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.
- 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.)
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 = 500 mUnits/mL and when patients are receiving a dose of zidovudine = 4200 mg/week.
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 = 13 g/dL) scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions.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.
Media Articles Related to Epogen (Epoetin Alfa)
FDA: New Warning for Procrit, Epogen, Aranesp
Source: MedicineNet epoetin alfa Specialty [2011.06.27]
Title: FDA: New Warning for Procrit, Epogen, Aranesp
Category: Health News
Created: 6/25/2011 11:01:00 AM
Last Editorial Review: 6/27/2011 12:00:00 AM
Aranesp Misbranding - Amgen Agrees $762 Million Payment
Source: Litigation / Medical Malpractice News From Medical News Today [2012.12.19]
After being found guilty of promoting off-label use of Aranesp (darbepoetin alfa), an anemia drug, Amgen Inc. agreed to pay $150 million in criminal fines and penalties. Prosecutors added that the company will also pay $612 in civil settlements. The settlement would include a payment to a former Aranesp product manager, Kassie Westmoreland, to resolve a whistleblower lawsuit...
FDA approves extended dosing of Aranesp
Source: The Doctors Lounge - Hematology
FDA has approved every-3-week dosing of Aranesp (darbepoetin alfa) for treatment of chemotherapy - induced anemia.
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. 
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)
An Open-Label Study to Evaluate the Effect of Every Other Week PROCRIT® (Epoetin Alfa) Dosing (40,000-60,000 Units) On Maintaining Quality of Life and Target Hemoglobin Levels in Anemic HIV-Infected Patients (CHAMPS II) [Completed]
The objective of this study was to treat anemic (Hemoglobin (Hb) < 12 g/dL) HIV-infected
subjects with once weekly (QW) PROCRIT (Epoetin alfa) to a target Hb of > 13 g/dL and then to
assess if the target Hb level and improvements in Quality of Life (QOL) could be maintained
with every other week (Q2W) PROCRIT (Epoetin alfa) dosing.
Using Iron With Procrit in Advanced Lung Cancer Patients With Chemotherapy-Induced Anemia [Suspended]
The purpose of this study is to find a better, more convenient way to improve anemia results
by increasing the amount of medication given at 3 week intervals. Researchers want to know if
giving a higher dose of Procrit® and intravenous (IV) iron once every 3 weeks would give
better results in treating anemia without the need for more office visits.
Epoetin Alfa for HIV-Associated Neuropathy Trial [Terminated]
The Safety and Effectiveness of PROCRIT (Epoetin Alfa) in Reducing the Number of Blood Transfusions Required by Patients Undergoing Elective Major Abdominal and/or Pelvic Surgery [Terminated]
The primary objective of this study is to compare the effect of giving PROCRIT (Epoetin alfa)
to patients before, during and after elective major abdominal surgery (perioperatively) to
that of patients receiving Standard of Care (SOC) on the proportion of patients receiving
pRBC (packed red blood cell) transfusions from day of surgery to the day of hospital
discharge. Standard of Care is defined as the treatment of patients according to the
hospital or institution's policy, but where patients will not receive PROCRIT (Epoetin alfa)
or any other erythropoiesis-stimulating agents (ESAs) (agents that stimulate the production
of red blood cells in the bone marrow).
Early and Standard Intervention With 120,000 Units of PROCRIT (Epoetin Alfa) Every Three Weeks in Patients Receiving Chemotherapy [Completed]
The purpose of this study is to evaluate the safety and efficacy of PROCRIT (Epoetin alfa)
when administered at 120,000 Units once every three weeks by comparing early dosing (Hb
11g/dL-12g/dL) vs. standard dosing (Hb< 11g/dL).
Reports of Suspected Epogen (Epoetin Alfa) Side Effects
Haemoglobin Decreased (63),
Drug Ineffective (59),
Therapeutic Response Decreased (55),
Aplasia Pure RED Cell (40),
Medication Error (34),
Anti-Erythropoietin Antibody Positive (15), more >>
Page last updated: 2012-12-19