Nick Manamley, MSc, is an employee of Amgen with Amgen stock ownership. Vigorous shaking or prolonged exposure to light should be avoided. Figure4 also displays the mean monthly Hb for those included in the DCR analysis over the study period. The geometric mean DCR of PEG-Epo to DA was 1.17, rising to 1.21 when the effect of RBC transfusions was taken into account. . The number of transfusions and units transfused increased approximately threefold from the pre-switch to the post-switch period. <>/Metadata 444 0 R/ViewerPreferences 445 0 R>> 2002;17(Suppl 5):6670. The site is secure. Mircera Injection (Methoxy Polyethylene Glycol-Epoetin Beta ) 6,610/ Piece Get Latest Price. Patients can also have iron-deficiency anemia and need iron replacement using one of the supplements listed in the previous Electrolytes and Minerals section of this lesson. 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)]. Nephrol Dial Transplant. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) Changes in ESA dosing and number of transfusions post-switch may have important health-economic implications. In these hemodialysis patients switched from DA to PEG-Epo the DCR was 1.17 and 1.21 after accounting for the effect of transfusions. Firstly, the study sample was drawn largely from a single country (France), which contributed over 70% of the patients and 10 of the 14 study sites. 1. Methoxy polyethylene glycol-epoetin beta injection is used to treat anemia in adults with chronic kidney disease (CKD) who may or may not be on dialysis or in children with CKD who are on dialysis. Longer-acting PEG-Epo contains a chemical bond between an amino group present in epoetin beta and methoxy polyethylene glycol (PEG) butanoic acid; the addition of PEG is responsible for an increase in serum half-life of epoetin beta, and in CKD patients on dialysis the terminal half-life of PEG-Epo after IV administration is 134h [6, 8]. doi: 10.1001/archinte.162.12.1401. Summary of the last hemoglobin concentrations recorded within 14days prior to red blood cell transfusions pre- and post-switch. Treatment for Anaemia [STRIATA] [8] and comPArator sTudy of C.E.R.A. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. Dialysis centers were expected to adhere to European Best Practice Guidelines for iron repletion [9]. AFFIRM demonstrated non-linearity of the dose relationship curve, with DCR decreasing as pre-switch DA dose increased. Please know that the sponsors of this site are not responsible for content on the site you are about to enter. _____ (if . Mircera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV (PDF/15.49 KB) First published: 02/08/2007 Last updated: 02/08/2007 Pharmacotherapeutic group Antianemic preparations Therapeutic indication Treatment of symptomatic anaemia associated with chronic kidney disease (CKD). Mircera with 1-step decrease as soon as Hgb is < 11.8 g/dL and last dose was administered 2 weeks ago or more. Administer Mircera as an intravenous injection at the dose (in micrograms) based on the total weekly ESA dose at the time of conversion (see Table 2). Values are means (arithmetic for hemoglobin, geometric for dose) with 95% confidence intervals. 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. 1985;28:15. Data were also manually reviewed prior to final analysis. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. This was particularly evident in patients whose pre-switch EP weekly DA dose was higher than 100g. Lancet. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. Low hemoglobin at hemodialysis initiation: an international study of anemia management and mortality in the early dialysis period. This medicine is not for treating anemia caused by cancer chemotherapy. A motion conversion mechanism 123 includes a yoke 153 and a rotatable member 149, which causes the yoke 152, . as a substitute for red blood cell transfusions in patients who require immediate correction of anemia. MIRCERA is indicated for the treatment of anemia associated with CKD in adult patients on dialysis and adult patients not on dialysis. Mircera (methoxy polyethylene glycol-epoetin beta) Summary of product characteristics. 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. Descriptions. The geometric mean DCR was 1.17 (95% CI 1.05, 1.29). Do not pool unused portions from the prefilled syringes. Response rates are defined in two ways: 1) Hgb levels > 12 g/dL or 2) an increase in Hgb of 2 g/dL from baseline. OK Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp GrepMed. Secondly, the DCR was calculated on a subset of patients which constituted approximately two-thirds of the total enrolled. reaction occurs. Last updated on Jul 26, 2022. Mircera is used to treat anemia caused by chronic kidney disease in adults, or in children at least 5 years old who are on hemodialysis. ^D[5j@%e ARANESP (darbepoetine alfa) 1 injection/sem. Epub 2011 Dec 2. aranesp to retacrit conversiontuto amigurumi grenouille au crochet. Dr. Peter Choi is the guarantor for this article, and takes responsibility for the integrity of the work as a whole. MIRCERA Classification: Erythropoiesis stimulating protein. A single hemoglobin excursion may not require a dosing change. Correspondence to Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. Drugs. sharing sensitive information, make sure youre on a federal Am J Kidney Dis. Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. MIRCERA can be administered once every 2 weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA. MIRCERA has an approximate molecular weight of 60 kDa. For adverse event reports, please contact us at safety@viforpharma.com,mircera@viforpharma.com or at 1-800-576-8295. reverse transcriptase polymerase chain reaction (RT-PCR) Amplification of RNA sequences by conversion to cDNA by nucleic acid hybridization A technique of nucleic acid reverse transcriptase, followed by the polymerase chain reac-analy sis via association of complementary single- stranded tion. In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL. Pharmacokinetic studies have shown that the meanSD terminal half-life of DA is 217.5h when administered intravenously (IV) [7]. In an additional analysis performed to assess the sensitivity of this result to the effects of transfusion by excluding those patients who received an RBC transfusion within 90days prior to or during either evaluation period, the DCR was 1.21 (95% CI 1.09, 1.35). The baseline (i.e., at time of switch) demographic and clinical characteristics of enrolled patients and those included in and excluded from the DCR analysis are displayed in Table1. In pediatric patients on hemodialysis, all reported adverse reactions regardless of causality (more than 5% incidence) were headache, nasopharyngitis, hypertension, vomiting, bronchitis, abdominal pain, arteriovenous fistula thrombosis, cough, device related infection, hyperkalemia, pharyngitis, pyrexia, thrombocytopenia, and thrombosis in device. Am J Kidney Dis. doi: 10.1002/14651858.CD010590.pub2. Excluding patients receiving a transfusion within 90 days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Conversion Dosing Guide: From epoetin alfa to Aranesp in patients with anemia due to CKD on dialysis. Resistance to Erythropoiesis-Stimulating Agents among Patients on Hemodialysis Is Typically Transient. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. 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. Article MIRCERA (methoxy polyethylene glycol-epoetin beta) is the first erythropoiesis-stimulating agent (ESA) approved by FDA for once-monthly administration. . J Manag Care Pharm. Canaud B, Mingardi G, Braun J, et al. The remaining enrolment was at four sites divided between three other countries. "BG0RjI G78 New anemia therapies: translating novel strategies from bench to bedside. <> Do you wish to proceed? 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 (darbepoetin alfa) and EPOGEN (epoetin alfa) are contraindicated in patients with: Pure red cell aplasia (PRCA) that begins after treatment with Aranesp, EPOGEN, or other erythropoietin protein drugs, Serious allergic reactions to Aranesp or EPOGEN. Publication management support was provided by Caterina Hatzifoti, PhD, of Amgen Europe GmbH. Intravenous C.E.R.A. 2023 Springer Nature Switzerland AG. 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. 2022;53(5):333-342. doi: 10.1159/000523947. 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. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Reasons for low Hb, e.g., acute intercurrent events such as bleeding, were not reported. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. See Instructions for Use for complete instructions on the preparation and administration of Mircera. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Provided by the Springer Nature SharedIt content-sharing initiative, Over 10 million scientific documents at your fingertips, Not logged in Macdougall IC, Obrador GT, El Nahas M. How important is transfusion avoidance in 2013? Results of the BlandAltman analysis investigating the concordance between mean weekly ESA doses in both evaluation periods are presented in Fig. 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). Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. doi: 10.1093/ndt/17.suppl_5.66. Indication Aranesp (darbepoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.Limitations of Use Aranesp has not been shown to improve quality of life, fatigue, or patient well-being. Asterisk Not all transfusions had an associated hemoglobin concentration in the 14-day period before transfusion. Before Methods: The dose of MIRCERA , given as a single intravenous or subcutaneous injection, should be based on the total weekly ESA dose at the time of conversion. Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. The geometric mean weekly dose of DA was 23.2g (95% CI 20.6, 26.3) in the month prior to switch. Box 1557, 6301, Zug, Switzerland, Amgen (UK) Limited, 240 Cambridge Science Park, Milton Road, Cambridge, UK, You can also search for this author in Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. This article does not contain any studies with human or animal subjects performed by any of the authors. 