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KEPIVANCE
Cytoprotective and supportive care agents
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Drug Name:

KEPIVANCE Rx

Generic Name and Formulations:
Palifermin 6.25mg/vial; lyophilized pwd for IV inj after reconstitution; preservative-free; contains mannitol.

Company:
Sobi, Inc.

Therapeutic Use:

Indications for KEPIVANCE:

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.

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.

Warnings/Precautions:

Potential for stimulation of tumor growth. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.

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.

Pharmacological Class:

Keratinocyte growth factor (recombinant).

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).

Generic Availability:

NO

How Supplied:

Single-use vials—3, 6

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