The MHRA is aware of very rare cases of severe cutaneous adverse reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, in patients treated with erythropoietins; some cases were fatal. Epoetin alfa was the first rhEPO produced and approved for pharmaceutical use, followed by several related products and by newer ESAs with the same mechanism but more prolonged action. 2009 Nov-Dec;15(9):741-50. doi: 10.18553/jmcp.2009.15.9.741. _____ (if . Due to the skewed nature of the dosing data, mean weekly ESA doses were reported using geometric means; these were derived by calculating the arithmetic mean of the data transformed on the natural logarithmic scale. The .gov means its official. 2012;59:444451. 2002;17(Suppl 5):6670. Avoid frequent dose adjustments. New anemia therapies: translating novel strategies from bench to bedside. No test of statistical significance was performed on any of the clinical characteristics. Mircera is administered by subcutaneous (SC) or intravenous (IV) injection (2.2). Each dosage strength of MIRCERA is designated by a unique syringe plunger color. Epub 2022 Apr 22. ^D[5j@%e In responding to hypoxia, erythropoietin interacts with erythroid progenitor . as a substitute for red blood cell transfusions in patients who require immediate correction of anemia. Resistance to Erythropoiesis-Stimulating Agents among Patients on Hemodialysis Is Typically Transient. MIRCERA is contraindicated in patients with: Please seefull Prescribing Information including Boxed WARNING, and Medication Guide(English, Espaol)for MIRCERA (methoxy polyethylene glycol-epoetin beta) Injection, for Intravenous or Subcutaneous Use. The geometric mean weekly ESA dose for those included in the DCR analysis is shown in Fig. 6). 2012 Jun;27(6):2303-11. doi: 10.1093/ndt/gfr677. Asterisk Not all transfusions had an associated hemoglobin concentration in the 14-day period before transfusion. Nick Manamley, MSc, is an employee of Amgen with Amgen stock ownership. The distribution of transfusions (Fig. Karaboyas A, Morgenstern H, Waechter S, Fleischer NL, Vanholder R, Jacobson SH, Sood MM, Schaubel DE, Inaba M, Pisoni RL, Robinson BM. Anemia Associated with Chronic Renal Failure, Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL, Drug class: recombinant human erythropoietins. Table 1 Mircera Starting Doses for Adult Patients Currently Receiving an ESA, Table 2 Mircera Starting Doses for Pediatric Patients Currently Receiving an ESA. 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. Data were collected from 7months before until 7months after switching treatment. There is limited information published on switching erythropoiesis-stimulating agent (ESA) treatment for anemia associated with chronic kidney disease (CKD) from darbepoetin alfa (DA) to methoxy polyethylene glycol-epoetin beta (PEG-Epo) outside the protocol of interventional clinical studies. ESAs resulted in decreased locoregional control/progression-free survival and/or overall survival. -, Macdougall IC. doi: 10.1038/ki.1985.109. Peter Choi, MB BChir, PhD, FRCP (UK), has received lecturing and consulting fees from Amgen, and has participated in advisory boards for Amgen. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Composition: Methoxy Polyethylene Glycol-Epoetin Beta. On June 7, 2018, the Food and Drug Administration approved methoxy polyethylene glycol-epoetin beta (Mircera, Vifor Pharma Inc.) for the treatment of pediatric patients 5 to 17 years of age on. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. . Hrl WH. Fewer than half of the patients achieved Hb in the 1012g/dL range by 7months post-switch. Kidney Med. Unauthorized use of these marks is strictly prohibited. This site needs JavaScript to work properly. HQ-MIR-1900027 Site last modified: January 2023. pediatric patients 5 to 17 years of age on hemodialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA. . Logistic regression was used to estimate an odds ratio comparing the number of patients receiving an RBC transfusion in the post-switch period relative to their dose ratio at switch (<1 vs. 1). Do you wish to proceed? Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. For adverse event reports, please contact us at safety@viforpharma.com,mircera@viforpharma.com or at 1-800-576-8295. Mircera works like the human protein called erythropoietin to help your body make more RBCs. 2014 Dec 8;2014(12):CD010590. NCI CPTC Antibody Characterization Program, Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. <>/Metadata 444 0 R/ViewerPreferences 445 0 R>>
MIRCERA (methoxy polyethylene glycol-epoetin beta) is the first erythropoiesis-stimulating agent (ESA) approved by FDA for once-monthly administration. Secondary outcomes included Hb concentrations and ESA use during the study period, and the incidence of red blood cell (RBC) transfusions. BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (. Nephrol Dial Transplant. A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks. This medicine is not for treating anemia caused by cancer chemotherapy. 2020 Sep 29;21(1):418. doi: 10.1186/s12882-020-02078-z. Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. methoxypolyethylene glycol-epoetin beta (meh-thok-see-pah-lee-eh-thih-leen gly-kol ee-poh-eh-tin bay-ta) , Mircera (trade name) Classification Therapeutic: antianemics Pharmacologic: hormones Pregnancy Category: C Indications Anemia due to chronic renal failure. a Mutually exclusive categories; patients are censored in the following, Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. In the month immediately prior to switch, the proportions of patients who had Hb below 10, 1012, and above 12g/dL were 7.3%, 54.4%, and 25.7%, respectively, with 12.6% missing. The regression analysis that examined the relationship between mean weekly ESA doses in the two evaluation periods indicated that the DCR is not linear; a significant (P=0.008) quadratic term was observed in the regression analysis, indicating that the predicted DCR decreased at higher pre-switch doses of DA (Fig. 2001;38:80312. 5) shows that most transfusions occurred in the first 4months post-switch. Packaging Size: 0.3 ml. Karaboyas A, Morgenstern H, Fleischer NL, Vanholder RC, Dhalwani NN, Schaeffner E, Schaubel DE, Akizawa T, James G, Sinsakul MV, Pisoni RL, Robinson BM. Disposition of patients. Action Stimulates erythropoesis (production of red blood cells). There are limitations in generalizing the findings of this study to the broader hemodialysis population. Nephrol Dial Transplant. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. For lack or loss of hemoglobin response to Aranesp or EPOGEN, initiate a search for causative factors. Conclusion: In patients on hemodialysis receiving ESAs, conversion from epoetin alfa to darbepoetin alfa was associated with an approximate and persistent reduction of 65% of the required dose. Aranesp and EPOGEN have not been shown to improve quality of life, fatigue, or patient well-being. - 94.130.71.173. MIRCERA is a registered trademark of F. Hoffmann-La Roche Ltd. All Vifor Pharma Groups intellectual rights, including copyright, are, The information provided in this site is intended only for healthcare. Mircera is packaged as single-dose prefilled syringes. Carrera F, Lok CE, de Francisco A, et al. Mean Hb was 11.5g/dL in the pre-switch EP and 11.4g/dL in the post-switch EP. Am J Kidney Dis. Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit. See Instructions for Use for complete instructions on the preparation and administration of MIRCERA, If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of MIRCERA. WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE CHRONIC KIDNEY DISEASE: Please see full Prescribing Information including Boxed WARNING, and Medication Guide(English, Espaol) for MIRCERA (methoxy polyethylene glycol-epoetin beta) Injection, for Intravenous or Subcutaneous Use. %
Horowitz J, Agarwal A, Huang F, Gitlin M, Gandra SR, Cangialose CB. Please know that Amgen, the sponsor of this site, is not responsible for the content on the site you are about to enter. This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited. At the moment forecasts for Mircera are $345m in 2015 rising to $552m in 2020, reflecting sales made outside the US. Inflammation and Erythropoiesis-Stimulating Agent Response in Hemodialysis Patients: A Self-matched Longitudinal Study of Anemia Management in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Injection: 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, 10,000 Units/mL, and 40,000 Units/mL of RETACRIT as a clear and colorless liquid in single-dose vials. 2020 Mar 26;2(3):286-296. doi: 10.1016/j.xkme.2020.01.007. Unable to load your collection due to an error, Unable to load your delegates due to an error. Studies of erythropoietin therapy in patients with chronic anemia of cancer as well as CIA document response rates ranging from ~60% to 85%. The https:// ensures that you are connecting to the Goodkin DA, Zhao J, Cases A, Nangaku M, Karaboyas A. If Hb exceeds a level needed to avoid RBC transfusions, withhold dose until Hb approaches a level where RBC transfusions may be required and reinitiate at a dose 40% below the previous dose. Google Scholar. stream
1:1 reference line, BlandAltman analysis of agreement between, BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose ( n, Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period., Red blood cell transfusions pre- and post-switch, Summary of the last hemoglobin concentrations recorded within 14 days prior to red, MeSH As shown in Tables2 and 3, the mean (standard error) monthly Hb remained stable across the observation period, with mean monthly concentration ranging from 11.42 (0.09) g/dL (Month 4) to 11.60 (0.09) g/dL (Month 2) pre-switch, and from 11.26 (0.10) g/dL (Month 4) to 11.67 (0.09) g/dL (Month 1) post-switch. In contrast, in the STRIATA study where stable hemodialysis patients receiving IV DA were randomized to Q2W PEG-Epo (outside current label guidance) or to continue on DA QW or Q2W, median PEG-Epo doses were described as stable across the 52-week post-switch period, although mean dose data were not reported [12]. Am J Kidney Dis. ferrous sulfate, Aranesp, Procrit, Retacrit. chemotherapy, MDS or MF, continued therapy) Please provide a hemoglobin level (g/dL) for your patient taken within the first 12 weeks of therapy with epoetin and include the date the lab was drawn. Data were also manually reviewed prior to final analysis. doi: 10.1053/ajkd.2001.27699. Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. No difference in conversion dosage could be determined between patients who were epoetin sensitive (<200 units/kg per week) or resistant (>200 units/kg per week, P = NS). Further exploration of the relationship between DA and PEG-Epo doses using the BlandAltman method [10], which circumvents the limitations of the regression method in this type of investigation, indicated that the variability in the dose differences increased as doses increased, while the level of concordance decreased with increasing ESA dose.
