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Aranesp Singleject Generic Name & Formulations
Legal Class
Rx
General Description
Darbepoetin alfa 10mcg/0.4mL, 25mcg/0.42mL, 40mcg/0.4mL, 60mcg/0.3mL, 100mcg/0.5mL, 150mcg/0.3mL, 200mcg/0.4mL, 300mcg/0.6mL, 500mcg/mL; per prefilled syringe; for IV or SC inj; preservative-free; contains polysorbate 80.
Pharmacological Class
Erythropoiesis stimulating protein.
See Also
How Supplied
Single-dose vials (25, 40, 60, 100, 150mcg)—4; Single-dose vial (200, 300mcg)—1; Single-dose prefilled syringes (10, 25, 40, 60, 100, 150mcg)—4; Single-dose prefilled syringes (200, 300, 500mcg)—1
Manufacturer
Generic Availability
NO
Aranesp Singleject Indications
Indications
Anemia of chronic kidney disease (CKD), including patients on and not on dialysis. Chemotherapy-induced anemia in patients with non-myeloid malignancies.
Aranesp Singleject Dosage and Administration
Adult
Initiate only when hemoglobin (Hgb) <10g/dL. CKD (on dialysis): initially 0.45mcg/kg IV or SC once weekly; or 0.75mcg/kg IV or SC once every 2 weeks. Patients on hemodialysis: IV route is recommended. CKD (not on dialysis): initially 0.45mcg/kg SC or IV given once at 4 week intervals. Reduce or interrupt dose if Hgb >10g/dL (not on dialysis) or >11g/dL (on dialysis). Cancer: initially 2.25mcg/kg SC once weekly or 500mcg SC once every 3 weeks. Discontinue after completion of chemotherapy course. Use lowest dose sufficient to avoid red blood cell transfusion. Converting from epoetin alfa, and for dose adjustments: see full labeling.
Children
Initiate only when hemoglobin (Hgb) <10g/dL. CKD: initially 0.45mcg/kg SC or IV once weekly; patients with CKD (not on dialysis): may also initiate at 0.75mcg/kg once every 2 weeks. Reduce or interrupt dose if Hgb >12g/dL. Cancer: not established.
Aranesp Singleject Contraindications
Contraindications
Uncontrolled hypertension. Pure red cell aplasia after Aranesp treatment or other erythropoietin protein drugs.
Aranesp Singleject Boxed Warnings
Boxed Warning
Increased risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access. Increased risk of tumor progression or recurrence in cancer patients.
Aranesp Singleject Warnings/Precautions
Warnings/Precautions
See full labeling. Increased mortality, MI, stroke, and thromboembolism. Coexistent cardiovascular disease and stroke. Increased risk of tumor progression or recurrence in those with cancer. Evaluate serum iron, ferritin, transferrin saturation before and during therapy; most patients will need iron supplementation. Monitor hemoglobin weekly for 4 weeks after start and dose changes, until stabilized, then periodically; reduce dose if hemoglobin increases >1g/dL in any 2-week period. Monitor BP (reduce or withhold dose if hypertension occurs), folate, Vit. B12, renal function, electrolytes, fluid balance, and for premonitory neurological symptoms. Seizure, cardiovascular, or hematologic disorders. Infection, inflammation, malignancy, occult blood loss, bone marrow fibrosis may reduce effectiveness; consider other etiologies in treatment failures. Discontinue immediately if serious allergic, anaphylactic, or cutaneous reaction (eg, SJS/TEN) occurs. Adjust dialysis ℞ as needed. Latex allergy. Pregnancy. Nursing mothers.
Aranesp Singleject Pharmacokinetics
See Literature
Aranesp Singleject Interactions
Not Applicable
Aranesp Singleject Adverse Reactions
Adverse Reactions
CKD: hypertension, dyspnea, peripheral edema, cough, procedural hypotension. Cancer: abdominal pain, edema, thrombovascular events.
Aranesp Singleject Clinical Trials
See Literature
Aranesp Singleject Note
Not Applicable
Aranesp Singleject Patient Counseling
See Literature
