Mircera is not the same as epoetin alfa (Procrit, Epogen). Do not mix Mircera with any parenteral solution. Aranesp and EPOGEN have not been shown to improve quality of life, fatigue, or patient well-being. Discard any unused portion. Active ingredient: methoxy polyethylene glycol-epoetin beta Inactive ingredients: mannitol, methionine, poloxamer 188, sodium phosphate monobasic monohydrate, and sodium sulfate. Anemia: an early complication of chronic renal insufficiency. Choi, P., Farouk, M., Manamley, N. et al. 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. For recommended dose equivalency, see Tables A and B (below). Macdougall IC. 3 DOSAGE FORMS AND STRENGTHS. 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). Epub 2014 Nov 1. Unauthorized use of these marks is strictly prohibited. Individual patients could contribute multiple transfusions to these analyses. Aranesp (darbepoetin alfa) Epogen (epoetin alfa) Mircera . 2013;28:10929. 2002;17(Suppl 5):6670. 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. 2023Vifor (International) Inc. All rights reserved. Excluding patients receiving a transfusion within 90 days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). eCollection 2020 May-Jun. Anemia Associated with Chronic Renal Failure, Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL, Drug class: recombinant human erythropoietins. sharing sensitive information, make sure youre on a federal Available for Android and iOS devices. Adverse reactions ( 10%) in Aranesp clinical studies in patients with CKD were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension. before initiating Mircera [see Warnings and Precautions (5.9)]. 1985;28:15. For patients who do not respond adequately over a 12-week escalation period, increasing the MIRCERA, Evaluate other causes of anemia. 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. 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. 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. Mircera ceiling is 200 mcg every two weeks (or 3.0 mcg/kg/2 weeks, whichever is lower). Google Scholar. Anemia response to Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) versus Epoetin Alfa (Eprex) in patients with chronic Kidney disease on Hemodialysis Published: September 05, 2017 42/47 is common in patients with a GFR below 30 ml/min/1.73m2 and contributes to many of the speciic symptoms of CKD. 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. 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. Accessed 18 October 2013. 1. 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. 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. The primary outcome measure, the geometric mean maintenance DCR, was calculated to be 1.17 (95% CI 1.05, 1.29). OK Conversion Dosing Guide: From epoetin alfa to Aranesp in patients with anemia due to CKD on dialysis. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Mircera works like the human protein called erythropoietin to help your body make more RBCs. For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. Mircera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV (PDF/15.49 KB) First published: 02/08/2007 Last updated: 02/08/2007 Pharmacotherapeutic group Antianemic preparations Therapeutic indication Treatment of symptomatic anaemia associated with chronic kidney disease (CKD). Please know that Amgen, the sponsor of this site, is not responsible for the content on the site you are about to enter. 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. 1:1 reference line indicates equal PEG-Epo and darbepoetin alfa doses. - , . Hb hemoglobin. -, Macdougall IC. The geometric mean weekly dose of DA was 23.2g (95% CI 20.6, 26.3) in the month prior to switch. 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. ONLY administer MIRCERA intravenously in pediatric patients. ^D[5j@%e 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). Tel: +1-650-344-3898 | Fax: +1-888-256-8883 | Email: info@palace-travel.com | | | LOG IN Bookshelf Epoetin beta and methoxy polyethylene glycol may increase tumor growth or decrease survival time in people with certain types of cancer. Adv Ther 30, 10071017 (2013). 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. 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. 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. 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. Epub 2022 Apr 22. The baseline (i.e., at time of switch) demographic and clinical characteristics of enrolled patients and those included in and excluded from the DCR analysis are displayed in Table1. 1MIRCERA [prescribing information]. Nephrol Dial Transplant. 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 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. Methoxy polyethylene glycol-epoetin (Mircera ) will be increased and decreased in 1-step or 2-step increments, based on scale above. 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. 