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. -, Macdougall IC. | DOWNLOAD SIZE: 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). }"nUEcJumC0ooF Bethesda, MD 20894, Web Policies 2014 Nov;31(11):1155-68. doi: 10.1007/s12325-014-0161-5. 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. Methoxy polyethylene glycol-epoetin beta, sold under the brand name Mircera, is a long-acting erythropoietin receptor activator (CERA) used for the treatment of anaemia associated with chronic kidney disease. Decreases in dose can occur more frequently. Patients were then switched to fortnightly darbepoetin alfa dosing treatments; the existing weekly dose being doubled and Hb levels fell from 125 to 110 g/L (P < 0.0001), despite an increase in the mean dose from 44.9 to 47.5 . Aranesp (darbepoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis. Shortened red blood cell age in patients with end-stage renal disease who were receiving haemodialysis: a cross-sectional study. 2013;28:10929. 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). ESA erythropoiesis-stimulating agent, Hb hemoglobin. Nephrol Dial Transplant. Active ingredient: methoxy polyethylene glycol-epoetin beta Inactive ingredients: mannitol, methionine, poloxamer 188, sodium phosphate monobasic monohydrate, and sodium sulfate. doi: 10.1038/ki.1985.109. Use caution in patients with coexistent cardiovascular disease and stroke. 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. A primary growth factor for erythroid development, erythropoietin is produced in the kidney and released into the bloodstream in response to hypoxia. 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). 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). For patients who do not respond adequately over a 12-week escalation period, increasing the MIRCERA, Evaluate other causes of anemia. 2). 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]. Statistical methods for assessing agreement between two methods of clinical measurement. Do not increase the dose more frequently than once every 4 weeks. Always store Mircera prefilled syringes in their original cartons. 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. Horowitz J, Agarwal A, Huang F, Gitlin M, Gandra SR, Cangialose CB. Anemia of chronic kidney disease (CKD) becomes increasingly prevalent and severe as kidney function declines [1], with over 90% of patients who require renal replacement therapy becoming anemic [2]. Nephrol Dial Transplant. The information provided in this site is intended only for healthcare professionals in the United States. Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. The distribution of transfusions (Fig. In CKD, anemia results primarily from decreased production of endogenous erythropoietin (EPO) by the kidney [3]. W\iA* Discard any unused portion. Full Prescribing Information, including Boxed WARNING, full Prescribing Information including Boxed WARNING, How to Use the MIRCERA Prefilled Syringe, Healthcare Provider and Patient Resources, full Prescribing Information, including Boxed WARNING. Anemia of end-stage renal disease (ESRD) Kidney Int. 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 . MIRCERA is a registered trademark of F. Hoffmann-La Roche Ltd. All Vifor Pharma Groups intellectual rights, including copyright, are reserved by the Vifor Pharma Group. [citation needed] Packaging Type: Injection. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study. Article However, the relationship between the pre- and post-switch ESA doses during the two evaluation periods was non-linear. Drug class: Recombinant human erythropoietins. Dosage form: injection, solution Each dosage strength of MIRCERA is designated by a unique syringe plunger color. Introduction: Red blood cell transfusions pre- and post-switch, Summary of the last hemoglobin concentrations recorded within 14days prior to red blood cell transfusions pre- and post-switch. % Conversion d'une EPO l'autre Conversion potine en darbpotine avec un facteur de conversion 200 UI = 1 g Bilan martial Suivi ferritine et taux de saturation de la transferrine (TSAT) tous les 3 mois. Pure red cell aplasia (PRCA) that begins after treatment with Mircera or other erythropoietin protein drugs. Administer MIRCERA intravenously once every 4 More ways to get app. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which Aranesp and EPOGEN are not approved). Data on clinical and laboratory parameters relating to CKD management were abstracted from patient records and entered into an anonymized study-specific central database by study center staff. Mircera may be used alone or with other medications. Hymes J, Bickimer T, Jackson JH, Bookhart BK, Mody SH, Tak Piech C. Curr Med Res Opin. 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. 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. [3] It is the first approved, chemically modified erythropoiesis-stimulating agent (ESA). As the study was entirely retrospective, ESA switching and dose conversion were performed without reference to a study protocol and there was no protocol-driven intervention in the clinical management of patients. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 5). Google Scholar. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these The number of RBC transfusions and units transfused in the post-switch period was approximately threefold higher compared to the pre-switch period. pee`T"c+l_WB,`km^;6#j(*m`&E`l${F6Q`&^=e`f(6]8ZE[VHNx-FRIhE&iJKvW`Vz^p@?Yk+S.DgR1rrB6yq2N$| The introduction of exogenous erythropoiesis-stimulating agents (ESAs) to clinical practice has transformed the care of patients with CKD, by ameliorating anemia, reducing transfusion requirements, and improving quality of life [4]. Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. Would you like email updates of new search results? 4. 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. 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). Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Adult Patients with CKD. Aranesp and EPOGEN increase the risk of seizures in patients with CKD. adult patients on dialysis and adult patients not on dialysis. 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. The primary outcome (DCR) for each patient was calculated as the mean weekly dose of PEG-Epo during the post-switch EP divided by the mean weekly dose of DA during the pre-switch EP. When administered subcutaneously, Mircera should be injected in the abdomen, arm or thigh. A single hemoglobin excursion may not require a dosing change. Patients stable on intravenous (iv) epoetin alfa will be randomized either to receive standard of care therapy (epoetin alfa (iv) 3 times weekly), or to receive Mircera 120-360 micrograms (iv), monthly. Studies of erythropoietin therapy in patients with chronic anemia of cancer as well as CIA document response rates ranging from ~60% to 85%. Do not use Mircera after the expiration date. 2002;162:14011408. The https:// ensures that you are connecting to the Conversion from Epoetin alfa or Darbepoetin alfa to MIRCERA in Pediatric Patients with CKD on Hemodialysis. Please click to see accompanying Aranesp full prescribing information and EPOGEN full prescribing information, including Boxed WARNINGS and Medication Guide. St. Gallen, Switzerland: Vifor (International) Inc.; June 2018. Amgen Europe B.V., Breda, The Netherlands, 29 August 2013. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000332/WC500026149.pdf. 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. Adverse Reactions: Hypertension, diarrhea,. Hb concentrations were reported as arithmetic means for each month. Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. An official website of the United States government. Internal You are now leaving AnemiaHub.com. AFFIRM may therefore help to guide expectations around potential differences in ESA dose requirements when switching hemodialysis patients from DA to PEG-Epo, although the reported mean maintenance DCR is not intended to predict the dose conversion ratio at the individual patient level. 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. 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. - , . Hb hemoglobin. ONLY administer MIRCERA intravenously in pediatric patients. In controlled clinical trials of patients with CKD comparing higher hemoglobin targets (13 to 14 g/dL) to lower targets (9 to 11.3 g/dL), ESAs increased the risk of death, myocardial infarction, stroke, congestive heart failure, thrombosis of hemodialysis vascular access, and other thromboembolic events in the higher target groups. ESAs resulted in decreased locoregional control/progression-free survival and/or overall survival. 33 Dose. For the purposes of this policy, a conversion factor of 3 should be used to estimate hematocrit when only the hemoglobin is measured, e.g., hemoglobin of 10 g/dL is approximately equal to a hematocrit of 30%, a hemoglobin of 11 g/dL is . Methoxy polyethylene glycol-epoetin beta injection causes the . Accessibility For lack or loss of hemoglobin response to Aranesp or EPOGEN, initiate a search for causative factors. Anyone you share the following link with will be able to read this content: Sorry, a shareable link is not currently available for this article. 2. . 2014 Dec 8;2014(12):CD010590. Learn about Mircera, potential side effects, proper use and dosing, and popular alternatives. 1MIRCERA [prescribing information]. Kidney Med. Immediately and permanently discontinue Aranesp or EPOGEN if a serious allergic Epub 2020 Aug 20. The dose of Mircera, given as a single intravenous or subcutaneous injection, should be based on the Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. 8600 Rockville Pike 2013;73:11730. Am J Nephrol. Kidney Int. 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. . Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. Results: In responding to hypoxia, erythropoietin interacts with erythroid progenitor . Editorial assistance in the preparation of this manuscript was provided by W. Mark Roberts, PhD, Montreal, Canada. EP evaluation period, PEG-Epo methoxy polyethylene glycol-epoetin beta. 4 x previous weekly epoetin alfa dose (Units)/125, e.g., 4 x 1500 Units of epoetin alfa per week/125 = 48 mcg of Mircera once every 4 weeks, 4 x previous weekly darbepoetin alfa dose (mcg)/0.55, e.g., 4 x 20 mcg of darbepoetin alfa per week/0.55 = 145.5 mcg of Mircera once every 4 weeks.