GBpoietin 10000 IU (IV/SC Injection)

Indications

• Treatment of anemia in Chronic Kidney Disease (CKD) patients
• Treatment of anemia in Zidovudine-treated HIV-infected patients
• Treatment of anemia in patients undergoing myelosuppressive chemotherapy
• Reduction of allogeneic RBC transfusions in noncardiac, nonvascular surgery patients
• Prevention of anemia of prematurity in infants with low birth weight and gestational age

Description

• Recombinant human erythropoietin (EPO)
• Expressed in Chinese hamster ovary cells
• Identical amino acid sequence to human urinary EPO
• Apparent molecular weight of about 30,400 daltons

Dosage

• Evaluation of iron stores and nutritional factors before and during treatment
• Monitoring hemoglobin levels at least weekly during therapy
• Adjusting therapy based on hemoglobin rate of rise, decline, and ESA responsiveness
• Initiating treatment based on hemoglobin levels in CKD patients on dialysis and not on dialysis
• Starting dose for Zidovudine-treated HIV-infected Patients

Administration

• Do not shake the product
• Protect syringe from light
• Inspect visually for particulate matter and discoloration before administration
• Discard unused portions of Erythropoietin alfa

Interaction

• Potentiation by simultaneous administration of haematinic agent like ferrous sulfate

Contraindications

• Uncontrolled hypertension
• Serious allergic reactions to Erythropoietin alfa
• Development of Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin

Side Effects

• Adverse reactions in CKD patients
• Adverse reactions in Zidovudine-treated HIV-infected Patients
• Adverse reactions in Cancer Patients on Chemotherapy
• Adverse reactions in Surgery Patients
• Adverse reactions in Premature infants

Pregnancy & Lactation

• No adequate and well-controlled studies in pregnant women
• Reproduction toxicology shown in animal studies
• Use in pregnancy only if benefit outweighs potential risk
• Use in lactating surgical patients participating in autologous blood predonation program not recommended
• Caution advised in nursing women with potential excretion in human milk

Overdose Effects

• Wide therapeutic margin
• Management with discontinuation or reduction of dosage
• Cases of severe hypertension observed following overdose

Therapeutic Class

• Drugs for Haemolytic Hypoplastic & Renal Anemia

Storage Conditions

• Store at 2°C to 8°C
• Do not freeze or shake
• Maintain temperature range until administration
• Store in original package to protect from light

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