Treatment of anaemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis and for the treatment of anaemia in patients with non-myeloid malignancies, where anaemia is due to the effect of concomitantly administered chemotherapy.
Stimulates erythropoiesis via division & differentiation of progenitor cells in bone marrow to induce the release of reticulocytes from the bone marrow into the bloodstream to become erythrocytes. Darbepoetin alfa binds to the erythropoietin receptor on erythroid progenitor cells, stimulating RBC production and differentiation.
Recommended starting dose for CKD patients on dialysis: 0.45 mcg/kg intravenously or subcutaneously weekly, or 0.75 mcg/kg intravenously or subcutaneously every 2 weeks Intravenous route is recommended for patients on haemodialysis. Recommended starting dose for patients with CKD not on dialysis: 0.45 mcg/kg intravenously or subcutaneously at 4 week intervals. Recommended starting dose for cancer patients on chemotherapy: 2.25 mcg/kg subcutaneously weekly, or 500 mcg subcutaneously every 3 weeks.
Contraindicated in patients with hypersensitivity to any of the ingredients in the composition. Uncontrolled hypertension, pure red cell aplasia that begins after treatment with darbepoetin.
Using Darbepoetin alfa to target a haemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit. Use caution in patients with coexistent cardiovascular disease and stroke. Increased Mortality and/or Increased Risk of Tumour Progression or Recurrence in Patients with Cancer. Control hypertension prior to initiating and during treatment with Darbepoetin alfa. Darbepoetin alfa increases the risk for seizures in patients with CKD. Increase monitoring of these patients for changes in seizure frequency or premonitory symptoms. If severe anaemia and low reticulocyte count develop during Darbepoetin alfa treatment, withhold Darbepoetin alfa and evaluate for PRCA.
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Exercise caution when administered to a nursing woman. Pediatric Use: Safety and efficacy not established in the initial treatment of anemic patients with CKD, in the transition from another erythropoietin in patients with CKD who are less than 1 year of age, or in pediatric patients with cancer.
No drug - drug interactions have been reported.
Patients with CKD: Adverse reactions in ≥ 10% of Aranesp-treated patients in clinical studies were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension. Cancer Patients Receiving Chemotherapy: Adverse reactions in ≥ 1% of treated patients in clinical studies were abdominal pain, edema, and thrombovascular events.
Store at 2 to 8 degrees C (36 to 46 degrees F). Do not freeze or shake.
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