Kepivance® is indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy requiring hematopoietic stem cell support.

The safety and efficacy of Kepivance® have not been established in patients with non-hematologic malignancies (see PRECAUTIONS).

The recommended dosage of Kepivance® is 60 mcg/kg/day, administered as an IV bolus injection for 3 consecutive days before and 3 consecutive days after myelotoxic therapy for a total of 6 doses.

The first 3 doses should be administered prior to myelotoxic therapy, with the third dose 24 to 48 hours before myelotoxic therapy (see PRECAUTIONS: Drug Interactions).

The last 3 doses should be administered post-myelotoxic therapy; the first of these doses should be administered after, but on the same day of hematopoietic stem cell infusion and at least 4 days after the most recent administration of Kepivance® (see PRECAUTIONS: Drug Interactions).

No dose adjustment is recommended for patients with renal impairment(see CLINICAL PHARMACOLOGY: Special Populations).

Do not use Kepivance® beyond the date stamped on the vial label.

Kepivance® lyophilized powder should only be reconstituted with Sterile Water for Injection, USP (not supplied). Kepivance® should be reconstituted aseptically by slowly injecting 1.2 mL of Sterile Water for Injection, USP (not supplied) to yield a final concentration of 5 mg/mL. The contents should be swirled gently during dissolution. Do not shake or vigorously agitate the vial.

Generally, dissolution of Kepivance® takes less than 3 minutes.

PROTECT FROM LIGHT

The reconstituted solution contains no preservatives and is intended for single use only. 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 Kepivance® may be allowed to reach room temperature for a maximum of 1 hour but should be protected from light. Discard Kepivance® left at room temperature for more than 1 hour. Do not freeze the reconstituted solution.

The reconstituted solution should be clear and colorless. Visually inspect the solution for discoloration and particulate matter before administration. Kepivance® should not be administered if discoloration or particulates are observed.

DO NOT FILTER the reconstituted solution during preparation or administration.

Kepivance® should be administered by intravenous bolus injection. If heparin is used to maintain an IV line, saline should be used to rinse the line prior to and after Kepivance® administration since Kepivance® has been shown to bind to heparin in vitro.

Kepivance® is supplied in vials containing 6.25 mg of palifermin.

Kepivance® is supplied in a dispensing pack containing 6 single-use vials (NDC 55513-520-06) or in a distribution case containing 4 dispensing packs (NDC 55513-520-06) [4 x 6 vial dispensing packs (24 x 6.25 mg/vial)].

The dispensing pack containing Kepivance® lyophilized powder should be stored in its carton and refrigerated at 2° to 8°C (36° to 46°F). PROTECT FROM LIGHT. Keep vials in pack until time of use.

This product, its production and/or its use may be covered by one or more US Patents, including US Patent Nos. 6,420,531 B1; 5,814,605; 5,824,643; and 5,677,278 as well as other patents or patents pending.

REFERENCES

1. Miller AB, Hoogstraten B, Staquet M, et al. Reporting results of cancer treatment. Cancer. 1981;47:207-214.

Manufactured by: Amgen Inc., One Amgen Center Drive Thousand Oaks, CA 91320-1799 USA Certain manufacturing operations have been performed by other firms. ã 200X Amgen Inc. All rights reserved. FDA Revision Date:12/12/2005.

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