Erythropoiesis stimulating agents (ESAs) stimulate the bone marrow to make more red blood cells and are United States Food and Drug Administration (FDA) approved for use in reducing the need for blood transfusion in patients with specific clinical indications.
What is an ESA blood transfusion?
A blood transfusion is a procedure in which blood from a donor is given to you through an intravenous (IV) line. Your doctor will determine if a blood transfusion is needed. ESAs are a class of drugs that stimulate the bone marrow to make more red blood cells.
What is an ESA drug?
ESAs are usually given to patients who have chronic (long-lasting) kidney disease or end-stage renal (kidney) disease. These patients usually have lower hemoglobin levels because they can't produce enough erythropoietin. ESAs are also prescribed for patients who have cancer. These patients often have anemia, which can be caused by chemotherapy.
Are hemoglobin levels important in ESA therapy?
Furthermore as emerging data suggests that ESA therapy may not be that benign, it is imperative to adhere to strict guidelines and keep hemoglobin levels on the recommended targets ranges. Such action can only be achieved by frequent monitoring of the patient to improve overall outcomes. References
Should ESA be used to treat cancer patients?
The FDA has warned that ESA should be administered only to avoid red blood cell transfusions in cancer patients as they do not improve the outcome of cancer treatment and do not alleviate fatigue or increase energy in these patients.
What is ESA treatment?
A substance that stimulates the bone marrow to make more red blood cells. ESAs are used to treat anemia caused by chronic kidney failure, some anticancer drugs, and certain treatments for HIV. They may also be used to lower the number of blood transfusions needed during and after certain major surgeries.
What is ESA blood?
Erythropoiesis-stimulating agents (ESA) are medications which stimulate the bone marrow to make red blood cells. They are used to treat anemia due to end stage kidney disease, chemotherapy, major surgery, or certain treatments in HIV/AIDS. In these situations they decrease the need for blood transfusions.
What does ESA mean in anemia?
Epoetin alfa and darbepoetin alfa are Erythropoiesis-Stimulating Agents (ESAs), approved for the treatment of anemia (low red blood cells) resulting from chronic kidney disease, chemotherapy, certain treatments for Human Immunodeficiency Virus (HIV), and also to reduce the number of blood transfusions during and after ...
What is an ESA in dialysis?
Erythropoiesis-stimulating agents (ESAs) act to replace endogenous erythropoietin for patients with end-stage renal disease having anemia. Today, ESAs remain the main tool for treating anemia associated with CKD.
How is ESA administered?
ESA can be given intravenously or subcutaneously. The route of administration of ESA will be determined by patient-oriented issues, treatment setting, efficacy considerations and the class of ESA being prescribed. For patients undergoing peritoneal dialysis, subcutaneous administration is the only route feasible.
What does ESA mean in healthcare?
Employment and Support Allowance has been designed to enable your patients to achieve their full potential through work and to help them to gain independence from benefits.
What stimulates bone marrow production?
This may happen when the oxygen content of body tissues is low, if there is loss of blood or anemia, or if the number of red blood cells decreases. If these things happen, the kidneys produce and release erythropoietin, which is a hormone that stimulates bone marrow to produce more red blood cells.
How do you increase red blood cell production?
Eating an iron-rich diet can increase your body's production of RBCs....Iron-rich foods include:red meat, such as beef.organ meat, such as kidney and liver.dark, leafy, green vegetables, such as spinach and kale.dried fruits, such as prunes and raisins.beans.legumes.egg yolks.
What are the common causes of ESA resistance?
The most common cause of ESA resistance is iron deficiency. Therefore, it is imperative that iron stores are adequate during ESA treatment. The second most common cause of ESA resistance is a chronic infection/inflammatory state, and such resistance is attributed to inflammatory cytokines (eg, IL-1).
When do you initiate ESA?
o Initiate ESA treatment when the hemoglobin level is less than 10 g/dL. o If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of ESA. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly.
Why do kidney patients need erythropoietin?
Your kidneys make an important hormone called erythropoietin (EPO). Hormones are chemical messengers that travel to tissues and organs to help you stay healthy. EPO tells your body to make red blood cells. When you have kidney disease, your kidneys cannot make enough EPO.
How do dialysis patients increase hemoglobin?
