<>/Metadata 444 0 R/ViewerPreferences 445 0 R>> Epub 2011 Dec 2. Part of Springer Nature. ?Ij{JVv:oC*#]}V#$M_T.zC>~] L%lq[Tn`QbWB./@ClVgrk)U-j#(0(D Vigorous shaking or prolonged exposure to light should be avoided. This article does not contain any studies with human or animal subjects performed by any of the authors. sharing sensitive information, make sure youre on a federal The relationship between the DA and PEG-Epo doses during the evaluation periods was explored through linear and quadratic regression. Dissertation Les Fausses Confidences Stratagme, Les Fromagers De Thirache Horaires, Archange Gabriel Pouvoir, Adeline Franois Mari, Rdiger Un Rapport Sur Un lve En Difficult . 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. 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. Each pre-filled syringe contains 0.3 ml or 0.6 ml. Federal government websites often end in .gov or .mil. 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. Locatelli F, Aljama P, Barany P, et al. Statistical methods for assessing agreement between two methods of clinical measurement. Slider with three articles shown per slide. Anemia of end-stage renal disease (ESRD). Aranesp (darbepoetin alfa), Dynepo (epoetin delta), Mircera (methyoxy polyethylene glycol-epoetin beta), Hematide, MRK-2578, INS-22, Retacrit (epoetin zeta), Neorecormon (epoetin beta), Silapo (epoetin zeta), Binocrit . 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. Careers. Excluding patients receiving a transfusion within 90days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Mircera is a prescription medicine used to treat the symptoms of Anemia associated with Chronic Renal Failure. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. See Instructions for Use for complete instructions on the preparation and administration of Mircera. ^D[5j@%e When adjusting therapy, consider hemoglobin rate of rise, rate of decline, ESA responsiveness, and hemoglobin variability. Donck J, Gonzalez-Tabares L, Chanliau J, Martin H, Stamatelou K, Manamley N, Farouk M, Addison J. Adv Ther. 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. Nephrol Dial Transplant. 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. Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. NCI CPTC Antibody Characterization Program, Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. doi: 10.1093/ndt/17.suppl_5.66. Disclaimer. In responding to hypoxia, erythropoietin interacts with erythroid progenitor . BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (. 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. before initiating MIRCERA. %PDF-1.7 In order to compare stable clinical scenarios for the purposes of DCR calculation, data evaluation periods (EPs) were utilized: Months 2 and 1 were defined as the pre-switch EP and Months +6 and +7 were defined as the post-switch EP. Of 302 patients enrolled, 206 had data available for DCR analysis. National Library of Medicine This article does not contain any studies with human or animal subjects performed by any of the authors. Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. Hb concentrations were reported as arithmetic means for each month. Anemia: an early complication of chronic renal insufficiency. Results: 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. 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. 8600 Rockville Pike Evaluate the iron status in all patients before and during treatment. Evaluation of Iron Stores and Nutritional Factors. For more information, please see the full Prescribing Information, including Boxed WARNING, and Medication Guide(English, Espaol) for MIRCERA. This site needs JavaScript to work properly. -. Amgen's two anemia drugs, Epogen and Aranesp, had sales of $6.6 billion last year, nearly half the company's total revenue. AFFIRM may therefore help to guide expectations around potential differences in ESA dose requirements when switching hemodialysis patients from DA to PEG-Epo, although the reported mean maintenance DCR is not intended to predict the dose conversion ratio at the individual patient level. Regression analysis indicated a non-linear relationship between pre- and post-switch ESA doses; DCR decreased with increasing pre-switch DA dose. The intravenous route is recommended for patients on hemodialysis because the intravenous route may be less immunogenic. The number of RBC transfusions and units transfused in the post-switch period was approximately threefold higher compared to the pre-switch period. Shortened red blood cell age in patients with end-stage renal disease who were receiving haemodialysis: a cross-sectional study. Concerning RBC transfusions, 36 patients received a transfusion; 7 were transfused in the pre-switch period only, 4 received a transfusion both pre- and post-switch, and 25 had a transfusion in the post-switch period only. All groups were assessed at the end of the study for safety and efficacy parameters. By Month 7 post-switch, the proportions of patients with Hb in these ranges were 9.7%, 48.1%, and 30.1%, respectively. 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). The geometric mean weekly ESA dose for those included in the DCR analysis is shown in Fig. 