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Aranesp(darbepoetin alfa)injection, for intravenous or subcutaneous use
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Aranesp safely and effectively. See full prescribing information for Aranesp.
Aranesp® ( darbepoetin alfa)
injection, for intravenous or subcutaneous use
Initial U.S. Approval: 2001
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE
See full prescribing information for complete boxed warning.
Chronic Kidney Disease:
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In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL (5.1).
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No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks.
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Use the lowest Aranesp dose sufficient to reduce the need for red blood cell (RBC) transfusions (5.1).
Cancer:
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ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers (Table 3, 5.3).
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Prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense Aranesp to patients with cancer (5.2).
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Use the lowest dose to avoid RBC transfusions (2.3).
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Use ESAs only for anemia from myelosuppressive chemotherapy (1.2).
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ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure (1.3).
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Discontinue following the completion of a chemotherapy course (2.3).
RECENT MAJOR CHANGES
Dosage and Administration:
Patients on Cancer Chemotherapy (2.3) 12/2013
INDICATIONS AND USAGE
Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to:
• Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1).
• The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).
Limitations of Use
Aranesp has not been shown to improve quality of life, fatigue, or patient well-being (1.3).
Aranesp is not indicated for use:
• In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy (1.3).
• In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure (1.3).
• As a substitute for RBC transfusions in patients who require immediate correction of anemia (1.3).
DOSAGE AND ADMINISTRATION
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Recommended starting dose for CKD patients on dialysis (2.2):
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0.45 mcg/kg intravenously or subcutaneously weekly, or
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0.75 mcg/kg intravenously or subcutaneously every 2 weeks
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Intravenous route is recommended for patients on hemodialysis
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Recommended starting dose for patients with CKD not on dialysis (2.2):
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0.45 mcg/kg intravenously or subcutaneously at 4 week intervals
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Recommended starting dose for cancer patients on chemotherapy (2.3):
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2.25 mcg/kg subcutaneously weekly or
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500 mcg subcutaneously every 3 weeks
DOSAGE FORMS AND STRENGTHS
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Single-dose vials: 25, 40, 60, 100, 200, 300, and 500 mcg/1 mL, and 150 mcg/0.75 mL (3)
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Single-dose prefilled syringes: 10 mcg/0.4mL, 25 mcg/0.42 mL,
40 mcg/0.4 mL,
60 mcg/0.3 mL, 100 mcg/0.5 mL, 150 mcg/0.3 mL,
200 mcg/0.4 mL,
300 mcg/0.6 mL, and 500 mcg/1 mL (3)
CONTRAINDICATIONS
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Uncontrolled hypertension (4)
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Pure red cell aplasia (PRCA) that begins after treatment with Aranesp or other erythropoietin protein drugs (4)
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Serious allergic reactions to Aranesp (4)
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