Iron. If you don't have enough iron in your body, your health care professional may prescribe iron supplements, either as a pill or intravenous (IV) infusion. If you're on dialysis, you may be given an IV iron supplement during your dialysis treatment. Iron supplements help your body make healthy red blood cells.
What is ESA REMS?
The ESA REMS consisted of a Medication Guide, communication plan, elements to assure safe use, implementation system, and a timetable for submission of assessments of the REMS. The REMS required that healthcare providers that prescribe, or prescribe and dispense, ESAs for patients with cancer, become certified.
When did the FDA change the labeling of ESAs?
During 2004-2009, the FDA took multiple regulatory actions, including labeling changes. In 2007, the Center for Medicare and Medicaid Services (CMS) made a National Coverage Determination (NCD) to limit coverage of ESAs for non-renal disease indications. These actions coincided with:
What is epoetin alfa used for?
Epoetin alfa and darbepoetin alfa are Erythropoiesis-Stimulating Agents (ESAs), approved for the treatment of anemia (low red blood cells) resulting from chronic kidney disease, chemotherapy, certain treatments for Human Immunodeficiency Virus (HIV), and also to reduce the number of blood transfusions during and after certain major surgeries. ESAs work like the human protein erythropoietin, which stimulates bone marrow to make red blood cells.Epoetin alfa (marketed as Procrit and Epogen) and darbepoetin alfa (marketed as Aranesp), are manufactured by Amgen, Inc.
What is ESA in medical terms?
Erythropoiesis-stimulating agents ( ESA) are medications which stimulate the bone marrow to make red blood cells. They are used to treat anemia due to end stage kidney disease, chemotherapy, major surgery, or certain treatments in HIV/AIDS. In these situations they decrease the need for blood transfusions.
What is an ESA?
Erythropoiesis-stimulating agent. Erythropoiesis-stimulating agents ( ESA) are medications which stimulate the bone marrow to make red blood cells. They are used to treat anemia due to end stage kidney disease, chemotherapy, major surgery, or certain treatments in HIV/AIDS.
What were the code words used for the EPO race?
Witnesses testified that code words used for EPO included "Edgar", "Poe", "Edgar Allan Poe", and "Zumo" (Spanish for 'juice').
Why do athletes use ESAs?
Therefore, the primary reason athletes may use ESAs is to improve oxygen delivery to muscles, which directly improves their endurance capacity. With the advent of recombinant erythropoietin in the 1990s, the practice of autologous and homologous blood transfusion has been partially replaced by injecting erythropoietin such that the body naturally produces its own red cells. ESAs increase hematocrit (% of blood volume that is red cell mass) and total red cell mass in the body, providing a good advantage in sports where such practice is banned. In addition to ethical considerations in sports, providing an increased red cell mass beyond the natural levels reduces blood flow due to increased viscosity, and increases the likelihood of thrombosis and stroke. Due to dangers associated with using ESAs, their use should be limited to the clinic where anemic patients are boosted back to normal hemoglobin levels (as opposed to going above the normal levels for performance advantage, leading to an increased risk of death).
When did EPO come into use?
Recombinant EPO is believed to have come into use in cycling about 1990. In theory, EPO use can increase VO 2 max by a significant amount, making it useful for endurance sports like cycling. Italian antidoping advocate Sandro Donati has claimed that the history of doping in cycling can be traced to the Italian Dr Francesco Conconi at the University of Ferrara. Conconi had worked on the idea of giving athletes transfusions of their own blood in the 1980s. Donati felt this work "opened the road to EPO . . . because blood doping was a trial to understand the role of EPO".
When was the EPO test performed?
Since 2002, EPO tests performed by US sports authorities have consisted of only a urine or "direct" test. From 2000–2006, EPO tests at the Olympics were conducted on both blood and urine. However, several compounds have been identified that can be taken orally to stimulate endogenous EPO production.
Who found Darbepoetin Alfa?
In 2002, at the Winter Olympic Games in Salt Lake City, Dr. Don Catlin, the founder and then-director of the UCLA Olympic Analytical Lab, reported finding darbepoetin alfa, a form of erythropoietin, in a test sample for the first time in sports.
When was epoetin alfa approved?
