mircera to aranesp conversion

Available for Android and iOS devices. Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. The number of RBC transfusions and units transfused in the post-switch period was approximately threefold higher compared to the pre-switch period. A BlandAltman analysis [10] was also performed to assess the agreement between ESA doses in the evaluation periods. The https:// ensures that you are connecting to the Karaboyas A, Morgenstern H, Waechter S, Fleischer NL, Vanholder R, Jacobson SH, Sood MM, Schaubel DE, Inaba M, Pisoni RL, Robinson BM. Please know that Amgen, the sponsor of this site, is not responsible for the content on the site you are about to enter. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events. MIRCERA is indicated for the treatment of anemia associated with CKD in adult patients on dialysis and adult patients not on dialysis. 4! 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]. 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. Open Access This article is distributed under the terms of the Creative Commons Attribution 2.0 International License (https://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The initial conversion factor was 200:1. -, Eschbach JW, Adamson JW. Accessed 18 October 2013. Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with Aranesp or EPOGEN. Differentiating factors between erythropoiesis-stimulating agents: an update to selection for anaemia of chronic kidney disease. Adv Ther 30, 10071017 (2013). https://doi.org/10.1007/s12325-013-0063-y, DOI: https://doi.org/10.1007/s12325-013-0063-y. 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. Discard any unused portion. <>/Metadata 444 0 R/ViewerPreferences 445 0 R>> When a patient with a darbepoetin (Aranesp) or erythropoietin order switches to . NCI CPTC Antibody Characterization Program, Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. 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). 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. 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. These adverse reactions included myocardial infarction and stroke. Epoetin beta and methoxy polyethylene glycol may increase tumor growth or decrease survival time in people with certain types of cancer. 1985;28:15. Accessibility Do not use the prefilled syringe more than once. By definition, the DCR could not be calculated for patients ineligible for the DCR analysis as these did not have the necessary parameters recorded in both EPs. MIRCERA, methoxy polyethylene glycol-epoetin beta, is an ESA which differs from erythropoietin through formation of a chemical bond between an amino group present in erythropoietin beta and methoxy polyethylene glycol (PEG) butanoic acid. 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). Please click the OK button below to continue. Table 1 Mircera Starting Doses for Adult Patients Currently Receiving an ESA, Table 2 Mircera Starting Doses for Pediatric Patients Currently Receiving an ESA. history of serious or severe allergic reactions to MIRCERA (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). The geometric mean DCR was 1.17 (95% CI 1.05, 1.29). What is the practical conversion dose when changing from epoetin alfa The primary finding of the study is that the DCR of PEG-Epo to DA was 1.17 (95% CI 1.05, 1.29). In pediatric patients, Mircera is administered by intravenous injection only (2.2). Excluding patients receiving a transfusion within 90 days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). New anemia therapies: translating novel strategies from bench to bedside. Epoetin alfa (Eprex [JanssenCilag], Binocrit [Sandoz], and epoetin zeta (Retacrit, - Hospira UK): the initial dose is 150 IU kg-1 given subcutaneously three times per week.5 -7 Alternatively, epoetin alfa can be administered at an initial dose of 450 IU kg 1 subcutaneously once weekly.5-7 The maximum recommended dose is 900 IU kg-1 The geometric mean weekly ESA dose for those included in the DCR analysis is shown in Fig. The dose of Mircera, given as a single intravenous or subcutaneous injection, should be based on the DA, launched in 2001 [5, 7], contains 5 N-linked oligosaccharide chains, rather than the 3 contained in short-acting epoetins, which confer an approximately threefold longer serum half-life and mean residence time, allowing extended inter-dosing intervals [6]. Nephrol Dial Transplant. Do not use Mircera after the expiration date. ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers. Administer MIRCERA intravenously once every 4 More ways to get app. Macdougall IC. New anemia therapies: translating novel strategies from bench to bedside. Epub 2022 Apr 22. 