Erythropoietin Beta is indicated 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.
• 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.

Its use in this indication must be balanced against the reported increased risk of thromboembolic events. Treatment should only be given to patients with moderate anemia (Hb 10–13 g/dl [6.21–8.07 mmol/l], no iron deficiency) if blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).

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 is a glycoprotein that, as a growth factor, primarily stimulates the formation of erythrocytes from its committed progenitors. It acts as a mitosis-stimulating factor and differentiation hormone.

Therapy with Recomron should be initiated by physicians experienced in the above mentioned indications. As anaphylactoid reactions were observed in isolated cases, it is recommended that the first dose be administered under medical supervision.

Substitution by any other biological medicinal product requires the consent of the prescribing physician.

The Recomron pre-filled syringe is ready for use. Only solutions which are clear or slightly opalescent, colourless and practically free of visible particles may be injected.

Recomron in pre-filled syringe is a sterile but unpreserved product. Under no circumstances should more than one dose be administered per syringe.

Treatment of anemic patients with chronic renal failure: The solution can be administered subcutaneously or intravenously. In case of intravenous administration, the solution should be injected over approximately 2 minutes, e.g. in hemodialysis patients via the arteriovenous fistula at the end of dialysis.

For non-hemodialysed patients, subcutaneous administration should always be preferred in order to avoid puncture of peripheral veins.

The recommended hemoglobin target is 10 -12 g/dL. The target hemoglobin should be determined individually in the presence of hypertension or existing cardiovascular, cerebrovascular or peripheral vascular diseases. It is recommended that hemoglobin is monitored at regular intervals (e.g. every two to four weeks) until stabilised and periodically thereafter.

Treatment with Recomron is divided into two stages: Correction phase -

Subcutaneous administration: The initial dosage is 3 x 20 IU/kg body weight per week. The dosage may be increased every 4 weeks by 3 x 20 IU/kg body weight/week if the Hb increase is not adequate (Hb <1.5 g/L per week). The weekly dose can also be divided into daily doses.

Intravenous administration: The initial dosage is 3 x 40 IU/kg per week. The dosage may be raised after 4 weeks to 80 IU/kg - three times per week - and by further increments of 20 IU/kg if needed, three times per week, at monthly intervals.

For both routes of administration, the maximum dose should not exceed 720 IU/kg per week.

No dedicated clinical interaction studies have been performed. Clinical experience has not given evidence for potential interaction of Recormon with other medicinal products. In animal experiments, epoetin did not increase the myelotoxicity of cytostatic medicinal products like etoposide, cisplatin, cyclophosphamide, and fluorouracil.

Erythropoietin Beta is contraindicated in patients with:

• Known hypersensitivity to the active substance or any of the excipients.
• Poorly controlled hypertension.

In the indication "increasing the yield of autologous blood", Recormon must not be used in patients who, in the month preceding treatment, have suffered a myocardial infarction or stroke, patients with unstable angina pectoris, or patients who are at increased risk of deep venous thrombosis such as those with a history of venous thromboembolic disease.

Rarely (≥1/10,000 to ≤1/1,000), skin reactions such as rash, pruritus, urticaria, or injection site reactions may occur. In very rare cases (≤1/10,000), anaphylactoid reactions have been reported. However, in controlled clinical studies, no increased incidence of hypersensitivity reactions was found. In very rare cases (≤1/10,000), particularly when starting treatment, flu-like symptoms such as fever, chills, headaches, pain in the limbs, malaise, and/or bone pain have been reported. These reactions were mild or moderate in nature and subsided after a couple of hours or days.

Pregnancy: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition, or postnatal development. For epoetin beta, all safety information with regard to exposure to Recormon during pregnancies has been gained from post-marketing experience. A review of the available post-marketing data does not show evidence of a causal association between harmful effects with respect to pregnancy, embryonal/fetal development, or postnatal development and treatment with Recormon. However, in the absence of clinical study data, caution should be exercised when prescribing to pregnant women.

Lactation: Only limited experience in human lactation has been gained. Endogenous erythropoietin is excreted in breast milk and readily absorbed by the neonatal gastrointestinal tract. A decision on whether to continue or discontinue breastfeeding or to continue or discontinue therapy with epoetin beta should be made taking into account the benefit of breastfeeding to the child and the benefit of epoetin beta therapy to the woman.

Pediatric use: Results of pediatric clinical studies have shown that, on average, the younger the patients, the higher the Recormon doses required. Nevertheless, the recommended dosing schedule should be followed as the individual response cannot be predicted.

Geriatric use: No dedicated studies in geriatric patients were performed. A large proportion of geriatric patients were included in clinical trials with Recormon. A need for special dose adjustments in the geriatric population was not identified.

Hepatic Impairment: No dedicated clinical trials were conducted in patients with hepatic impairment. No special dosage instructions are available.

The therapeutic range of Recormon is wide, and individual response to therapy must be considered when Recormon treatment is initiated. Overdose can result in manifestations of an exaggerated pharmacodynamic effect, e.g., excessive erythropoiesis which may be associated with life-threatening complications of the cardiovascular system. In case of excessive hemoglobin levels, Recormon should be temporarily withheld. If clinically indicated, phlebotomy may be performed.

Drugs for Haemolytic Hypoplastic & Renal Anemia

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.