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). Over the last 25years, several originator and biosimilar ESAs have been introduced for the management of CKD anemia, starting with the first generation short-acting recombinant erythropoietin agents (epoetin alfa and beta) and latterly with two longer-acting molecules, darbepoetin alfa (DA) and methoxy polyethylene glycol-epoetin beta (PEG-Epo), which combine a significantly increased half-life and lower binding affinity for the EPO receptor, allowing them to stimulate erythropoiesis for longer periods and to be administered less frequently [5, 6]. reaction occurs. There are significant negative consequences associated with increased transfusion requirement in dialysis patients, including production of sensitizing anti-human leukocyte antigen (HLA) antibodies which, despite advances in immunosuppressant therapy [13], may impair or prevent transplantation in patients otherwise eligible for receipt of a kidney graft. If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of MIRCERA. 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). Pure red cell aplasia (PRCA) that begins after treatment with Mircera or other erythropoietin protein drugs. . 2001;38:80312. https://doi.org/10.1007/s12325-013-0063-y, DOI: https://doi.org/10.1007/s12325-013-0063-y. MIRCERA- methoxy polyethylene glycol-epoetin beta Mircera Injection: Uses, Dosing & Side Effects - Drugs.com Empirical methods to calculate an erythropoiesis-stimulating agent dose conversion ratio in nondialyzed patients with chronic kidney disease. Dose Conversion Ratio in Hemodialysis Patients Switched from Of the 302 patients enrolled, 206 (68%) were included in the DCR analysis. Methoxy Polyethylene Glycol-Epoetin Beta (Injection Route) 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. Blistering and skin exfoliation reactions including Erythema multiforme and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with ESAs (including Aranesp, Serious and fatal reactions including gasping syndrome can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including EPOGEN. risks. 2 0 obj Article }"nUEcJumC0ooF Mircera solution for injection in pre-filled syringe Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. These adverse reactions included myocardial infarction and stroke. ARANESP single-dose strengths can be combined 4,* You can more . Use caution in patients with coexistent cardiovascular disease and stroke. A single hemoglobin excursion may not require a dosing change. 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. Mourad Farouk is an employee of Amgen with Amgen stock ownership. Mircera is packaged as single-dose prefilled syringes. Dr. Gerald Diaz @GeraldMD. 8600 Rockville Pike PDF Methoxy polyethylene glycol-epoetin beta (Mircera ) Protocol Epub 2011 Dec 2. | DOWNLOAD SIZE: 2004;19(Suppl 2):ii1631. 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. For recommended dose equivalency, see Tables A and B (below). Waiting game continues with Mircera launch | Evaluate Macdougall IC, Obrador GT, El Nahas M. How important is transfusion avoidance in 2013? For patients who do not respond adequately over a 12-week escalation period, increasing the MIRCERA, Evaluate other causes of anemia. [3] It is the first approved, chemically modified erythropoiesis-stimulating agent (ESA). Methoxy polyethylene glycol-epoetin beta | Drugs | BNF | NICE 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. before initiating MIRCERA. Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. Available for Android and iOS devices. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) However, the relationship between the pre- and post-switch ESA doses during the two evaluation periods was non-linear. In CKD, anemia results primarily from decreased production of endogenous erythropoietin (EPO) by the kidney [3]. 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. Pharmacotherapy Update - Automatic Therapeutic Interchange Program Do not use the prefilled syringe more than once. Revised European Best Practice Guidelines for the management of anaemia in patients with chronic renal failure. PubMed This site needs JavaScript to work properly. MIRCERA is indicated for the treatment of anemia associated with CKD in adult patients on dialysis and adult patients not on dialysis. When adjusting therapy, consider hemoglobin rate of rise, rate of decline, ESA responsiveness, and hemoglobin variability. ^D[5j@%e Box 1557, 6301, Zug, Switzerland, Amgen (UK) Limited, 240 Cambridge Science Park, Milton Road, Cambridge, UK, You can also search for this author in 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. 2009 Nov-Dec;15(9):741-50. doi: 10.18553/jmcp.2009.15.9.741. Examine each prefilled syringe for the expiration date. WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE. Mircera (methoxy polyethylene glycol / epoetin beta) dosing - Medscape 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. Packaging Size: 0.3 ml. MIRCERA can be administered once every 2 weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. 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. Accessed 18 October 2013. 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. Conversion - Epoetin alfa (Procrit) to Darbepoetin | GrepMed Descriptions. All groups were assessed at the end of the study for safety and efficacy parameters. Conversion from Another ESA: dosed once every 4 weeks based on total 2012;59:444451. 