Aranesp

— THERAPEUTIC CATEGORIES —
  • Anemias

Aranesp Generic Name & Formulations

General Description

Darbepoetin alfa 25mcg/mL, 40mcg/mL, 60mcg/mL, 100mcg/mL, 150mcg/0.75mL, 200mcg/mL, 300mcg/mL, 500mcg/mL; for IV or SC inj; preservative-free; contains polysorbate 80.

Pharmacological Class

Erythropoiesis stimulating protein.

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 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 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 Contraindications

Contraindications

Uncontrolled hypertension. Pure red cell aplasia after Aranesp treatment or other erythropoietin protein drugs.

Aranesp 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 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 Pharmacokinetics

See Literature

Aranesp Interactions

Not Applicable

Aranesp Adverse Reactions

Adverse Reactions

CKD: hypertension, dyspnea, peripheral edema, cough, procedural hypotension. Cancer: abdominal pain, edema, thrombovascular events.

Aranesp Clinical Trials

See Literature

Aranesp Note

Not Applicable

Aranesp Patient Counseling

See Literature