Darbepoetin alfa

Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis. The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. Limitations of Use Aranesp has not been shown to improve quality of life, fatigue, or patient well-being. Aranesp is not indicated for use: In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy. In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure. In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion.

Aranesp stimulates erythropoiesis by the same mechanism as endogenous erythropoietin.

Recommended starting dose for patients with CKD 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 hemodialysis 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 pediatric patients with CKD: - 0.45 mcg/kg intravenously or subcutaneously weekly - patients with CKD not on dialysis may also be initiated at 0.75 mcg/kg every 2 weeks Recommended starting dose for patients with cancer on chemotherapy: - 2.25 mcg/kg subcutaneously weekly, or - 500 mcg subcutaneously every 3 weeks

Aranesp is contraindicated in patients with: Uncontrolled hypertension. Pure red cell aplasia (PRCA) that begins after treatment with Aranesp or other erythropoietin protein drugs. Serious allergic reactions to Aranesp. Uncontrolled hypertension.

WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE Chronic Kidney Disease: In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis -stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL. Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism: Using Aranesp to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit ( 5.1 and 14.1 ). Use caution in patients with coexistent cardiovascular disease and stroke. Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with Cancer.

The following clinically significant adverse reactions are discussed in greater detail in other sections of the label: Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with Cancer Hypertension Seizures Pure Red Cell Aplasia Serious Allergic Reactions Severe Cutaneous Reactions Patients with CKD: Adverse reactions in ≥ 10% of Aranesp-treated patients in clinical studies were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension. Patients with Cancer Receiving Chemotherapy: Adverse reactions in ≥ 1% of Aranesp-treated patients in clinical studies were abdominal pain, edema, and thrombovascular events.

Store at 36°F to 46°F (2°C to 8°C). Do not freeze. Do not shake. Protect from light, store Aranesp in the carton until use.