The data from this study were analyzed using SAS Statistical Software v9.2 (SAS Institute Inc., Cary, NC, USA). MIRCERA has an approximate molecular weight of 60 kDa. The primary outcome measure, the geometric mean maintenance DCR, was calculated to be 1.17 (95% CI 1.05, 1.29). Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events [see Boxed Warning and Clinical Studies (14)]. eCollection 2020 May-Jun. 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. 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. Aranesp (darbepoetin alfa) | Dosing Considerations 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery. Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. 6); the mean (SD) Hb within 14days prior to transfusion in these periods was 8.8 (1.41) and 8.3 (1.26), respectively. 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. Macdougall IC, Obrador GT, El Nahas M. How important is transfusion avoidance in 2013? Bookshelf Mircera | definition of Mircera by Medical dictionary Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Methoxy polyethylene glycol-epoetin beta injection causes the . 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. Mourad Farouk is an employee of Amgen with Amgen stock ownership. Avoid frequent dose adjustments. Epoetin zeta | Drugs | BNF | NICE Epub 2022 Apr 22. 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). endobj Accounting for the effect of transfusion, the DCR was 1.21 (95% CI 1.09, 1.35). PubMed 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 -. In controlled clinical trials of patients with cancer, ESAs increased the risks for death and serious adverse cardiovascular reactions. There are limitations in generalizing the findings of this study to the broader hemodialysis population. Eligible patients were randomized, either to continue on the previous regimen of Epoetin, or to receive Darbepoetin alfa or continuous erythropoietin receptor activator (C.E.R.A) for a total period of 40 weeks. 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. In particular, the likelihood of a transfusion during the post-switch period was significantly higher in patients with a dose ratio below 1 at switch. Injection: 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, 10,000 Units/mL, and 40,000 Units/mL of RETACRIT as a clear and colorless liquid in single-dose vials. Mircera (Methoxy Polyethylene glycol-epoetin beta): Uses - RxList 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. Macdougall IC. Google Scholar. . Anemia: an early complication of chronic renal insufficiency. No difference in conversion dosage could be determined between patients who were epoetin sensitive (<200 units/kg per week) or resistant (>200 units/kg per week, P = NS). Nephrol Dial Transplant. 10PAGE BROCHURE Mircera with 1-step decrease as soon as Hgb is < 11.8 g/dL and last dose was administered 2 weeks ago or more. doi: 10.1038/ki.1985.109. Cochrane Database Syst Rev. Clipboard, Search History, and several other advanced features are temporarily unavailable. 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. Association of erythropoietin resistance and fibroblast growth factor 23 in dialysis patients: Results from the Japanese Dialysis Outcomes and Practice Patterns Study. MIRCERA Dosage & Rx Info | Uses, Side Effects - MPR Figure4 also displays the mean monthly Hb for those included in the DCR analysis over the study period. The geometric mean weekly dose of DA was 23.2g (95% CI 20.6, 26.3) in the month prior to switch. Discard any unused portion. -, Macdougall IC. Please click to see accompanying Aranesp full prescribing information and EPOGEN full prescribing information, including Boxed WARNINGS and Medication Guide. . HQ-MIR-1900027 Site last modified: January 2023. Kidney Med. Secondly, the DCR was calculated on a subset of patients which constituted approximately two-thirds of the total enrolled. "BG0RjI G78 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 geometric mean weekly ESA dose for those included in the DCR analysis is shown in Fig. 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]. Revised European Best Practice Guidelines for the management of anaemia in patients with chronic renal failure. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Not all pack sizes may be marketed. Studies of erythropoietin therapy in patients with chronic anemia of cancer as well as CIA document response rates ranging from ~60% to 85%. 2009 Nov-Dec;15(9):741-50. doi: 10.18553/jmcp.2009.15.9.741. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. 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. Do not pool unused portions from the prefilled syringes. PubMedGoogle Scholar. The study comprised a 14-month observation period. 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. Mircera can be administered once every two weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA (see Table 1). 2012;59:444451. Article EXTON, Pa., July 31, 2018 /PRNewswire/ -- Plagued by regulatory delays, the FDA finally granted approval for Retacrit in May 2018, making it the first biosimilar erythropoietin-stimulating agent (ESA) to become available in the US market. <> 6). 1:1 reference line, BlandAltman analysis of agreement between, BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose ( n, Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period., Red blood cell transfusions pre- and post-switch, Summary of the last hemoglobin concentrations recorded within 14 days prior to red, MeSH Please enable it to take advantage of the complete set of features! doi: 10.1053/ajkd.2001.27699. Aranesp (darbepoetin alfa) prescribing information, Amgen. Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. Peter Choi, MB BChir, PhD, FRCP (UK), has received lecturing and consulting fees from Amgen, and has participated in advisory boards for Amgen. 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. ARANESP (darbepoetine alfa) 1 injection/sem. 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. 2022;53(5):333-342. doi: 10.1159/000523947. Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. Mircera (methoxy polyethylene glycol / epoetin beta) dosing - Medscape PMC Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. The Cost-Effectiveness of Continuous Erythropoiesis Receptor - Hindawi 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]. 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. A single hemoglobin excursion may not require a dosing change. Of 302 patients enrolled, 206 had data available for DCR analysis. Dissertation Les Fausses Confidences Stratagme, Les Fromagers De Thirache Horaires, Archange Gabriel Pouvoir, Adeline Franois Mari, Rdiger Un Rapport Sur Un lve En Difficult . Conversion Dosing Guide: from Epoetin Alfa to Aranesp in Patients with Please know that Amgen, the sponsor of this site, is not responsible for the content on the site you are about to enter. Le bilan martial est dpendant de l'tat inflammatoire et la protine C ractive (CRP) est galement suivi tous les 3 mois pour cela. Use the lowest Mircera dose sufficient to reduce the need for red blood cell (RBC) transfusions. BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (n=205). Mircera is not the same as epoetin alfa (Procrit, Epogen). Please click the OK button below to continue. Mechanism of Action. 2 0 obj 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. Karaboyas A, Morgenstern H, Fleischer NL, Vanholder RC, Dhalwani NN, Schaeffner E, Schaubel DE, Akizawa T, James G, Sinsakul MV, Pisoni RL, Robinson BM. When administered subcutaneously, Mircera should be injected in the abdomen, arm or thigh. Conversion from Epoetin alfa or Darbepoetin alfa to MIRCERA in Pediatric Patients with CKD on Hemodialysis. 2002;162:14018. A primary growth factor for erythroid development, erythropoietin is produced in the kidney and released into the bloodstream in response to hypoxia. Tolman et al. Aranesp Dosing Calculator75 mcg/kg as an IV or SC injection once every PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which Aranesp and EPOGEN are not approved). Eligible patients had received hemodialysis for 12 months and DA for 7 months. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. - 94.130.71.173. 1986;327:30710. This medicine is not for treating anemia caused by cancer chemotherapy. This analysis indicated that the concordance decreased with increasing dose. ESAs resulted in decreased locoregional control/progression-free survival and/or overall survival. 2001;38:80312. 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. Nephrol Dial Transplant. 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. WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE CHRONIC KIDNEY DISEASE: Please see full Prescribing Information including Boxed WARNING, and Medication Guide(English, Espaol) for MIRCERA (methoxy polyethylene glycol-epoetin beta) Injection, for Intravenous or Subcutaneous Use. . Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Conversion - Epoetin alfa (Procrit) to Darbepoetin | GrepMed Amgen Wins Patent Battle Over Roche's Anemia Drug