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For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. 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. aranesp to retacrit conversion The MHRA is aware of very rare cases of severe cutaneous adverse reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, in patients treated with erythropoietins; some cases were fatal. Canaud B, Mingardi G, Braun J, et al. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Peter Choi. Karaboyas A, Morgenstern H, Waechter S, Fleischer NL, Vanholder R, Jacobson SH, Sood MM, Schaubel DE, Inaba M, Pisoni RL, Robinson BM. 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 number of transfusions and units transfused increased approximately threefold from the pre-switch to the post-switch period. Vifor (International) Inc. MIRCERA- methoxy polyethylene glycol-epoetin 2010;25:400917. BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (. 2002;162:14018. Conversion Dosing Guide: from Epoetin Alfa to Aranesp in Patients with Revised European Best Practice Guidelines for the management of anaemia in patients with chronic renal failure. This analysis indicated that the concordance decreased with increasing dose. Once the hemoglobin has been stabilized, MIRCERA, If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of MIRCERA. Use the Previous and Next buttons to navigate the slides or the slide controller buttons at the end to navigate through each slide. Clipboard, Search History, and several other advanced features are temporarily unavailable. The geometric mean weekly dose of DA was 23.2g (95% CI 20.6, 26.3) in the month prior to switch. Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. 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]. 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. MIRCERA is a registered trademark of F. Hoffmann-La Roche Ltd. All Vifor Pharma Groups intellectual rights, including copyright, are reserved by the Vifor Pharma Group. 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. Google Scholar. Comparison Among Erythropoietin Stimulating Agents 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. Avoid frequent dose adjustments. 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. 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. doi: 10.1053/ajkd.2001.27699. 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. Part of Springer Nature. The initial conversion factor was 200:1. 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. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (19881994). The primary finding of the study is that the DCR of PEG-Epo to DA was 1.17 (95% CI 1.05, 1.29). Disclaimer. Mircera would also have competed with Aranesp and with Procrit . 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. doi: 10.1001/archinte.162.12.1401. Mircera | European Medicines Agency Administer Mircera either intravenously or subcutaneously in adult patients and only intravenously in pediatric patients. 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). Article 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]. 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. doi: 10.1002/14651858.CD010590.pub2. Dose Conversion Ratio in Hemodialysis Patients Switched from }"nUEcJumC0ooF Generic name: Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL ribosome A ribonuclear protein complex that binds to mRNA nucleotide A basic . A brochure to help you understand how to dose and administer Aranesp, and to convert from epoetin alfa to Aranesp in patients with anemia due to CKD. In conclusion, this study has shown that in a cohort of European hemodialysis patients who converted from DA to PEG-Epo (and who completed 67months treatment with PEG-Epo post-conversion), there was an approximately 20% increase in the g dose required to achieve a comparable Hb profile. Mircera (Methoxy Polyethylene glycol-epoetin beta): Uses - RxList Red blood cell transfusions pre- and post-switch were quantified. Nephrol Dial Transplant. Mircera contains no preservatives. Data were also manually reviewed prior to final analysis. The geometric mean weekly ESA doses were 24.1 g DA in the pre-switch EP and 28.6 g PEG-Epo in the post-switch EP. Am J Kidney Dis. Mean Hb was 11.5g/dL in the pre-switch EP and 11.4g/dL in the post-switch EP. 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). %
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. If Hb exceeds a level needed to avoid RBC transfusions, withhold dose until Hb approaches a level where RBC transfusions may be required and reinitiate at a dose 40% below the previous dose. St. Gallen, Switzerland: Vifor (International) Inc.; June 2018. ferrous sulfate, Aranesp, Procrit, Retacrit. Resistance to Erythropoiesis-Stimulating Agents among Patients on Hemodialysis Is Typically Transient. 2013;73:11730. Clin Kidney J. We comply with the HONcode standard for trustworthy health information. 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. 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. Preservation of anemia control and weekly ESA dosage after conversion from PEG-Epoetin beta to darbepoetin alfa in adult hemodialysis patients: the TRANSFORM study. Department of Nephrology, John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, 2305, Australia, Amgen (Europe) GmbH, Dammstrasse 23, P.O. The data from this study were analyzed using SAS Statistical Software v9.2 (SAS Institute Inc., Cary, NC, USA). Available for Android and iOS devices. 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. There were 16 transfusions and 34 units transfused in the pre-switch period, versus 48 transfusions and 95 units transfused post-switch. 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]. afK ] T z"$qu9H$}W//~||!+iO7^Q)|F.j+m
ZJ7CY\7\lO7OGPno? Visit. The intravenous route is recommended for patients on hemodialysis because the intravenous route may be less immunogenic. FOIA 2 0 obj
