Anemia Due To Chronic Kidney Disease: Darbepoetin Alfa is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis. Anemia Due To Chemotherapy In Patients With Cancer: Darbepoetin Alfa is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese Hamster Ovary (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.
Usual Adult Dose for Anemia Associated with Chronic Renal Failure: Chronic Kidney Disease (CKD) Patients Not on Dialysis: Initial dose: 0.45 mcg/kg IV or subcutaneously once every 4 weeks as appropriate Comments: Initiate treatment only when hemoglobin is less than 10 g/dL, rate of hemoglobin decline indicates likelihood of requiring RBC transfusion, and reducing risk of alloimmunization and/or other RBC transfusion-related risks is a goal. CKD Patients on Dialysis: Initial dose: 0.45 mcg/kg IV or subcutaneously once a week or 0.75 mcg/kg once every 2 weeks as appropriate Comments: Initiate treatment when hemoglobin is less than 10 g/dL. IV route is recommended for patients on hemodialysis. Usual Adult Dose for Anemia Associated with Chemotherapy: Initial dose: 2.25 mcg/kg subcutaneously once a week or 500 mcg subcutaneously once every 3 weeks Duration of therapy: Until completion of chemotherapy course Comments: Initiate treatment if hemoglobin is less than 10 g/dL and a minimum of 2 additional months of chemotherapy is planned. Use the lowest dose necessary to avoid RBC transfusions. Use: Treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy.
No formal drug interaction studies have been conducted with Darbepoetin alfa.
Darbepoetin is contraindicated in patients with: Uncontrolled hypertension Pure red cell aplasia (PRCA) that begins after treatment with Darbepoetin or other erythropoietin protein drugs Serious allergic reactions to Darbepoetin
Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism; Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with cancer; Hypertension; Seizures; Serious allergic reaction; Severe Cutaneous Reactions.
Pregnancy Category C. It is not known whether Darbepoetin Alfa is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Darbepoetin Alfa is administered to a nursing woman.
Over dosage with Darbepoetin alfa can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Darbepoetin alfa 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 Darbepoetin Alfa in the carton until use. Do not use Darbepoetin Alfa that has been shaken or frozen.
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