Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. FOIA Locatelli F, Aljama P, Barany P, et al. The site is secure. Unauthorized use of these marks is strictly prohibited. Tables2 and 3 also summarize the proportion of patients in different Hb categories by study month. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. For recommended dose equivalency, see Tables A and B (below). 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. 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. Tel: +1-650-344-3898 | Fax: +1-888-256-8883 | Email: info@palace-travel.com | | | LOG IN Not all pack sizes may be marketed. 2013;73:11730. eCollection 2020 Jun. PEG-Epo methoxy polyethylene glycol-epoetin beta. 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. However, the relationship between the pre- and post-switch ESA doses during the two evaluation periods was non-linear. ARANESP (darbepoetine alfa) 1 injection/sem. Mean Hb was 11.5g/dL in the pre-switch EP and 11.4g/dL in the post-switch EP. Changes in ESA dosing and number of transfusions post-switch may have important health-economic implications. endobj The number of transfusions and units transfused increased approximately threefold from the pre-switch to the post-switch period. 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. https://doi.org/10.1007/s12325-013-0063-y, DOI: https://doi.org/10.1007/s12325-013-0063-y. Once Every Two Weeks (mcg/every two weeks). Publication management support was provided by Caterina Hatzifoti, PhD, of Amgen Europe GmbH. 2009 Nov-Dec;15(9):741-50. doi: 10.18553/jmcp.2009.15.9.741. Individualize dosing and use the lowest dose of Mircera sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. 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 patients treated with Aranesp or EPOGEN. A decade in the anaemia market - 10 products seen top . Visit. 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). Accessibility reverse transcriptase polymerase chain reaction (RT-PCR) Amplification of RNA sequences by conversion to cDNA by nucleic acid hybridization A technique of nucleic acid reverse transcriptase, followed by the polymerase chain reac-analy sis via association of complementary single- stranded tion. Values are means (arithmetic for hemoglobin, geometric for dose) with 95% confidence intervals. 2014 Nov;31(11):1155-68. doi: 10.1007/s12325-014-0161-5. 3. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Monitor patients closely for new-onset seizures, premonitory symptoms, or change in seizure frequency. Methoxy polyethylene glycol-epoetin (Mircera ) will be increased and decreased in 1-step or 2-step increments, based on scale above. There were 16 transfusions and 34 units transfused in the pre-switch period, versus 48 transfusions and 95 units transfused post-switch. Full Prescribing Information, including Boxed WARNING, full Prescribing Information including Boxed WARNING, How to Use the MIRCERA Prefilled Syringe, Healthcare Provider and Patient Resources, full Prescribing Information, including Boxed WARNING. Disposition of patients. 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]. pure red cell aplasia (PRCA) that begins after treatment with MIRCERA or other erythropoietin protein drugs. DCR geometric mean maintenance dose conversion ratio, EP evaluation period, ESA erythropoiesis-stimulating agent, Hb hemoglobin, PEG-Epo methoxy polyethylene glycol-epoetin beta. Macdougall IC. Results of the BlandAltman analysis investigating the concordance between mean weekly ESA doses in both evaluation periods are presented in Fig. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) It is not known if Mircera is safe and effective in children younger than 5 years of age. The recommended RETACRIT regimens are: 300 Units/kg per day subcutaneously for 15 days total: administered daily for 10 days before surgery, on the day of surgery, and for 4 days after surgery. 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. 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. Data quality and completeness were aided by automatic edit checks built into the database software. 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. Department of Nephrology, John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, 2305, Australia, Amgen (Europe) GmbH, Dammstrasse 23, P.O. 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery. If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of MIRCERA. 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. BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (n=205). doi: 10.1053/j.ajkd.2011.11.013. ou toutes les 2 semaines (ou par mois en prdialyse) la dose requise Avant 1 an : non indiqu 11 ans : comme chez l'adulte MIRCERA (potine bta - MPG [mthoxy-polythylne glycol]) 1 injection mensuelle la dose requise Non indiqu At the moment forecasts for Mircera are $345m in 2015 rising to $552m in 2020, reflecting sales made outside the US. 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. }"nUEcJumC0ooF 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). Mircera is used to reduce or avoid the need for RBC transfusions. Peter Choi, MB BChir, PhD, FRCP (UK), has received lecturing and consulting fees from Amgen, and has participated in advisory boards for Amgen. Please click to see accompanying Aranesp full prescribing information and EPOGEN full prescribing information, including Boxed WARNINGS and Medication Guide. There is no evidence that Mircera alters the metabolism of other medicinal products. 2023Vifor (International) Inc. All rights reserved. %PDF-1.7 Vigorous shaking or prolonged exposure to light should be avoided. Hb hemoglobin. . 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. Pure red cell aplasia (PRCA) that begins after treatment with MIRCERA, History of serious or severe allergic reactions to MIRCERA. Aranesp (darbepoetin alfa) prescribing information, Amgen. More severe cases were recorded with long-acting agents (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta). Mircera is packaged as single-dose prefilled syringes. This site needs JavaScript to work properly. | DOWNLOAD SIZE: Evaluation of Iron Stores and Nutritional Factors. Excluding patients receiving a transfusion within 90 days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). We comply with the HONcode standard for trustworthy health information. 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. Anemia: an early complication of chronic renal insufficiency. 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 regression analysis that examined the relationship between mean weekly ESA doses in the two evaluation periods indicated that the DCR is not linear; a significant (P=0.008) quadratic term was observed in the regression analysis, indicating that the predicted DCR decreased at higher pre-switch doses of DA (Fig. 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 . Peter Choi. Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (19881994). 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. 3 0 obj Learn how to combine multiple dosing options for precise titration and individualize anemia management.1. 