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  • Recormon
    / Roche


    Active Ingredient
    Epoeitin Beta 4000, 5000, 6000, 10000, 30000 IU

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Pre-filled Syringe (solution for injection)

    6 x 4,000 IU/0.3 ml

    partial basket chart 11270 18300

    Pre-filled Syringe (solution for injection)

    6 x 5,000 IU/0.3 ml

    partial basket chart 11271 18303

    Pre-filled Syringe (solution for injection)

    6 x 6,000 IU/0.3 ml

    partial basket chart 11272 18035

    Pre-filled Syringe (solution for injection)

    6 x 10,000 IU/0.3 ml

    partial basket chart 11273 18034

    Pre-filled Syringe (solution for injection)

    6 x 30,000 IU/0.3 ml

    partial basket chart 12324 18332

    Related information


    Dosage

    Anaphylactoid reactions were observed in isolated cases, it is recommended that the first dose be administered under medical supervision.
    Treatment of anaemic patients with chronic renal failure: In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL. No trial has identified a hemoglobin target level, Epoetin Beta dose, or dosing strategy that does not increase these risks. Individualize dosing and use the lowest dose of Epoetin Beta sufficient to reduce the need for RBC transfusions. Physicians and patients should weigh thepossible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events. Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician’s evaluation of the individual patient’s clinical course and condition is necessary. Epoetin beta should be administered either subcutaneously or intravenously in order to increase haemoglobin to not greater than 11 g/dl. Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid puncture of peripheral veins. In case of intravenous administration, the solution should be injected over approx. 2 minutes, e.g. in haemodialysis patients via the arterio-venous fistula at the end of dialysis.
    For patients with Chronic Renal Failure on dialysis:  Initiate Epoetin Beta treatment when the hemoglobin level is less than 10 g/dL. If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Epoetin Beta.
    For patients with Chronic Renal Failure not on dialysis: Consider initiating Epoetin Beta treatment only when the hemoglobin level is less than 10 g/dL and the following onsiderations apply: The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion and, reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal. If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of Epoetin Beta, and use the lowest dose of Epoetin Beta sufficient to reduce the need for RBC transfusions. Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed. Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/dl (6.2 mmol/l) to 11 g/dl (6.83 mmol/I). A sustained haemoglobin level of greater than 11 g/dl should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 11 g/dl are observed are described below. A rise in haemoglobin of greater than 2 g/dl (1.25 mmol/l) over a four week period should be avoided. If it occurs, appropriate dose adjustment should be made as provided. If the rate of rise in haemoglobin is greater than 2 g/dl (1.25 mmol/l) in one month or if the haemoglobin level is increasing and approaching 11 g/dl the dose is to be reduced by approximately 25 %. If the haemoglobin level continues to increase, therapy should be interrupted until the hemoglobin level begins to decrease, at which point therapy should be restarted at a dose approximately 25 % below the previously administered dose Patients should be monitored closely to ensure that the lowest approved effective dose of Epoetin beta is used to provide adequate control of the symptoms of anaemia whilst maintaining a haemoglobin concentration below or at 11 g/dl. Caution should be exercised with escalation of Epoetin beta doses in patients with chronic renal failure. In patients with a poor haemoglobin response to Epoetin beta, alternative explanations for the poor response 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.
    Treatment with Epoetin beta 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 and week if the increase of Hb is not adequate (< 0.25 g/dl 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.
    Maintenance phase: To maintain an Hb of between 10 and 11 g/dl, the dosage is initially reduced to half of the previously administered amount. Subsequently, the dose is adjusted at intervals of one or two weeks individually for the patient (maintenance dose). In the case of subcutaneous administration, the weekly dose can be given as one injection per week or in divided doses three or seven times per week. Patients who are stable on a once weekly dosing regimen may be switched to once every two weeks administration. In this case dose increases may be necessary. Results of clinical studies in children have shown that, on average, the younger the patients, the higher the Epoetin beta doses required. Nevertheless, the recommended dosing schedule should be followed as the individual response cannot be predicted. Treatment with Epoetin beta is normally a long-term therapy. It can, however, be interrupted, if necessary, at any time. Data on the once weekly dosing schedule are based on clinical studies with a treatment duration of 24 weeks.
