Production of endogenous erythropoietin is impaired in patients with chronic. All of the patients had been taking eprexerypo injected into a vein for at least eight weeks before they were either switched to epoetin alfa hexal or remained on eprexerypo. Patients may require additional heparin during dialysis to prevent clotting of the vascular access or artificial kidney. Thromboembolism, thrombosis of vascular access and tumor progression or recurrence see full prescribing information for complete boxed warning. Positive results with this medication can decrease the need for blood transfusions. Chapter 49 drugs used to treat anemias free download as. These medications may interact and cause very harmful effects.
Contraindications known hypersensitivity to epokine or to other. Epoetin alfa recombinant procrit is administered to maintain or increase the patients rbc level. Epoetin alfa intravenous therapy dose biochemistry scribd. Epoetin is manufactured and marketed by amgen under the trade name epogen. Pdf extended epoetin alfa dosing in chronic kidney disease. There is a dose response relationship with this effect. Epoetin alfa is a manmade, injectable drug for treating anemia associated with chronic kidney failure for people who are or will be receiving dialysis. Variations, taking into account individual circumstances, may be appropriate. Variations, taking into account individual circumstances, may. People with some types of cancer have died sooner when using this medicine epoetin alfa vials. Once the target hb level has been reached, it can be maintained by using epoetin alfa. Epoetin alfa is a glycoprotein consisting of 165 amino acids synthesized using recombinant dna technology. A randomized, noninferiority study in adults on hemodialysis.
Nursing process focus clients receiving epoetin alfa. Erythropoietin clinical indications it is given subcutaneously or intravenously for the treatment of anemia associated with renal failure or for patients on dialysis. Epoetin alfa e poe e tin al fa helps your body make more red blood cells. May, 2019 there were more deaths from disease progression in the epoetin alfa plus soc arm 59% vs. Esas increase the risk of death, myocardial infarction, stroke, venous.
Epoetin alfa injection interactions with other medication. The committee could funding for epoetin alfa eprex 20,000iu prefilled syringe is available as a general benefit on the ontario drug benefit formulary for the treatment of chemotherapyinduced anemia. Nov 10, 2014 epoetin alfa is a prescription medication used to treat anemia caused by chronic kidney disease, chemotherapy in patients with certain types of cancer, and the hiv medication zidovudine. Study 4 was a randomized, openlabel, controlled, factorial design study in which darbepoetin alfa was administered to prevent anemia in 733 women receiving neo.
Scribd is the worlds largest social reading and publishing site. In patients with chronic kidney disease, the first evidence that epoetin alfa is producing a positive response is an increase in the reticulocyte count within 10 days. Epoetin alfa induces erythropoiesis by stimulating the division and differentiation of committed erythroid progenitor cells. Persons with disabilities having problems accessing the pdf files below may call 301 7963634 for assistance. Determine hct twice weekly until it is stabilized in the target range 3033% and the maintenance dose of epoetin alfa has been determined. The client exhibits an increase in hematocrit level and improvement in anemiarelated symptoms. Epoetin alfa is a prescription medication used to treat anemia caused by chronic kidney disease, chemotherapy in patients with certain types of cancer, and the hiv medication zidovudine. Jul 25, 2018 study 8 was a multicenter, randomized, doubleblind study epoetin alfa vs.
Do not freeze epoetin alfa, and throw away the medication if it has become frozen. Epoetin alfa is not approved for the treatment of anemia due to other factors in hiv infected patients. Darbepoetin alfa, epoetin alfa, and methoxy polyethylene glycolepoetin beta page 3 of unitedhealthcare oxford clinical policy effective 10012017 19962017, oxford health plans, llc esas are unproven and not medically necessary to treat anemia of ckd in patients not on dialysis for a hematocrit greater than 30%. When fewer red blood cells are produced, you can develop a condition called anemia epoetin alfa is used to treat anemia caused by chemotherapy or chronic kidney disease, or anemia caused by taking zidovudine to treat. Nursing process focus clients receiving epoetin alfa evaluation of outcome criteria evaluate the effectiveness of drug therapy by confirming that client goals and expected outcomes have been met see planning. This is not a complete list of side effects and others may occur. This medicine also raised the chance of tumor growth and the. The limited available data on epoetin alfa use in pregnant women are insufficient to determine a drug associated risk of adverse developmental outcomes. Side effects of epogen epoetin alfa, warnings, uses rxlist. Study 8 was a multicenter, randomized, doubleblind study epoetin alfa vs. It mimics naturally occurring erythropoietin, which is produced by the kidneys, and stimulates the division and differentiation of cells within bone marrow to produce rbcs. Food and drug administration 10903 new hampshire avenue silver spring, md 20993 1888infofda 18884636332 contact fda. Due data were collected upon entry into the study through medical record. Dobutamine dobutrex daviss drug guide nursing central.
