Epoetin

What it is and how it works

Mechanism of Action Epoetin alfa products stimulate erythropoiesis by the same mechanism as endogenous erythropoietin.

Indications

is an erythropoiesis-stimulating agent (ESA) indicated for: • Treatment of anemia due to o Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis . o Zidovudine in patients with Human Immunodeficiency Virus (HIV) infection . o 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 RETACRIT has not been shown to improve quality of life, fatigue, or patient well-being . RETACRIT 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 .

Dosage and administration (summary)

• 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).

Contraindications

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

Warnings and precautions

• 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 . • Hypertension: Control hypertension prior to initiating and during treatment with RETACRIT .

Pregnancy

Pregnancy Risk Summary RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in pregnant women . When therapy with RETACRIT is needed during pregnancy, use a benzyl alcohol-free formulation (i.e., single-dose vial).

Storage and supply

Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. When exposed to freezing temperatures, the green area of the freeze strip indicator in the carton of the multiple-dose vials will show signs of cloudy or white discoloration. Do not shake.

Source: Epoetin Alfa-Epbx (Retacrit) — US FDA prescribing information, 2025-06-22, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.