palifermin
palifermin
Pharmacologic class: Keratinocyte growth factor (KGF) (rDNA origin)
Therapeutic class: Biologic and immunologic agent
Pregnancy risk category C
Action
Produced by recombinant DNA technology in Escherichia coli; binds to KGF receptor on cell surface, resulting in epithelial cell proliferation, differentiation, and migration
Availability
Powder for injection (lyophilized): 6.25 mg in single-use vials
Indications and dosages
➣ To decrease incidence and duration of severe oral mucositis in patients with hematologic malignancies who are receiving myelotoxic therapy requiring hematopoietic stem cell support
Adults: 60 mcg/kg/day I.V. bolus injection for 3 consecutive days before and 3 consecutive days after myelotoxic therapy, for a total of six doses. Give first three doses before myelotoxic therapy, with third dose given 24 to 48 hours before such therapy. Administer last three doses after myelotoxic therapy, with first of these given after (but on same day of) hematopoietic stem cell infusion and at least 4 days after most recent palifermin dose.
Contraindications
• Hypersensitivity to drug, its components, or E. coli-derived proteins
Precautions
Use cautiously in:
• patients with nonhematologic cancers
• use with melphalan 200 mg/m2 as a conditioning regimen (not recommended)
• elderly patients
• pregnant or breastfeeding patients
• children (safety and efficacy not established).
Administration
• Reconstitute powder with 1.2 ml sterile water for injection to yield final concentration of 5 mg/ml.
See Swirl vial gently during dissolution; don't shake or vigorously agitate.
• Don't filter reconstituted solution during preparation or administration.
• Use immediately (within 1 hour) after reconstituting; protect from light.
• When heparin is used to maintain I.V. line, use normal saline solution to rinse line before and after palifermin administration.
• Administer by I.V. bolus injection.
• Don't give within 24 hours before, during infusion of, or within 24 hours after myelotoxic chemotherapy.
Adverse reactions
CNS: dysesthesia
CV: hypertension
EENT: tongue discoloration or thickening
Musculoskeletal: pain, arthralgias
Skin: rash, pruritus, skin toxicities, erythema
Other: altered taste, edema, fever
Interactions
Drug-drug. Heparin: possible binding
Drug-diagnostic tests. Amylase, lipase: increased
Patient monitoring
• Monitor serum amylase and lipase levels frequently.
Patient teaching
• Instruct patient to report adverse reactions, including rash, itching, skin redness, swelling, discolored tongue, and altered taste.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs and tests mentioned above.
palifermin
(pa-liff-er-min) palifermin,Kepivance
(trade name)Classification
Therapeutic: cytoprotective agentsPharmacologic: keratinocyte growth factors
Indications
Action
Therapeutic effects
Pharmacokinetics
Time/action profile (levels)
| ROUTE | ONSET | PEAK | DURATION |
|---|---|---|---|
| IV | unknown | end of dose | unknown |
Contraindications/Precautions
Adverse Reactions/Side Effects
Dermatologic
- skin toxicity (most frequent)
Gastrointestinal
- oral toxicity (most frequent)
Metabolic
- ↑ amylase
- ↑ lipase
Musculoskeletal
- arthralgia (most frequent)
Neurologic
- dysesthesia (most frequent)
Interactions
Drug-Drug interaction
Binds to and inactivates heparin (flush tubing between use).Administration within 24 hr after myelotoxic therapy (chemotherapy/radiation) ↑ severity and duration of mucositis.Route/Dosage
Availability
Nursing implications
Nursing assessment
- Assess level of oral mucositis prior to and periodically during therapy.
- Lab Test Considerations: May cause ↑ serum lipase and amylase; usually reversible.
- May cause proteinuria.
Potential Nursing Diagnoses
Acute pain (Indications)Impairedoral mucous membrane (Indications)
Implementation
- Do not administer palifermin within 24 hr before, during infusion, or 24 hr after infusion of myelotoxic chemotherapy.
- Administer doses for 3 consecutive days before (third dose 24–48 hr prior to chemotherapy) and 3 consecutive days after myelotoxic chemotherapy (fourth dose on same day as hematopoietic stem cells infusion after infusion is completed and at least 4 days after most recent palifermin administration) for a total of 6 doses.
Intravenous Administration
- pH: No Data.
- Diluent: Reconstitute palifermin powder by slowly injecting 1.2 mL of sterile water for injection aseptically.Concentration: 5 mg/mL. Swirl gently; do not shake or vigorously agitate. Solution should be clear and colorless; do not administer solution that is discolored or contains particulate matter. Dissolution usually takes less than 3 minutes. Administer immediately after reconstitution or refrigerate and administer within 24 hr. Do not freeze. Allow to reach room temperature for up to 1 hr. Protect from light. Discard palifermin after expiration date or if left at room temperature for more than 1 hr.
- Rate: Administer via bolus injection. Do not use a filter.
- Y-Site Incompatibility: heparin. If heparin solution is used to maintain IV line, flush with 0.9% NaCl prior to and after use of palifermin.
Patient/Family Teaching
- Explain the purpose of palifermin to patient.
- Inform patient of evidence of tumor growth and stimulation in cell culture and animal models.
- Advise patient to notify health care professional if rash, erythema, edema, pruritus, oral/perioral dysesthesia (tongue discoloration, tongue thickening, alteration of taste) occur.
Evaluation/Desired Outcomes
- Decrease in incidence and duration of oral mucositis in patients receiving myelotoxic therapy requiring hematopoietic stem cell support.