ℹ️ Compiled from public regulatory records · Last regulator revision: February 20, 2026🚩 Report this page
Epoetin Alfa
Active ingredient
Sold asEpostim · Binocrit · Abseamed
GB MHRACA Health CanadaEU EMA
Drug class
-
Availability
See label
Routes
Subcutaneous, Intravenous
Markets covered
3
Products on record
30
Overview
Epoetin Alfa is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised February 20, 2026[1]
4). 4). g. cardiovascular status, pre-existing anaemia at the start of chemotherapy) for the treatment of anaemia and reduction of transfusion requirements. Abseamed is indicated in adults in a predonation programme to increase the yield of autologous blood.
1 mmol/L], no iron deficiency), if blood saving 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).
Abseamed is indicated for non-iron deficient adults prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions. g. 1 mmol/L) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1 800 mL).
Abseamed is indicated for the treatment of symptomatic anaemia (haemoglobin concentration of ≤ 10 g/dL) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (< 200 mU/mL).
CACanada· Health Canada
11 products
Uses
CAOfficial regulatory label· revised March 22, 2025[2]
EPREX® (epoetin alfa) is indicated to elevate or maintain the red blood cell level (as manifested by the hematocrit or hemoglobin determinations) and to decrease the need for transfusions. Eprex therapy is not intended for patients who require immediate correction of severe anemia.
Eprex may obviate the need for maintenance transfusions but is not a substitute for emergency transfusion. Blood pressure should be adequately controlled prior to init iation of Eprex therapy and must be closely monitored and controlled during treatment.
Eprex therapy is not indicated for other specific causes of anemia with established treatments such as iron or folate deficiencies, hemolysis or gastrointestinal bleeding which should be managed appropriately. Eprex is indicated for: the treatment of anemia associated with chronic renal failure (CRF), including patients on dialysis (end-stage renal disease) and patients not on dialysis (see 4 DOSAGE AND ADMINISTRATION, CRF PATIENTS).
EUEuropean Union· EMA
3 products
Uses
EUOfficial regulatory label· revised July 11, 2025[3]
4). 4). g. cardiovascular status, pre-existing anaemia at the start of chemotherapy) for the treatment of anaemia and reduction of transfusion requirements. 4 Epoetin alfa HEXAL is indicated in adults in a predonation programme to increase the yield of autologous blood.
1 mmol/L], no iron deficiency), if blood saving 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 alfa HEXAL is indicated for non-iron deficient adults prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions. g. 1 mmol/L) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1 800 mL).
Epoetin alfa HEXAL is indicated for the treatment of symptomatic anaemia (haemoglobin concentration of ≤ 10 g/dL) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (< 200 mU/mL).
Sources & citations
[1]MHRA (UK) · PLGB112430034 · revised February 20, 2026
[2]Health Canada (DPD) · 02231583 · revised March 22, 2025
[3]European Medicines Agency · EMEA/H/C/000726 · revised July 11, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
How to take
GBOfficial regulatory label· revised February 20, 2026[1]
Treatment with Abseamed has to be initiated under the supervision of physicians experienced in the management of patients with the above indications. Posology All other causes of anaemia (iron, folate or vitamin B12 deficiency, aluminium intoxication, infection or inflammation, blood loss, haemolysis and bone marrow fibrosis of any origin) should be evaluated and treated prior to initiating therapy with epoetin alfa, and when deciding to increase the dose.
4). Treatment of symptomatic anaemia in adult chronic renal failure patients Anaemia symptoms and sequelae may vary with age, gender, and co-morbid medical conditions; a physician’s evaluation of the individual patient’s clinical course and condition is necessary.
5 mmol/L). 5 mmol/L). 25 mmol/L) over a four week period should be avoided. If it occurs, appropriate dose adjustment should be made as provided. Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin concentration range may be observed.
5 mmol/L). 5 mmol/L) should be avoided. 5 mmol/L) reduce the Abseamed dose by 25%. 5 mmol/L) and then reinstitute Abseamed therapy at a dose 25% below the previous dose. 5 mmol/L). Caution should be exercised with escalation of erythropoiesis-stimulating agent (ESA)doses in patients with CRF.
