KEPIVANCE- palifermin injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

palifermin (UNII: QMS40680K6) (palifermin - UNII:QMS40680K6)

Available from:

Swedish Orphan Biovitrum AB (publ)

INN (International Name):

palifermin

Composition:

palifermin 6.25 mg in 1.2 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Kepivance is indicated 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. Kepivance is indicated as supportive care for preparative regimens predicted to result in ≥ WHO Grade 3 mucositis in the majority of patients. 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 in the setting of autologous 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. The safety and efficacy of Kepivance have not been established in patients with non-hematologic malignancies )]. The safety and efficacy of Kepivance have not been established in patients with non-hematologic malignancies

Product summary:

Kepivance is supplied as a lyophilized powder in single-dose vials containing 5.16 mg of palifermin. Kepivance vials are supplied in: 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.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

KEPIVANCE- PALIFERMIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
SWEDISH ORPHAN BIOVITRUM AB (PUBL)
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KEPIVANCE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR KEPIVANCE.
KEPIVANCE (PALIFERMIN) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
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 in the setting of autologous 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. ( 1.1)
Limitations of Use
The safety and efficacy of Kepivance have not been established in
patients with non-hematologic
malignancies ( 1.2, 5.1)
Kepivance was 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. ( 1.2, 14.3)
Kepivance is not recommended for use with melphalan 200 mg/m
as a conditioning regimen ( 14.2).
DOSAGE AND ADMINISTRATION
Administer as an intravenous bolus injection at a dose of 60
mcg/kg/day for 3 consecutive days before and
3 consecutive days after myelotoxic therapy for a total of 6 doses (
2.1)
Administer the first 3 doses prior to myelotoxic therapy with the
third dose 24 to 48 hours before
myelotoxic therapy ( 2.1)
Administer the last 3 doses after myelotoxic therapy is complete with
the first of these doses on the
day of hematopoietic stem cell infusion after the infusion is
completed, and at least 7 days after the
most recent administration of Kepivance ( 2.1)
DOSAGE FORMS AND STRENGTHS
For injection: 5.16 mg lyophilized powder in single-dose vials (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Potential for stimulation of tumor