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Palifermin

Medically reviewed by Drugs.com. Last updated on Sep 1, 2020.

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 ~30% lower in patients >65 years of age compared with patients ≤65 years of age.

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.

Reconstitution

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.

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

Antineoplastic Agents: Palifermin may enhance the adverse/toxic effect of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Consider therapy modification

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

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

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Cardiovascular: Edema (28%)

Central nervous system: Pain (16%), dysesthesia (12%; includes hypoesthesia, oral hyperesthesia, paresthesia)

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

Gastrointestinal: Increased serum amylase (62%, grades 3/4: 38%), increased serum lipase (28%, grades 3/4: 11%), mouth discoloration (≤17%), swelling of mouth (≤17%), tongue discoloration (≤17%), tongue edema (≤17%), dysgeusia (16%)

Miscellaneous: Fever (39%)

1% to 10%:

Immunologic: Antibody development (2%)

Neuromuscular & skeletal: Arthralgia (10%)

<1%, postmarketing, and/or case reports: Cataract, cough, genital edema (vaginal), hyperpigmentation (flexural), palmar-plantar erythrodysesthesia (hand-foot syndrome), perineal pain, rhinitis, vaginal disease (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).

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 Considerations

Based on data from animal reproduction studies, in utero exposure to palifermin may cause fetal harm.

Patient Education

What is this drug used for?

• It is used to lower how often mouth sores form and shorten how long they last.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Joint pain

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Tongue changes

• Swelling

• Change in taste

• Numbness or tingling of mouth

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.