    Treatment of chemotherapy-induced anaemia in cancer patients: Epoetin beta should be administered by the subcutaneous route to patients with anaemia (e.g. haemoglobin concentration ≤ 10g/dl (6.2 mmol/l)). Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician’s evaluation of the individual patient’s clinical course and condition is necessary. The weekly dose can be given as one injection per week or in divided doses 3 to 7 times per week. The recommended initial dose is 30,000 IU per week (corresponding to approximately 450 IU/kg body weight per week, based on an average weighted patient). Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed. Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/dl (6.2 mmol/l) to 11 g/dl (6.83 mmol/l). A sustained haemoglobin level of greater than 11 g/dl should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 11 g/dl are observed are described below. If, after 4 weeks of therapy, the haemoglobin value has increased by at least 1 g/dl (0.62 mmol/l), the current dose should be continued. If the haemoglobin value has not increased by at least 1 g/dl (0.62 mmol/l), a doubling of the weekly dose should be considered. If, after 8 weeks of therapy, the haemoglobin value has not increased by at least 1 g/dl (0.62 mmol/l), response is unlikely and treatment should be discontinued. The therapy should be continued up to 4 weeks after the end of chemotherapy The maximum dose should not exceed 60,000 IU per week. Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced by 25 to 50 % in order to maintain haemoglobin at that level. Appropriate dose titration should be considered. If the haemoglobin exceeds 11 g/dl the dose should be reduced by approximately 25 to 50 %. Treatment with Epoetin beta should be temporarily discontinued if haemoglobin levels exceed 13 g/dl (8.1 mmol/l). Therapy should be reinitiated at approximately 25 % lower than the previous dose after haemoglobin levels fall to 11 g/dl or below. If the rise in haemoglobin is greater than 2 g/dl (1.3 mmol/l) in 4 weeks, the dose should be reduced by 25 to 50 %. Patients should be monitored closely to ensure that the lowest approved dose of Epoetin beta is used to provide adequate control of the symptoms of anaemia.
    Treatment for increasing the amount of autologous blood: The solution is administered intravenously over approx. 2 minutes or subcutaneously. Epoetin beta is administered twice weekly over 4 weeks. On those occasions where the patient’s PCV allows blood donation, i.e. PCV ≥ 33 %, Epoetin beta is administered at the end of blood donation. During the entire treatment period, a PCV of 48 % should not be exceeded. The dosage must be determined by the surgical team individually for each patient as a function of the required amount of pre-donated blood and the endogenous red cell reserve: The required amount of pre-donated blood depends on the anticipated blood loss, use of blood conserving procedures and the physical condition of the patient. This amount should be that quantity which is expected to be sufficient to avoid homologous blood transfusions. The required amount of pre-donated blood is expressed in units whereby one unit in the nomogram is equivalent to 180 ml red cells. The ability to donate blood depends predominantly on the patient’s blood volume and baseline PCV. Both variables determine the endogenous red cell reserve, which can be calculated according to the following formula. Endogenous red cell reserve = blood volume [ml] x (PCV – 33) ÷ 100
    Women: blood volume [ml] = 41 [ml/kg] x body weight [kg] + 1200 [ml]  Men: blood volume [ml] = 44 [ml/kg] x body weight [kg] + 1600 [ml] (body weight ≥ 45 kg) The indication for treatment with Epoetin beta and, if given, the single dose should be determined from the required amount of pre-donated blood and the endogenous red cell reserve according to the graphs in the prescribing information. The single dose thus determined is administered twice weekly over 4 weeks. The maximum dose should not exceed 1600 IU/kg body weight per week for intravenous or 1200 IU/kg per week for subcutaneous administration.
    Method of administration: The Epoetin beta 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. Epoetin beta in pre-filled syringe is a sterile but unpreserved product. Under no circumstances should more than one dose be administered per syringe; the medicinal product is for single use only.                   