This medicine may raise the chance of heart attack, stroke, heart failure, blood clots, and death. Drug study copy hypertension medical specialties scribd. Epoetin alfa and darbepoetin alfa may cause the body to make more red blood cells. Epoetin alfa is also used before and after certain types of surgery to decrease the chance that blood transfusions will be needed. They are used to treat anemia caused by chemotherapy in patients with cancer. Each singleuse vial bottle of this medicine is for one use only.
Mar 07, 2020 epoetin alfa induces erythropoiesis by stimulating the division and differentiation of committed erythroid progenitor cells. To assess the utility of using a computer software program to determine whether epoetin alfa therapy drug use evaluation due criteria were met. Epoetin alfa was approved by the fda on december 31, 1990, for the treatment of anemia associated with zidovudine therapy in hiv infected adults and children. Each 1 ml singledose vial of 2,000, 3,000, 4,000, 10,000, 40,000 units of epoetin alfa epbx injection contains 0. Epoetin alfa hexal european drugs reference encyclopedia. Esas increase the risk of death, myocardial infarction, stroke. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The limited available data on epoetin alfa use in pregnant women are insufficient to determine a drugassociated risk.
Eligible patients were to have received epoetin alfa once every 2 weeks q2w, 3 weeks q3w, 4 weeks q4w, or q4w administered subcutaneously for at least 3 months to maintain hb or 11. Drug study free download as powerpoint presentation. Epoetin alfa hexal, injected into a vein, was compared with the reference medicine in one main study involving 479 patients with anaemia caused by kidney problems. Learn vocabulary, terms, and more with flashcards, games, and other study tools. Amgen incorporated application no 103234orig1s5166 approval date. Each 1 ml singledose vial of 2,000, 3,000, 4,000, 10,000, 40,000 units of epoetinalfaepbx injection contains 0. Drugs used in hypoplastic, haemolytic and renal anaemias. May, 2019 our epogen epoetin alfa side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Epoetin alfa or darbepoetin alfa in treating patients with.
Pdf extended epoetin alfa dosing in chronic kidney. Epogen epoetin alfainjection, for intravenous or subcutaneous use initial u. Highlights of prescribing information these highlights do not include all the information needed to use epogensafely and effectively. The recommendations in this online publication do not indicate an exclusive course of treatment or serve as a standard of medical care. Epogen epoetin alfa procrit epoetin alfa for the purposes of the coverage rationale, all hematocrit hct values are either pretreatment for the first 46 weeks of therapy or obtained during treatment to assess ongoing titration and safety. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication education rems cme, and. If you have questions about this medicine talk to your doctor, pharmacist, or health care provider. Epoetin alfa drug monograph pediatric care online aap. This protein may be reduced when you have kidney failure or use certain medications.
Get emergency medical help if you have signs of an allergic reaction hives, sweating, rapid pulse, wheezing, trouble breathing, severe dizziness or fainting, swelling in your face or throat or a severe skin reaction fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling epoetin alfa can cause serious side effects. Before using epoetin alfa, tell your doctor or pharmacist if you are allergic to it. Computer software was designed to allow pharmacists to enter patient data such as haematocrit results and iron stores into a database. Discuss the risks and benefits of epoetin alfa with your doctor, as this medication may rarely cause very serious possibly fatal side effects, including blood clots, heart attack. Eprex injection in prefilled syringes is stabilised with glycine 5 mgml and polysorbate 80 0.