1). Treatment with Abseamed is divided into two stages – correction and maintenance phase. Adult haemodialysis patients In patients on haemodialysis where intravenous access is readily available, administration by the intravenous route is preferable.
Correction phase The starting dose is 50 IU/kg, 3 times per week. 5 mmol/L) is achieved (this should be done in steps of at least four weeks). Maintenance phase The recommended total weekly dose is between 75 IU/kg and 300 IU/kg. 5 mmol/L).
75 mmol/L) may require higher maintenance doses than patients whose initial anaemia is less severe (> 8 g/dL or > 5 mmol/L). Adult patients with renal insufficiency not yet undergoing dialysis Where intravenous access is not readily available Abseamed may be administered subcutaneously.
Correction phase Starting dose of 50 IU/kg, 3 times per week, followed if necessary by a dosage increase with 25 IU/kg increments (3 times per week) until the desired goal is achieved (this should be done in steps of at least four weeks).
Maintenance phase During the maintenance phase, Abseamed can be administered either 3 times per week, and in the case of subcutaneous administration, once weekly or once every 2 weeks. 5 mmol/L). Extending dose intervals may require an increase in dose.
The maximum dosage should not exceed 150 IU/kg, 3 times per week, 240 IU/kg (up to a maximum of 20 000 IU) once weekly, or 480 IU/kg (up to a maximum of 40 000 IU) once every 2 weeks. Adult peritoneal dialysis patients Where intravenous access is not readily available Abseamed may be administered subcutaneously.
Correction phase The starting dose is 50 IU/kg, 2 times per week. Maintenance phase The recommended maintenance dose is between 25 IU/kg and 50 IU/kg, 2 times per week in 2 equal injections. 5 mmol/L). Treatment of adult patients with chemotherapy-induced anaemia 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.
g. 2 mmol/L)). The initial dose is 150 IU/kg subcutaneously, 3 times per week. Alternatively, Abseamed can be administered at an initial dose of 450 IU/kg subcutaneously once weekly. 5 mmol/L). Due to intra-patient variability, occasional individual haemoglobin concentrations for a patient above and below the desired haemoglobin concentration range may be observed.
Haemoglobin variability […]
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised February 20, 2026[1]
Summary of the safety profile The most frequent adverse drug reaction during treatment with epoetin alfa is a dose-dependent increase in blood pressure or aggravation of existing hypertension. 4). The most frequently occurring adverse drug reactions observed in clinical studies of epoetin alfa are diarrhoea, nausea, vomiting, pyrexia and headache.
Influenza-like illness may occur especially at the start of treatment. Respiratory tract congestion, which includes events of upper respiratory tract congestion, nasal congestion and nasopharyngitis, have been reported in studies with extended interval dosing in adult patients with renal insufficiency not yet undergoing dialysis.
4). Tabulated list of adverse reactions Of a total 3 417 subjects in 25 randomised, double-blinded, placebo or standard of care controlled studies, the overall safety profile of epoetin alfa was evaluated in 2 094 anaemic subjects. Included were 228 epoetin alfa-treated CRF subjects in 4 CRF studies (2 studies in pre-dialysis [N = 131 exposed CRF subjects] and 2 in dialysis [N = 97 exposed CRF subjects]); 1 404 exposed cancer subjects in 16 studies of anaemia due to chemotherapy; 147 exposed subjects in 2 studies for autologous blood donation; 213 exposed subjects in 1 study in the perisurgical period, and 102 exposed subjects in 2 MDS studies.
Adverse drug reactions reported by ≥ 1% of subjects treated with epoetin alfa in these studies are shown in the table below.
Frequency estimate:
Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10,000 to < 1/1 000); very rare (< 1/10 000), not known (cannot be estimated from the available data). 4). 4). Hypertensive crisis with encephalopathy and seizures, requiring the immediate attention of a physician and intensive medical care, have occurred also during epoetin alfa treatment in patients with previously normal or low blood pressure.
