WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and THROMBOEMBOLIC EVENTS, and INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE
Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.
Cancer:
- ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers (see WARNINGS: Table 1).
- To decrease these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusion.
- Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
- ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure.
- Discontinue following the completion of a chemotherapy course.
Perisurgery: EPOGEN® increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.
(See WARNINGS: Increased Mortality, Serious Cardiovascular and Thromboembolic Events, WARNINGS: Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence, INDICATIONS AND USAGE, and DOSAGE AND ADMINISTRATION.)
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EPOGEN SUMMARY
Erythropoietin is a glycoprotein which stimulates red blood cell production. It is produced in the kidney and stimulates the division and differentiation of committed erythroid progenitors in the bone marrow. EPOGEN® (Epoetin alfa), a 165 amino acid glycoprotein manufactured by recombinant DNA technology, has the same biological effects as endogenous erythropoietin.
EPOGEN® is indicated for the treatment of anemia associated with CRF, including patients on dialysis (ESRD) and patients not on dialysis. EPOGEN® 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 in these patients.
Non-dialysis patients with symptomatic anemia considered for therapy should have a hemoglobin less than 10 g/dL.
EPOGEN® is not intended for patients who require immediate correction of severe anemia. EPOGEN® may obviate the need for maintenance transfusions but is not a substitute for emergency transfusion.
Prior to initiation of therapy, the patient's iron stores should be evaluated. Transferrin saturation should be at least 20% and ferritin at least 100 ng/mL. Blood pressure should be adequately controlled prior to initiation of EPOGEN® therapy, and must be closely monitored and controlled during therapy.
EPOGEN® should be administered under the guidance of a qualified physician (see DOSAGE AND ADMINISTRATION).
EPOGEN® is indicated for the treatment of anemia related to therapy with zidovudine in HIV-infected patients. EPOGEN® 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 in these patients. EPOGEN® is not indicated for the treatment of anemia in HIV-infected patients due to other factors such as iron or folate deficiencies, hemolysis, or gastrointestinal bleeding, which should be managed appropriately.
EPOGEN®, at a dose of 100 Units/kg TIW, is effective in decreasing the transfusion requirement and increasing the red blood cell level of anemic, HIV-infected patients treated with zidovudine, when the endogenous serum erythropoietin level is
EPOGEN® is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy. EPOGEN® is indicated to decrease the need for transfusions in patients who will be receiving concomitant chemotherapy for a minimum of 2 months. EPOGEN® is not indicated for the treatment of anemia in cancer patients due to other factors such as iron or folate deficiencies, hemolysis, or gastrointestinal bleeding, which should be managed appropriately.
EPOGEN® is indicated for the treatment of anemic patients (hemoglobin >10 to 18-20 EPOGEN® is indicated for patients at high risk for perioperative transfusions with significant, anticipated blood loss. EPOGEN® is not indicated for anemic patients who are willing to donate autologous blood. The safety of the perioperative use of EPOGEN® has been studied only in patients who are receiving anticoagulant prophylaxis.
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NEWS HIGHLIGHTS
Published Studies Related to Epogen (Epoetin Alfa)
Comparison of the pharmacokinetic and pharmacodynamic profiles of one US-marketed and two European-marketed epoetin alfas: a randomized prospective study. [2011]
BACKGROUND: HX575, licensed under the brand names Binocrit(R), Epoetin Alfa Hexal(R), and Abseamed(R), was approved in 2007 as the first biosimilar recombinant human erythropoietin alfa (epoetin alfa) in the EU using Erypo(R)/Eprex(R) as reference product. OBJECTIVES: The aim of this study was to investigate the bioequivalence and potency of registered epoetin alfa products that have not been compared before in a randomized controlled clinical study... CONCLUSION: The results show, for the first time in a prospective randomized clinical study, equivalent bioavailability at steady state and similar potency of the US-marketed Epogen(R) and the European-marketed Binocrit(R). Differences in the formulation between the epoetin alfa products had no apparent clinical impact. The high degree of similarity between Epogen(R) and Erypo(R)/Eprex(R) provides justification for linking and comparing results from clinical studies that were conducted using either US- or European-marketed epoetin alfa products.
Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. [2010.12]
BACKGROUND: Several studies with erythropoiesis-stimulating agents claim that maintenance therapy of renal anaemia may be possible at extended dosing intervals; however, few studies were randomized, results varied, and comparisons between agents were absent. We report results of a multi-national, randomized, prospective trial comparing haemoglobin maintenance with methoxy polyethylene glycol-epoetin beta and darbepoetin alfa administered once monthly... CONCLUSIONS: Methoxy polyethylene glycol-epoetin beta maintained target haemoglobin more successfully than darbepoetin alfa at once-monthly dosing intervals despite dose increases with darbepoetin alfa.
