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. PubMedGoogle Scholar. 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. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). endobj 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. 2021 Jan;26(1):46-53. doi: 10.1111/nep.13765. Randomized clinical studies have reported data on switching from DA to PEG-Epo (Stabilizing haemoglobin TaRgets in dialysis following IV C.E.R.A. DCR geometric mean maintenance dose conversion ratio, EP evaluation period, ESA erythropoiesis-stimulating agent, Hb hemoglobin, PEG-Epo methoxy polyethylene glycol-epoetin beta. 6); the mean (SD) Hb within 14days prior to transfusion in these periods was 8.8 (1.41) and 8.3 (1.26), respectively. St. Gallen, Switzerland: Vifor (International) Inc.; June 2018. Do not use the prefilled syringe more than once. Peter Choi. Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. Treatment: Treat to anemia in people with chronic kidney disease. history of serious or severe allergic reactions to MIRCERA (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). 2009 Nov-Dec;15(9):741-50. doi: 10.18553/jmcp.2009.15.9.741. Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. chemotherapy, MDS or MF, continued therapy) Please provide a hemoglobin level (g/dL) for your patient taken within the first 12 weeks of therapy with epoetin and include the date the lab was drawn. Vifor (International) Inc. MIRCERA- methoxy polyethylene glycol-epoetin When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. 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). The site is secure. }"nUEcJumC0ooF The study sample comprised adult patients (age 18years) with CKD who received maintenance hemodialysis between January 2008 and August 2011 and whose ESA treatment was switched from IV DA to IV PEG-Epo. Nephrol Dial Transplant. <>/Metadata 444 0 R/ViewerPreferences 445 0 R>> Summary of the last hemoglobin concentrations recorded within 14days prior to red blood cell transfusions pre- and post-switch. Methoxy polyethylene glycol-epoetin beta - Wikipedia Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. Of 302 patients enrolled, 206 had data available for DCR analysis. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 33 Dose. History of serious or severe allergic reactions to Mircera (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). Mircera Dosage Guide - Drugs.com Mircera at Best Price in India - IndiaMART Regression analysis indicated a non-linear relationship between pre- and post-switch ESA doses; DCR decreased with increasing pre-switch DA dose. Accounting for the effect of transfusion, the DCR was 1.21 (95% CI 1.09, 1.35). Aranesp and EPOGEN have not been shown to improve quality of life, fatigue, or patient well-being. 2012 Jun;27(6):2303-11. doi: 10.1093/ndt/gfr677. Asterisk Not all transfusions had an associated hemoglobin concentration in the 14-day period before transfusion. before initiating MIRCERA. Conversion from Epoetin alfa or Darbepoetin alfa to MIRCERA in Pediatric Patients with CKD on Hemodialysis. Do not mix Mircera with any parenteral solution. doi: 10.1053/j.ajkd.2011.11.013. Learn how to combine multiple dosing options for precise titration and individualize anemia management.1. EP evaluation period, PEG-Epo methoxy polyethylene glycol-epoetin beta. as a substitute for red blood cell transfusions in patients who require immediate correction of anemia. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. 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. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Google Scholar. 4! . PDF Anmie chez l'insuffisant rnal : comment utiliser les agents stimulant Inflammation and Erythropoiesis-Stimulating Agent Response in Hemodialysis Patients: A Self-matched Longitudinal Study of Anemia Management in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Anemia: an early complication of chronic renal insufficiency. . Donck J, Gonzalez-Tabares L, Chanliau J, Martin H, Stamatelou K, Manamley N, Farouk M, Addison J. Adv Ther. 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. Eligible patients had received hemodialysis for 12 months and DA for 7 months. 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. This medicine is not for treating anemia caused by cancer chemotherapy. MIRCERA Dosage & Rx Info | Uses, Side Effects - MPR 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. 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. Aranesp Dosing Calculator75 mcg/kg as an IV or SC injection once every https://doi.org/10.1007/s12325-013-0063-y, DOI: https://doi.org/10.1007/s12325-013-0063-y. Eligible patients had received hemodialysis for 12months and DA for 7months. Pfizer's Retacrit, the First Erythropoietin Stimulating - BioSpace 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. ribosome A ribonuclear protein complex that binds to mRNA nucleotide A basic . Each dosage strength of MIRCERA is designated by a unique syringe plunger color. 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 . (0.6MB), Anemia Assessment and Management Brochure, Pathophysiology of Anemia in Patients with CKD, * Case studies and patient profiles are hypothetical, WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE. Anemia: an early complication of chronic renal insufficiency. This suggests that the decision to transfuse was consistent with respect to Hb over the observation period (Fig. . Drug class: Recombinant human erythropoietins. 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. Tables2 and 3 also summarize the proportion of patients in different Hb categories by study month. 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. % 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. Karaboyas A, Morgenstern H, Waechter S, Fleischer NL, Vanholder R, Jacobson SH, Sood MM, Schaubel DE, Inaba M, Pisoni RL, Robinson BM. For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%. 2008;23:365461. Mircera contains no preservatives. 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 > 1 g/dL over 2 weeks may contribute to these The dose of Mircera, given as a single intravenous or subcutaneous injection, should be based on the Mircera (methoxy polyethylene glycol-epoetin beta) is an erythropoiesis-stimulating agent (ESA). PDF Methoxy polyethylene glycol-epoetin beta (Mircera ) Protocol Examine each prefilled syringe for the expiration date. Nephrol Dial Transplant. Methoxy polyethylene demonstrated that the dose efficiency after SC and IV ad- glycol-epoetin b (PEG-epoetin b; Mircera; F. Hoffmann- ministration was . When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. 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. reaction occurs. 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. 2019 Jul 5;13(3):425-433. doi: 10.1093/ckj/sfz065. For Pediatric Patients with CKD on hemodialysis: Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Pediatric Patients with CKD Treated with Hemodialysis. Conversion - Epoetin alfa (Procrit) to Darbepoetin | GrepMed Publication management support was provided by Caterina Hatzifoti, PhD, of Amgen Europe GmbH.