Monograph Details
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Hematology
> Anemias
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ARANESP |
| Manufacturer |
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Amgen, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Erythropoiesis stimulating protein. |
| Generic Name |
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Darbepoetin alfa 25micrograms/mL, 40micrograms/mL, 60micrograms/mL, 100micrograms/mL, 150micrograms/0.75mL, 200micrograms/mL, 300micrograms/mL, 500micrograms/mL; for IV or SC inj; preservative-free; contains albumin (human) or polysorbate 80. |
| Also |
• ARANESP SINGLEJECT
• ARANESP SURECLICK
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| Indications |
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Anemia of chronic renal failure (CRF), including patients on and not on dialysis. Chemotherapy-induced anemia in patients with non-myeloid malignancies. |
| Children |
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Not recommended. |
| Adults |
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CRF (not currently on epoetin alfa): initially 0.45micrograms/kg SC or IV once weekly. Cancer: initially 2.25micrograms/kg SC once weekly or 500micrograms SC once every 3 weeks. Discontinue after completion of chemotherapy course. Adjust dose to maintain hemoglobin level (target 10–12g/dL; max 12g/dL) sufficient to avoid red blood cell transfusion; see literature. Converting from epoetin alfa, and for dose adjustment: see literature. |
| Contraindications |
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Uncontrolled hypertension. Do not use in patients with pure red cell aplasia due to erythropoietin antibodies. |
| Precautions |
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See literature. 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; withhold dose if hemoglobin exceeds 12g/dL. 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, severe albumin toxicity, bone marrow fibrosis may reduce effectiveness; consider other etiologies in treatment failures. Adjust dialysis Rx as needed. Latex allergy. Pregnancy (Cat.C). Nursing mothers. |
| Adverse Reactions |
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Infection, hyper- or hypotension, myalgia, headache, GI upset, dyspnea, edema, arthralgia, limb or back pain, arrhythmia/cardiac arrest, cough, fatigue, chest pain, dizziness, pruritus, clotted vascular access, CHF, flu-like symptoms, local reactions, asthenia, seizure, iron deficiency. Increased risk of death, cardiovascular or thrombotic events if hemoglobin >12g/dL. May stimulate tumor growth, shorten time to tumor progression or overall survival if hemoglobin ≥12g/dL. Cancer patients also: pneumonia, dehydration. |
| How Supplied |
Single-dose vials (25, 40, 60, 100, 150, 200, 300micrograms)—4
Single-dose vial (200, 300, 500micrograms)—1
Single-dose prefilled syringes (25, 40, 60, 100, 150, 200, 300micrograms)—4
Single-dose prefilled syringes (200, 300, 500micrograms)—1
Single-dose prefilled SureClick autoinjector (25, 40, 60, 100, 150, 200, 300, 500micrograms)—1 |
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