Darbagen 40

• 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.

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.

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

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

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.

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.