Table 1 Mircera Starting Doses for Adult Patients Currently Receiving an ESA, Table 2 Mircera Starting Doses for Pediatric Patients Currently Receiving an ESA. Please know that Amgen, the sponsor of this site, is not responsible for the content on the site you are about to enter. Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (19881994). 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery. 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. 2019 Jul 5;13(3):425-433. doi: 10.1093/ckj/sfz065. You may also report negative side effects of prescription drugs to the Food and Drug Administration (FDA). 1 0 obj A motion conversion mechanism 123 includes a yoke 153 and a rotatable member 149, which causes the yoke 152, . The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Pure red cell aplasia (PRCA) that begins after treatment with MIRCERA, History of serious or severe allergic reactions to MIRCERA. 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. Epub 2011 Dec 2. 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. <> Values are means (arithmetic for hemoglobin, geometric for dose) with 95% confidence intervals. Treatment for Anaemia [STRIATA] [8] and comPArator sTudy of C.E.R.A. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. 4 0 obj Please click to see accompanying Aranesp full prescribing information and EPOGEN full prescribing information, including Boxed WARNINGS and Medication Guide. A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks. 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. 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. Mechanism of Action. darbepoetin alfa (Aransep) pre-filled syringe, injectable vial epoetin alfa (Epogen; Procrit) injectable methoxy polyethylene glycol-epoetin beta (Mircera) pre-filled syringe Conditions Medications Dialysis patients can . 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. 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. Anemia of end-stage renal disease (ESRD) Kidney Int. Available for Android and iOS devices. Patients were required to fulfill the following criteria for study entry: switched from treatment with DA to treatment with PEG-Epo at least 7months before study enrollment; receipt of hemodialysis for at least 12months prior to switching; receipt of IV DA for at least 7months immediately prior to switching; receipt of at least 1 dose of PEG-Epo after switching; and provision of informed consent, according to local requirements. Federal government websites often end in .gov or .mil. - , . 2 0 obj 2008;23:365461. Pure red cell aplasia (PRCA) that begins after treatment with Mircera or other erythropoietin protein drugs. Choi, P., Farouk, M., Manamley, N. et al. Treatment: Treat to anemia in people with chronic kidney disease. Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Pediatric Patients with CKD Treated with Hemodialysis 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. 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. 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. Show detailed description Study Design Go to Peter Choi. More severe cases were recorded with long-acting agents (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta). Statistical methods for assessing agreement between two methods of clinical measurement. 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. Am J Nephrol. ferrous sulfate, Aranesp, Procrit, Retacrit. An observational cohort study of extended dosing (once every 2 weeks or once monthly) regimens with darbepoetin alfa in patients with chronic kidney disease not on dialysis: the EXTEND study. Learn about Mircera, potential side effects, proper use and dosing, and popular alternatives. Palmer SC, Saglimbene V, Mavridis D, Salanti G, Craig JC, Tonelli M, Wiebe N, Strippoli GF. Accounting for the effect of transfusion, the DCR was 1.21 (95% CI 1.09, 1.35). Revised European Best Practice Guidelines for the management of anaemia in patients with chronic renal failure. 3. The number of transfusions and units transfused increased approximately threefold from the pre-switch to the post-switch period. 3 0 obj Dissertation Les Fausses Confidences Stratagme, Les Fromagers De Thirache Horaires, Archange Gabriel Pouvoir, Adeline Franois Mari, Rdiger Un Rapport Sur Un lve En Difficult . _____ (if . 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. }"nUEcJumC0ooF The geometric mean weekly ESA dose for those included in the DCR analysis is shown in Fig. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these There are limitations in generalizing the findings of this study to the broader hemodialysis population. 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. The relationship between the DA and PEG-Epo doses during the evaluation periods was explored through linear and quadratic regression. 2020 Mar 26;2(3):286-296. doi: 10.1016/j.xkme.2020.01.007. 2004;19(Suppl 2):ii1631. risks. government site. Section III: Treatment of renal anaemia. Conclusion: A dose approximating 0. This medicine is not for treating anemia caused by cancer chemotherapy. doi: 10.1093/ndt/17.suppl_5.66. 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. adult patients on dialysis and adult patients not on dialysis. 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. The dose of Mircera, given as a single intravenous or subcutaneous injection, should be based on the 5). 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]. In CKD, anemia results primarily from decreased production of endogenous erythropoietin (EPO) by the kidney [3]. 