4). 4). More cases have been reported with subcutaneous route of administration, compared with the intravenous route. 7%) subjects experienced TVEs (sudden death, ischaemic stroke, embolism, and phlebitis). All TVEs occurred in the epoetin alfa group and in the first 24 weeks of the study.
Three were confirmed TVE and in the remaining case (sudden death), the thromboembolic event was not confirmed. Two subjects had significant risk factors (atrial fibrillation, heart failure and thrombophlebitis). Paediatric population with chronic renal failure on haemodialysis The exposure of paediatric patients with chronic renal failure on haemodialysis in clinical studies and post-marketing experience is limited.
No paediatric-specific adverse reactions not mentioned previously in the table above, or any that were not consistent with the underlying disease were reported in this population. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in Google play or Apple App store, and […]
GBOfficial regulatory label· Warnings and precautions· revised February 20, 2026[1]
Traceability In order to improve the traceability of erythropoiesis stimulating agents (ESAs), the trade name and the batch number of the administered ESA should be clearly recorded (or stated) in the patient file. Patients should only be switched from one ESA to another under appropriate supervision.
General In all patients receiving epoetin alfa, blood pressure should be closely monitored and controlled as necessary. Epoetin alfa should be used with caution in the presence of untreated, inadequately treated or poorly controllable hypertension.
It may be necessary to add or increase anti-hypertensive treatment. If blood pressure cannot be controlled, epoetin alfa treatment should be discontinued. Hypertensive crisis with encephalopathy and seizures, requiring the immediate attention of a physician and intensive medical care, have occurred also during epoetin alfa treatment in patients with previously normal or low blood pressure.
8). Epoetin alfa should be used with caution in patients with epilepsy, history of seizures, or medical conditions associated with a predisposition to seizure activity such as CNS infections and brain metastases. Epoetin alfa should be used with caution in patients with chronic liver failure.
The safety of epoetin alfa has not been established in patients with hepatic dysfunction. 8). These include venous and arterial thromboses and embolism (including some with fatal outcomes), such as deep venous thrombosis, pulmonary emboli, retinal thrombosis, and myocardial infarction.
Additionally, cerebrovascular accidents (including cerebral infarction, cerebral haemorrhage and transient ischaemic attacks) have been reported. g. deep venous thrombosis, pulmonary embolism, and cerebral vascular accident). In all patients, haemoglobin levels should be closely monitored due to a potential increased risk of thromboembolic events and fatal outcomes when patients are treated at haemoglobin levels above the concentration range for the indication of use.
There may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with epoetin alfa. This regresses during the course of continued therapy. In addition, thrombocythaemia above the normal range has been reported.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised February 20, 2026[1]
1. 4). - Uncontrolled hypertension. - All contraindications associated with autologous blood predonation programmes should be respected in patients being supplemented with Abseamed. The use of Abseamed in patients scheduled for major elective orthopaedic surgery and not participating in an autologous blood predonation programme is contraindicated in patients with severe coronary, peripheral arterial, carotid or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident.
- Surgery patients who for any reason cannot receive adequate antithrombotic prophylaxis.
This is not medical advice. Consult a qualified healthcare professional.
1 Pediatrics). the treatment of transfusion-dependent anemia related to therapy with zidovudine in HIV-infected patients. Eprex is effective in HIV-infected patients treated with zidovudine, when the endogenous serum erythropoietin level is ≤ 500 mU/mL and when patients are receiving a dose of zidovudine ≤ 4200 mg/week.
the treatment of anemia due to the effect of concomitantly administered chemotherapy based on studies that have shown a reduction in the need for red blood cell (RBC) transfusions in patients with advanced or metastatic, non-myeloid malignancies receiving chemotherapy for a minimum of 2 months.
Studies to determine whether Eprex increases mortality or decreases progression-free /recurrence-free survival are ongoing. - In patients with a long life expectancy, the decision to administer erythropoiesis-stimulating agents (ESAs) should be based on a benefit-risk assessment with the participation of the individual patient.