2010;25:400917. 2001;38:803812. 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. Do not mix Mircera with any parenteral solution. endobj Immediately and permanently discontinue Aranesp or EPOGEN if a serious allergic Nephrol Dial Transplant. reaction occurs. 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. For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp GrepMed. Packaging Size: 0.3 ml. 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. risks. St. Gallen, Switzerland: Vifor (International) Inc.; June 2018. 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. 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. Each dosage strength of MIRCERA is designated by a unique syringe plunger color. Composition: Methoxy Polyethylene Glycol-Epoetin Beta. Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. Pure red cell aplasia (PRCA) that begins after treatment with Mircera or other erythropoietin protein drugs. See Instructions for Use for complete instructions on the preparation and administration of MIRCERA, If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of MIRCERA. 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. Fewer than half of the patients achieved Hb in the 1012g/dL range by 7months post-switch. Medically reviewed by Drugs.com. Values are means (arithmetic for hemoglobin, geometric for dose) with 95% confidence intervals. aMutually exclusive categories; patients are censored in the following order: first at death post-switch, then at loss to follow-up post-switch, then at receipt of an ESA other than PEG-Epo, and finally lack of an Hb measurement in either or both EPs. In the first month after switch, these proportions were 10.2%, 48.5% and 37.4%, respectively. -, Macdougall IC. There were 16 transfusions and 34 units transfused in the pre-switch period, versus 48 transfusions and 95 units transfused post-switch. Nephrol Dial Transplant. The geometric mean weekly ESA dose for those included in the DCR analysis is shown in Fig. Resistance to Erythropoiesis-Stimulating Agents among Patients on Hemodialysis Is Typically Transient. Mircera (methoxy polyethylene glycol-epoetin beta) Summary of product characteristics. Careers. 6); the mean (SD) Hb within 14days prior to transfusion in these periods was 8.8 (1.41) and 8.3 (1.26), respectively. This article does not contain any studies with human or animal subjects performed by any of the authors. National Library of Medicine Conversion from Another ESA: dosed once every 4 weeks based on total weekly epoetin alfa or darbepoetin alfa dose at time of conversion (2.2). The majority of patients with CKD will require supplemental iron during the course of ESA therapy. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. 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. If severe anemia and low reticulocyte count develop during treatment with Aranesp or EPOGEN, withhold Aranesp or EPOGEN and evaluate patients for neutralizing antibodies to erythropoietin. Cochrane Database Syst Rev. Mircera would also have competed with Aranesp and with Procrit . Internal You are now leaving AnemiaHub.com. This medicine is not for treating anemia caused by cancer chemotherapy. The relationship between the DA and PEG-Epo doses during the evaluation periods was explored through linear and quadratic regression. 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. and transmitted securely. 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. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 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. 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. 1. Unable to load your collection due to an error, Unable to load your delegates due to an error. Provided by the Springer Nature SharedIt content-sharing initiative, Over 10 million scientific documents at your fingertips, Not logged in This study and the article processing charges were funded by Amgen Europe GmbH, Zug, Switzerland. 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. 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). 2022;53(5):333-342. doi: 10.1159/000523947. 4 x previous weekly epoetin alfa dose (Units)/125, e.g., 4 x 1500 Units of epoetin alfa per week/125 = 48 mcg of Mircera once every 4 weeks, 4 x previous weekly darbepoetin alfa dose (mcg)/0.55, e.g., 4 x 20 mcg of darbepoetin alfa per week/0.55 = 145.5 mcg of Mircera once every 4 weeks. 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. This medicine is not used to treat anemia caused by cancer medicines. Eschbach JW, Adamson JW. Nephrol Dial Transplant. 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. Always store Mircera prefilled syringes in their original cartons. 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. 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. Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Adult Patients with CKD. Action Stimulates erythropoesis (production of red blood cells). official website and that any information you provide is encrypted 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. In responding to hypoxia, erythropoietin interacts with erythroid progenitor . WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE. 8600 Rockville Pike Carrera F, Lok CE, de Francisco A, et al. Am J Kidney Dis. in the treatment of anemia due to cancer chemotherapy. 2021 Jan;26(1):46-53. doi: 10.1111/nep.13765. 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. 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. 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 . Excluding patients receiving a transfusion within 90days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. For adverse event reports, please contact us at safety@viforpharma.com,mircera@viforpharma.com or at 1-800-576-8295. Please click the OK button below to continue. doi: 10.1093/ndt/17.suppl_5.66. Preservation of anemia control and weekly ESA dosage after conversion from PEG-Epoetin beta to darbepoetin alfa in adult hemodialysis patients: the TRANSFORM study. Low hemoglobin at hemodialysis initiation: an international study of anemia management and mortality in the early dialysis period. Mircera ceiling is 200 mcg every two weeks (or 3.0 mcg/kg/2 weeks, whichever is lower). 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 : 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). Aranesp (darbepoetin alfa) Summary of product characteristics. ferrous sulfate, Aranesp, Procrit, Retacrit. History of serious or severe allergic reactions to Mircera (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). EPOGEN from multidose vials contains benzyl alcohol and is contraindicated in neonates, infants, pregnant women, and lactating women. Association of erythropoietin resistance and fibroblast growth factor 23 in dialysis patients: Results from the Japanese Dialysis Outcomes and Practice Patterns Study. 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%. Revised European Best Practice Guidelines for the management of anaemia in patients with chronic renal failure. Epub 2011 Dec 2.
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