Epoetin Alfa [Recombinant Human Erythropoietin]: Brands, Price & Uses in Bangladesh

Epoetin Alfa [Recombinant Human Erythropoietin] is a recombinant human erythropoiesis-stimulating agent indicated for the treatment of anemia in the following clinically established settings:

• Anemia due to chronic kidney disease (CKD): in patients on dialysis and in patients not on dialysis, to reduce the need for red blood cell (RBC) transfusion. This is the primary, best-established FDA-approved indication.
• Anemia due to zidovudine therapy in HIV-infected patients with endogenous serum erythropoietin levels ≤500 mUnits/mL and receiving zidovudine doses ≤4200 mg/week.
• Anemia due to concomitant myelosuppressive chemotherapy in patients with non-myeloid malignancies, when the anticipated course of chemotherapy is for a minimum of two additional months after starting therapy. It is not indicated when the intent of chemotherapy is curative.
• Reduction of allogeneic RBC transfusion in patients with pre-operative hemoglobin between 10 and 13 g/dL undergoing elective, non-cardiac, non-vascular surgery with high anticipated blood loss. It is not indicated for patients undergoing cardiac or vascular surgery due to increased risk of thrombotic events.

Epoetin Alfa [Recombinant Human Erythropoietin] is not indicated and should not be used to improve quality of life, sense of well-being, or for the treatment of anemia due to any cause other than those listed above. It has not been shown to improve symptoms of fatigue.

Before initiating Epoetin Alfa [Recombinant Human Erythropoietin], correct or exclude other causes of anemia (iron, folate, or vitamin B12 deficiency, hemolysis, bleeding, infection). Evaluate iron status in all patients; iron supplementation is recommended for patients whose serum ferritin is below 100 mcg/L or whose serum transferrin saturation is below 20%, as adequate iron stores are necessary for an optimal response.

Anemia of Chronic Kidney Disease

Anemia due to Zidovudine in HIV-Infected Patients

Starting dose 100 Units/kg, 3 times weekly (IV or subcutaneous); if response is inadequate after 8 weeks, dose may be increased in increments of 50-100 Units/kg 3 times weekly. Doses above 300 Units/kg 3 times weekly are unlikely to provide additional benefit.

Anemia due to Chemotherapy in Non-Myeloid Malignancies

Starting dose 150 Units/kg subcutaneously 3 times weekly, or 40,000 Units subcutaneously once weekly, continued until completion of a chemotherapy course. Dose is adjusted based on hemoglobin response and rate of rise. Discontinue if no response (hemoglobin rise, reduced transfusion need) after 8 weeks of therapy.

Reduction of Transfusions in Surgery Patients

300 Units/kg subcutaneously once daily for 15 days (starting 10 days before surgery, on the day of surgery, and for 4 days after), or 600 Units/kg subcutaneously once weekly starting 21 days before surgery, plus a dose on the day of surgery. Deep venous thrombosis prophylaxis is recommended during use in this setting.

Administration Notes

• Administer by intravenous or subcutaneous injection only, as directed by the treating physician; not for oral use.
• Do not shake the vial/syringe vigorously — vigorous shaking may denature the protein, rendering it biologically inactive.
• Do not use if discolored or if particulate matter is present.
• See Precautions and Warnings for hemoglobin monitoring requirements.

The most commonly reported side effects of Epoetin Alfa [Recombinant Human Erythropoietin] include:

• Hypertension (very common; requires regular blood pressure monitoring)
• Headache
• Arthralgia and myalgia (joint and muscle pain)
• Pyrexia (fever) and flu-like symptoms
• Nausea, vomiting
• Injection site pain or reaction
• Dizziness

Serious side effects (see Precautions and Warnings for full detail) include an increased risk of death, myocardial infarction, stroke, and venous thromboembolism, particularly when hemoglobin is raised above target levels; seizures; pure red cell aplasia; and serious allergic reactions (anaphylaxis, angioedema, bronchospasm, skin reactions including Stevens-Johnson syndrome). Patients should seek urgent medical care for chest pain, sudden weakness, shortness of breath, leg swelling/pain, seizures, or signs of a severe allergic reaction.