Eporen 5000IU/0.5ml Injection

Eporen is an erythropoiesis-stimulating agent (ESA) indicated for:

Treatment of anemia due to:

• Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis.
• Zidovudine in HIV-infected patients.
• The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.

Prevention of anemia of prematurity in infants with a birth weight of 750 to 1500 gm and gestational age of less than 34 weeks.

Description

Eporen 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. The apparent molecular weight of erythropoietin is about 30,400 daltons.

AdministrationPreparation and Administration-Do not shake. Do not use Erythropoietin alfa that has been shaken or frozen.Protect syringe from light.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Administration

Preparation and Administration-

• Do not shake. Do not use Erythropoietin alfa that has been shaken or frozen.
• Protect syringe from light.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use any syringe exhibiting particulate matter or discoloration.
• Discard unused portions of Erythropoietin alfa.

Interaction

There are no known clinically significant drug interactions but the effect of Eporen may be potentiated by the simultaneous therapeutic administration of a haematinic agent such as ferrous sulphate when a deficiency state exists.

Contraindications

• Uncontrolled hypertension.
• Serious allergic reactions to Erythropoietin alfa.
• Patients who develop Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin should not receive Erythropoietin alfa or any other erythropoietin.

Side Effects

Adverse reactions in 5% of Eporen treated patients in clinical studies were:

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

Overdose Effects

The therapeutic margin of Eporen is very wide. Eporen overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Eporen dosage and/or with phlebotomy, as clinically indicated. Cases of severe hypertension have been observed following overdose with ESAs.

Therapeutic Class

Drugs for Haemolytic Hypoplastic & Renal Anemia

Storage Conditions

Store at 2ºC to 8ºC. Do not freeze or shake. This temperature range should be closely maintained until administration to the patient. Store in original package in order to protect from light.