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Kepivance Generic Name & Formulations
Legal Class
Rx
General Description
Palifermin 6.25mg/vial; lyophilized pwd for IV inj after reconstitution; preservative-free; contains mannitol.
Pharmacological Class
Keratinocyte growth factor (recombinant).
How Supplied
Single-dose vials—3, 6
Manufacturer
Generic Availability
NO
Kepivance Indications
Indications
To decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of autologous hematopoietic stem cell support. As supportive care for preparative regimens predicted to result in ≥ WHO Grade 3 mucositis in the majority of patients.
Limitations of Use
Not established in non-hematologic malignancies. 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. Not for use with melphalan 200mg/m2 as conditioning regimen.
Kepivance Dosage and Administration
Adult
See full labeling. Give as IV bolus inj for 6 doses total. 60mcg/kg per day for 3 consecutive days before myelotoxic therapy (give 3rd dose 24–48hrs prior to beginning myelotoxic therapy); then 60mcg/kg per day for 3 consecutive days after myelotoxic therapy completion (give 1st dose on the day of hematopoietic stem cell infusion after the infusion is completed, and at least 7 days after the most recent palifermin dose).
Children
Not recommended.
Kepivance Contraindications
Not Applicable
Kepivance Boxed Warnings
Not Applicable
Kepivance Warnings/Precautions
Warnings/Precautions
Potential for stimulation of tumor growth. Elderly. Pregnancy. Nursing mothers: not recommended (during and for ≥2 weeks after the last dose).
Kepivance Pharmacokinetics
See Literature
Kepivance Interactions
Interactions
If heparin is used to maintain IV line, rinse line with saline before and after palifermin use. Do not give palifermin before, during, or within 24hrs of myelotoxic chemotherapy.
Kepivance Adverse Reactions
Adverse Reactions
Skin toxicities (rash, erythema, edema, pruritus), oral toxicities (dysesthesia, tongue discoloration, tongue thickening, alteration of taste), fever, pain, arthralgias, dysesthesia, elevated serum amylase (Grade 3/4).
Kepivance Clinical Trials
See Literature
Kepivance Note
Not Applicable
Kepivance Patient Counseling
See Literature
