Erythropoietin Alfa

Erythropoietin Alfa belongs to the drugs for haemolytic hypoplastic & renal anemia group. Doctors prescribe it mainly for anemia due to Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis, Zidovudine in HIV-infected patients, and anemia due to myelosuppressive chemotherapy.

Erythropoietin alfa is recombinant human erythropoietin (EPO). It is expressed in Chinese hamster ovary cells and has a 165 amino acid sequence identical to that of human urinary EPO.

• Anemia due to Chronic Kidney Disease: In patients on dialysis and not on dialysis.
• Zidovudine in HIV-infected Patients: Anemia prevention and treatment.
• Anemia due to Chemotherapy: Due to myelosuppressive chemotherapy effects (with at least 2 additional months of planned chemotherapy).
• Reduction of Allogeneic RBC Transfusions: In elective, noncardiac, nonvascular surgery patients.
• Prevention of Anemia of Prematurity: In infants with birth weight 750-1500 gm and gestational age less than 34 weeks.

Drugs for Haemolytic Hypoplastic & Renal Anemia

Erythropoietin Alfa (Recombinant)

Erythropoietin alfa is recombinant human erythropoietin (EPO). It is expressed in Chinese hamster ovary cells and has a 165 amino acid sequence identical to that of human urinary EPO; the two are indistinguishable on the basis of functional assays.

Erythropoietin alfa stimulates the differentiation and proliferation of erythroid precursors, stimulating the release of reticulocytes into the circulation, and synthesis of cellular haemoglobin.

Adult Dose:

• CKD (On dialysis): 50-100 units/kg IV/SC 3 times weekly; initiate when Hb <10 g/dL.
• CKD (Not on dialysis): 50-100 units/kg IV/SC 3 times weekly; initiate when Hb <10 g/dL.
• Zidovudine-treated HIV patients: 100 units/kg IV/SC 3 times weekly.
• Chemotherapy-Related Anemia: 150 units/kg SC 3 times weekly or 40,000 units SC once weekly.
• Preparation for Surgery: 300 units/kg SC daily for 15 days or 600 units/kg SC in 4 doses.
• Prevention of Anemia of Prematurity: 3x250 IU/kg SC per week (start by day 3 of life, 6 weeks).

Child Dose (5-18 years): 600 units/kg IV once weekly.

Your doctor or nurse will give you this medicine. Kindly do not self administer. Do not shake. Protect from light.

If you miss a dose of Erythropoietin Alfa, please consult your doctor.

Common Side Effects (≥5%):

• CKD Patients: Hypertension, arthralgia, muscle spasm, pyrexia, dizziness, vascular occlusion, upper respiratory tract infection.
• Zidovudine-treated HIV Patients: Pyrexia, cough, rash, injection site irritation.
• Cancer Patients on Chemotherapy: Nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, headache, depression, dysphagia, hypokalemia, thrombosis.
• Surgery Patients: Nausea, vomiting, pruritus, headache, injection site pain, chills, DVT, cough, hypertension.
• Premature infants: Fall in serum ferritin values (>10%).

Precautions:

• Uncontrolled hypertension: caution.
• History of seizure, thrombocytosis, chronic hepatic impairment, ischaemic vascular disease, malignant tumours, epilepsy; recent MI or CVA: caution.
• Iron deficiency, infection, inflammatory disorders, haemolysis and aluminium intoxication may decrease response.
• Regularly monitor platelet counts and serum-potassium concentrations.
• Control haematocrit levels.
• Monitor hemoglobin at least weekly until stable, then monthly.
• If hemoglobin rises rapidly (>1 g/dL in 2 weeks), reduce dose by 25%.

Contraindications:

• Uncontrolled hypertension
• Serious allergic reactions to Erythropoietin alfa
• Patients who develop Pure Red Cell Aplasia (PRCA) following any erythropoietin treatment

Drug Interactions: No clinically significant drug interactions. Effect may be potentiated by haematinic agents (e.g., ferrous sulphate) when a deficiency state exists.

Food Interactions: It is not known whether it is safe to consume alcohol with Erythropoietin Alfa. Consult your doctor.

Use in Pregnancy: No adequate and well-controlled studies in pregnant women. Animal studies have shown reproduction toxicology. In CKD patients, use only if potential benefit outweighs potential risk to the fetus.

Use in Lactation: It is not known whether exogenous Erythropoietin alfa is excreted in human milk. Use with caution.

Pediatric Use: 5-18 years: dosage provided above. Under 5 years: safety not established for some indications.

Geriatric Use: No specific dosage adjustment is necessary for elderly patients.

Renal Impairment: Dosage guidelines for CKD patients provided above. IV route recommended for dialysis patients.

Hepatic Impairment: Use with caution in patients with liver disease.

Overdose: Therapeutic margin is very wide. Overdosage can cause hemoglobin levels above desired level; manage with discontinuation or reduction of dosage and/or phlebotomy. Severe hypertension has been observed.

Storage: Store at 2-8°C. Do not freeze or shake. Store in original package to protect from light.

Erythropoietin Alfa