Indications

Kepivance is a mucocutaneous epithelial human growth factor indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy requiring hematopoietic stem cell support. Kepivance is indicated as supportive care for preparative regimens predicted to result in ≥ WHO Grade 3 mucositis in the majority of patients.

Limitations of Use

The safety and effcacy of Kepivance have not been established in patients with non-hematologic malignancies [see WARNINGS AND PRECAUTIONS]. I Kepivance is not recommended for use with melphalan 200 mg/m² as a conditioning regimen [See Clinical Studies].

Recommended Dosage Regimen

The recommended dose of Kepi vance is 60 mcg/kg/day, administered as an intravenous bolus injection for 3 consecutive days before aiid 3 consecutive days after myelotoxic therapy, for a total of 6 doses. Administer the first 3 doses prior to myelotoxic therapy.

Administer the third dose 24 to 48 hours prior to beginning myelotoxic therapy [see DRUG INTERACTIONS].

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 more than 4 days after the most recent administration of Kepivance [see DRUG INTERACTIONS].

Preparation and Administration

Preparation

Prepare the solution for infusion, using aseptic technique, as follows:

• Reconstitute Kepivance lyophilized powder with Sterile Water for Injection, USP (not supplied) by slowly injecting 1.2 mL of Sterile Water for Injection, USP to yield a final concentration of 5 mg/mL.
• Swirl the contents gently during dissolution. Do not shake or vigorously agitate the viaL. Dissolution of Kepivance can take up to 3 minutes.
• Visually inspect the solution for discoloration and particulate matter before administration. The reconstituted solution should be clear and colorless. Do not administer Kepivance if discoloration or particulates are observed. Do not fiter the reconstituted solution during preparation or administration. Do not freeze the reconstituted solution. Protect from light.

Administration

• Administer Kepivance by intravenous bolus injection. If heparin is used to maintain an intravenous line, rinse the line with saline prior to and after Kepivance administration [see DRUG INTERACTIONS].
• The reconstituted solution contains no preservatives and is intended for single use only. Discard any unused portion.
• Following reconstitution, it is recommended that the product be used immediately. If not used immediately, the reconstituted solution of Kepivance may be stored refrigerated in its carton at 2° to 8°C (36° to 46°F) for up to 24 hours.
• Prior to injection, allow Kepivance to reach room temperature for a maximum of i hour protected from light. Discard Kepivance left at room temperature for more than 1 hour.

Dosage Forms and Strengths

6.25 mg lyophilized powder in single-use vials.

Kepivance is supplied as a lyophilized powder in single use vials containing 6.25 mg of palifermin. Kepivance vials are supplied in:

• a dispensing pack containing 3 vials (NDC 66658- 112-03)
• a dispensing pack containing 6 vials (NDC 66658-112-06)
• a distribution case containing 4 dispensing packs (NDC 66658-112-24) (4 x 6 vial dispensing packs (24 x 6.25 mg/vial)).

Store Kepivance vials in the dispensing pack in its carton refrigerated at 2° to 8°C (36° to 46°F) until time of use. Protect from light.

Manufactured by: Swedish Orphan Biovitrum AB (publ) SE- 112 76 Stockholm, Sweden.

Last reviewed on RxList: 12/6/2011
This monograph has been modified to include the generic and brand name in many instances.