official website and that any information you provide is encrypted Amgen Wins Patent Battle Over Roche's Anemia Drug 2001;38:803812. 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. Therapeutic effects . Peter Choi, MB BChir, PhD, FRCP (UK), has received lecturing and consulting fees from Amgen, and has participated in advisory boards for Amgen. Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. Pharmacokinetic studies have shown that the meanSD terminal half-life of DA is 217.5h when administered intravenously (IV) [7]. For adverse event reports, please contact us at safety@viforpharma.com,mircera@viforpharma.com or at 1-800-576-8295. Mircera at Best Price in India - IndiaMART 33 Dose. 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Le bilan martial est dpendant de l'tat inflammatoire et la protine C ractive (CRP) est galement suivi tous les 3 mois pour cela. Macdougall IC, Obrador GT, El Nahas M. How important is transfusion avoidance in 2013? 2004;19(Suppl 2):ii1631. Insertion mechanism for drug delivery device - AMGEN INC. Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. The AFFIRM study was designed as a retrospective, longitudinal cohort analysis to estimate the DCR in a population of hemodialysis patients achieving comparable Hb after switching from IV DA to IV PEG-Epo in a real-world setting. ^D[5j@%e Methoxy polyethylene glycol-epoetin (Mircera ) will be increased and decreased in 1-step or 2-step increments, based on scale above. PDF Drug Name: Erythropoietin Stimulating Agents (ESAs) Clinical Indication Aranesp and EPOGEN have not been shown to improve quality of life, fatigue, or patient well-being. We comply with the HONcode standard for trustworthy health information. <> -, Macdougall IC. Medically reviewed by Drugs.com. Aranesp and EPOGEN increase the risk of seizures in patients with CKD. 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. Active ingredient: methoxy polyethylene glycol-epoetin beta Inactive ingredients: mannitol, methionine, poloxamer 188, sodium phosphate monobasic monohydrate, and sodium sulfate. Hb concentrations were reported as arithmetic means for each month. (PDF) Conversion from epoetin beta to darbepoetin: What is the This medicine is not for treating anemia caused by cancer chemotherapy. 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). Disposition of patients. 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. HHS Vulnerability Disclosure, Help BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (n=205). doi: 10.1053/ajkd.2001.27699. See this image and copyright information in PMC. 2021 Jan;26(1):46-53. doi: 10.1111/nep.13765. There were 16 transfusions and 34 units transfused in the pre-switch period, versus 48 transfusions and 95 units transfused post-switch. Slider with three articles shown per slide. Mourad Farouk is an employee of Amgen with Amgen stock ownership. Donck J, Gonzalez-Tabares L, Chanliau J, Martin H, Stamatelou K, Manamley N, Farouk M, Addison J. Adv Ther. endobj 2009 Nov-Dec;15(9):741-50. doi: 10.18553/jmcp.2009.15.9.741. Epub 2022 Apr 22. Association of erythropoietin resistance and fibroblast growth factor 23 in dialysis patients: Results from the Japanese Dialysis Outcomes and Practice Patterns Study. ONLY administer MIRCERA intravenously in pediatric patients. Evaluate the iron status in all patients before and during treatment. aranesp to retacrit conversion . Not all pack sizes may be marketed. . For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. 3 0 obj When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. Cochrane Database Syst Rev. Methods: Of 302 patients enrolled, 206 had data available for DCR analysis. 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. 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). 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. If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of MIRCERA. 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. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. afK ] T z"$qu9H$}W//~||!+iO7^Q)|F.j+m ZJ7CY\7\lO7OGPno? Strength: 100 mcg / 0.3ml. Low hemoglobin at hemodialysis initiation: an international study of anemia management and mortality in the early dialysis period. Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. <> St. Gallen, Switzerland: Vifor (International) Inc.; June 2018. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Generic name: Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL 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. 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. Mircera: Basics, Side Effects & Reviews - GoodRx BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (. Federal government websites often end in .gov or .mil. Mircera works like the human protein called erythropoietin to help your body make more RBCs. 