Version May 2024
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 beginning after (but on the same day) as HSCT infusion and at least 7 days after the most recent palifermin dose.
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.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
(For additional information see "Palifermin: Pediatric drug information")
Oral mucositis associated with autologous hematopoietic stem cell transplant (HSCT) conditioning regimens; prevention or treatment (decrease severity of): N ote: Although an FDA-approved indication, administration of palifermin is not recommended due to adverse effect profile, potential negative effects on cancer outcomes, cost, and restricted availability (Patel 2021).
Children and Adolescents: IV: 60 mcg/kg/day once daily for 3 consecutive days before myelotoxic therapy, with the third dose administered 24 to 48 hours before conditioning regimen and for 3 consecutive days after myelotoxic conditioning therapy. The first of the postconditioning doses is given on the same day as HSCT infusion (after infusion is complete) and at least 7 days after the most recent dose of palifermin. Total regimen is 6 doses.
Oral mucositis associated with allogeneic hematopoietic stem cell transplant (HSCT) conditioning regimens; prevention or treatment (decrease severity of): Limited data available: Note: Routine administration of palifermin is not recommended due to adverse effect profile, potential negative effects on cancer outcomes, cost, and restricted availability.
Children and Adolescents: IV: 60 mcg/kg/day once daily for 3 consecutive days before myelotoxic therapy, with the third dose administered 24 to 48 hours before conditioning regimen begins and for 3 consecutive days after myeloablative conditioning therapy. The first of the postconditioning doses is given on the same day as HSCT infusion (after infusion is complete) and at least 7 days after the most recent dose of palifermin. Total regimen is 6 doses (Lauritano 2014; Morris 2016; POGO [Sung 2017]).
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.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Incidences are reported as part of combination chemotherapy regimens in adults.
>10%:
Cardiovascular: Edema (28%)
Dermatologic: Erythema of skin (32%), pruritus (35%), skin rash (62%)
Gastrointestinal: Dysgeusia (16%), increased serum amylase (62%), increased serum lipase (28%), mouth discoloration (≤17%), tongue discoloration (≤17%)
Hypersensitivity: Mouth edema (≤17%), tongue edema (≤17%)
Infection: Infection (47% to 50%)
Nervous system: Dysesthesia (12%; including hyperesthesia, hypoesthesia, paresthesia), pain (16%)
Miscellaneous: Fever (39%)
1% to 10%:
Immunologic: Antibody development (2%; no evidence of neutralizing activity)
Neuromuscular & skeletal: Arthralgia (10%)
Postmarketing:
Dermatologic: Palmar-plantar erythrodysesthesia (Keijzer 2007), papular rash (King 2009)
Genitourinary: Genital edema (vaginal), vaginal disease (erythema)
Ophthalmic: Cataract
There are no contraindications listed in the manufacturer's labeling.
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 the growth of 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).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution Reconstituted, Intravenous [preservative free]:
Kepivance: 5.16 mg (1 ea); 6.25 mg (1 ea [DSC])
No
Solution (reconstituted) (Kepivance Intravenous)
5.16 mg (per each): $3,976.33
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IV: 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.
Parenteral: IV: Administer by IV bolus. Allow solution to reach room temperature while protecting from light prior to administration; do not use if at room temperature >1 hour. If heparin is used to maintain the patency of the IV line, flush line with normal saline prior to and after palifermin administration. Do not administer palifermin during or within 24 hours before or after chemotherapy. Do not filter.
Hazardous agent (NIOSH 2016 [group 2]).
Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020).
Note: Facilities may perform risk assessment of some hazardous drugs to determine if appropriate for alternative handling and containment strategies (USP-NF 2020). Refer to institution-specific handling policies/procedures.
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 the majority of patients).
Limitations of use: Safety and efficacy have not been established for nonhematologic malignancies. Palifermin 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.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
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. Risk D: 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. Risk C: Monitor therapy
Heparins (Low Molecular Weight): May increase the serum concentration of Palifermin. Risk C: Monitor therapy
Based on data from animal reproduction studies, in utero exposure to palifermin may cause fetal harm.
It is not known if palifermin is present in breast milk.
Because of the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during therapy and for at least 2 weeks after the last palifermin dose.
Monitor for oral mucositis.
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.
Half-life elimination: Children and Adolescents: Mean range: 2.6 to 5.6 hours; Adults: 4.5 hours (range: 3.3 to 5.7 hours).
Older adult: 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.
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