hours)

Special Populations: Elderly

In a single-dose study of 90 mcg/kg/dose or 180 mcg/kg/dose, average clearance was approximately 30% lower in patients older than 65 years compared with patients ≤65 years.

Use: Labeled Indications

Oral mucositis: To decrease the incidence and duration of severe oral mucositis associated with hematologic malignancies in patients receiving myelotoxic therapy in the setting of autologous hematopoietic stem cell support (when the preparative regimen is expected to result in mucositis ≥ grade 3 in most patients).

Limitations of use: Use (safety and efficacy) is not established for nonhematologic malignancies; use is not recommended with conditioning regimens containing melphalan 200 mg/m2. Palifermin was not effective in decreasing the incidence of severe mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of allogeneic hematopoietic stem cell support.

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Dosing: Adult

Oral mucositis associated with autologous hematopoietic stem cell transplant (HSCT) conditioning regimens: IV: 60 mcg/kg/day for 3 consecutive days before and 3 consecutive days after myelotoxic therapy; total of 6 doses (Spielberger, 2004)

Note: Administer first 3 doses prior to myelotoxic therapy, with the third dose given 24 to 48 hours before beginning the myelotoxic conditioning regimen. Administer the last 3 doses after completion of the myelotoxic conditioning regimen, with the first of these doses after (but on the same day) as HSCT infusion and at least 7 days after the most recent dose of palifermin.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling; however, based on a pharmacokinetic study, renal impairment has minimal to no impact on palifermin pharmacokinetics.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Reconstitution

Hazardous agent; use appropriate precautions for handling and disposal (NIOSH 2014 [group 2]).

To reconstitute, slowly add 1.2 mL SWFI, to a final concentration of 5 mg/mL. Swirl gently; do not shake or vigorously agitate. May take up to 3 minutes to dissolve; reconstituted solution should be clear and colorless. Do not filter during preparation or administration.

Administration

Administer by IV bolus. If heparin is used to maintain the patency of the IV line, flush line with saline prior to and after palifermin administration. Do not administer palifermin during or within 24 hours before or after chemotherapy. Allow solution to reach room temperature prior to administration; do not use if at room temperature >1 hour. Do not filter.

Hazardous agent; use appropriate precautions for handling and disposal (NIOSH 2014 [group 2]).

Compatibility

Incompatible with heparin.

Storage

Store intact vials at 2°C to 8°C (36°F to 46°F). Protect from light. Although the manufacturer recommends immediate use, reconstituted vials are stable for up to 24 hours refrigerated. Bring to room temperature for up to 1 hour prior to administration; however, do not use if left at room temperature >1 hour. Protect reconstituted solution from light. Do not freeze reconstituted product.

Drug Interactions

Heparin: May increase the serum concentration of Palifermin. Management: If heparin is used to maintain an intravenous line, rinse the line with saline prior to and after palifermin administration. Monitor therapy

Heparin (Low Molecular Weight): May increase the serum concentration of Palifermin. Monitor therapy

Adverse Reactions

>10%:

Cardiovascular: Edema (28%)

Central nervous system: Fever (39%); pain (16%); dysesthesia (oral hyperesthesia, hypoesthesia, and paresthesia 12%)

Dermatologic: Rash (62%; grade 3: 3%), pruritus (35%), erythema (32%)

Gastrointestinal: Serum amylase increased (62%, grades 3/4: 38%), serum lipase increased (28%, grades 3/4: 11%), mouth/tongue discoloration or thickness (17%), taste alteration (16%)

1% to 10%:

Neuromuscular & skeletal: Arthralgia (10%)

Miscellaneous: Antibody formation (2%)

<1% (Limited to important or life-threatening): Cataracts, cough, flexural hyperpigmentation, palmar-plantar erythrodysesthesia syndrome (hand-foot syndrome), perianal pain, rhinitis, vaginal edema, vaginal erythema

Warnings/Precautions

Concerns related to adverse effects:

• Mucocutaneous effects: Edema, erythema, pruritus, rash, oral/perioral dysesthesia, taste alteration, tongue discoloration, and tongue thickening may occur; instruct patients to report mucocutaneous effects. The median onset of cutaneous toxicities (following initial dose) is 6 days; median duration is 5 days.

Disease-related concerns:

• Nonhematologic malignancies: Safety and efficacy have not been established with nonhematologic malignancies; effect on the growth of keratinocyte growth factor (KGF) receptor expressing, nonhematopoietic human tumors is not known. Palifermin has been shown to enhance epithelial tumor cell lines in vitro.

Concurrent drug therapy issues:

• Myelotoxic chemotherapy: Do not administer within 24 hours before, during, or after myelotoxic chemotherapy; may increase the severity and duration of oral mucositis (due to the increased sensitivity of rapidly dividing epithelial cells).

Special handling:

• Hazardous agent: Use appropriate precautions for handling and disposal (NIOSH 2014 [group 2]).

Other warnings/precautions:

• Appropriate use: The Multinational Association of Supportive Care in Cancer and the International Society for Oral Oncology (MASCC/ISOO) guidelines for the prevention and treatment of mucositis recommend palifermin (at the FDA-approved dose) for the prevention of oral mucositis in patients with hematologic malignancies who are receiving high-dose chemotherapy and total body irradiation with autologous stem cell transplantation (Lalla 2014). Guidelines from the American Society of Clinical Oncology (ASCO) for the use of chemotherapy and radiotherapy protectants (Hensley 2008) recommend the use of palifermin to decrease the incidence of severe mucositis in patients undergoing autologous stem-cell transplantation with a total body irradiation (TBI) conditioning regimen. According to the ASCO guidelines, data are insufficient to recommend palifermin when the conditioning regimen is chemotherapy only. Palifermin may be considered in patients undergoing myeloablative allogeneic stem-cell transplantation with a TBI conditioning regimen, however data are again insufficient to recommend palifermin when the conditioning regimen is chemotherapy only. Due to a lack of appropriate data, the guidelines also do not recommend palifermin use in non-stem-cell transplantation treatment regimens or for use when treating solid tumors.

Monitoring Parameters

Monitor for oral mucositis

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events were observed in animal reproduction studies.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience change in taste or joint pain. Have patient report immediately to prescriber tongue changes, edema, or tingling of mouth (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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