Erythropoietin Beta

Erythropoietin Beta belongs to the drugs for haemolytic hypoplastic and renal anemia group. Doctors prescribe it mainly for Treatment of symptomatic anemia associated with chronic kidney disease (CKD) in patients on dialysis, Treatment of symptomatic renal anemia in patients not yet undergoing dialysis and Prevention of anemia of prematurity in infants with a birth weight of 750 to 1500 g and a gestational age of less than 34 weeks.

Erythropoietin beta is identical in its amino acid and carbohydrate composition to erythropoietin that has been isolated from the urine of anemic patients. Erythropoietin is a glycoprotein that stimulates the formation of erythrocytes from its committed progenitors. It acts as a mitosis-stimulating factor and differentiation hormone.

• Symptomatic anemia associated with CKD: Treatment of CKD-related anemia in patients on dialysis.
• Renal anemia (not on dialysis): Treatment of symptomatic renal anemia in patients not yet undergoing dialysis.
• Prevention of anemia of prematurity: In infants with birth weight 750-1500 g and gestational age less than 34 weeks.
• Chemotherapy-related anemia: Treatment of symptomatic anemia in adult patients with non-myeloid malignancies receiving chemotherapy.

Drugs for Haemolytic Hypoplastic and Renal Anemia

Erythropoietin Beta (Recombinant)

Erythropoietin beta is identical in its amino acid and carbohydrate composition to erythropoietin that has been isolated from the urine of anemic patients. Erythropoietin is a glycoprotein that stimulates the formation of erythrocytes from its committed progenitors. It acts as a mitosis-stimulating factor and differentiation hormone.

Erythropoietin beta stimulates RBC production in the bone marrow. It acts as a mitosis-stimulating factor and differentiation hormone.

Adult Dose:

• SC administration: Initial: 3 x 20 IU/kg/week; may increase every 4 weeks by 3 x 20 IU/kg/week.
• IV administration: Initial: 3 x 40 IU/kg/week; may increase after 4 weeks to 80 IU/kg/week.
• Maximum dose: Should not exceed 720 IU/kg/week.
• Target Hb: 10-12 g/dL.

Prevention of anemia of prematurity: 3x250 IU/kg SC per week (start by day 3 of life, 6 weeks).

Your doctor or nurse will give you this medicine. Kindly do not self administer. Administered via SC or IV route. For IV administration, inject over approximately 2 minutes (via arteriovenous fistula at end of dialysis for hemodialysis patients). For non-hemodialysed patients, SC route preferred.

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

Rare Side Effects (>=1/10,000 to <=1/1,000):

• Skin reactions (rash, pruritus, urticaria)
• Injection site reactions

Very Rare Side Effects (<=1/10,000):

• Anaphylactoid reactions
• Flu-like symptoms (fever, chills, headaches, limb pain, malaise, bone pain)

Precautions:

• First dose should be administered under medical supervision due to risk of anaphylactoid reactions.
• Target hemoglobin should be determined individually in presence of hypertension or cardiovascular, cerebrovascular, peripheral vascular diseases.
• Monitor hemoglobin at regular intervals (every 2-4 weeks) until stabilised and periodically thereafter.
• Only clear or slightly opalescent, colourless solutions free of visible particles may be injected.
• Do not administer more than one dose per syringe.

Contraindications:

• Known hypersensitivity to active substance or any excipients
• Poorly controlled hypertension
• In the indication increasing the yield of autologous blood: patients who have suffered MI or stroke in preceding month, unstable angina, increased risk of DVT

Drug Interactions: No dedicated clinical interaction studies performed. Clinical experience has not given evidence for potential interaction. In animal experiments, epoetin did not increase myelotoxicity of cytostatic medicinal products.

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

Use in Pregnancy: Animal studies do not indicate direct or indirect harmful effects. Post-marketing data does not show evidence of causal association. However, caution should be exercised when prescribing to pregnant women.

Use in Lactation: Limited experience in human lactation. Endogenous erythropoietin is excreted in breast milk and readily absorbed by neonatal GI tract. Decision should consider benefit of breastfeeding to child and benefit of therapy to woman.

Pediatric Use: Pediatric clinical studies show that younger patients require higher Recormon doses. Recommended dosing schedule should be followed.

Geriatric Use: No dedicated studies in geriatric patients. Large proportion included in clinical trials. No special dose adjustments identified.

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

Hepatic Impairment: No dedicated clinical trials conducted. No special dosage instructions available.

Overdose: Therapeutic range is wide. Overdose can result in excessive erythropoiesis associated with life-threatening cardiovascular complications. If excessive hemoglobin levels, temporarily withhold Recormon; phlebotomy may be performed if clinically indicated.

Storage: Store in refrigerator at 2-8 degree C. Keep vial/cartridge/pre-filled syringe in outer carton to protect from light.