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. Anemia: an early complication of chronic renal insufficiency. Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. <> eCollection 2020 May-Jun. Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp GrepMed. Recombinant human erythropoietins: very rare risk of severe cutaneous Bethesda, MD 20894, Web Policies endobj 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. PDF Mircera, INN: methoxy polyethylene glycol-epoetin beta Clin Kidney J. 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). Nephrol Dial Transplant. 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 PubMedGoogle Scholar. 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. Amgen Wins Patent Battle Over Roche's Anemia Drug 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). Use the Previous and Next buttons to navigate the slides or the slide controller buttons at the end to navigate through each slide. 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. Editorial assistance in the preparation of this manuscript was provided by W. Mark Roberts, PhD, Montreal, Canada. See this image and copyright information in PMC. Prise en charge anmie rnale - Nephro.blog Do not pool unused portions from the prefilled syringes. A single hemoglobin excursion may not require a dosing change. (PDF) Amgen Business Review - library.corporate-ir.netlibrary.corporate Vifor (International) Inc. MIRCERA- methoxy polyethylene glycol-epoetin 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. Administer Mircera either intravenously or subcutaneously in adult patients and only intravenously in pediatric patients. 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. Action Stimulates erythropoesis (production of red blood cells). Active ingredient: methoxy polyethylene glycol-epoetin beta Inactive ingredients: mannitol, methionine, poloxamer 188, sodium phosphate monobasic monohydrate, and sodium sulfate. )E]$&m"t "N5LQmgh-QZi`T0 hacpBYKUYRw@aMB/|n|'Y#h$8]#|zf. Bookshelf The majority of patients who were transfused during the pre- and post-switch observation periods had Hb 10g/dL within the 14days prior to transfusion; only 1 patient during each period had Hb >11g/dL within the 14-day pre-transfusion interval. New anemia therapies: translating novel strategies from bench to bedside. Use the lowest Mircera dose sufficient to reduce the need for red blood cell (RBC) transfusions. doi: 10.1053/j.ajkd.2011.11.013. What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? doi: 10.1053/ajkd.2001.27699. Am J Nephrol. Please click to see accompanying Aranesp full prescribing information and EPOGEN full prescribing information, including Boxed WARNINGS and Medication Guide. In responding to hypoxia, erythropoietin interacts with erythroid progenitor . The site is secure. 3 0 obj Adv Ther 30, 10071017 (2013). Data were collected from 7months before until 7months after switching treatment. In recent years, the trend has been to use higher doses of epoetin alfa (eg, 60,000 U once per week), recognizing that MDS RBC precursors may have relative intrinsic resistance to EPO. This was particularly evident in patients whose pre-switch EP weekly DA dose was higher than 100g. Karaboyas A, Morgenstern H, Fleischer NL, Vanholder RC, Dhalwani NN, Schaeffner E, Schaubel DE, Akizawa T, James G, Sinsakul MV, Pisoni RL, Robinson BM. Anemia of end-stage renal disease (ESRD) Kidney Int. Hrl WH. Pfizer's Retacrit, the First Erythropoietin Stimulating - BioSpace 2023 Springer Nature Switzerland AG. %PDF-1.7 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]. 3 DOSAGE FORMS AND STRENGTHS. The information provided in this site is intended only for healthcare professionals in the United States. Erythropoietins: A common mechanism of action - Academia.edu The geometric mean weekly dose of DA was 23.2g (95% CI 20.6, 26.3) in the month prior to switch. The long-acting r-HuEPO methoxy polyethylene glycol-epoetin beta (Mircera) has been associated with a risk of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) following a. doi: 10.1002/14651858.CD010590.pub2. This article does not contain any studies with human or animal subjects performed by any of the authors. The .gov means its official. "BG0RjI G78 Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp #Pharmacology #Hematology #Nephrology. 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. Packaging Type: Injection. 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. Indication 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.Limitations of Use Aranesp has not been shown to improve quality of life, fatigue, or patient well-being. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) In controlled clinical trials of patients with CKD comparing higher hemoglobin targets (13 to 14 g/dL) to lower targets (9 to 11.3 g/dL), ESAs increased the risk of death, myocardial infarction, stroke, congestive heart failure, thrombosis of hemodialysis vascular access, and other thromboembolic events in the higher target groups. Mircera is a prescription medicine used to treat the symptoms of Anemia associated with Chronic Renal Failure.
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