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. Le bilan martial est dpendant de l'tat inflammatoire et la protine C ractive (CRP) est galement suivi tous les 3 mois pour cela. Lancet. risks. Tables2 and 3 also summarize the proportion of patients in different Hb categories by study month. 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. Association of erythropoietin resistance and fibroblast growth factor 23 in dialysis patients: Results from the Japanese Dialysis Outcomes and Practice Patterns Study. Available for Android and iOS devices. Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (19881994). Choi, P., Farouk, M., Manamley, N. et al. Randomized clinical studies have reported data on switching from DA to PEG-Epo (Stabilizing haemoglobin TaRgets in dialysis following IV C.E.R.A. Brand: Mircera. Each dosage strength of MIRCERA is designated by a unique syringe plunger color. Box 1557, 6301, Zug, Switzerland, Amgen (UK) Limited, 240 Cambridge Science Park, Milton Road, Cambridge, UK, You can also search for this author in Tolman et al. HHS Vulnerability Disclosure, Help 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. Last updated on Jul 26, 2022. [citation needed] Asterisk Not all transfusions had an associated hemoglobin concentration in the 14-day period before transfusion. Arch Intern Med. Administer MIRCERA intravenously once every 4 More ways to get app. Methods: 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. 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. 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. 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. -, Macdougall IC. doi: 10.1001/archinte.162.12.1401. This analysis indicated that the concordance decreased with increasing dose. history of serious or severe allergic reactions to MIRCERA (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). official website and that any information you provide is encrypted 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. Nephrol Dial Transplant. 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. 2014 Dec 8;2014(12):CD010590. There were 16 transfusions and 34 units transfused in the pre-switch period, versus 48 transfusions and 95 units transfused post-switch. Dosage form: injection, solution The data from this study were analyzed using SAS Statistical Software v9.2 (SAS Institute Inc., Cary, NC, USA). Learn how to combine multiple dosing options for precise titration and individualize anemia management.1. doi: 10.1002/14651858.CD010590.pub2. Hrl WH. Pure red cell aplasia (PRCA) that begins after treatment with Mircera or other erythropoietin protein drugs. All calculations should be confirmed before use. 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. When a patient with a darbepoetin (Aranesp) or erythropoietin order switches to . 1986;327:30710. Disposition of patients. Macdougall IC, Obrador GT, El Nahas M. How important is transfusion avoidance in 2013? 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. 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. Conversion from Another ESA: dosed once every 4 weeks based on total Mircera will be administered IV to HD patients, and SC to PD patients. Epoetin alfa was the first rhEPO produced and approved for pharmaceutical use, followed by several related products and by newer ESAs with the same mechanism but more prolonged action. 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 and transmitted securely. 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. Please click the OK button below to continue. Mircera is not the same as epoetin alfa (Procrit, Epogen). The distribution of transfusions (Fig. Peter Choi, MB BChir, PhD, FRCP (UK), has received lecturing and consulting fees from Amgen, and has participated in advisory boards for Amgen. Mourad Farouk is an employee of Amgen with Amgen stock ownership. 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. Of 302 patients enrolled, 206 had data available for DCR analysis. A total of 302 eligible patients were enrolled at 14 European hemodialysis centers, with 57% of patients enrolled at 10 French sites, 18% at 2 Spanish sites, 17% at 1 UK site, and 8% at 1 German site. Epub 2014 Nov 1. 3. in the treatment of anemia due to cancer chemotherapy. If you are a healthcare professional outside of the US, please, visit www.mircera.global, The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion, and, Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal, For adverse event reports, please contact us at, You may also report negative side effects of prescription drugs to, the Food and Drug Administration (FDA). Before Karaboyas A, Morgenstern H, Fleischer NL, Vanholder RC, Dhalwani NN, Schaeffner E, Schaubel DE, Akizawa T, James G, Sinsakul MV, Pisoni RL, Robinson BM. 5). Eligible patients had received hemodialysis for 12months and DA for 7months. Article Decreases in dose can occur more frequently. 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 remaining enrolment was at four sites divided between three other countries. Peter Choi. 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. endobj Article PubMed Bookshelf 2022;53(5):333-342. doi: 10.1159/000523947. Administer Mircera either intravenously or subcutaneously in adult patients and only intravenously in pediatric patients. 