This should take into account the specific clinical context such as (but not limited to) the type of tumor and its stage, the degree of anemia, life expectancy, the environment in which the patient is being treated and known risks of transfusions and ESAs.
- If appropriate, red blood cell transfusion should be the preferred treatment for the management of anemia in patients with a long life expectancy and who are receiving myelosuppressive chemotherapy. - Eprex is not indicated for use in patients receiving hormonal agents, therapeutic biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy.
the treatment of patients who are undergoing major elective surgery (including patients who do not wish to or are not eligible to participate in an autologous blood donation (ABD) program) and have a pretreatment hemoglobin of > 100 to ≤ 130 g/ L.
Eprex therapy is indicated to reduce allogeneic blood transfusions and hasten erythroid recovery in these patients. 0 Page 5 of 75 the facilitation of autologous blood collection within a predeposit program. Eprex may decrease the risk of receiving allogeneic blood transfusions in patients with hemoglobin of 100-130 g/L who are scheduled for major elective surgery and are expected to require more blood than that which can be obtained through autologous blood collection techniques in the absence of Eprex.
1 Pediatrics Pediatrics (1 month -16 years): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of Eprex in pediatric patients has been established; therefore, Health Canada has authorized an indication for pediatric use.
3 Pediatrics and 14 CLINICAL TRIALS, CRF, Pediatric CRF Patients on Dialysis). 2 Geriatrics No data available.
How to take
CAOfficial regulatory label· revised March 22, 2025[2]
4 Administration XX/2022 7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance 08/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed . RECENT MAJOR LABEL CHANGES .....................................................................................
2 TABLE OF CONTENTS .......................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION............................................................... 4 1 INDICATIONS..............................................................................................................
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[2]
, Hypertension). Increased Mortality, Serious Adverse Cardiovascular Reactions, Thromboemb olic Events and Stroke During hemodialysis, patients treated with Eprex may require increased anticoagulation with heparin to prevent clotting of the artificial kidney.
25 events per patient -year on Eprex therapy. 04 events per patient-year of Eprex therapy. Patients with pre- existing vascular disease should be monitored closely. Patients with CRF experienced greater risks for death, serious adverse cardiovascular reactions and stroke when administered ESAs to target hemoglobin levels of 130 g/L and above in clinical studies.
No trial has identified a hemoglobin target level, dose or dosing strategy that does not increase these risks. Patients with CRF and an insufficient hemoglobin response to ESA therapy may be at even greater risk for adverse cardiovascular reactions and mortality than other patients.
Eprex and other ESAs increased the risks for death and for serious adverse cardiovascular reactions and thromboembolic events in controlled clinical trials of patients with cancer. These reactions included myocardial infarction, stroke, congestive heart failure and an increased risk of serious arterial and venous thromboembolic events including hemodialysis vascular access thrombosis.
0 Page 17 of 75 to these risks (see 14 CLINICAL TRIALS, CRF; CANCER). CRF patients with hypo-responsiveness to ESAs may be at an increased risk for mortality and adverse cardiovascular reactions. These patients should be evaluated for treatable conditions (see 7 WARNINGS AND PRECAUTIONS: Lack or Loss of Response and 4 DOSAGE AND ADMINISTRATION: CRF PATIENTS).
g. deep venous thrombosis or pulmonary embolism) (see 14 CLINICAL TRIALS and 4 DOSAGE AND ADMINISTRATION, CRF PATIENTS; CANCER PATIENTS RECEIVING CHEMOTHERAPY). To minimize the risks for death and serious adverse cardiovascular reactions, Eprex and other ESAs should follow the recommended dose for each indication.
For CRF patients, individualize dosing to achieve and maintain hemoglobin levels within the recommended range of 100 -115 g/L. The hemoglobin concentrations should not exceed 120 g/L; the rate of hemoglobin increase should not exceed 10 g/L in any 2-week period.
For patients with cancer, use the lowest dose sufficient to avoid blood transfusions (see 4 DOSAGE AND ADMINISTRATION). Cardiovascular – Surgery Patients Rarely, blood pressure may rise in the perioperative period in patie nts being treated with Eprex.
