DCR geometric mean maintenance dose conversion ratio, EP evaluation period, ESA erythropoiesis-stimulating agent, Hb hemoglobin, PEG-Epo methoxy polyethylene glycol-epoetin beta. volume30,pages 10071017 (2013)Cite this article. Secondly, the DCR was calculated on a subset of patients which constituted approximately two-thirds of the total enrolled. 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). Asterisk Not all transfusions had an associated hemoglobin concentration in the 14-day period before transfusion. Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. The odds ratio for receiving a transfusion was twice as high in patients switched at a dose ratio less than 1 when compared to those switched at 1:1 or higher. [citation needed] Mircera is packaged as single-dose prefilled syringes. This site needs JavaScript to work properly. Recombinant human erythropoietin is effective in 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. ONLY administer MIRCERA intravenously in pediatric patients. In responding to hypoxia, erythropoietin interacts with erythroid progenitor . Canaud B, Mingardi G, Braun J, et al. Packaging Type: Injection. Report to the Judicial Council. Evaluate the iron status in all patients before and during treatment. 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. Peter Choi, MB BChir, PhD, FRCP (UK), has received lecturing and consulting fees from Amgen, and has participated in advisory boards for Amgen. Monitor patients closely for new-onset seizures, premonitory symptoms, or change in seizure frequency. Mircera is not the same as epoetin alfa (Procrit, Epogen). Data quality and completeness were aided by automatic edit checks built into the database software. 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. 1986;327:30710. "BG0RjI G78 Discontinue MIRCERA, When administered subcutaneously, MIRCERA. Therapeutic effects . }"nUEcJumC0ooF In pediatric patients, Mircera is administered by intravenous injection only (2.2). Low hemoglobin at hemodialysis initiation: an international study of anemia management and mortality in the early dialysis period. Matsumura K, Okumiya T, Sugiura T, Takahashi N, Yamamoto Y, Kikuchi S, Fujii K, Otagaki M, Shiojima I. BMC Nephrol. 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. More severe cases were recorded with long-acting agents (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta). Intravenous C.E.R.A. 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 . This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. Please see full Prescribing Information including Boxed WARNING, and Medication Guide for MIRCERA (methoxy polyethylene glycol-epoetin beta) Injection, for Intravenous or Subcutaneous Use. 8600 Rockville Pike Each pre-filled syringe contains 0.3 ml or 0.6 ml. We comply with the HONcode standard for trustworthy health information. ferrous sulfate, Aranesp, Procrit, Retacrit. 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]. Discard any unused portion. Dialysis centers were expected to adhere to European Best Practice Guidelines for iron repletion [9]. afK ] T z"$qu9H$}W//~||!+iO7^Q)|F.j+m ZJ7CY\7\lO7OGPno? For Adult Patients with CKD not on dialysis: Refer patients who self-administer Mircera to the Instructions for Use [see Patient Counseling Information (17)]. Of 302 patients enrolled, 206 had data available for DCR analysis. Mechanism of Action. A BlandAltman analysis [10] was also performed to assess the agreement between ESA doses in the evaluation periods. Accessed 18 October 2013. 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. Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp GrepMed. before initiating Mircera [see Warnings and Precautions (5.9)]. Donck J, Gonzalez-Tabares L, Chanliau J, Martin H, Stamatelou K, Manamley N, Farouk M, Addison J. Adv Ther. Methods: For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. 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. Medically reviewed by Drugs.com. Eschbach JW, Adamson JW. Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with Aranesp or EPOGEN. 6). Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. Epub 2011 Dec 2. 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. RBC transfusions were reported in terms of number of transfusions and number of units transfused, using descriptive statistics. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. 10PAGE BROCHURE MIRCERA Interactions: May require increased anticoagulation (heparin) during hemodialysis. 2010;25:400917. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. New anemia therapies: translating novel strategies from bench to bedside. Editorial assistance in the preparation of this manuscript was provided by W. Mark Roberts, PhD, Montreal, Canada. Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. MIRCERA has an approximate molecular weight of 60 kDa. The number of RBC transfusions and units transfused in the post-switch period was approximately threefold higher compared to the pre-switch period. _____ (if . 2023Vifor (International) Inc. All rights reserved. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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. Kidney Med. A single hemoglobin excursion may not require a dosing change. Would you like email updates of new search results? Am J Nephrol. If Hgb remains >= 12 g/dL for more than 2 months, return to regular Hgb testing policy. Dose Conversion Ratio in Hemodialysis Patients Switched from Darbepoetin Alfa to PEG-Epoetin Beta: AFFIRM Study. doi: 10.1053/j.ajkd.2011.11.013. Mircera will be administered IV to HD patients, and SC to PD patients. 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 . A decade in the anaemia market - 10 products seen top . Action Stimulates erythropoesis (production of red blood cells). 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. 3 DOSAGE FORMS AND STRENGTHS. 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. 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. 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. 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. . These findings were observed in studies of patients with advanced head and neck cancer receiving radiation therapy, in patients receiving chemotherapy for metastatic breast cancer or lymphoid malignancy, and in patients with non-small cell lung cancer or various malignancies who were not receiving chemotherapy or radiotherapy. MIRCERA is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia associated with chronic kidney disease (CKD) in: MIRCERA is not indicated and is not recommended for use: MIRCERA has not been shown to improve quality of life, fatigue, or patient well-being. Do not mix Mircera with any parenteral solution. Correspondence to The intravenous route is recommended for patients on hemodialysis because the intravenous route may be less immunogenic. Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (19881994) Arch Intern Med. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events. Methoxy polyethylene glycol-epoetin beta injection causes the . MIRCERA is indicated for the treatment of anemia associated with CKD in adult patients on dialysis and adult patients not on dialysis. This article does not contain any studies with human or animal subjects performed by any of the authors.
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