Epoetin alpha improves the response to antiviral treatment in HCV-related chronic hepatitis. [2010.10]
BACKGROUND: The conventional antiviral treatment of chronic hepatitis related to hepatitis C virus (HCV) often leads to anemia. In this case, it is necessary to reduce ribavirin dose or stop treatment, thus reducing the rate of sustained virological response. AIM: We investigated whether epoetin alpha administration improves treatment adherence and leads to higher percentage of response at the end of therapy and sustained virological response... CONCLUSIONS: In patients with 1b HCV-related chronic hepatitis who develop anemia during antiviral treatment, administration of epoetin alpha increases hemoglobin levels and the end-of-treatment rate and sustains virological response by improving treatment adherence.
Epoetin alfa reduces blood transfusion requirements in patients with intertrochanteric fracture. [2010.06]
PURPOSE: The purpose of this study is to identify the potential benefits or complications from the use of epoetin alfa in patients with intertrochanteric fracture... CONCLUSIONS: Patients with intertrochanteric fractures seem to benefit from the use of epoetin alfa because it is safe and reduces the need for blood transfusions. Copyright (c) 2010 Elsevier Inc. All rights reserved.
Epoetin alfa in patients with advanced-stage Hodgkin's lymphoma: results of the randomized placebo-controlled GHSG HD15EPO trial. [2010.05.01]
PURPOSE: To determine whether epoetin alfa reduces anemia-related fatigue, improves other aspects of health-related patient-recorded outcomes (PROs), reduces the number of RBC transfusions, and has an impact on freedom from treatment failure (FFTF) and overall survival (OS) in patients with advanced-stage Hodgkin's lymphoma (HL)... CONCLUSION: Epoetin alfa administered at 40,000 U weekly parallel to BEACOPP chemotherapy was safe in patients with advanced-stage HL and reduced the number of RBC transfusions but had no impact on fatigue and other PRO domains.
Clinical Trials Related to Epogen (Epoetin Alfa)
Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa [Completed]
The purpose of this study is to show biosimilarity of HX575 epoetin alfa with the US
licensed reference product Epogen®/Procrit® when applied subcutaneously. This study is
intended to generate data supporting that the efficacy and safety under treatment with HX575
and Epogen®/Procrit® are comparable.
Comparison Among Erythropoietin Stimulating Agents [Completed]
* Background: Despite extensive use, to the best of our knowledge, no trial has
simultaneously compared the three currently used erythropoietin stimulating agents (ESAs) in
a prospective manner, in treatment of anemia of end stage renal disease (ESRD) patients.
* Patients and Methods: All haemodialysis patients in Qatar who were treated with short
acting Epoetin alfa or beta were screened. Eligible patients were randomized, either to
continue on the previous regimen of Epoetin, or to receive Darbepoetin alfa or continuous
erythropoietin receptor activator (C. E.R. A) for a total period of 40 weeks. All groups were
assessed at the end of the study for safety and efficacy parameters.
A Phase 3 Study Comparing the Effects of Subcutaneous Epoetin Hospira and Epoetin Alfa (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin [Completed]
The purpose of this study is to demonstrate therapeutic equivalence of subcutaneous (SC)
Epoetin Hospira compared to SC Epogen (Amgen), based on maintenance of hemoglobin (Hb)
levels and study drug dose requirements in patients treated for anemia associated with
chronic renal failure and on hemodialysis.
A Phase 3 Study Comparing the Effects of Intravenous Epoetin Hospira and Epoetin Alfa (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin [Completed]
The purpose of this study is to demonstrate therapeutic equivalence of IV Epoetin Hospira
compared to IV Epogen (Amgen), based on maintenance of Hb levels and study drug dose
requirements in patients treated for anemia associated with chronic renal failure and on
hemodialysis.
An Efficacy and Safety Study of Epoetin Alfa for Initiation and Maintenance Treatment of Patients With Anemia Associated With Chronic Kidney Disease [Completed]
The purpose of this study is to demonstrate that once weekly and once every-2-weeks
treatment with epoetin alfa, in patients with anemia associated with chronic kidney disease,
is not less effective than the approved treatment with epoetin alfa that is given 3 times
weekly with respect to changes in hemoglobin.
Reports of Suspected Epogen (Epoetin Alfa) Side Effects
Haemoglobin Decreased (63),
Drug Ineffective (59),
Therapeutic Response Decreased (55),
Aplasia Pure RED Cell (40),
Anaemia (36),
Medication Error (34),
Dyspnoea (20),
Fatigue (19),
Hospitalisation (16),
Anti-Erythropoietin Antibody Positive (15), more >>
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Page last updated: 2011-12-09
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