1. Although the reasons for transfusion were not recorded, the pre-transfusion Hb concentrations within 14days prior to transfusion remained similar for transfusions occurring both pre- and post-switch. Administer Mircera either intravenously or subcutaneously in adult patients and only intravenously in pediatric patients. Use the lowest Mircera dose sufficient to reduce the need for red blood cell (RBC) transfusions. Hb concentrations were reported as arithmetic means for each month. 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. 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. MIRCERA is indicated for the treatment of anemia associated with CKD in adult patients on dialysis and adult patients not on dialysis. Preservation of anemia control and weekly ESA dosage after conversion from PEG-Epoetin beta to darbepoetin alfa in adult hemodialysis patients: the TRANSFORM study. A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. Palmer SC, Saglimbene V, Mavridis D, Salanti G, Craig JC, Tonelli M, Wiebe N, Strippoli GF. 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. Immediately and permanently discontinue Aranesp or EPOGEN if a serious allergic See Instructions for Use for complete instructions on the preparation and administration of Mircera. Mechanism of Action. Mean Hb was 11.5g/dL in the pre-switch EP and 11.4g/dL in the post-switch EP. FOIA Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Adult Patients with CKD 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). 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. 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. WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE. The intravenous route is recommended for patients on hemodialysis because the intravenous route may be less immunogenic. MIRCERA [prescribing information]. When adjusting therapy, consider hemoglobin rate of rise, rate of decline, ESA responsiveness, and hemoglobin variability. 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. Kidney Med. before initiating MIRCERA. . When administered subcutaneously, Mircera should be injected in the abdomen, arm or thigh. 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)]. 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. These findings were observed in studies of patients with advanced head and neck cancer receiving radiation therapy, in patients receiving chemotherapy for metastatic breast cancer or lymphoid malignancy, and in patients with non-small cell lung cancer or various malignancies who were not receiving chemotherapy or radiotherapy. Changes in ESA dosing and number of transfusions post-switch may have important health-economic implications. DCR geometric mean maintenance dose conversion ratio, EP evaluation period, ESA erythropoiesis-stimulating agent, Hb hemoglobin, PEG-Epo methoxy polyethylene glycol-epoetin beta. Am J Kidney Dis. Mircera Injection (Methoxy Polyethylene Glycol-Epoetin Beta ) 6,610/ Piece Get Latest Price. 2012;59:44451. -, Kazmi WH, Kausz AT, Khan S, et al. 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. 2008;23:365461. 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. For Pediatric Patients with CKD on hemodialysis: Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Pediatric Patients with CKD Treated with Hemodialysis. 2013;73:11730. The regression analysis that examined the relationship between mean weekly ESA doses in the two evaluation periods indicated that the DCR is not linear; a significant (P=0.008) quadratic term was observed in the regression analysis, indicating that the predicted DCR decreased at higher pre-switch doses of DA (Fig. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Excluding patients receiving a transfusion within 90days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). Epoetin alfa (Eprex [JanssenCilag], Binocrit [Sandoz], and epoetin zeta (Retacrit, - Hospira UK): the initial dose is 150 IU kg-1 given subcutaneously three times per week.5 -7 Alternatively, epoetin alfa can be administered at an initial dose of 450 IU kg 1 subcutaneously once weekly.5-7 The maximum recommended dose is 900 IU kg-1 HHS Vulnerability Disclosure, Help . The site is secure. Reasons for low Hb, e.g., acute intercurrent events such as bleeding, were not reported. 2009 Nov-Dec;15(9):741-50. doi: 10.18553/jmcp.2009.15.9.741. 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. There were 16 transfusions and 34 units transfused in the pre-switch period, versus 48 transfusions and 95 units transfused post-switch. Mourad Farouk is an employee of Amgen with Amgen stock ownership. See this image and copyright information in PMC. 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. - 94.130.71.173. 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 The majority of patients with CKD will require supplemental iron during the course of ESA therapy. All patients who fulfilled pre-specified criteria for completeness of Hb and dosing data were included in the DCR analysis: i.e., those who had received DA or PEG-Epo as the only ESA in the 1month prior to and during the pre- or post-switch EPs, respectively, and who had dosing information and at least 1 Hb value in each of the evaluation periods. Aranesp and EPOGEN increase the risk of seizures in patients with CKD. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. 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. Generic name: Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL New anemia therapies: translating novel strategies from bench to bedside. A motion conversion mechanism 123 includes a yoke 153 and a rotatable member 149, which causes the yoke 152, . reaction occurs. 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. Introduction: 33 Dose. Use caution in patients with coexistent cardiovascular disease and stroke. Accessibility 1 0 obj The relationship between the DA and PEG-Epo doses during the evaluation periods was explored through linear and quadratic regression. Initial Treatment: 0.6 mcg/kg body weight administered once every two weeks (2.2). risks. Would you like email updates of new search results? 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%. }"nUEcJumC0ooF 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- Please know that the sponsors of this site are not responsible for content on the site you are about to enter. Eschbach JW, Adamson JW. 2014 Dec 8;2014(12):CD010590. History of serious or severe allergic reactions to Mircera (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). A decade in the anaemia market - 10 products seen top . 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. 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. 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. 3. Contributed by. Unable to load your collection due to an error, Unable to load your delegates due to an error. Please enable it to take advantage of the complete set of features! Internal You are now leaving AnemiaHub.com. 4! When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (n=205). Of the 302 patients enrolled, 206 (68%) were included in the DCR analysis. PubMed All groups were assessed at the end of the study for safety and efficacy parameters. An observational cohort study of extended dosing (once every 2 weeks or once monthly) regimens with darbepoetin alfa in patients with chronic kidney disease not on dialysis: the EXTEND study. aMutually exclusive categories; patients are censored in the following order: first at death post-switch, then at loss to follow-up post-switch, then at receipt of an ESA other than PEG-Epo, and finally lack of an Hb measurement in either or both EPs. Appropriately control hypertension prior to initiation of and during treatment with MIRCERA, Seizures have occurred in patients participating in MIRCERA, For lack or loss of hemoglobin response to MIRCERA, If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. In the month immediately prior to switch, the proportions of patients who had Hb below 10, 1012, and above 12g/dL were 7.3%, 54.4%, and 25.7%, respectively, with 12.6% missing. Yves Dimitrov, Julie Rieger, Thierry Hannedouche, Toru Kawai, Yoshie Kusano, Takao Masaki, Shubhadeep D. Sinha, Vamsi Krishna Bandi, Santosh Durugkar, Jonathan Barratt, Frank Dellanna, Michael Reusch, Terumasa Hayashi, Hideki Kato, Ichiei Narita, Rufaida Mazahir, Kanav Anand & P. K. Pruthi, Giovanna Stoppa, Carmen DAmore, ESAVIEW Study Group, Ylenia Ingrasciotta, Valeria Belleudi, On behalf of the Italian Biosimilars Network (I-BioNetwork), Luciano A. Pedrini, Mario Comelli, Stefano Stuard, Advances in Therapy Low hemoglobin at hemodialysis initiation: an international study of anemia management and mortality in the early dialysis period. As shown in Tables2 and 3, the mean (standard error) monthly Hb remained stable across the observation period, with mean monthly concentration ranging from 11.42 (0.09) g/dL (Month 4) to 11.60 (0.09) g/dL (Month 2) pre-switch, and from 11.26 (0.10) g/dL (Month 4) to 11.67 (0.09) g/dL (Month 1) post-switch. afK ] T z"$qu9H$}W//~||!+iO7^Q)|F.j+m ZJ7CY\7\lO7OGPno? Section III: Treatment of renal anaemia. Mircera (methoxy polyethylene glycol-epoetin beta) Summary of product characteristics. doi: 10.1002/14651858.CD010590.pub2. OZZ Clipboard, Search History, and several other advanced features are temporarily unavailable. Publication management support was provided by Caterina Hatzifoti, PhD, of Amgen Europe GmbH. In pediatric patients, Mircera is administered by intravenous injection only (2.2). In controlled clinical trials of patients with cancer, ESAs increased the risks for death and serious adverse cardiovascular reactions. 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 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. Each pre-filled syringe contains 0.3 ml or 0.6 ml. Secondly, the DCR was calculated on a subset of patients which constituted approximately two-thirds of the total enrolled. 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. The number of RBC transfusions and units transfused in the post-switch period was approximately threefold higher compared to the pre-switch period. These adverse reactions included myocardial infarction and stroke.