1985;28:15. 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. 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. Amgen Business Review November 7, 2008 Strategic Outlook Kevin Sharer CEO 3 Provided November 7, 2008 as part of an oral presentation and is qualified by such, contains forward-looking Use the Previous and Next buttons to navigate the slides or the slide controller buttons at the end to navigate through each slide. Google Scholar. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. An official website of the United States government. Immediately and permanently discontinue Aranesp or EPOGEN if a serious allergic The site is secure. species. 2012;59:444451. Donck J, Gonzalez-Tabares L, Chanliau J, Martin H, Stamatelou K, Manamley N, Farouk M, Addison J. Adv Ther. A decade in the anaemia market - 10 products seen top . Individual patients could contribute multiple transfusions to these analyses. Monitor patients closely for new-onset seizures, premonitory symptoms, or change in seizure frequency. Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. 2. Mircera (methoxy polyethylene glycol / epoetin beta) dosing, indications, interactions, adverse effects, and more Drugs & Diseases methoxy polyethylene glycol / epoetin beta (Rx) Brand and. PEG-Epo methoxy polyethylene glycol-epoetin beta. a Mutually exclusive categories; patients are censored in the following, Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. 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]. 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. 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. stream PubMed Drugs. In pediatric patients, Mircera is administered by intravenous injection only (2.2). Epoetin alfa (Procrit, Epogen) acts like the hormone we have in our body, whereas Mircera . ARANESP single-dose strengths can be combined 4,* You can more . The .gov means its official. 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 Aranesp, Serious and fatal reactions including gasping syndrome can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including EPOGEN. 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. PEG-Epo was approved in 2009 for administration Q2W or once a month (QM) to patients on dialysis [5, 8]. ?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`. 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). Disposition of patients. 3. Of 302 patients enrolled, 206 had data available for DCR 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. Nephrol Dial Transplant. 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. 10PAGE BROCHURE 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. Please know that the sponsors of this site are not responsible for content on the site you are about to enter. Dose Conversion Ratio in Hemodialysis Patients Switched from Darbepoetin Alfa to PEG-Epoetin Beta: AFFIRM Study. Most frequent adverse reactions (5%) in adult patients with CKD treated with MIRCERA. Introduction: HHS Vulnerability Disclosure, Help Discard any unused portion. The geometric mean DCR was 1.17 (95% CI 1.05, 1.29). MIRCERA (methoxy polyethylene glycol-epoetin beta) is the first erythropoiesis-stimulating agent (ESA) approved by FDA for once-monthly administration. Aranesp (darbepoetin alfa) Summary of product characteristics. There is no evidence that Mircera alters the metabolism of other medicinal products. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. . Individualize dosing and use the lowest dose of MIRCERA. 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. Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp #Pharmacology #Hematology #Nephrology. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. 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. Mircera Injection (Methoxy Polyethylene Glycol-Epoetin Beta ) 6,610/ Piece Get Latest Price. In controlled clinical trials of patients with cancer, ESAs increased the risks for death and serious adverse cardiovascular reactions. Janet Addison is an employee of Amgen with Amgen stock options. Changes in ESA dosing and number of transfusions post-switch may have important health-economic implications. Mircera is not the same as epoetin alfa (Procrit, Epogen). Eschbach JW, Adamson JW. 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. The AFFIRM study was designed as a retrospective, longitudinal cohort analysis to estimate the DCR in a population of hemodialysis patients achieving comparable Hb after switching from IV DA to IV PEG-Epo in a real-world setting. This medicine is not used to treat anemia caused by cancer medicines. Evaluate the iron status in all patients before and during treatment. 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 However, healthcare-resource utilization and cost data were not collected in this study, preventing comparison of these variables between the pre-switch and post-switch periods. Hb concentrations were reported as arithmetic means for each month. 1:1 reference line indicates equal PEG-Epo and darbepoetin alfa doses. A single hemoglobin excursion may not require a dosing change. NCI CPTC Antibody Characterization Program, Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. 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. ESAs resulted in decreased locoregional control/progression-free survival and/or overall survival. 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).