In particular, the likelihood of a transfusion during the post-switch period was significantly higher in patients with a dose ratio below 1 at switch. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. Cancel, Aranesp (darbepoetin alfa) Prescribing Information, EPOGEN (epoetin alfa) Prescribing Information, Aranesp and EPOGEN Important Safety Information, Prescribing Information, Important Safety Information, Dosing Information and Indications, DOWNLOAD ARANESP PRESCRIBING INFORMATION. Macdougall IC. In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events [see Boxed Warning and Clinical Studies (14)]. The WHO has set the daily-defined dose (DDD) for epoetin beta and darbepoetin at 1000 U and 4.5 g respectively, which gives a conversion factor of 222:1 . A BlandAltman analysis [10] was also performed to assess the agreement between ESA doses in the evaluation periods. The aims of the Aranesp Efficiency Relative to Mircera (AFFIRM) study were primarily to estimate the maintenance dose conversion ratio (DCR) of PEG-Epo to DA in a population of European hemodialysis patients switched from DA to PEG-Epo and with comparable mean hemoglobin (Hb) in the pre- and post-switch periods, and secondarily to investigate In the absence of PRCA, follow dosing recommendations for management of patients with an insufficient response to MIRCERA, Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in the postmarketing setting in patients treated with MIRCERA, PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which MIRCERA, If severe anemia and low reticulocyte count develop during treatment with MIRCERA, Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, tachycardia, pruritus, skin rash and urticaria have been reported in patients treated with MIRCERA, Blistering and skin exfoliation reactions including Erythema multiforme and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with ESAs (including MIRCERA, Patients may require adjustments in their dialysis prescription after initiation of MIRCERA, Most frequent adverse reactions ( 5%) in adult patients with CKD treated with MIRCERA. Eschbach JW, Adamson JW. The study sample comprised adult patients (age 18years) with CKD who received maintenance hemodialysis between January 2008 and August 2011 and whose ESA treatment was switched from IV DA to IV PEG-Epo. An additional analysis was performed to explore the effect of transfusions on the DCR, by exclusion of patients with a transfusion within 90days prior to or during either EP from the analysis. In recent years, the trend has been to use higher doses of epoetin alfa (eg, 60,000 U once per week), recognizing that MDS RBC precursors may have relative intrinsic resistance to EPO. Please click to see accompanying Aranesp full prescribing information and EPOGEN full prescribing information, including Boxed WARNINGS and Medication Guide. . Conversion from Another ESA: dosed once every 4 weeks based on total weekly epoetin alfa or darbepoetin alfa dose at time of conversion (2.2). Dissertation Les Fausses Confidences Stratagme, Les Fromagers De Thirache Horaires, Archange Gabriel Pouvoir, Adeline Franois Mari, Rdiger Un Rapport Sur Un lve En Difficult . Dose Conversion Ratio in Hemodialysis Patients Switched from Darbepoetin Alfa to PEG-Epoetin Beta: AFFIRM Study. In the first month after switch, these proportions were 10.2%, 48.5% and 37.4%, respectively. Conversion from Another ESA: dosed once every 4 weeks based on total RBC transfusions were reported in terms of number of transfusions and number of units transfused, using descriptive statistics. 4. Excluding patients receiving a transfusion within 90days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). 1985;28:15. Mircera will be administered IV to HD patients, and SC to PD patients. Always store Mircera prefilled syringes in their original cartons. Pure red cell aplasia (PRCA) that begins after treatment with MIRCERA, History of serious or severe allergic reactions to MIRCERA. Anemia response to Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) versus Epoetin Alfa (Eprex) in patients with chronic Kidney disease on Hemodialysis Published: September 05, 2017 42/47 is common in patients with a GFR below 30 ml/min/1.73m2 and contributes to many of the speciic symptoms of CKD. volume30,pages 10071017 (2013)Cite this article. 2014 Nov;31(11):1155-68. doi: 10.1007/s12325-014-0161-5. CAS 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. Methoxy polyethylene glycol-epoetin beta, the active substance of MIRCERA, is a continuous erythropoietin receptor activator that shows a different activity at the receptor level characterized by a slower association to and faster dissociation from the receptor, a reduced specific activity in vitro with an increased activity in vivo, as well as an increased half-life, in contrast to . Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. 3 DOSAGE FORMS AND STRENGTHS. If Hb increases by < 1 g/dL and remains < 10 g/dL after 6 weeks of therapy: If dosing QW, then increase dose to 4.5 mcg/kg/week. 2023Vifor (International) Inc. All rights reserved. The information provided in this site is intended only for healthcare professionals in the United States. Aranesp (darbepoetin alfa) Summary of product characteristics. MIRCERA is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia associated with chronic kidney disease (CKD) in: MIRCERA is not indicated and is not recommended for use: MIRCERA has not been shown to improve quality of life, fatigue, or patient well-being. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. Bland JM, Altman DG. <>
PubMed DCR was calculated for patients with Hb and ESA data available in both evaluation periods (EP; Months 1 and 2 were defined as the pre-switch EP, and Months 6 and 7 as the post-switch EP). 1: 21% of the excluded patients had died or were lost to follow-up during the post-switch period; 45% were no longer receiving PEG-Epo by Months +6 and +7 post-switch; and 34% had no Hb value reported for one or both EPs. Mircera (methoxy polyethylene glycol-epoetin beta) Summary of product characteristics. Careers. There were 16 transfusions and 34 units transfused in the pre-switch period, versus 48 transfusions and 95 units transfused post-switch. Aranesp (darbepoetin alfa) prescribing information, Amgen. Macdougall IC. In the evaluation periods, the geometric mean weekly DA dose in the pre-switch EP was 24.1g (95% CI 21.3, 27.1) while the geometric mean weekly PEG-Epo dose in the post-switch EP was 28.6g (95% CI 26.0, 31.5). OZZ Patients included in the analysis were less likely to be diabetic (32% vs. 40%), more likely to be receiving DA at a longer dosing interval (60% vs. 73% at QW; 19% vs. 3% less frequently than Q2W), and received a lower geometric mean weekly dose of DA during the pre-switch EP (24.1 vs. 37.7g). Matsumura K, Okumiya T, Sugiura T, Takahashi N, Yamamoto Y, Kikuchi S, Fujii K, Otagaki M, Shiojima I. BMC Nephrol. In CKD, anemia results primarily from decreased production of endogenous erythropoietin (EPO) by the kidney [3]. history of serious or severe allergic reactions to MIRCERA (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). Am J Nephrol. Accounting for the effect of transfusion, the DCR was 1.21 (95% CI 1.09, 1.35). For recommended dose equivalency, see Tables A and B (below). Clipboard, Search History, and several other advanced features are temporarily unavailable. A motion conversion mechanism 123 includes a yoke 153 and a rotatable member 149, which causes the yoke 152, . Finally, our study indicates that the risk of transfusion was higher in the post-switch compared with the pre-switch period, with an approximate threefold rise observed in the number of transfusions and units transfused post-switch. https://doi.org/10.1007/s12325-013-0063-y, DOI: https://doi.org/10.1007/s12325-013-0063-y. Preservation of anemia control and weekly ESA dosage after conversion from PEG-Epoetin beta to darbepoetin alfa in adult hemodialysis patients: the TRANSFORM study. The conversion from EpoB to CERA (methoxy polyethylene glycol-epoetin beta; Mircera; Hoffmann-La Roche Ltd., Basel, Switzerland) once monthly was already decided by the health care payer policy, who is the provider of erythropoietin stimulating agents for all patients, and was planned after a period of 6 months. -, Eschbach JW, Adamson JW. AFFIRM (Aranesp Efficiency Relative to Mircera) was a retrospective, multi-site, observational study designed to estimate the population mean maintenance dose conversion ratio [DCR; dose ratio achieving comparable hemoglobin level (Hb) between two evaluation periods] in European hemodialysis patients whose treatment was switched from DA to PEG-Epo. sharing sensitive information, make sure youre on a federal Mechanism of Action. Contributed by. Reasons for low Hb, e.g., acute intercurrent events such as bleeding, were not reported. The aims of the Aranesp Efficiency Relative to Mircera (AFFIRM) study were primarily to estimate the maintenance dose conversion ratio (DCR) of PEG-Epo to DA in a population of European hemodialysis patients switched from DA to PEG-Epo and with comparable mean hemoglobin (Hb) in the pre- and post-switch periods, and secondarily to investigate parameters of clinical management of anemia in this group of patients, in real-world clinical practice. 