Epogenprocrit epoetin alfa new warnings on september 29, 2017, the fda approved updates to the warnings and precautions section of the epogenprocrit epoetin alfa drug label regarding severe cutaneous reactions and risk of serious adverse reactions due to benzyl alcohol preservative. Authorised by the european medicines agency on 28 august 2007, it stimulates erythropoiesis increasing red blood cell levels and is used to treat anemia, commonly associated with chronic kidney failure and cancer chemotherapy. Epoetin alfa is also used to treat anemia in individuals with hiv infection and in patients with cancer who are receiving chemotherapy. Epoetin alfa epogen, procrit, epoetin alfaepbx retacrit reference number. A safety and efficacy study for epoetin alfa in pre. Committee to evaluate drugs ced epoetin alfa additional. Epoetin alfa epogen, procrit is a drug prescribed for the treatment of anemia associated with chronic kidney failure for people who are or will be receiving dialysis. This randomized clinical trial is studying four different schedules of epoetin alfa or darbepoetin alfa to compare how well they work in treating patients with. Epoetin alfa is a recombinant human erythropoietin marketed in the us since 1989 as an orphan drug for the treatment of anemia resulting from kidney failure and was the first erythropoietin preparation to be approved for the treatment of anemia in premature infants. Comparison of darbepoetin alfa and epoetin alfa in the. Tell your doctor if you have or have ever had heart disease, a stroke, deep venous thrombosis dvt.
Epogen, procrit epoetin alfa uses, side effects, dosage. Subcutaneous epoetin alfa epbx versus epoetin alfa in endstage kidney disease. Our epogen epoetin alfa side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication. The client exhibits an increase in hematocrit level. Chemotherapy drugs chemotherapy pharmaceutical drug scribd. Chemotherapy drugs chemotherapy pharmaceutical drug. Get emergency medical help if you have signs of an allergic reaction hives, sweating, rapid pulse, wheezing, trouble breathing, severe dizziness or fainting, swelling in your face or throat or a severe skin reaction fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling. Epoetin alfa is a manmade form of a protein that helps your body produce red blood cells. The study drug epoetin alfa procrit, ortho biotech, 40,000 u or an identicalappearing placebo was administered by means of subcutaneous injection on study day 1 and weekly thereafter, for a. Eprex epoetin alfa anemia caused by monitor renal studies, urinalysis.
Epoetin alfa is only part of a complete treatment program that may also include a special diet. Epoetin alfa drug use evaluation using a software system. Nursing process focus clients receiving epoetin alfa drugs. Epoetin alfa is a human erythropoietin produced in cell culture using recombinant dna technology. To compare the effectiveness of darbepoetin alfa with epoetin alfa recombinant human erythropoietin rhuepo for achieving transfusion independence and increasing hemoglobin concentrations in critically ill patients.
Biological medicines must be prescribed and dispensed by brand name, see biological medicines and biosimilar medicines, under guidance on prescribing. Each 1 ml singledose vial of 2,000, 3,000, 4,000, 10,000, 40,000 units of epoetinalfa epbx injection contains 0. Erythropoietin the mechanism of action of epoetin alfa epogen this drug acts like the natural glycoprotein erythropoietin to stimulate the production of rbc in the bone marrow. Using epoetin alfa injection products increases the risk that blood clots will form in or move to the legs, lungs, or brain. Epoetin alfa is also used to treat anemia in individuals with hiv infection and in patients with cancer who are receiving chemotherapy erythropoietin is a protein that normally is made in the body by the kidney. Eprex is the tradename in australia and new zealand for epoetin alfa rch rhuepo. By continuing to browse this site you are agreeing to our use of cookies. Call your doctor for medical advice about side effects.
Assess reason for drug administration such as presencehistory of. A safety and efficacy study for epoetin alfa in predialysis subjects. Further study is necessary to clarify the optimal target haematocrit for epoetin alfa therapy, as well as the possible effects of nutritional support, growth hormone in paediatric patients, and. Epogen epoetin alfa dose, indications, adverse effects. Listing a study does not mean it has been evaluated by the u. Consider the benefits and risks of epoetin alfa singledose vials for the mother and possible risks to the fetus when prescribing epoetin alfa to a pregnant woman. There were more deaths from disease progression in the epoetin alfa plus soc arm 59% vs. Efficacy and safety of epoetin alfa in critically ill. Erythropoietin 2 syringe chronic kidney disease scribd. Next seen, within 2 to 6 weeks is an increase in the rbc count and hb level.
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