DOSAGE AND ADMINISTRATION
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.
Pre-myelotoxic therapy: 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 ).
Post-myelotoxic therapy: 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 ).
Preparation of Kepivance
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.
Administration of Kepivance
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 (see PRECAUTIONS: Drug Interactions).
How Supplied
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 2º to 8ºC (36º to 46ºF). PROTECT FROM LIGHT. Keep vials in pack until time of use.
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