Therefore, blood pressure should be monitored. Thrombotic/Vascular Events Independent of Eprex treatment, thrombotic and vascular events may occur in surgical patients with underlying cardiovascular disease following repeated phlebotomy.
Therefore, routine volume replacement should be performed in such patients in autologous blood donation programs. , sickle cell anemia, myelodysplastic syndromes, or hypercoagulable disorders). Hepatic/Biliary/Pancreatic Hepatic Dysfunction The safety of Eprex has not been established in patients with hepatic dysfunction.
Use in Patients with Known Porphyria:
The initial presentation or exacerbation of porphyria has been observed rarely in Eprex -treated patients. Eprex should be used with caution in patients with known porphyria. 0 Page 18 of 75 rate of rise of hemoglobin. This effect may be related to an increased rate of n ucleic acid synthesis in the bone marrow.
Consequently, Eprex should be administered with caution to patients with a history of gout. Immune Pure Red Cell Aplasia Cases of pure red cell aplasia (PRCA) and of severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin have been reported in patients treated with Eprex.
This has been reported in patients receiving Eprex. Any patient who develops a sudden loss of response to Eprex, accompanied by severe anemia and low reticulocyte count should be evaluated for the etiology of loss of effect, including the presence of neutralizing antibodies to erythropoietin.
If anti-erythropoietin antibody-associated anemia is suspected, withhold Eprex and other erythropoietic proteins. Contact Janssen Inc. at 1-800-567-3331 to perform assays for binding and neutralizing antibodies. Eprex should be permanently discontinued in patients with antibody-mediated anemia.
Patients should not be switched to other erythropoietic proteins as antibodies may cross-react (see 8 ADVERSE REACTIONS). Monitoring and Laboratory Tests Hematology All patients receiving Eprex should have hematocrit/hemoglobin levels measured once a week until hematocrit/hemoglobin has been stabilized and measured periodically thereafter (see Monitoring and Laboratory Tests – CRF Patients, Hematology for additional laboratory monitoring in CRF patients).
There may be a moderate dose-dependent rise in the platelet count, within the normal range, during treatment with Eprex. […]
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[2]
, Sensitivity/Resistance 08/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed . RECENT MAJOR LABEL CHANGES .....................................................................................
2 TABLE OF CONTENTS .......................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION............................................................... 4 1 INDICATIONS..............................................................................................................
12 5 OVERDOSAGE ......................................................................................................... 12 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ...................... 13 7 WARNINGS AND PRECAUTIONS ............................................................................
1 Special Populations .......................................................................................... 1 Pregnant Women .......................................................................................... 2 Breast-feeding...............................................................................................
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised March 22, 2025[2]
Eprex (epoetin alfa) is contraindicated in patients: who develop pure red cell aplasia (PRCA) following treatment with any erythropoiesis regulating hormone (see 7 WARNINGS AND PRECAUTIONS, Immune); with uncontrolled hypertension; with known hypersensitivity to mammalian cell-derived products or any component of the product; (see 4 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING); who for any reason cannot receive adequate antithrombotic treatment.
The use of Eprex in patients scheduled for elective surgery and not participating in an autologous blood donation program is contraindicated in patients with severe coronary, peripheral arterial, carotid, or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident.
Contraindications defined by the guidelines and methods of practice for ABD programs should be respected in patients receiving Eprex. 0 Page 6 of 75
This is not medical advice. Consult a qualified healthcare professional.
How to take
EUOfficial regulatory label· revised July 11, 2025[3]
Treatment with Epoetin alfa HEXAL has to be initiated under the supervision of physicians experienced in the management of patients with the above indications. Posology All other causes of anaemia (iron, folate or vitamin B12 deficiency, aluminium intoxication, infection or inflammation, blood loss, haemolysis and bone marrow fibrosis of any origin) should be evaluated and treated prior to initiating therapy with epoetin alfa, and when deciding to increase the dose.
4). Treatment of symptomatic anaemia in adult chronic renal failure patients Anaemia symptoms and sequelae may vary with age, gender, and co-morbid medical conditions; a physician’s evaluation of the individual patient’s clinical course and condition is necessary.
