Darbepoetin alfa

Darbepoetin alfa is an erythropoiesis-stimulating protein produced in CHO cells by recombinant DNA technology. It is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. It stimulates the bone marrow to produce more red blood cells, which helps treat anemia.

• Anemia due to Chronic Kidney Disease (dialysis and non-dialysis patients)
• Anemia due to cancer chemotherapy

Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in CHO cells by recombinant DNA technology. It is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone.

Darbepoetin alfa stimulates division and differentiation of progenitor cells in the bone marrow to induce the release of reticulocytes, which become erythrocytes, thereby increasing red blood cell production.

Adult - CKD (dialysis & non-dialysis): Initial dose 0.45 mcg/kg IV/SC once weekly; or 0.75 mcg/kg every 2 weeks; or 1.5 mcg/kg once monthly. Initiate when Hb <10 g/dL.

Child (≥1 year): 0.45 mcg/kg IV/SC once weekly; or 0.75 mcg/kg every 2 weeks (non-dialysis).

Chemotherapy-induced anemia: 500 mcg (6.75 mcg/kg) once every 3 weeks SC; or 2.25 mcg/kg once weekly SC.

This medicine is given as a subcutaneous or intravenous injection by a healthcare professional. Do not shake. Protect from light. Do not use Darbepoetin alfa that has been frozen.

If you miss a dose of Darbepoetin alfa, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose. Do not double the dose.

Common: Hypertension, stroke, thromboembolic events, convulsions, allergic reactions, rash/erythema, and Pure Red Cell Aplasia (PRCA).

Use with caution in patients with controlled hypertension, seizures, PRCA, or allergy history. Monitor blood pressure regularly. Inform doctor if symptoms of very high blood pressure (severe headache, vision problems, nausea, vomiting, seizures) occur. Discontinue if shortness of breath or skin rash develops.

Uncontrolled hypertension; Pure Red Cell Aplasia (PRCA); serious allergic reactions.

No formal drug interaction studies have been conducted with Darbepoetin alfa. May antagonize hypotensive effect and increase risk of hyperkalemia with ACE inhibitors and angiotensin II receptor antagonists.

It is not known whether it is safe to consume alcohol with Darbepoetin alfa. Please consult your doctor.

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Should be used during pregnancy only if clearly needed.

It is not known whether Darbepoetin alfa is excreted in human milk. Caution should be exercised when administered to a nursing woman.

Safety and efficacy in pediatric patients younger than 1 year of age have not been established.

No specific dosage adjustment is necessary for elderly patients. However, caution should be exercised.

Renal impairment: Safe to use in patients with kidney disease. No dose adjustment recommended.

Hepatic impairment: Use with caution in patients with liver disease. Dose adjustment may be needed.

Overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of dosage and/or with phlebotomy, as clinically indicated.

Store at 2°C to 8°C. Do not freeze. Do not shake. Protect from light; store in the carton until use. Do not use if shaken or frozen.

Darbepoetin alfa