6); the mean (SD) Hb within 14days prior to transfusion in these periods was 8.8 (1.41) and 8.3 (1.26), respectively. The remaining enrolment was at four sites divided between three other countries. 2020 Sep 29;21(1):418. doi: 10.1186/s12882-020-02078-z. About ARANESP (darbepoetin alfa) | Amgen ESA | HCP Statistical methods for assessing agreement between two methods of clinical measurement. This compares with a 35% decline in Epogen sales during the same period to $1.13bn, as competition from Mircera and biosimilars, like by Sandoz' Binocrit, reach the markets. Dr. Gerald Diaz @GeraldMD. The .gov means its official. 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. Mean Hb was 11.5 g/dL in the pre-switch EP and 11.4 g/dL in the post-switch EP. endobj MIRCERA- methoxy polyethylene glycol-epoetin beta Drugs. This study and the article processing charges were funded by Amgen Europe GmbH, Zug, Switzerland. doi: 10.1002/14651858.CD010590.pub2. Product Information and Dosing | Mircera This article does not contain any studies with human or animal subjects performed by any of the authors. 33 Dose. 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. Action Stimulates erythropoesis (production of red blood cells). - 94.130.71.173. 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 is used to treat anemia caused by chronic kidney disease in adults, or in children at least 5 years old who are on hemodialysis. Fewer than half of the patients achieved Hb in the 1012g/dL range by 7months post-switch. 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. Anemia of end-stage renal disease (ESRD). 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. Hb hemoglobin. Last updated on Jul 26, 2022. Pharmacokinetic studies have shown that the meanSD terminal half-life of DA is 217.5h when administered intravenously (IV) [7]. Accounting for the effect of transfusion, the DCR was 1.21 (95% CI 1.09, 1.35). FDA approves Mircera for anemia associated with chronic kidney disease Waiting game continues with Mircera launch | Evaluate 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. Unable to load your collection due to an error, Unable to load your delegates due to an error. Evaluate the iron status in all patients before and during treatment. Cochrane Database Syst Rev. 2002;17(Suppl 5):6670. species. A brochure to help you understand how to dose and administer Aranesp, and to convert from epoetin alfa to Aranesp in patients with anemia due to CKD. For lack or loss of hemoglobin response to Aranesp or EPOGEN, initiate a search for causative factors. Mircera Dosage Guide - Drugs.com Clin Kidney J. W\iA* Results of the BlandAltman analysis investigating the concordance between mean weekly ESA doses in both evaluation periods are presented in Fig. Dose Conversion Ratio in Hemodialysis Patients Switched from Darbepoetin Alfa to PEG-Epoetin Beta: AFFIRM Study. 2013;73:11730. (PDF) Amgen Business Review - library.corporate-ir.netlibrary.corporate 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. Please see full Prescribing Information including Boxed WARNING, and Medication Guide for MIRCERA (methoxy polyethylene glycol-epoetin beta) Injection, for Intravenous or Subcutaneous Use. Dose by Weight Chart - Resourcehub Epogen Dosage Guide - Drugs.com Epogen, Procrit (epoetin alfa) dosing, indications, interactions For Adult Patients with CKD not on dialysis: Refer patients who self-administer Mircera to the Instructions for Use [see Patient Counseling Information (17)]. Medically reviewed by Drugs.com. BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (. Methoxy polyethylene glycol-epoetin beta - Wikipedia 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. The site is secure. Injection: 30 mcg, 50 mcg, 75 mcg, 100 mcg, 120 mcg, 150 mcg, 200 mcg, or 250 mcg in 0.3 mL solution in single- Association of erythropoietin resistance and fibroblast growth factor 23 in dialysis patients: Results from the Japanese Dialysis Outcomes and Practice Patterns Study. Methoxy polyethylene glycol-epoetin (Mircera ) will be increased and decreased in 1-step or 2-step increments, based on scale above. ARANESP (darbepoetine alfa) 1 injection/sem. Among patients switched from DA to PEG-Epo, the mean monthly PEG-Epo dose was increased from 159g at the switch to 263g at Week 26 and 273g at Month 1112 [11]. Aranesp (darbepoetin alfa) Epogen (epoetin alfa) Mircera . Article 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). FOIA The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Initial Treatment: 0.6 mcg/kg body weight administered once every two weeks (2.2). Use caution in patients with coexistent cardiovascular disease and stroke. as a substitute for red blood cell transfusions in patients who require immediate correction of anemia. What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (n=205). 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. Drug class: Recombinant human erythropoietins. Choi, P., Farouk, M., Manamley, N. et al. Prise en charge anmie rnale - Nephro.blog Tables2 and 3 also summarize the proportion of patients in different Hb categories by study month. All groups were assessed at the end of the study for safety and efficacy parameters. A total of 302 eligible patients were enrolled at 14 European hemodialysis centers, with 57% of patients enrolled at 10 French sites, 18% at 2 Spanish sites, 17% at 1 UK site, and 8% at 1 German site. 2012;59:444451. 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. ferrous sulfate, Aranesp, Procrit, Retacrit. Mourad Farouk is an employee of Amgen with Amgen stock ownership. Roche Registration Ltd., Welwyn Garden City, UK, 19 June 2012. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000739/WC500033672.pdf. 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 . 1 0 obj 2001;38:80312. Methoxy polyethylene glycol-epoetin beta | Drugs | BNF | NICE pure red cell aplasia (PRCA) that begins after treatment with MIRCERA or other erythropoietin protein drugs. 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). Peter Choi, MB BChir, PhD, FRCP (UK), has received lecturing and consulting fees from Amgen, and has participated in advisory boards for Amgen. There was neither any requirement for a center to have been using DA as their sole long-acting ESA pre-switch, nor for every DA-treated patient to have been switched to PEG-Epo. 2004;19(Suppl 2):ii1631. . Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. Dr. Peter Choi is the guarantor for this article, and takes responsibility for the integrity of the work as a whole. 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. The geometric mean weekly ESA doses were 24.1g DA in the pre-switch EP and 28.6g PEG-Epo in the post-switch EP. : | , pee`T"c+l_WB,`km^;6#j(*m`&E`l${F6Q`&^=e`f(6]8ZE[VHNx-FRIhE&iJKvW`Vz^p@?Yk+S.DgR1rrB6yq2N$| Yves Dimitrov, Julie Rieger, Thierry Hannedouche, Toru Kawai, Yoshie Kusano, Takao Masaki, Shubhadeep D. Sinha, Vamsi Krishna Bandi, Santosh Durugkar, Jonathan Barratt, Frank Dellanna, Michael Reusch, Terumasa Hayashi, Hideki Kato, Ichiei Narita, Rufaida Mazahir, Kanav Anand & P. K. Pruthi, Giovanna Stoppa, Carmen DAmore, ESAVIEW Study Group, Ylenia Ingrasciotta, Valeria Belleudi, On behalf of the Italian Biosimilars Network (I-BioNetwork), Luciano A. Pedrini, Mario Comelli, Stefano Stuard, Advances in Therapy risks. MIRCERA (methoxy polyethylene glycol-epoetin beta) is the first erythropoiesis-stimulating agent (ESA) approved by FDA for once-monthly administration. 1985;28:15. Part of Springer Nature. %PDF-1.7 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. HQ-MIR-1900027 Site last modified: January 2023. 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]. Vigorous shaking or prolonged exposure to light should be avoided. Internal You are now leaving AnemiaHub.com. Each dosage strength of MIRCERA is designated by a unique syringe plunger color. Following initiation of therapy and after each dose adjustment, monitor hemoglobin weekly until the hemoglobin level is stable and sufficient to minimize the need for RBC transfusion. 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. Mircera (methoxy polyethylene glycol / epoetin beta) dosing - Medscape Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Secondly, the DCR was calculated on a subset of patients which constituted approximately two-thirds of the total enrolled. Eschbach JW, Adamson JW. Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (19881994) Arch Intern Med. before initiating Mircera [see Warnings and Precautions (5.9)]. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. At the moment forecasts for Mircera are $345m in 2015 rising to $552m in 2020, reflecting sales made outside the US. Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp GrepMed. The number of transfusions and units transfused increased approximately threefold from the pre-switch to the post-switch period. }"nUEcJumC0ooF 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. Please click to see accompanying Aranesp full prescribing information and EPOGEN full prescribing information, including Boxed WARNINGS and Medication Guide. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Data were collected from 7months before until 7months after switching treatment. 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. Careers. government site. Slider with three articles shown per slide. Aranesp (darbepoetin alfa) Summary of product characteristics. 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. doi: 10.1038/ki.1985.109. 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. This paper presents the findings of a retrospective, multi-center, observational study of hemodialysis patients switched from DA to PEG-Epo for the treatment of anemia. Clipboard, Search History, and several other advanced features are temporarily unavailable. PDF Aranesp, Epogen, Mircera, Procrit, Retacrit - Cigna 2009 Nov-Dec;15(9):741-50. doi: 10.18553/jmcp.2009.15.9.741. It is not known if Mircera is safe and effective in children younger than 5 years of age. National Library of Medicine 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. Do not pool unused portions from the prefilled syringes. Randomized clinical studies have reported data on switching from DA to PEG-Epo (Stabilizing haemoglobin TaRgets in dialysis following IV C.E.R.A. Anemia of end-stage renal disease (ESRD) Kidney Int. Values are means (arithmetic for hemoglobin, geometric for dose) with 95% confidence intervals. Recombinant human erythropoietins: very rare risk of severe cutaneous Bookshelf This analysis indicated that the concordance decreased with increasing dose. A single hemoglobin excursion may not require a dosing change. The majority of patients who were transfused during the pre- and post-switch observation periods had Hb 10g/dL within the 14days prior to transfusion; only 1 patient during each period had Hb >11g/dL within the 14-day pre-transfusion interval. PubMed Mircera solution for injection in pre-filled syringe - Summary of Methoxy polyethylene glycol-epoetin beta injection causes the . 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. 20,000 Units/2 mL (10,000 Units/mL) and 20,000 Units/mL of RETACRIT as a clear and colorless liquid in multiple-dose vials (contains benzyl alcohol). Mircera solution for injection in pre-filled syringe We comply with the HONcode standard for trustworthy health information. Revised European Best Practice Guidelines for the management of anaemia in patients with chronic renal failure. Administer Mircera intravenously once every 4 weeks to pediatric patients (ages 5 to 17 years) whose hemoglobin level has been stabilized by treatment with an ESA. No test of statistical significance was performed on any of the clinical characteristics. aranesp to retacrit conversiontuto amigurumi grenouille au crochet. Usui T, Zhao J, Fuller DS, Hanafusa N, Hasegawa T, Fujino H, Nomura T, Zee J, Young E, Robinson BM, Nangaku M. Nephrology (Carlton). maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study. 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. Always store Mircera prefilled syringes in their original cartons. 2020 Mar 26;2(3):286-296. doi: 10.1016/j.xkme.2020.01.007. (PDF) Conversion from epoetin beta to darbepoetin: What is the Aztec notes.docx - The kidneys are the primary organ of the In conclusion, this study has shown that in a cohort of European hemodialysis patients who converted from DA to PEG-Epo (and who completed 67months treatment with PEG-Epo post-conversion), there was an approximately 20% increase in the g dose required to achieve a comparable Hb profile. 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. Google Scholar. Hymes J, Bickimer T, Jackson JH, Bookhart BK, Mody SH, Tak Piech C. Curr Med Res Opin. 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. 3. Mircera is administered by subcutaneous (SC) or intravenous (IV) injection (2.2). Disclaimer. OK Methods: For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. PDF Limitations of Use Mircera is not indicated and is not recommended for Studies of erythropoietin therapy in patients with chronic anemia of cancer as well as CIA document response rates ranging from ~60% to 85%. The enrolling dialysis centers were situated in France, Germany, Spain and the UK, and each was expected to enroll a minimum of 20 patients into the study. Adverse reactions ( 5%) in EPOGEN clinical studies in patients with CKD were hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. Aranesp (darbepoetin alfa) | Dosing Considerations OZZ Vifor (International) Inc. MIRCERA- methoxy polyethylene glycol-epoetin 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. The distribution of Hb values reported within the 14days prior to transfusion was described; if multiple Hb values were recorded, the value closest to the transfusion date was utilized. 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. Pure red cell aplasia (PRCA) that begins after treatment with Mircera or other erythropoietin protein drugs. 2). Am J Kidney Dis. Individual patients could contribute multiple transfusions to these analyses. [3] It is the first approved, chemically modified erythropoiesis-stimulating agent (ESA). MIRCERA Interactions: May require increased anticoagulation (heparin) during hemodialysis. 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).