    recommended drugs

    Indications

    Treatment of anemia associated with chronic renal failure (renal anemia) in patients on dialysis. Treatment of symptomatic renal anemia in patients not yet undergoing dialysis. Treatment of anemia in adult patients with solid tumors receiving chemotherapy. Treatment of anemia in adult patients with multiple myeloma, low grade non-Hodgkin’s lymphoma or chronic lymphocytic leukemia, who have a relative erythropoietin deficiency and are receiving anti-tumor therapy. Deficiency is defined as an inappropriately low serum erythropoietin level in relation to the degree of anemia. Increasing the yield of autologous blood from patients in a pre-donation program. 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 and 5 or more units for males).


    Contra-Indications

    Poorly controllable hypertension and known hypersensitivity to the active substance or to any of the excipients. 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 risk of deep venous thrombosis such as those with a history of venous thromboembolic disease.


    Special Precautions

    Epoetin beta should be used with caution in the presence of refractory anaemia with excess blasts in transformation, epilepsy, thrombocytosis, and chronic liver failure. Folic acid and vitamin B12 deficiencies should be ruled out as they reduce the effectiveness of Epoetin beta. Caution should be exercised with escalation of Epoetin beta doses in patients with chronic renal failure since high cumulative epoetin doses may be associated with an increased risk of mortality, serious cardiovascular and cerebrovascular events. In patients with a poor haemoglobin response to epoetins, alternative explanations for the poor response should be considered. In order to ensure effective erythropoiesis, iron status should be evaluated for all patients prior to and during treatment and supplementary iron therapy may be necessary and conducted in accordance with therapeutic guidelines. Severe aluminium overload due to treatment of renal failure may compromise the effectiveness of Epoetin beta. The indication for treatment with Epoetin beta of nephrosclerotic patients not yet undergoing dialysis should be defined individually, as a possible acceleration of progression of renal failure cannot be ruled out with certainty.
    Pure red cell aplasia (PRCA): PRCA caused by neutralising anti-erythropoietin antibodies has been reported in association with erythropoietin therapy, including Epoetin beta. These antibodies have been shown to cross-react with all erythropoietic proteins, and patients suspected or confirmed to have neutralising antibodies to erythropoietin should not be switched to Epoetin beta.
    PRCA in patients with Hepatitis C: A paradoxical decrease in haemoglobin and development of severe anaemia associated with low reticulocyte counts should prompt to discontinue treatment with epoetin and perform anti-erythropoietin antibody testing. Cases have been reported in patients with hepatitis C treated with interferon and ribavirin, when epoetins are used concomitantly. Epoetins are not approved in the management of anaemia associated with hepatitis C.
    Blood pressure monitoring: An increase in blood pressure or aggravation of existing hypertension, especially in cases of rapid PCV increase can occur. These increases in blood pressure can be treated with medicinal products. If blood pressure rises cannot be controlled by drug therapy, a transient interruption of Epoetin beta therapy is recommended. Particularly at beginning of therapy, regular monitoring of the blood pressure is recommended, including between dialyses. Hypertensive crisis with encephalopathy-like symptoms may occur and require the immediate attention of a physician and intensive medical care. Particular attention should be paid to sudden stabbing migraine like headaches as a possible warning sign.
    Chronic renal failure: In chronic renal failure patients there may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with Epoetin beta, especially after intravenous administration. This regresses during the course of continued therapy. It is recommended that the platelet count be monitored regularly during the first 8 weeks of therapy.
    Haemoglobin concentration: In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended before. In clinical trials, an increased risk of death and serious cardiovascular events or cerebrovascular events including stroke was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 11 g/dl.
    Effect on tumour growth: Epoetins are growth factors that primarily stimulate red blood cell production. Erythropoietin receptors may be expressed on the surface of a variety of tumour cells. As with all growth factors, there is a concern that epoetins could stimulate the growth of tumours. In several controlled studies, epoetins have not been shown to improve overall survival or decrease the risk of tumour progression in patients with anaemia associated with cancer. There may be an increase in blood pressure which can be treated with drugs. It is therefore recommended to monitor blood pressure, in particular in the initial treatment phase in cancer patients. Platelet counts and haemoglobin level should also be monitored at regular intervals in cancer patients. In patients in an autologous blood predonation programme there may be an increase in platelet count, mostly within the normal range. Therefore, it is recommended that the platelet count be determined at least once a week in these patients. If there is an increase in platelets of more than 150 x 109/l or if platelets rise above the normal range, treatment with Epoetin beta should be discontinued. In chronic renal failure patients an increase in heparin dose during haemodialysis is frequently required during the course of therapy with Epoetin beta as a result of the increased packed cell volume. Occlusion of the dialysis system is possible if heparinisation is not optimum. Serum potassium and phosphate levels should be monitored regularly during therapy with Epoetin beta. Potassium elevation has been reported in a few uraemic patients receiving Epoetin beta, though causality has not been established. If an elevated or rising potassium level is observed then consideration should be given to ceasing administration of Epoetin beta until the level has been corrected.
    Misuse: Misuse by healthy persons may lead to an excessive increase in packed cell volume. This may be associated with life-threatening complications of the cardiovascular system.
    Excipients: Epoetin beta in pre-filled syringe contains up to 0.3 mg phenylalanine/syringe as an excipient. Therefore this should be taken into consideration in patients affected with severe forms of phenylketonuria. This medicinal product contains less than 1 mmol sodium (23 mg) per syringe, i.e. essentially “sodium-free”.
    Epoetin beta: In order to improve the traceability of erythropoiesis-stimulating agents (ESAs), the trade name of the administered ESA should be clearly recorded (or: stated) in the patient file.


    Side Effects

    Approximately 8% of patients treated are expected to experience adverse reactions, observed predominantly in patients with chronic renal failure or underlying malignancies.
    Most commonly: Increase in blood pressure, aggravation of existing hypertension and headache. Thromboembolic event.
    For full details see prescribing information.


    Drug interactions

    The clinical results obtained so far do not indicate any interaction with other substances.


    Pregnancy and Lactation

    Pregnancy: For epoetin beta no clinical data on exposed pregnancies are available. Caution should be exercised when prescribing to pregnant women.
    Lactation: It is unknown whether epoetin beta is excreted in human milk. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with epoetin beta should be made taking into account the benefit of breast-feeding to the child and the benefit of epoetin beta therapy to the woman.           


    Overdose

    The therapeutic margin of Recormon is very wide. Even at very high serum levels no symptoms of poisoning have been observed.


    Manufacturer
    Roche Diagnostic GmbH
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