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. 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. 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. W\iA* Karaboyas A, Morgenstern H, Fleischer NL, Vanholder RC, Dhalwani NN, Schaeffner E, Schaubel DE, Akizawa T, James G, Sinsakul MV, Pisoni RL, Robinson BM. 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. MIRCERA can be administered once every 2 weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA. Table 1 Mircera Starting Doses for Adult Patients Currently Receiving an ESA, Table 2 Mircera Starting Doses for Pediatric Patients Currently Receiving an ESA. Matsumura K, Okumiya T, Sugiura T, Takahashi N, Yamamoto Y, Kikuchi S, Fujii K, Otagaki M, Shiojima I. BMC Nephrol. 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. 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. Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. 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. 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. doi: 10.1038/ki.1985.109. Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Adult Patients with CKD. Revised European Best Practice Guidelines for the management of anaemia in patients with chronic renal failure. 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. )E]$&m"t "N5LQmgh-QZi`T0 hacpBYKUYRw@aMB/|n|'Y#h$8]#|zf. 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. In the absence of PRCA, follow dosing recommendations for management of patients with an insufficient response to MIRCERA, 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 the postmarketing setting in patients treated with MIRCERA, PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which MIRCERA, If severe anemia and low reticulocyte count develop during treatment with MIRCERA, Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, tachycardia, pruritus, skin rash and urticaria have been reported in patients treated with MIRCERA, 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 MIRCERA, Patients may require adjustments in their dialysis prescription after initiation of MIRCERA, Most frequent adverse reactions ( 5%) in adult patients with CKD treated with MIRCERA. Provided by the Springer Nature SharedIt content-sharing initiative, Over 10 million scientific documents at your fingertips, Not logged in Association of erythropoietin resistance and fibroblast growth factor 23 in dialysis patients: Results from the Japanese Dialysis Outcomes and Practice Patterns Study. The number of transfusions and units transfused increased approximately threefold from the pre-switch to the post-switch period. Changes in ESA dosing and number of transfusions post-switch may have important health-economic implications. For recommended dose equivalency, see Tables A and B (below). There were 16 transfusions and 34 units transfused in the pre-switch period, versus 48 transfusions and 95 units transfused post-switch. doi: 10.1053/j.ajkd.2011.11.013. 1. All groups were assessed at the end of the study for safety and efficacy parameters. Red blood cell transfusions pre- and post-switch were quantified. Part of Springer Nature. Nephrol Dial Transplant. 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. Amgen Business Review November 7, 2008 Strategic Outlook Kevin Sharer CEO 3 Provided November 7, 2008 as part of an oral presentation and is qualified by such, contains forward-looking Do not use the prefilled syringe more than once. Amgen's two anemia drugs, Epogen and Aranesp, had sales of $6.6 billion last year, nearly half the company's total revenue. Methoxy polyethylene glycol-epoetin (Mircera ) will be increased and decreased in 1-step or 2-step increments, based on scale above. Always store Mircera prefilled syringes in their original cartons. Am J Kidney Dis. Dialysis centers were expected to adhere to European Best Practice Guidelines for iron repletion [9]. 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 you wish to proceed? 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. A BlandAltman analysis [10] was also performed to assess the agreement between ESA doses in the evaluation periods. 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. Decreases in dose can occur more frequently. Bland JM, Altman DG. Examine each prefilled syringe for the expiration date. Packaging Size: 0.3 ml. 2). Careers. 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. Mircera is administered by subcutaneous (SC) or intravenous (IV) injection (2.2). }"nUEcJumC0ooF (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. 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. 2013;73:11730. Mircera will be administered IV to HD patients, and SC to PD patients. as a substitute for red blood cell transfusions in patients who require immediate correction of anemia. Peter Choi, MB BChir, PhD, FRCP (UK), has received lecturing and consulting fees from Amgen, and has participated in advisory boards for Amgen. 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. At the moment forecasts for Mircera are $345m in 2015 rising to $552m in 2020, reflecting sales made outside the US. Lancet. In controlled clinical trials of patients with cancer, ESAs increased the risks for death and serious adverse cardiovascular reactions. 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. Treatment: Treat to anemia in people with chronic kidney disease. Dose by Weight Chart - Resourcehub Epogen Dosage Guide - Drugs.com Epogen, Procrit (epoetin alfa) dosing, indications, interactions 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. PubMed risks. Mircera is not the same as epoetin alfa (Procrit, Epogen). Administer MIRCERA intravenously once every 4 More ways to get app. 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. 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. 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. Evaluation of Iron Stores and Nutritional Factors. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. This article does not contain any studies with human or animal subjects performed by any of the authors. The geometric mean DCR was 1.17 (95% CI 1.05, 1.29). Differentiating factors between erythropoiesis-stimulating agents: an update to selection for anaemia of chronic kidney disease. Available for Android and iOS devices. | DOWNLOAD SIZE: Of 302 patients enrolled, 206 had data available for DCR analysis. You may also report negative side effects of prescription drugs to the Food and Drug Administration (FDA). 2020 Mar 26;2(3):286-296. doi: 10.1016/j.xkme.2020.01.007. Results: and transmitted securely. 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. Carrera F, Lok CE, de Francisco A, et al. Of 302 patients enrolled, 206 had data available for DCR analysis. 4. 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. 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. 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. 2004;19(Suppl 2):ii1631. 2022;53(5):333-342. doi: 10.1159/000523947. Nephrol Dial Transplant. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. PubMed 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. A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks. I certify that I am a healthcare professional in the US. ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers. Nephrol Dial Transplant. Google Scholar. 