5 mmol/L). 5 mmol/L). 25 mmol/L) over a four week period should be avoided. If it occurs, appropriate dose adjustment should be made as provided. Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin concentration range may be observed.
5 mmol/L). 5 mmol/L) should be avoided. 5 mmol/L) reduce the Epoetin alfa HEXAL dose by 25%. 5 mmol/L) and then reinstitute Epoetin alfa HEXAL therapy at a dose 25% below the previous dose. 5 mmol/L). 5 Caution should be exercised with escalation of erythropoiesis-stimulating agent (ESA)doses in patients with CRF.
1). Treatment with Epoetin alfa HEXAL is divided into two stages – correction and maintenance phase. Adult haemodialysis patients In patients on haemodialysis where intravenous access is readily available, administration by the intravenous route is preferable.
Correction phase The starting dose is 50 IU/kg, 3 times per week. 5 mmol/L) is achieved (this should be done in steps of at least four weeks). Maintenance phase The recommended total weekly dose is between 75 IU/kg and 300 IU/kg. 5 mmol/L).
75 mmol/L) may require higher maintenance doses than patients whose initial anaemia is less severe (> 8 g/dL or > 5 mmol/L). Adult patients with renal insufficiency not yet undergoing dialysis Where intravenous access is not readily available Epoetin alfa HEXAL may be administered subcutaneously.
Correction phase Starting dose of 50 IU/kg, 3 times per week, followed if necessary by a dosage increase with 25 IU/kg increments (3 times per week) until the desired goal is achieved (this should be done in steps of at least four weeks).
Maintenance phase During the maintenance phase, Epoetin alfa HEXAL can be administered either 3 times per week, and in the case of subcutaneous administration, once weekly or once every 2 weeks. 5 mmol/L). Extending dose intervals may require an increase in dose.
The maximum dosage should not exceed 150 IU/kg, 3 times per week, 240 IU/kg (up to a maximum of 20 000 IU) once weekly, or 480 IU/kg (up to a maximum of 40 000 IU) once every 2 weeks. Adult peritoneal dialysis patients Where intravenous access is not readily available Epoetin alfa HEXAL may be administered subcutaneously.
Correction phase The starting dose is 50 IU/kg, 2 times per week. Maintenance phase 6 The recommended maintenance dose is between 25 IU/kg and 50 IU/kg, 2 times per week in 2 equal injections. 5 mmol/L). Treatment of adult patients with chemotherapy-induced anaemia 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.
g. 2 mmol/L)). The initial dose is 150 IU/kg subcutaneously, 3 times per week. Alternatively, Epoetin alfa HEXAL can be administered at an initial dose of 450 IU/kg subcutaneously once weekly. 5 mmol/L). Due to intra-patient variability, occasional individual haemoglobin concentrations for a […]
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised July 11, 2025[3]
Summary of the safety profile The most frequent adverse drug reaction during treatment with epoetin alfa is a dose-dependent increase in blood pressure or aggravation of existing hypertension. 4). The most frequently occurring adverse drug reactions observed in clinical studies of epoetin alfa are diarrhoea, nausea, vomiting, pyrexia and headache.
Influenza-like illness may occur especially at the start of treatment. Respiratory tract congestion, which includes events of upper respiratory tract congestion, nasal congestion and nasopharyngitis, have been reported in studies with extended interval dosing in adult patients with renal insufficiency not yet undergoing dialysis.
4). Tabulated list of adverse reactions Of a total 3 417 subjects in 25 randomised, double-blinded, placebo or standard of care controlled studies, the overall safety profile of epoetin alfa was evaluated in 2 094 anaemic subjects. Included were 228 epoetin alfa-treated CRF subjects in 4 CRF studies (2 studies in pre-dialysis [N = 131 exposed CRF subjects] and 2 in dialysis [N = 97 exposed CRF subjects]); 1 404 exposed cancer subjects in 16 studies of anaemia due to chemotherapy; 147 exposed subjects in 2 studies for autologous blood donation; 213 exposed subjects in 1 study in the perisurgical period, and 102 exposed subjects in 2 MDS studies.