6); the mean (SD) Hb within 14days prior to transfusion in these periods was 8.8 (1.41) and 8.3 (1.26), respectively. Regardless of possible differences in their clinical characteristics it should be borne in mind that patients were not selected for inclusion in the DCR analysis on the basis of their fulfilling any clinical, Hb or ESA dose requirements: all patients who had Hb measurements in both EPs, a DA dose in the pre-switch EP and a PEG-Epo dose in the post-switch EP were eligible for inclusion. DCR geometric mean maintenance dose conversion ratio, EP evaluation period, ESA erythropoiesis-stimulating agent, Hb hemoglobin, PEG-Epo methoxy polyethylene glycol-epoetin beta. There are significant negative consequences associated with increased transfusion requirement in dialysis patients, including production of sensitizing anti-human leukocyte antigen (HLA) antibodies which, despite advances in immunosuppressant therapy [13], may impair or prevent transplantation in patients otherwise eligible for receipt of a kidney graft. J Manag Care Pharm. Although the reasons for transfusion were not recorded, the pre-transfusion Hb concentrations within 14days prior to transfusion remained similar for transfusions occurring both pre- and post-switch. Following administration, remove the needle from the injection site and then release the plunger to allow the needle guard to move up until the entire needle is covered. 2012;59:44451. Of 302 patients enrolled, 206 had data available for DCR analysis. Please see full Prescribing Information including Boxed WARNING, and Medication Guide for MIRCERA (methoxy polyethylene glycol-epoetin beta) Injection, for Intravenous or Subcutaneous Use. 10PAGE BROCHURE
Please know that the sponsors of this site are not responsible for content on the site you are about to enter. Mircera is a prescription medicine used to treat the symptoms of Anemia associated with Chronic Renal Failure. You may also report negative side effects of prescription drugs to the Food and Drug Administration (FDA). Epoetin beta and methoxy polyethylene glycol may increase tumor growth or decrease survival time in people with certain types of cancer.
Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in patients treated with Aranesp or EPOGEN. This suggests that the decision to transfuse was consistent with respect to Hb over the observation period (Fig. Slider with three articles shown per slide. History of serious or severe allergic reactions to Mircera (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). Months 7 to 1 constituted the pre-switch period, with switch defined as the date of first administration of PEG-Epo, and Months +1 to +7 constituted the post-switch period. Anemia of end-stage renal disease (ESRD). Article Before Am J Kidney Dis. Initial Treatment: 0.6 mcg/kg body weight administered once every two weeks (2.2). - , . Discard any unused portion. 1:1 reference line indicates equal PEG-Epo and darbepoetin alfa doses. Arch Intern Med. Over the last 25years, several originator and biosimilar ESAs have been introduced for the management of CKD anemia, starting with the first generation short-acting recombinant erythropoietin agents (epoetin alfa and beta) and latterly with two longer-acting molecules, darbepoetin alfa (DA) and methoxy polyethylene glycol-epoetin beta (PEG-Epo), which combine a significantly increased half-life and lower binding affinity for the EPO receptor, allowing them to stimulate erythropoiesis for longer periods and to be administered less frequently [5, 6]. randomized patients to darbepoetin or epoetin beta once weekly after the patients had been treated with epoetin beta three times weekly. Conversion from Another ESA: dosed once monthly or once every two weeks based on total weekly epoetin alfa or darbepoetin alfa dose at time of conversion (2.2). Geometric mean weekly PEG-Epo dose at Month 1 post-switch was 26.7g (95% CI 24.4, 29.3), rising to 29g (95% CI 26.2, 32.2) by Month 7 post-switch. AFFIRM (Aranesp Efficiency Relative to Mircera) was a retrospective, multi-site, observational study designed to estimate the population mean maintenance dose conversion ratio [DCR; dose ratio achieving comparable hemoglobin level (Hb) between two evaluation periods] in European hemodialysis patients whose treatment was switched from DA to PEG-Epo. FOIA \ab/`IR 4%jI ^w7qQNA Tq Wz.oVfCVBT{h*>\\3u#P@"wW7|pIMB7 Part of Springer Nature. More severe cases were recorded with long-acting agents (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta). and transmitted securely. Anemia of end-stage renal disease (ESRD) Kidney Int. PMC The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 2013;28:10929.
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