Epoetin Beta

Epoetin 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).

Epoetin 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 Recormon 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.

Lyophilisate and solvent for solution for injection: The multidose preparation can be used for several patients. To avoid the risk of cross-infection, always follow aseptic techniques and use disposable sterile syringes and needles for each administration.

Solution for injection in pre-filled syringe: The Recormon pre-filled syringe is ready for use. Under no circumstances should more than one dose be administered per syringe; the medicinal product is for single use only.

Treatment of patients with anemia due to chronic kidney disease: The reconstituted solution can be administered subcutaneously or intravenously. In case of intravenous administration, the solution should be injected over approx. 2 minutes, e.g. in hemodialysis patients via the arterio-venous fistula at the end of dialysis. For non-hemodialysed patients, subcutaneous administration should always be preferred in order to avoid puncture of peripheral veins. In CKD patients, the aim of treatment is to reach a target Hb level of 10–12 g/dl. An Hb level of 12 g/dl should not be exceeded. If the rise in hemoglobin is greater than 2 g/dl (1.3 mmol/l) in 4 weeks, an appropriate dose reduction should be considered. In the presence of hypertension or existing cardiovascular, cerebrovascular or peripheral vascular diseases, the weekly increase in Hb and the target Hb should be determined individually taking into account the clinical picture. Patients should be monitored closely to ensure that the lowest dose of Recormon is used to provide adequate control of the symptoms of anemia.

* চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'

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.

Epoetin 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. Endogeneous 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.

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

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.

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