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. before initiating Mircera [see Warnings and Precautions (5.9)]. Nephrol Dial Transplant. The .gov means its official. Conversion Dosing Guide: from Epoetin Alfa to Aranesp in Patients with Geometric mean weekly PEG-Epo dose at Month 1 post-switch was 26.7g (95% CI 24.4, 29.3), rising to 29g (95% CI 26.2, 32.2) by Month 7 post-switch. PDF Limitations of Use Mircera is not indicated and is not recommended for - , . Of 302 patients enrolled, 206 had data available for DCR analysis. PDF Anmie chez l'insuffisant rnal : comment utiliser les agents stimulant Horowitz J, Agarwal A, Huang F, Gitlin M, Gandra SR, Cangialose CB. 2013;28:10929. Editorial assistance in the preparation of this manuscript was provided by W. Mark Roberts, PhD, Montreal, Canada. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Resistance to Erythropoiesis-Stimulating Agents among Patients on Hemodialysis Is Typically Transient. DA, launched in 2001 [5, 7], contains 5 N-linked oligosaccharide chains, rather than the 3 contained in short-acting epoetins, which confer an approximately threefold longer serum half-life and mean residence time, allowing extended inter-dosing intervals [6]. More severe cases were recorded with long-acting agents (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta). Excluding patients receiving a transfusion within 90days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). Differentiating factors between erythropoiesis-stimulating agents: an update to selection for anaemia of chronic kidney disease. 3. . Epoetin zeta | Drugs | BNF | NICE MIRCERA has an approximate molecular weight of 60 kDa. 1. Aranesp (darbepoetin alfa) Epogen (epoetin alfa) Mircera . <>/Font<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> By definition, the DCR could not be calculated for patients ineligible for the DCR analysis as these did not have the necessary parameters recorded in both EPs. Drugs. Epub 2014 Nov 1. Do not mix Mircera with any parenteral solution. Mircera will be administered IV to HD patients, and SC to PD patients. Mircera is used to reduce or avoid the need for RBC transfusions. Control hypertension prior to initiating and during treatment with Aranesp or EPOGEN. 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. Mircera: Uses, Taking, Side Effects, Warnings - Medicine.com 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. Eligible patients had received hemodialysis for 12months and DA for 7months. [3] It is the first approved, chemically modified erythropoiesis-stimulating agent (ESA). 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. 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. 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. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these 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. The primary outcome measure, the geometric mean maintenance DCR, was calculated to be 1.17 (95% CI 1.05, 1.29). Most frequent adverse reactions (5%) in adult patients with CKD treated with MIRCERA. Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. Administer MIRCERA intravenously once every 4 More ways to get app. This medicine is not used to treat anemia caused by cancer medicines. 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). 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. Arch Intern Med. Kazmi WH, Kausz AT, Khan S, et al. 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. Descriptions. Article 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. It is not known if Mircera is safe and effective in children younger than 5 years of age. *Data from a multicenter, randomized, open-label study comparing epoetin, given 1, 2, or 3 times weekly IV or SC, with ARANESP , at a reduced dose frequency, in dialysis patients (N = 522).Dose adjustments were made as necessary and per study protocol to maintain individual patients' Hb within a target range of -1.0 to +1.5 g/dL of their baseline Hb and between 9 g/dL and 13 g/dL for up . )E]$&m"t "N5LQmgh-QZi`T0 hacpBYKUYRw@aMB/|n|'Y#h$8]#|zf. Clin Kidney J. These adverse reactions included myocardial infarction and stroke. The conversion from EpoB to CERA (methoxy polyethylene glycol-epoetin beta; Mircera; Hoffmann-La Roche Ltd., Basel, Switzerland) once monthly was already decided by the health care payer policy, who is the provider of erythropoietin stimulating agents for all patients, and was planned after a period of 6 months. Mircera (methoxy polyethylene glycol-epoetin beta) is an erythropoiesis-stimulating agent (ESA). ESAs resulted in decreased locoregional control/progression-free survival and/or overall survival. 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. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) Aztec notes.docx - The kidneys are the primary organ of the Dose Conversion Ratio in Hemodialysis Patients Switched from Darbepoetin Alfa to PEG-Epoetin Beta: AFFIRM Study, https://doi.org/10.1007/s12325-013-0063-y, CERA conversion to darbepoetin alfa in 154 hemodialysis patients, Long-term maintenance of hemoglobin levels in hemodialysis patients treated with bi-weekly epoetin beta pegol switched from darbepoetin alfa: a single-center, 12-month observational study in Japan, Efficacy, tolerability and safety of darbepoetin alfa injection for the treatment of anemia associated with chronic kidney disease (CKD) undergoing dialysis: a randomized, phase-III trial, Safety of Roxadustat Versus Erythropoiesis-Stimulating Agents in Patients with Anemia of Non-dialysis-Dependent or Incident-to-Dialysis Chronic Kidney Disease: Pooled Analysis of Four Phase 3 Studies, Initial responsiveness to darbepoetin alfa and its contributing factors in non-dialysis chronic kidney disease patients in Japan, Comparison of darbepoetin alpha and recombinant human erythropoietin for treatment of anemia in pediatric chronic kidney disease: a non-inferiority trial from India, Comparative Safety of Originator and Biosimilar Epoetin Alfa Drugs: An Observational Prospective Multicenter Study, In Search of Predictors of Switching Between Erythropoiesis-Stimulating Agents in Clinical Practice: A Multi-Regional Cohort Study, Mixed hemodiafiltration reduces erythropoiesis stimulating agents requirement in dialysis patients: a prospective randomized study, http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000332/WC500026149.pdf, http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000739/WC500033672.pdf, https://creativecommons.org/licenses/by/2.0. Methoxy polyethylene glycol-epoetin beta | Drugs | BNF | NICE Anemia of end-stage renal disease (ESRD) Kidney Int. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. history of serious or severe allergic reactions to MIRCERA (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). pure red cell aplasia (PRCA) that begins after treatment with MIRCERA or other erythropoietin protein drugs. This was particularly evident in patients whose pre-switch EP weekly DA dose was higher than 100g. 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. 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. Methoxy polyethylene glycol-epoetin beta, the active substance of MIRCERA, is a continuous erythropoietin receptor activator that shows a different activity at the receptor level characterized by a slower association to and faster dissociation from the receptor, a reduced specific activity in vitro with an increased activity in vivo, as well as an increased half-life, in contrast to . 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. 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. -, Macdougall IC. The relationship between the DA and PEG-Epo doses during the evaluation periods was explored through linear and quadratic regression. This article does not contain any studies with human or animal subjects performed by any of the authors. 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. 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. Article When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. PubMed Mircera Injection: Uses, Dosing & Side Effects - Drugs.com Carrera F, Lok CE, de Francisco A, et al. 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. Mircera solution for injection in pre-filled syringe - Summary of Prise en charge anmie rnale - Nephro.blog There were 16 transfusions and 34 units transfused in the pre-switch period, versus 48 transfusions and 95 units transfused post-switch. 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. Values are means (arithmetic for hemoglobin, geometric for dose) with 95% confidence intervals. A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia and transmitted securely. 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. Due to the skewed nature of the dosing data, mean weekly ESA doses were reported using geometric means; these were derived by calculating the arithmetic mean of the data transformed on the natural logarithmic scale. For lack or loss of hemoglobin response to Aranesp or EPOGEN, initiate a search for causative factors. Conversion - Epoetin alfa (Procrit) to Darbepoetin | GrepMed Examine each prefilled syringe for the expiration date. Conversion Dosing Guide: From epoetin alfa to Aranesp in patients with anemia due to CKD on dialysis. Please click the OK button below to continue. doi: 10.1002/14651858.CD010590.pub2. 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. pediatric patients 5 to 17 years of age on hemodialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA. Longer-acting PEG-Epo contains a chemical bond between an amino group present in epoetin beta and methoxy polyethylene glycol (PEG) butanoic acid; the addition of PEG is responsible for an increase in serum half-life of epoetin beta, and in CKD patients on dialysis the terminal half-life of PEG-Epo after IV administration is 134h [6, 8].
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