 |
|
|
|
|
| Indication and Usage |
| |
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.1
The safety and efficacy of Kepivance® have not been established in patients with non-hematologic malignancies.1
Kepivance® is contraindicated in patients with known hypersensitivity to E coli-derived proteins, palifermin, or any other component of the product.1
Kepivance® is supplied as a sterile, white, preservative-free, lyophilized powder containing 6.25 mg of palifermin in a single-dose vial. It must be reconstituted with 1.2 mL of sterile water for injection.1
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)].1
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.1
Kepivance® should be unpacked and refrigerated. Kepivance® should not be stored in the original shipping container. Vials should be kept in their carton to protect them from light until time of use. Reconstituted solutions of Kepivance® may be stored refrigerated at 2° to 8°C (36° to 46°F) for up to 24 hours. Shaking should be avoided. Before injection, Kepivance® may be allowed to reach room temperature for a maximum of 1 hour but should be protected from light. Kepivance® left at room temperature for more than 1 hour should be discarded. Freezing should be avoided; however, if accidentally frozen, Kepivance® should be allowed to thaw in the refrigerator before administration. If accidentally frozen a second time, Kepivance® should be discarded (see retail fact sheet).
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.1
| 1 |
Kepivance® (palifermin) prescribing information. |
ABOUT ORAL MUCOSITIS
ABOUT KEPIVANCE®
TOOLS AND RESOURCES
FOR NURSES
FOR PHARMACISTS
IMPORTANT PRODUCT SAFETY INFORMATION
|
 |
|
| |
|
|
|
|
|