10PAGE BROCHURE There is no evidence that Mircera alters the metabolism of other medicinal products. 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). Reasons for exclusion of 96 enrolled patients from the DCR analysis are presented in Fig. Table 1 Mircera Starting Doses for Adult Patients Currently Receiving an ESA, Table 2 Mircera Starting Doses for Pediatric Patients Currently Receiving an ESA. Pure red cell aplasia (PRCA) that begins after treatment with MIRCERA, History of serious or severe allergic reactions to MIRCERA. 2019 Jul 5;13(3):425-433. doi: 10.1093/ckj/sfz065. MIRCERA, methoxy polyethylene glycol-epoetin beta, is an ESA which differs from erythropoietin through formation of a chemical bond between an amino group present in erythropoietin beta and methoxy polyethylene glycol (PEG) butanoic acid. 2023Vifor (International) Inc. All rights reserved. Am J Kidney Dis. The geometric mean weekly dose of DA was 23.2g (95% CI 20.6, 26.3) in the month prior to switch. 2013;73:11730. Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. ESAs resulted in decreased locoregional control/progression-free survival and/or overall survival. The conversion rate was 354:1 in patients requiring high (>200 IU/kg/week) doses of epoetin and 291:1 in patients requiring low doses. FOIA In contrast, in the STRIATA study where stable hemodialysis patients receiving IV DA were randomized to Q2W PEG-Epo (outside current label guidance) or to continue on DA QW or Q2W, median PEG-Epo doses were described as stable across the 52-week post-switch period, although mean dose data were not reported [12]. Macdougall IC. Values are means (arithmetic for hemoglobin, geometric for dose) with 95% confidence intervals. 2008;23:365461. When administered subcutaneously, Mircera should be injected in the abdomen, arm or thigh. Packaging Size: 0.3 ml. 3 DOSAGE FORMS AND STRENGTHS. Revised European Best Practice Guidelines for the management of anaemia in patients with chronic renal failure. 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). MIRCERA comes in pre-filled syringes with laminated plunger stopper and tip cap with one needle 27G1/2. Report to the Judicial Council. 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%. There were 16 transfusions and 34 units transfused in the pre-switch period, versus 48 transfusions and 95 units transfused post-switch. The geometric mean weekly ESA doses were 24.1g DA in the pre-switch EP and 28.6g PEG-Epo in the post-switch EP. Am J Kidney Dis. eCollection 2020 Jun. Excluding patients receiving a transfusion within 90 days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). 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. Please click to see accompanying Aranesp full prescribing information and EPOGEN full prescribing information, including Boxed WARNINGS and Medication Guide. Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (19881994) Arch Intern Med. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. The pre-transfusion Hb concentrations were similar for transfusions occurring both pre- and post-switch (Fig. Mircera (methoxy polyethylene glycol-epoetin beta) Summary of product characteristics. Mircera contains no preservatives. . New anemia therapies: translating novel strategies from bench to bedside. Unauthorized use of these marks is strictly prohibited. x]r9r}W#k Eligible patients had received hemodialysis for 12 months and DA for 7 months. 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. Macdougall IC. Aranesp (darbepoetin alfa) Epogen (epoetin alfa) Mircera . (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. Nephrol Dial Transplant. Strength: 100 mcg / 0.3ml. PMC . Anemia: an early complication of chronic renal insufficiency. Injection: 30 mcg, 50 mcg, 75 mcg, 100 mcg, 120 mcg, 150 mcg, 200 mcg, or 250 mcg in 0.3 mL solution in single- 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. The enrolling dialysis centers were situated in France, Germany, Spain and the UK, and each was expected to enroll a minimum of 20 patients into the study. Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. 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. Mircera belongs to a class of drugs called Hematopoietic Growth Factors. \ab/`IR 4%jI ^w7qQNA Tq Wz.oVfCVBT{h*>\\3u#P@"wW7|pIMB7 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 parameters of clinical management of anemia in this group of patients, in real-world clinical practice. Administer Mircera as an intravenous injection at the dose (in micrograms) based on the total weekly ESA dose at the time of conversion (see Table 2). In pediatric patients on hemodialysis, all reported adverse reactions regardless of causality (more than 5% incidence) were headache, nasopharyngitis, hypertension, vomiting, bronchitis, abdominal pain, arteriovenous fistula thrombosis, cough, device related infection, hyperkalemia, pharyngitis, pyrexia, thrombocytopenia, and thrombosis in device. eCollection 2020 May-Jun. At the moment forecasts for Mircera are $345m in 2015 rising to $552m in 2020, reflecting sales made outside the US.
When We Were Young Tickets Resale,
The Family Stone House Floor Plan,
Articles M