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Trade Names:
Kepivance
- Powder for injection, lyophilized 6.25 mg

Mechanism of Action

Pharmacology

Binding of keratinocyte growth factor may result in proliferation, differentiation, and migration of epithelial cells.

Pharmacokinetics

Distribution

Shows linear pharmacokinetics and has extravascular distribution. Steady-state Vd appears to be 2-fold higher in cancer patients compared with healthy volunteers.

Elimination

Total body clearance appears to be 2- to 4-fold higher in cancer patients compared with healthy volunteers. Elimination t _½ is 3.3 to 5.7 hr.

Indications and Usage

Decrease incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy requiring hematopoietic stem cell support.

Contraindications

Hypersensitivity to Escherichia coli -derived proteins, or any component of the product.

Dosage and Administration

IV Three 60 mcg/kg/day doses administered prior to myelotoxic therapy, with third dose 24 to 48 hr before myelotoxic therapy.

IV Three 60 mcg/kg/day doses administered after myelotoxic therapy, with the first of these doses given after, but on the same day of hematopoietic stem cell infusion and at least 4 days after the most recent administration of palifermin.

General Advice

• For IV bolus injection only. Not for intradermal, subcutaneous, IM, continuous or intermittent IV infusion, or intra-arterial administration.
• Dose is administered once daily for 3 consecutive days before and 3 consecutive days after myelotoxic therapy, for a total of 6 doses.
• Do not administer palifermin within 24 hr before, during infusion of, or within 24 hr after administration of myelotoxic chemotherapy.
• Reconstitute powder for injection by slowly injecting 1.2 mL sterile water for injection into vial. Gently swirl contents to dissolve (should take less than 3 min). Do not shake or vigorously agitate vial. Reconstituted solution provides 5 mg palifermin/mL.
• Do not administer if solution is cloudy, discolored, or contains particulate matter.
• Administer prescribed dose by IV bolus injection. If heparin is used to maintain IV line, use saline to flush line prior to and after palifermin administration because palifermin binds to heparin.
• Do not filter reconstituted solution during preparation or administration.

Storage/Stability

• Reconstituted solution contains no preservatives and should be administered immediately. If not administered immediately, reconstituted solution may be stored in its carton in refrigerator (36° to 46°F) for up to 24 hr. Do not freeze reconstituted solution. Prior to injection, refrigerated reconstituted solution may be allowed to reach room temperature for a maximum of 1 hr while protecting solution from exposure to light. Discard any solution left at room temperature for more than 1 hr.
• Vials contain no preservative. Discard any unused portion of reconstituted solution. Do not combine unused portions.
• Store unopened vials in carton in refrigerator (36° to 46°F). Protect from light. Keep vials in pack until time of use.

Drug Interactions

Because administration of palifermin within 24 hr of chemotherapy has resulted in increased severity and duration of oral mucositis, do not give palifermin within 24 hr before, during infusion, or within 24 hr after myelotoxic chemotherapy.

Because palifermin binds to heparin in vitro, if heparin is used to maintain an IV line, rinse the line with saline prior to and after palifermin administration.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Hypertension (7%).

CNS

Dysesthesia (hyperesthesia, hypoesthesia, paresthesia) (12%).

Dermatologic

Rash (62%); pruritus (35%); erythema (32%).

GI

Mouth/tongue thickness or discoloration (17%); altered taste (16%).

Lab Tests

Elevated serum amylase (62%, grade 3/4 [38%]); elevated serum lipase (28%; grade 3/4 [11%]).

Musculoskeletal

Arthralgia (10%).

Miscellaneous

Fever (39%); edema (28%); pain (16%).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Patient Information

• Explain name, dose, action, potential side effects, and potential risks, including potential for stimulation of tumor growth if used in patient with nonhematologic malignancy.
• Advise patient that medication will be prepared and administered by a health care professional in a health care setting.
• Advise patient that medication may cause skin or mucus membrane side effects (eg, rash, redness, edema, itching, abnormal skin sensations around the mouth, tongue discoloration, tongue thickening, taste alteration) and to report these side effects, or any others, to health care professional.