Initer

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

Adverse reactions in 5% of Erythropoietin alfa 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%)

There are no adequate and well-controlled studies in pregnant women. Studies in animals have shown reproduction toxicology. Consequently:

• In chronic renal failure patients, Erythropoietin alfa should be used in pregnancy only if the potential benefit outweighs the potential risk to the foetus.
• In pregnant or lactating surgical patients participating in an autologous blood predonation programme, the use of Erythropoietin alfa is not recommended.

It is not known whether exogenous Erythropoietin alfa is excreted in human milk. Erythropoietin alfa should be used with caution in nursing women. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Erythropoietin alfa should be made taking into account the benefit of breast feeding to the child and the benefit of Erythropoietin alfa therapy to the woman.

Drugs for Haemolytic Hypoplastic & Renal Anemia

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

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.