Adverse drug reactions reported by ≥ 1% of subjects treated with epoetin alfa in these studies are shown in the table below.
Frequency estimate:
Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000), not known (cannot be estimated from the available data). 4). 4). Hypertensive crisis with encephalopathy and seizures, requiring the immediate attention of a physician and intensive medical care, have occurred also during epoetin alfa treatment in patients with previously normal or low blood pressure.
4). 4). More cases have been reported with subcutaneous route of administration, compared with the intravenous route. 7%) subjects experienced TVEs (sudden death, ischaemic stroke, embolism, and phlebitis). All TVEs occurred in the epoetin alfa group and in the first 24 weeks of the study.
Three were confirmed TVE and in the remaining case (sudden death), the thromboembolic event was not confirmed. Two subjects had significant risk factors (atrial fibrillation, heart failure and thrombophlebitis). Paediatric population with chronic renal failure on haemodialysis The exposure of paediatric patients with chronic renal failure on haemodialysis in clinical studies and post-marketing experience is limited.
No paediatric-specific adverse reactions not mentioned previously in the table above, or any that were not consistent with the underlying disease were reported in this population. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
EUOfficial regulatory label· Warnings and precautions· revised July 11, 2025[3]
Traceablility In order to improve the traceability of erythropoiesis-stimulating agents (ESAs), the trade name and the batch number of the administered ESA should be clearly recorded (or stated) in the patient file. Patients should only be switched from one ESA to another under appropriate supervision.
General In all patients receiving epoetin alfa, blood pressure should be closely monitored and controlled as necessary. Epoetin alfa should be used with caution in the presence of untreated, inadequately treated or poorly controllable hypertension.
It may be necessary to add or increase anti-hypertensive treatment. If blood pressure cannot be controlled, epoetin alfa treatment should be discontinued. Hypertensive crisis with encephalopathy and seizures, requiring the immediate attention of a physician and intensive medical care, have occurred also during epoetin alfa treatment in patients with previously normal or low blood pressure.
8). Epoetin alfa should be used with caution in patients with epilepsy, history of seizures, or medical conditions associated with a predisposition to seizure activity such as CNS infections and brain metastases. Epoetin alfa should be used with caution in patients with chronic liver failure.
The safety of epoetin alfa has not been established in patients with hepatic dysfunction. 8). These include venous and arterial thromboses and embolism (including some with fatal outcomes), such as deep venous thrombosis, pulmonary emboli, retinal thrombosis, and myocardial infarction.
Additionally, cerebrovascular accidents (including cerebral infarction, cerebral haemorrhage and transient ischaemic attacks) have been reported. g. deep venous thrombosis, pulmonary embolism, and cerebral vascular accident). In all patients, haemoglobin levels should be closely monitored due to a potential increased risk of thromboembolic events and fatal outcomes when patients are treated at haemoglobin levels above the concentration range for the indication of use.
There may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with epoetin alfa. This regresses during the course of continued therapy. In addition, 12 thrombocythaemia above the normal range has been reported.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised July 11, 2025[3]
1. 4). 11 - Uncontrolled hypertension. - All contraindications associated with autologous blood predonation programmes should be respected in patients being supplemented with Epoetin alfa HEXAL. The use of Epoetin alfa HEXAL in patients scheduled for major elective orthopaedic surgery and not participating in an autologous blood predonation programme is contraindicated in patients with severe coronary, peripheral arterial, carotid or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident.
- Surgery patients who for any reason cannot receive adequate antithrombotic prophylaxis.
This is not medical advice. Consult a qualified healthcare professional.
It is recommended that the platelet count is regularly monitored during the first 8 weeks of therapy. All other causes of anaemia (iron, folate or vitamin B12 deficiency, aluminium intoxication, infection or inflammation, blood loss, haemolysis and bone marrow fibrosis of any origin) should be evaluated and treated prior to initiating therapy with epoetin alfa, and when deciding to increase the dose.