Since the approval of recombinant human erythropoietin (epoetin alfa) by the US FDA in 1989 , epoetin alfa and similar agents now collectively known as erythropoietin stimulating agents (ESA) have become the standard of care for the treatment of the erythropoietin-deficient anemia that occurs in most patients with CKD.
What tests are used to diagnose hemolysis?
Tests of hemolysis such as total bilirubin, lactate dehyrogenase, urine hemosiderin, urine hemoglobin, haptoglobin, and a peripheral smear should be performed to diagnose the presence of hemolysis. By far, haptoglobin is the most specific of these tests and a depressed value indicates significant hemolysis.
What is erythropoietin in the kidney?
Erythropoietin is a hormone synthesized in the kidney responsible for red blood cell maturation in the bone marrow. It is deficient in the majority of patients with advanced kidney disease thereby predisposing to anemia.
Is epoetin alfa marketed as Procrit?
In the US, epoetin alfa is also marketed as Procrit®(Ortho Biotech) primarily in pre-ESRD patients. In Europe epoetin alfa (Eprex®, Ortho Biotech) and epoetin beta (Neorecormon®, Roche), different only in glycosylation were approved for the treatment of anemia of CKD.
Is recombinant human erythropoietin a substitute for CKD
Although recombinant human erythropoietin is a substitute for the deficiency observed in CKD, therapy of anemia often involves many other issues detailed below that need to be considered in order to effectively correct anemia, reduce costs and minimize side effects. Impact of anemia on health.
Which organ is the primary source of erythropoietin?
The kidney is the primary site of erythropoietin production in adults (Ratcliffe et al 1995). Studies utilizing transgenic mice suggest that a population of interstitial fibroblasts (also known as the type I interstitial cell) are the major source of renal erythropoietin synthesis (Maxwell et al 1993).
Can iron deficiency cause blood draw?
Iron deficiency may result from nutritional deficiency as well as blood losses from occult gastrointestinal hemorrhage, menstruation, and blood draws. Blood draws are particularly significant in hemodialysis patients in whom up to 2 g of iron can be lost per year (KDOQI 2006).
What is ESA used for?
ESAs are also used for patients with low hemoglobin due to cancer treatments or AIDS. The ESA, Epotein Alfa (also called Eprex or EPO) has been approved by Health Canada to be given to patients having an operation since the mid 1990’s. Eprex is given to increase hemoglobin before the operation.
What does it mean to have a higher hemoglobin level before an operation?
Going into an operation with a higher hemoglobin means your hemoglobin does not become as low after the operation. You are less likely to need a blood transfusion.
How long does eprex need to be at room temperature?
Eprex needs to be at room temperature for 10 to 15 minutes before the needle is given to you. If Eprex is at room temperature for longer than 60 minutes, it should not be used. Eprex should not be shaken. Eprex should be protected from light by storing it in its box or a brown bag.
What is the main ingredient in erythropoietin?
It is the main ingredient that controls the number of red blood cells made in the bone marrow. Red blood cells ( hemoglobin) carry oxygen to the body’s cells, giving the body’s organs energy to work properly. Erythropoesis stimulating agents ...
Does Eprex need a blood transfusion?
You are less likely to need a blood transfusion. Like all medications, Eprex treatment does not have a 100% guarantee. Some patients might not respond to Eprex as well or may lose more blood than usual and may still need a blood transfusion.
Does Eprex cause PRCA?
With PRCA, the bone marrow does not respond to Eprex and severe anemia develops. The treatment for PRCA might include regular blood transfusions, medications, or a bone marrow transplant. The exact cause of PRCA is not clearly known. The patient blood management team should be notified of any side effects.
Abstract
Background: Anemia is a frequent condition in patients receiving chemotherapy. ESA are effective to control this condition, but a recently published meta-analysis and warnings from regulatory agencies have pointed to a possible increase in mortality in these patients.
Author notes
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Is ESA necessary for lymphocytic leukemia?
ESA treatment for the anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma, and lymphocy tic leukemia is only reasonable and necessary under the following specified conditions:
Is ESA treatment necessary?
ESA treatment is not reasonable and necessary for beneficiaries with certain clinical conditions, either because of a deleterious effect of the ESA on their underlying disease or because the underlying disease increases their risk of adverse effects related to ESA use. These conditions include:
