mircera to aranesp conversion

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. For recommended dose equivalency, see Tables A and B (below). Do not increase the dose more frequently than once every 4 weeks. Values are means (arithmetic for hemoglobin, geometric for dose) with 95% confidence intervals. Use the lowest Mircera dose sufficient to reduce the need for red blood cell (RBC) transfusions. 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. Reasons for exclusion of 96 enrolled patients from the DCR analysis are presented in Fig. 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. This medicine is not for treating anemia caused by cancer chemotherapy. 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. Composition: Methoxy Polyethylene Glycol-Epoetin Beta. Google Scholar. The geometric mean weekly ESA dose for those included in the DCR analysis is shown in Fig. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. Canaud B, Mingardi G, Braun J, et al. Goodkin DA, Zhao J, Cases A, Nangaku M, Karaboyas A. [3] It is the first approved, chemically modified erythropoiesis-stimulating agent (ESA). doi: 10.1053/ajkd.2001.27699. Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. New anemia therapies: translating novel strategies from bench to bedside. Am J Nephrol. These adverse reactions included myocardial infarction and stroke. Figure4 also displays the mean monthly Hb for those included in the DCR analysis over the study period. -, Macdougall IC. Mircera (methoxy polyethylene glycol / epoetin beta) dosing, indications, interactions, adverse effects, and more Drugs & Diseases methoxy polyethylene glycol / epoetin beta (Rx) Brand and. 33 Dose. Epoetin alfa (Procrit, Epogen) acts like the hormone we have in our body, whereas Mircera . 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. 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). . aranesp to retacrit conversiontuto amigurumi grenouille au crochet. 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. 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. Aranesp and EPOGEN increase the risk of seizures in patients with CKD. Statistical methods for assessing agreement between two methods of clinical measurement. In CKD, anemia results primarily from decreased production of endogenous erythropoietin (EPO) by the kidney [3]. -, Eschbach JW, Adamson JW. Methoxy polyethylene glycol-epoetin beta injection causes the . Nephrol Dial Transplant. \ab/`IR 4%jI ^w7qQNA Tq Wz.oVfCVBT{h*>\\3u#P@"wW7|pIMB7 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. In the first month after switch, these proportions were 10.2%, 48.5% and 37.4%, respectively. Association of erythropoietin resistance and fibroblast growth factor 23 in dialysis patients: Results from the Japanese Dialysis Outcomes and Practice Patterns Study. Accessed 18 October 2013. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. Karaboyas A, Morgenstern H, Waechter S, Fleischer NL, Vanholder R, Jacobson SH, Sood MM, Schaubel DE, Inaba M, Pisoni RL, Robinson BM. MIRCERA can be administered once every 2 weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA. This study and the article processing charges were funded by Amgen Europe GmbH, Zug, Switzerland. The data from this study were analyzed using SAS Statistical Software v9.2 (SAS Institute Inc., Cary, NC, USA). Visit. For patients who do not respond adequately over a 12-week escalation period, increasing the MIRCERA, Evaluate other causes of anemia. Secondly, the DCR was calculated on a subset of patients which constituted approximately two-thirds of the total enrolled. 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. Available for Android and iOS devices. 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. Adv Ther 30, 10071017 (2013). Shortened red blood cell age in patients with end-stage renal disease who were receiving haemodialysis: a cross-sectional study. 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). Conversion from Epoetin alfa or Darbepoetin alfa to MIRCERA in Pediatric Patients with CKD on Hemodialysis. doi: 10.1053/j.ajkd.2011.11.013. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. Carrera F, Lok CE, de Francisco A, et al. Please click to see accompanying Aranesp full prescribing information and EPOGEN full prescribing information, including Boxed WARNINGS and Medication Guide. History of serious or severe allergic reactions to Mircera (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). The majority of patients with CKD will require supplemental iron during the course of ESA therapy. "BG0RjI G78 Mircera belongs to a class of drugs called Hematopoietic Growth Factors. Logistic regression analysis showed a higher likelihood of a transfusion during the post-switch period among patients with a dose ratio at switching of <1. ESAs resulted in decreased locoregional control/progression-free survival and/or overall survival. The mean (95% CI) monthly Hb immediately prior to switch, in Month 1 post-switch, and in Month 7 post-switch was 11.5g/dL (11.3, 11.7), 11.7g/dL (11.5, 11.9), and 11.4g/dL (11.3, 11.6), respectively. ?z_IxD1&S&L)@g7NI\H |a_,I17KFu[7+n h?b}xqm5Ed]N8+3ei^Rh/0up20]S=NoPAN$Z$L+u'Hp5v;'QyBQT 8}"{=xVqe)gR&yOs^sfT#B cf#xF`=bXMdCV?s&KS|`q9HT=,[='q6s1UE J$KxBE hg*~'ct'p|YTs1c->uLd_614J)q)g>QR`~*B9GewhNBPs j "It(Y%kRz}=!ayvw^`c]n986kR+LBZ:l~(hf !|p)-b=@|] aRQ:SIRwn$Ip 8v-S"-j0G;r:@ElyDkDE#4H~n{x4P*jS '.P4F lZhBW0t*1b`&wIU_=(>|@"1A`. doi: 10.1001/archinte.162.12.1401. Nephrol Dial Transplant. . 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 . 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. 2 0 obj Eligible patients had received hemodialysis for 12 months and DA for 7 months. This suggests that the decision to transfuse was consistent with respect to Hb over the observation period (Fig. Do not use the prefilled syringe more than once. Nephrol Dial Transplant. 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]. Medically reviewed by Drugs.com. MIRCERA is indicated for the treatment of anemia associated with CKD in adult patients on dialysis and adult patients not on dialysis. Dose Conversion Ratio in Hemodialysis Patients Switched from Darbepoetin Alfa to PEG-Epoetin Beta: AFFIRM Study. 2019 Jul 5;13(3):425-433. doi: 10.1093/ckj/sfz065. National Library of Medicine Kidney Int. MIRCERA is available, for all strengths, in pack sizes of 1 and also pack size of 3 for the strengths 30, 50, 75 micrograms/0.3ml. The primary finding of the study is that the DCR of PEG-Epo to DA was 1.17 (95% CI 1.05, 1.29). sharing sensitive information, make sure youre on a federal 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). Unauthorized use of these marks is strictly prohibited. Federal government websites often end in .gov or .mil. }"nUEcJumC0ooF Individualize dosing and use the lowest dose of MIRCERA. Preservation of anemia control and weekly ESA dosage after conversion from PEG-Epoetin beta to darbepoetin alfa in adult hemodialysis patients: the TRANSFORM study. 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. -, Kazmi WH, Kausz AT, Khan S, et al. 2022;53(5):333-342. doi: 10.1159/000523947. Aranesp (darbepoetin alfa) Summary of product characteristics. 2012 Jun;27(6):2303-11. doi: 10.1093/ndt/gfr677. Secondary outcomes included Hb concentrations and ESA use during the study period, and the incidence of red blood cell (RBC) transfusions. Evaluate the iron status in all patients before and during treatment. Dose Conversion Ratio in Hemodialysis Patients Switched from Darbepoetin Alfa to PEG-Epoetin Beta: AFFIRM Study, https://doi.org/10.1007/s12325-013-0063-y, CERA conversion to darbepoetin alfa in 154 hemodialysis patients, Long-term maintenance of hemoglobin levels in hemodialysis patients treated with bi-weekly epoetin beta pegol switched from darbepoetin alfa: a single-center, 12-month observational study in Japan, Efficacy, tolerability and safety of darbepoetin alfa injection for the treatment of anemia associated with chronic kidney disease (CKD) undergoing dialysis: a randomized, phase-III trial, Safety of Roxadustat Versus Erythropoiesis-Stimulating Agents in Patients with Anemia of Non-dialysis-Dependent or Incident-to-Dialysis Chronic Kidney Disease: Pooled Analysis of Four Phase 3 Studies, Initial responsiveness to darbepoetin alfa and its contributing factors in non-dialysis chronic kidney disease patients in Japan, Comparison of darbepoetin alpha and recombinant human erythropoietin for treatment of anemia in pediatric chronic kidney disease: a non-inferiority trial from India, Comparative Safety of Originator and Biosimilar Epoetin Alfa Drugs: An Observational Prospective Multicenter Study, In Search of Predictors of Switching Between Erythropoiesis-Stimulating Agents in Clinical Practice: A Multi-Regional Cohort Study, Mixed hemodiafiltration reduces erythropoiesis stimulating agents requirement in dialysis patients: a prospective randomized study, http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000332/WC500026149.pdf, http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000739/WC500033672.pdf, https://creativecommons.org/licenses/by/2.0. This analysis indicated that the concordance decreased with increasing dose. afK ] T z"$qu9H$}W//~||!+iO7^Q)|F.j+m ZJ7CY\7\lO7OGPno? 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]. Resistance to Erythropoiesis-Stimulating Agents among Patients on Hemodialysis Is Typically Transient. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. species. 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]. 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. doi: 10.1002/14651858.CD010590.pub2. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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 . Dialysis centers were expected to adhere to European Best Practice Guidelines for iron repletion [9]. PubMed Bethesda, MD 20894, Web Policies No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. eCollection 2020 Jun. 1. Please know that Amgen, the sponsor of this site, is not responsible for the content on the site you are about to enter. Randomized clinical studies have reported data on switching from DA to PEG-Epo (Stabilizing haemoglobin TaRgets in dialysis following IV C.E.R.A. Kazmi WH, Kausz AT, Khan S, et al. Dr. Peter Choi is the guarantor for this article, and takes responsibility for the integrity of the work as a whole. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. 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. 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. Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. 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. Generic name: Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL government site. Data were also manually reviewed prior to final analysis. 2020 Sep 29;21(1):418. doi: 10.1186/s12882-020-02078-z. 2020 Mar 26;2(3):286-296. doi: 10.1016/j.xkme.2020.01.007. Strength: 100 mcg / 0.3ml. Active ingredient: methoxy polyethylene glycol-epoetin beta Inactive ingredients: mannitol, methionine, poloxamer 188, sodium phosphate monobasic monohydrate, and sodium sulfate. Introduction: 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. Once Every Two Weeks (mcg/every two weeks). and darbepOetin alfa in patieNts Undergoing dialySis [PATRONUS] [9]); however, there is a lack of published literature on switching in patients receiving routine clinical care (i.e., outside interventional clinical trials). More severe cases were recorded with long-acting agents (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta). This article does not contain any studies with human or animal subjects performed by any of the authors. PubMedGoogle Scholar. Brand: Mircera. -, Macdougall IC. %PDF-1.7 The distribution of transfusions (Fig. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. Nephrol Dial Transplant. Janet Addison is an employee of Amgen with Amgen stock options. 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). Asterisk Not all transfusions had an associated hemoglobin concentration in the 14-day period before transfusion. 1. For lack or loss of hemoglobin response to Aranesp or EPOGEN, initiate a search for causative factors. Locatelli F, Aljama P, Barany P, et al. Tolman et al. In responding to hypoxia, erythropoietin interacts with erythroid progenitor . Mircera Injection (Methoxy Polyethylene Glycol-Epoetin Beta ) 6,610/ Piece Get Latest Price. Do not use Mircera after the expiration date. Patients were excluded if they had participated in any interventional study within 30days before the 7-month period preceding the switch or at any subsequent time up to 7months after the switch. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these Macdougall IC, Obrador GT, El Nahas M. How important is transfusion avoidance in 2013? Mircera (methoxy polyethylene glycol-epoetin beta) Summary of product characteristics. Cost (BNF 60, March 2013) Aranesp (darbepoetin alfa) - 14.68-220.22 (10 micrograms syringe to 150 microgram syringe) NeoRecormon Mircera (methoxy polyethylene glycol-epoetin beta) - 44.05-220.22 (30 microgram syringe to 150 microgram syringe . Low hemoglobin at hemodialysis initiation: an international study of anemia management and mortality in the early dialysis period. Vigorous shaking or prolonged exposure to light should be avoided. Mircera ceiling is 200 mcg every two weeks (or 3.0 mcg/kg/2 weeks, whichever is lower). The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. In controlled clinical trials of patients with cancer, ESAs increased the risks for death and serious adverse cardiovascular reactions. Horowitz J, Agarwal A, Huang F, Gitlin M, Gandra SR, Cangialose CB. 2002;17(Suppl 5):6670. 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. Aranesp and EPOGEN have not been shown to improve quality of life, fatigue, or patient well-being. Article PEG-Epo methoxy polyethylene glycol-epoetin beta. Please click the OK button below to continue. Before 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. 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. 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. Red blood cell transfusions pre- and post-switch were quantified. Am J Kidney Dis. MIRCERA has an approximate molecular weight of 60 kDa. 5) shows that most transfusions occurred in the first 4months post-switch. The information provided in this site is intended only for healthcare professionals in the United States. doi: 10.1093/ndt/17.suppl_5.66. Studies of erythropoietin therapy in patients with chronic anemia of cancer as well as CIA document response rates ranging from ~60% to 85%. before initiating MIRCERA. 2). Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. 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 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 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. Part of Springer Nature. Nephrol Dial Transplant. The number of transfusions and units transfused increased approximately threefold from the pre-switch to the post-switch period. HQ-MIR-1900027 Site last modified: January 2023. Fewer than half of the patients achieved Hb in the 1012g/dL range by 7months post-switch. adult patients on dialysis and adult patients not on dialysis. % 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. The .gov means its official. Do not mix Mircera with any parenteral solution. 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. 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 If you are a healthcare professional outside of the US, please, visit www.mircera.global, The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion, and, Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal, For adverse event reports, please contact us at, You may also report negative side effects of prescription drugs to, the Food and Drug Administration (FDA). Section III: Treatment of renal anaemia. 2014 Nov;31(11):1155-68. doi: 10.1007/s12325-014-0161-5. 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. 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. -. 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. Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. Mircera with 1-step decrease as soon as Hgb is < 11.8 g/dL and last dose was administered 2 weeks ago or more. 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. DA can be administered once a week (QW) or once every 2weeks (Q2W) to hemodialysis patients. _____ (if . A single hemoglobin excursion may not require a dosing change. We comply with the HONcode standard for trustworthy health information. Excursions of Hb values above and below the range of 1012g/dL [9] were more common in the post-switch compared to the pre-switch period. 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. 2001;38:803812. Excluding patients receiving a transfusion within 90 days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). 2012;59:444451. ARANESP single-dose strengths can be combined 4,* You can more . Values are means (arithmetic for hemoglobin, geometric for dose) with 95% confidence intervals. Support for this assistance was funded by Amgen. A BlandAltman analysis [10] was also performed to assess the agreement between ESA doses in the evaluation periods. There is no evidence that Mircera alters the metabolism of other medicinal products. Mircera can be administered once every two weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA (see Table 1). [citation needed] There were 16 transfusions and 34 units transfused in the pre-switch period, versus 48 transfusions and 95 units transfused post-switch. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. Discard any unused portion. 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. Clipboard, Search History, and several other advanced features are temporarily unavailable. Each pre-filled syringe contains 0.3 ml or 0.6 ml.

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