Epoetin

Epogen is an erythropoiesis-stimulating agent (ESA) indicated for: Treatment of anemia due to: - Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis. - Zidovudine in patients with Human Immunodeficiency Virus (HIV) infection. - The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery. Limitations of Use Epogen has not been shown to improve quality of life, fatigue, or patient well-being. Epogen is not indicated for use: In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.

Epogen stimulates erythropoiesis by the same mechanism as endogenous erythropoietin.

Evaluate iron status before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia before initiating treatment. In pregnant women, lactating women, neonates, infants: Use only single-dose vials. Patients with CKD: Initial dose: 50 to 100 Units/kg 3 times weekly (adults) and 50 Units/kg 3 times weekly (pediatric patients). Individualize maintenance dose. Intravenous route recommended for patients on hemodialysis. Patients on Zidovudine due to HIV infection: 100 Units/kg 3 times weekly. Patients with Cancer on Chemotherapy: 40,000 Units weekly or 150 Units/kg 3 times weekly (adults), 600 Units/kg intravenously weekly (pediatric patients ≥ 5 years). Surgery Patients: 300 Units/kg per day daily for 15 days or 600 Units/kg weekly.

Epogen is contraindicated in patients with: Uncontrolled hypertension Pure red cell aplasia (PRCA) that begins after treatment with Epogen or other erythropoietin protein drugs Serious allergic reactions to Epogen Epogen from multiple-dose vials contains benzyl alcohol and is contraindicated in: Neonates, infants, pregnant women, and lactating women. Uncontrolled hypertension. Pure red cell aplasia (PRCA) that begins after treatment with Epogen or other erythropoietin protein drugs. Serious allergic reactions to Epogen. Use of the multiple-dose vials containing benzyl alcohol in neonates, infants, pregnant women, and lactating women

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 with chronic kidney disease (CKD) 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 ESAs 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 serious 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 PRCA Serious Allergic Reactions Severe Cutaneous Reactions Patients with CKD: Adverse reactions in ≥ 5% of Epogen-treated patients in clinical studies were hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection. Patients on Zidovudine due to HIV infection: Adverse reactions in ≥ 5% of Epogen-treated patients in clinical studies were pyrexia, cough, rash, and injection site irritation.

Store at 36°F to 46°F (2°C to 8°C). Do not freeze. Do not shake. Store Epogen vials in the original carton until use to protect from light.