Dosing and uses of Kepivance (palifermin)
Adult dosage forms and strengths
powder for injection
- 6.25mg
Oral Mucositis
Indicated for severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy requiring hematopoietic stem cell support
Also indicated as supportive care for preparative regimens predicted to result in WHO Grade 3 or greater mucositis in the majority of patients
60 mcg/kg IV bolus 3 consecutive days before and 3 consecutive days after myelotoxic therapy (6 doses total)
Dosage schedule
- Premyelotoxic therapy
- Administer the first 3 doses prior to myelotoxic therapy
- Administer the third dose 24-48 hr prior to beginning myelotoxic therapy
- Postmyelotoxic therapy
- Administer the last 3 doses after myelotoxic therapy is complete
- Administer the first of these doses on the day of hematopoietic stem cell infusion after the infusion is completed, and at least 7 days after the most recent administration of palifermin (ie, 3rd premyelotoxic dose)
Dosage modification
Renal or hepatic impairment: Dose adjustment not necessary
Limitation of Use
The safety and efficacy of not established in patients with non-hematologic malignancies
Not effective in decreasing incidence of severe mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of allogeneic hematopoietic stem cell support
Not recommended for use with melphalan 200 mg/m² as a conditioning regimen
Pediatric dosage forms and strengths
Safety and efficacy not established
Kepivance (palifermin) adverse (side) effects
>10%
Elevated serum amylase (62%)
Rash (62%)
Fever (39%)
Pruritus (35%)
Erythema (32%)
Edema (28%)
Elevated serum lipase (28%)
Mouth/tongue thickness/discoloration (17%)
proteinuria (17%)
Pain (16%)
Taste altered (16%)
Dysesthesia (12%)
1-10%
Arthralgia (10%)
Hypertension (7%)
Antibody formation (2%)
<1%
Cough
Vaginal erythema
Vaginal edema
Cataracts
Perianal pain
Rhinitis
Warnings
Contraindications
Hypersensitivity to palifermin or E coli-derived proteins
Cautions
Do not administer <24 hr before, during, or <24 hr after myelotoxic treatment; may worsen mucositis
Potential for tumor growth stimulation
Safety/efficacy not established for nonhematologic malignancies
Do not freeze reconstituted solution
Not recommended for use with melphalan 200 mg/m² as a conditioning regimen
Pregnancy and lactation
Pregnancy category: C
Lactation: Not recommended
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Kepivance (palifermin)
Mechanism of action
Recombinant human keratinocyte growth factor, stimulates epithelial cell differentiation, proliferation, and migration in many tissues
Pharmacokinetics
Half-Life, Elimination: 3.3-5.7 hr
Onset: 48 hr
Administration
IV Preparation
Reconstitute aseptically by injecting 1.2 mL sterile water for injection to yield a concentration of 5 mg/mL
Gently swirl to mix - do not shake vigorously
Reconstituted solution should be clear & colorless - do not use if discolored or turbid, do not filter
IV Administration
IV bolus
If heparin is used to maintain an IV line, rinse with saline before & after palifermin administration
Storage
Reconstituted IV solution may be stored at 2-8°C for up to 24 hr
Do not freeze reconstituted solution
Do not let reconstituted solution sit at room temp >1 hr
Protect from light