More severe cases were recorded with long-acting agents (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta). 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. MIRCERA has an approximate molecular weight of 60 kDa. EPOGEN from multidose vials contains benzyl alcohol and is contraindicated in neonates, infants, pregnant women, and lactating women. Fewer than half of the patients achieved Hb in the 1012g/dL range by 7months post-switch. Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp GrepMed. Dose Conversion Ratio in Hemodialysis Patients Switched from Darbepoetin Alfa to PEG-Epoetin Beta: AFFIRM Study. sharing sensitive information, make sure youre on a federal 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. Adverse Reactions: Hypertension, diarrhea,. Mircera: Basics, Side Effects & Reviews - GoodRx 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. 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. Dissertation Les Fausses Confidences Stratagme, Les Fromagers De Thirache Horaires, Archange Gabriel Pouvoir, Adeline Franois Mari, Rdiger Un Rapport Sur Un lve En Difficult . Mircera solution for injection in pre-filled syringe Cochrane Database Syst Rev. PEG-Epo was approved in 2009 for administration Q2W or once a month (QM) to patients on dialysis [5, 8]. American Society of Hematology Self-Assessment Program (Adam - Scribd Hymes J, Bickimer T, Jackson JH, Bookhart BK, Mody SH, Tak Piech C. Curr Med Res Opin. Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. 2023 Springer Nature Switzerland AG. Janet Addison is an employee of Amgen with Amgen stock options. 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). Tel: +1-650-344-3898 | Fax: +1-888-256-8883 | Email: info@palace-travel.com | | | LOG IN A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks. Epoetin alfa (Procrit, Epogen) acts like the hormone we have in our body, whereas Mircera . PDF Mircera, INN: methoxy polyethylene glycol-epoetin beta Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events. Galle JC, Claes K, Kiss I, Winearls CG, Herlitz H, Guerin A, Di Giulio S, Suranyi MG, Bridges I, Addison J, Farouk M. Nephrol Dial Transplant. Mechanism of Action. 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 Eligible patients had received hemodialysis for 12 months and DA for 7 months. For patients who do not respond adequately over a 12-week escalation period, increasing the MIRCERA, Evaluate other causes of anemia. Careers. Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. Before Epub 2011 Dec 2. Strength: 100 mcg / 0.3ml. | DOWNLOAD SIZE:
PDF Highlights of Prescribing Information ----------------------- Dosage stream
doi: 10.1053/j.ajkd.2011.11.013. MIRCERA- methoxy polyethylene glycol-epoetin beta Mircera may be used alone or with other medications. The .gov means its official. MIRCERA comes in pre-filled syringes with laminated plunger stopper and tip cap with one needle 27G1/2. Do not use the prefilled syringe more than once. National Library of Medicine 2020 Sep 29;21(1):418. doi: 10.1186/s12882-020-02078-z. AFFIRM demonstrated non-linearity of the dose relationship curve, with DCR decreasing as pre-switch DA dose increased. 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. More severe cases were recorded with long-acting agents (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta). The information provided in this site is intended only for healthcare professionals in the United States. . You may also report negative side effects of prescription drugs to the Food and Drug Administration (FDA). When adjusting therapy, consider hemoglobin rate of rise, rate of decline, ESA responsiveness, and hemoglobin variability. Report to the Judicial Council. Individualize dosing and use the lowest dose of MIRCERA. 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. For more information, please see the full Prescribing Information, including Boxed WARNING, and Medication Guide(English, Espaol) for MIRCERA. By Month 7 post-switch, the proportions of patients with Hb in these ranges were 9.7%, 48.1%, and 30.1%, respectively. 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). Table 1 Mircera Starting Doses for Adult Patients Currently Receiving an ESA, Table 2 Mircera Starting Doses for Pediatric Patients Currently Receiving an ESA. 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. Among patients switched from DA to PEG-Epo, the mean monthly PEG-Epo dose was increased from 159g at the switch to 263g at Week 26 and 273g at Month 1112 [11]. 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. _____ (if . What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Prise en charge anmie rnale - Nephro.blog Mircera will be administered IV to HD patients, and SC to PD patients. Excluding patients receiving a transfusion within 90 days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Mircera (methoxy polyethylene glycol / epoetin beta) dosing, indications, interactions, adverse effects, and more Drugs & Diseases methoxy polyethylene glycol / epoetin beta (Rx) Brand and. Red blood cell transfusions pre- and post-switch were quantified. Mircera solution for injection in pre-filled syringe - Summary of Shortened red blood cell age in patients with end-stage renal disease who were receiving haemodialysis: a cross-sectional study. Each dosage strength of MIRCERA is designated by a unique syringe plunger color. Product Information and Dosing | Mircera This article does not contain any studies with human or animal subjects performed by any of the authors. 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. 20,000 Units/2 mL (10,000 Units/mL) and 20,000 Units/mL of RETACRIT as a clear and colorless liquid in multiple-dose vials (contains benzyl alcohol). Palmer SC, Saglimbene V, Mavridis D, Salanti G, Craig JC, Tonelli M, Wiebe N, Strippoli GF. A decade in the anaemia market - 10 products seen top . Epoetin zeta | Drugs | BNF | NICE 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. Each pre-filled syringe contains 0.3 ml or 0.6 ml. Disposition of patients. %PDF-1.7
Mircera is a prescription medicine used to treat the symptoms of Anemia associated with Chronic Renal Failure. 2004;19(Suppl 2):ii1631. In controlled clinical trials of patients with cancer, ESAs increased the risks for death and serious adverse cardiovascular reactions. -. Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. Eligible patients had received hemodialysis for 12months and DA for 7months. Macdougall IC.