Recormon 2000 IU/0.3 ml (IV/SC Injection)

Indications

• 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
• 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
• Treatment of symptomatic anemia in adult patients with non-myeloid malignancies receiving chemotherapy
• Increasing the yield of autologous blood from patients in a pre-donation programme

Pharmacology

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

Dosage & Administration

• Therapy with Recormon should be initiated by physicians experienced in the above-mentioned indications
• First dose should be administered under medical supervision
• Lyophilisate and solvent for solution for injection can be used for several patients
• Reconstituted solution can be administered subcutaneously or intravenously

Interaction

• No dedicated clinical interaction studies have been performed
• Clinical experience has not given evidence for potential interaction of Recormon with other medicinal products

Contraindications

• Known hypersensitivity to the active substance or any of the excipients
• Poorly controlled hypertension
• Recormon must not be used in patients who have suffered a myocardial infarction or stroke

Side Effects

• Skin reactions such as rash, pruritus, urticaria or injection site reactions may occur
• Anaphylactoid reactions have been reported in very rare cases
• Flu-like symptoms such as fever, chills, headaches, pain in the limbs, malaise and/or bone pain have been reported in very rare cases

Pregnancy & Lactation

• Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development
• Caution should be exercised when prescribing to pregnant women
• Limited experience in human lactation has been gained

Use in Special Populations

• Results of pediatric clinical studies have shown that, on average, the younger the patients, the higher the Recormon doses required
• No need for special dose adjustments in the geriatric population was identified

Overdose Effects

• Overdose can result in manifestations of an exaggerated pharmacodynamic effect
• Excessive erythropoiesis may be associated with life-threatening complications of the cardiovascular system
• Recormon should be temporarily withheld in case of excessive hemoglobin levels
• Phlebotomy may be performed if clinically indicated

Therapeutic Class

• Drugs for Haemolytic Hypoplastic & Renal Anemia

Storage Conditions

• Store in a refrigerator 2°C–8°C
• Keep the vial/cartridge/pre-filled syringe in the outer carton, in order to protect from light

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