1: 21% of the excluded patients had died or were lost to follow-up during the post-switch period; 45% were no longer receiving PEG-Epo by Months +6 and +7 post-switch; and 34% had no Hb value reported for one or both EPs. Hrl WH. Article 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. It is not known if Mircera is safe and effective in children younger than 5 years of age. Publication management support was provided by Caterina Hatzifoti, PhD, of Amgen Europe GmbH. Accessibility Mean Hb was 11.5 g/dL in the pre-switch EP and 11.4 g/dL in the post-switch EP. <>/Font<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Editorial assistance in the preparation of this manuscript was provided by W. Mark Roberts, PhD, Montreal, Canada. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. If Hb increases by < 1 g/dL and remains < 10 g/dL after 6 weeks of therapy: If dosing QW, then increase dose to 4.5 mcg/kg/week. 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. For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. OZZ This study and the article processing charges were funded by Amgen Europe GmbH, Zug, Switzerland. DCR geometric mean maintenance dose conversion ratio, EP evaluation period, ESA erythropoiesis-stimulating agent, Hb hemoglobin, PEG-Epo methoxy polyethylene glycol-epoetin beta. 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. Tel: +1-650-344-3898 | Fax: +1-888-256-8883 | Email: info@palace-travel.com | | | LOG IN 2014 Nov;31(11):1155-68. doi: 10.1007/s12325-014-0161-5. 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. Shortened red blood cell age in patients with end-stage renal disease who were receiving haemodialysis: a cross-sectional study. Dissertation Les Fausses Confidences Stratagme, Les Fromagers De Thirache Horaires, Archange Gabriel Pouvoir, Adeline Franois Mari, Rdiger Un Rapport Sur Un lve En Difficult . History of serious or severe allergic reactions to Mircera (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). PEG-Epo methoxy polyethylene glycol-epoetin beta. PubMedGoogle Scholar. 3. This was particularly evident in patients whose pre-switch EP weekly DA dose was higher than 100g. Box 1557, 6301, Zug, Switzerland, Amgen (UK) Limited, 240 Cambridge Science Park, Milton Road, Cambridge, UK, You can also search for this author in Secondary outcomes included Hb concentrations and ESA use during the study period, and the incidence of red blood cell (RBC) transfusions. The information provided in this site is intended only for healthcare professionals in the United States. Conversion from darbepoetin or erythropoietin to Mircera 1. 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 pediatric patients, Mircera is administered by intravenous injection only (2.2). The initial conversion factor was 200:1. Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. Brand: Mircera. Anemia of end-stage renal disease (ESRD) Kidney Int. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) . Usui T, Zhao J, Fuller DS, Hanafusa N, Hasegawa T, Fujino H, Nomura T, Zee J, Young E, Robinson BM, Nangaku M. Nephrology (Carlton). Bookshelf "BG0RjI G78 Mircera with 1-step decrease as soon as Hgb is < 11.8 g/dL and last dose was administered 2 weeks ago or more. Results of the BlandAltman analysis investigating the concordance between mean weekly ESA doses in both evaluation periods are presented in Fig. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. Epoetin beta and methoxy polyethylene glycol may increase tumor growth or decrease survival time in people with certain types of cancer. 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. 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. Please click the OK button below to continue. Use caution in patients with coexistent cardiovascular disease and stroke. in the treatment of anemia due to cancer chemotherapy. MIRCERA Classification: Erythropoiesis stimulating protein. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. 2013;28:10929. Data were also manually reviewed prior to final analysis. 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. The remaining enrolment was at four sites divided between three other countries. Palmer SC, Saglimbene V, Mavridis D, Salanti G, Craig JC, Tonelli M, Wiebe N, Strippoli GF. government site. Empirical methods to calculate an erythropoiesis-stimulating agent dose conversion ratio in nondialyzed patients with chronic kidney disease. These adverse reactions included myocardial infarction and stroke. 2 0 obj 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. . Statistical methods for assessing agreement between two methods of clinical measurement. 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). This suggests that the decision to transfuse was consistent with respect to Hb over the observation period (Fig. Patients were then switched to fortnightly darbepoetin alfa dosing treatments; the existing weekly dose being doubled and Hb levels fell from 125 to 110 g/L (P < 0.0001), despite an increase in the mean dose from 44.9 to 47.5 . OK Adverse Reactions: Hypertension, diarrhea,. Peter Choi. Am J Nephrol. Mircera is packaged as single-dose prefilled syringes. 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. ARANESP single-dose strengths can be combined 4,* You can more . Read reviews from GoodRx users who have taken Mircera and find the latest news on the drug. -, Macdougall IC. Use caution in patients with coexistent cardiovascular disease and stroke. FOIA endobj 1985;28:15. 3. There were 16 transfusion events in the pre-switch period and 48 post-switch, with a total of 34 units transfused pre-switch and 95 units in the post-switch period (Fig. -, Eschbach JW, Adamson JW. Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. Slider with three articles shown per slide. Article The majority of patients with CKD will require supplemental iron during the course of ESA therapy. This article does not contain any studies with human or animal subjects performed by any of the authors. For more information, please see the full Prescribing Information, including Boxed WARNING, and Medication Guide(English, Espaol) for MIRCERA. 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 know that Amgen, the sponsor of this site, is not responsible for the content on the site you are about to enter. Macdougall IC. Further exploration of the relationship between DA and PEG-Epo doses using the BlandAltman method [10], which circumvents the limitations of the regression method in this type of investigation, indicated that the variability in the dose differences increased as doses increased, while the level of concordance decreased with increasing ESA dose. Adverse reactions ( 10%) in Aranesp clinical studies in patients with CKD were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension. 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. 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. 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. a Mutually exclusive categories; patients are censored in the following, Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (19881994) Arch Intern Med. Reasons for low Hb, e.g., acute intercurrent events such as bleeding, were not reported. BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (n=205). 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 Medically reviewed by Drugs.com. The .gov means its official. 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.