In most cases, the ferritin values in the serum fall simultaneously with the rise in packed cell volume. 2). For the selection of the best treatment option according to the patient’s needs, current treatment guidelines on iron supplementation in combination with dose instructions approved and outlined in the SmPC of the iron medication should be followed: - For chronic renal failure patients, iron supplementation is recommended if serum ferritin levels are below 100 ng/mL.
- For cancer patients, iron supplementation is recommended if transferrin saturation is below 20%. - For patients in an autologous predonation programme, iron supplementation should be administered several weeks prior to initiating the autologous predeposit in order to achieve high iron stores prior to starting epoetin alfa therapy, and throughout the course of epoetin alfa therapy.
- For patients scheduled for major elective orthopaedic surgery, iron supplementation should be administered throughout the course of epoetin alfa therapy. If possible, iron supplementation should be initiated prior to starting epoetin alfa therapy to achieve adequate iron stores.
Very rarely, development of or exacerbation of porphyria has been observed in epoetin alfa-treated patients. Epoetin alfa should be used with caution in patients with porphyria. Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment.
More severe cases have been observed with long-acting epoetins. At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, Abseamed should be withdrawn immediately and an alternative treatment considered.
If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of Abseamed, treatment with Abseamed must not be restarted in this patient at any time. Pure Red Cell Aplasia (PRCA) Antibody-mediated PRCA has been reported after months to years of epoetin alfa treatment.
Cases have also been reported in patients with hepatitis C treated with interferon and ribavirin, when ESAs are used concomitantly. Epoetin alfa is not approved in the management of anaemia associated with hepatitis C. g. iron, folate or vitamin B12 deficiency, […]
56 PATIENT MEDICATION INFORMATION .............................................................................. 0 Page 4 of 75 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS EPREX® (epoetin alfa) is indicated to elevate or maintain the red blood cell level (as manifested by the hematocrit or hemoglobin determinations) and to decrease the need for transfusions.
Eprex therapy is not intended for patients who require immediate correction of severe anemia. Eprex may obviate the need for maintenance transfusions but is not a substitute for emergency […]
It is recommended that the platelet count is regularly monitored during the first 8 weeks of therapy. All other causes of anaemia (iron, folate or vitamin B12 deficiency, aluminium intoxication, infection or inflammation, blood loss, haemolysis and bone marrow fibrosis of any origin) should be evaluated and treated prior to initiating therapy with epoetin alfa, and when deciding to increase the dose.
In most cases, the ferritin values in the serum fall simultaneously with the rise in packed cell volume. 2). For the selection of the best treatment option according to the patient’s needs, current treatment guidelines on iron supplementation in combination with dose instructions approved and outlined in the SmPC of the iron medication should be followed: - For chronic renal failure patients, iron supplementation is recommended if serum ferritin levels are below 100 ng/mL.
- For cancer patients, iron supplementation is recommended if transferrin saturation is below 20%. - For patients in an autologous predonation programme, iron supplementation should be administered several weeks prior to initiating the autologous predeposit in order to achieve high iron stores prior to starting epoetin alfa therapy, and throughout the course of epoetin alfa therapy.
- For patients scheduled for major elective orthopaedic surgery, iron supplementation should be administered throughout the course of epoetin alfa therapy. If possible, iron supplementation should be initiated prior to starting epoetin alfa therapy to achieve adequate iron stores.
Very rarely, development of or exacerbation of porphyria has been observed in epoetin alfa-treated patients. Epoetin alfa should be used with caution in patients with porphyria. Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment.
More severe cases have been observed with long-acting epoetins. At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, Epoetin alfa HEXAL should be withdrawn immediately and an alternative treatment considered.
If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of Epoetin alfa HEXAL, treatment with Epoetin alfa HEXAL must not be restarted in this patient at any time. Pure Red Cell Aplasia (PRCA) Antibody-mediated PRCA has been reported after months to years of epoetin alfa treatment.
Cases have also been reported in patients with hepatitis C treated with interferon and ribavirin, when ESAs are used concomitantly. Epoetin alfa is not approved in the management of anaemia associated with hepatitis C. g. iron, folate […]