33 Dose. 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. 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. doi: 10.1001/archinte.162.12.1401. 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 See Instructions for Use for complete instructions on the preparation and administration of Mircera. 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). Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. Red blood cell transfusions pre- and post-switch were quantified. Macdougall IC. In responding to hypoxia, erythropoietin interacts with erythroid progenitor . What is the practical conversion dose when changing from epoetin alfa Shortened red blood cell age in patients with end-stage renal disease who were receiving haemodialysis: a cross-sectional study. Arch Intern Med. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) A BlandAltman analysis [10] was also performed to assess the agreement between ESA doses in the evaluation periods. Accessed 18 October 2013. 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. - 94.130.71.173. 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. Methoxy polyethylene glycol-epoetin beta - Wikipedia stream
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. : | , The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Am J Kidney Dis. Of the 302 patients enrolled, 206 (68%) were included in the DCR analysis. Each dosage strength of MIRCERA is designated by a unique syringe plunger color. 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. Differentiating factors between erythropoiesis-stimulating agents: an update to selection for anaemia of chronic kidney disease. 2020 Sep 29;21(1):418. doi: 10.1186/s12882-020-02078-z. Clipboard, Search History, and several other advanced features are temporarily unavailable. Treatment for Anaemia [STRIATA] [8] and comPArator sTudy of C.E.R.A. MIRCERA is available, for all strengths, in pack sizes of 1 and also pack size of 3 for the strengths 30, 50, 75 micrograms/0.3ml. Visit. Conversion Dosing Guide: From epoetin alfa to Aranesp in patients with anemia due to CKD on dialysis. For adverse event reports, please contact us at safety@viforpharma.com,mircera@viforpharma.com or at 1-800-576-8295. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 2008;23:365461. MIRCERA is a registered trademark of F. Hoffmann-La Roche Ltd. All Vifor Pharma Groups intellectual rights, including copyright, are, The information provided in this site is intended only for healthcare. All groups were assessed at the end of the study for safety and efficacy parameters. Use caution in patients with coexistent cardiovascular disease and stroke. Mircera solution for injection in pre-filled syringe Article Google Scholar. 2012;59:44451. Mircera at Best Price in India - IndiaMART Please know that Amgen, the sponsor of this site, is not responsible for the content on the site you are about to enter. 2001;38:803812. AFFIRM demonstrated non-linearity of the dose relationship curve, with DCR decreasing as pre-switch DA dose increased. Mircera Injection: Uses, Dosing & Side Effects - Drugs.com pee`T"c+l_WB,`km^;6#j(*m`&E`l${F6Q`&^=e`f(6]8ZE[VHNx-FRIhE&iJKvW`Vz^p@?Yk+S.DgR1rrB6yq2N$| Google Scholar. Randomized clinical studies have reported data on switching from DA to PEG-Epo (Stabilizing haemoglobin TaRgets in dialysis following IV C.E.R.A. afK ] T z"$qu9H$}W//~||!+iO7^Q)|F.j+m
ZJ7CY\7\lO7OGPno? If Hgb remains >= 12 g/dL for more than 2 months, return to regular Hgb testing policy. PubMedGoogle Scholar. Eligible patients had received hemodialysis for 12 months and DA for 7 months. Mourad Farouk is an employee of Amgen with Amgen stock ownership. 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. 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. FDA approves Mircera for anemia associated with chronic kidney disease PDF Methoxy polyethylene glycol-epoetin beta (Mircera ) Protocol Mircera is a prescription medicine used to treat the symptoms of Anemia associated with Chronic Renal Failure. The geometric mean weekly dose of DA was 23.2g (95% CI 20.6, 26.3) in the month prior to switch. 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. before initiating Mircera [see Warnings and Precautions (5.9)]. Mechanism of Action. Read reviews from GoodRx users who have taken Mircera and find the latest news on the drug. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. 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. )E]$&m"t "N5LQmgh-QZi`T0 hacpBYKUYRw@aMB/|n|'Y#h$8]#|zf. Results of the BlandAltman analysis investigating the concordance between mean weekly ESA doses in both evaluation periods are presented in Fig. 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. American Society of Hematology Self-Assessment Program (Adam - Scribd 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. 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. Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. Finally, our study indicates that the risk of transfusion was higher in the post-switch compared with the pre-switch period, with an approximate threefold rise observed in the number of transfusions and units transfused post-switch. Methoxy polyethylene glycol-epoetin beta injection causes the . PDF Aranesp, Epogen, Mircera, Procrit, Retacrit - Cigna PDF Drug Name: Erythropoietin Stimulating Agents (ESAs) Clinical Indication By Month 7 post-switch, the proportions of patients with Hb in these ranges were 9.7%, 48.1%, and 30.1%, respectively. The geometric mean weekly ESA dose for those included in the DCR analysis is shown in Fig. Amgen's two anemia drugs, Epogen and Aranesp, had sales of $6.6 billion last year, nearly half the company's total revenue. The https:// ensures that you are connecting to the Kidney Int. 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. Administer Mircera either intravenously or subcutaneously in adult patients and only intravenously in pediatric patients. MIRCERA Interactions: May require increased anticoagulation (heparin) during hemodialysis. We comply with the HONcode standard for trustworthy health information. In controlled clinical trials of patients with cancer, ESAs increased the risks for death and serious adverse cardiovascular reactions. %PDF-1.7
Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. MIRCERA- methoxy polyethylene glycol-epoetin beta Individualize dosing and use the lowest dose of MIRCERA. pure red cell aplasia (PRCA) that begins after treatment with MIRCERA or other erythropoietin protein drugs. EPOGEN from multidose vials contains benzyl alcohol and is contraindicated in neonates, infants, pregnant women, and lactating women. Discard any unused portion. Mircera solution for injection in pre-filled syringe - Summary of Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (19881994) Arch Intern Med. Generic name: Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL Figure4 also displays the mean monthly Hb for those included in the DCR analysis over the study period. Procrit dosing calculator | Math Applications Packaging Type: Injection. Dialysis centers were expected to adhere to European Best Practice Guidelines for iron repletion [9]. Mircera (methoxy polyethylene glycol-epoetin beta) is an erythropoiesis-stimulating agent (ESA). Peter Choi. 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. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. 2013;73:11730. 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). The odds ratio for receiving a transfusion was twice as high in patients switched at a dose ratio less than 1 when compared to those switched at 1:1 or higher. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) 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. Treatment: Treat to anemia in people with chronic kidney disease. Last updated on Jul 26, 2022. The introduction of exogenous erythropoiesis-stimulating agents (ESAs) to clinical practice has transformed the care of patients with CKD, by ameliorating anemia, reducing transfusion requirements, and improving quality of life [4]. The pre-transfusion Hb concentrations were similar for transfusions occurring both pre- and post-switch (Fig. Methoxy polyethylene demonstrated that the dose efficiency after SC and IV ad- glycol-epoetin b (PEG-epoetin b; Mircera; F. Hoffmann- ministration was . Please click to see accompanying Aranesp full prescribing information and EPOGEN full prescribing information, including Boxed WARNINGS and Medication Guide. 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 patients treated with Aranesp or EPOGEN. Methoxy polyethylene glycol-epoetin beta, sold under the brand name Mircera, is a long-acting erythropoietin receptor activator (CERA) used for the treatment of anaemia associated with chronic kidney disease. (PDF) Amgen Business Review - library.corporate-ir.netlibrary.corporate Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. Google Scholar. Results: Methods: PMC 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. Article darbepoetin alfa (Aransep) pre-filled syringe, injectable vial epoetin alfa (Epogen; Procrit) injectable methoxy polyethylene glycol-epoetin beta (Mircera) pre-filled syringe Conditions Medications Dialysis patients can . Mircera | definition of Mircera by Medical dictionary Learn how to combine multiple dosing options for precise titration and individualize anemia management.1. Provided by the Springer Nature SharedIt content-sharing initiative, Over 10 million scientific documents at your fingertips, Not logged in The PATRONUS study, in which stable hemodialysis patients receiving IV DA were randomized either to QM PEG-Epo or to Q2W DA for 26weeks [11], described an increase in post-switch dose requirement. 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. 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). No test of statistical significance was performed on any of the clinical characteristics. doi: 10.1053/ajkd.2001.27699. PDF Limitations of Use Mircera is not indicated and is not recommended for *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 . Bookshelf 1. Values are means (arithmetic for hemoglobin, geometric for dose) with 95% confidence intervals. Medically reviewed by Drugs.com. 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. Methoxy Polyethylene Glycol-Epoetin Beta (Injection Route) In the evaluation periods, the geometric mean weekly DA dose in the pre-switch EP was 24.1g (95% CI 21.3, 27.1) while the geometric mean weekly PEG-Epo dose in the post-switch EP was 28.6g (95% CI 26.0, 31.5). 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)]. Aranesp (darbepoetin alfa) Summary of product characteristics. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. 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. PDF Anmie chez l'insuffisant rnal : comment utiliser les agents stimulant 2019 Jul 5;13(3):425-433. doi: 10.1093/ckj/sfz065. 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- 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. Tolman et al. Mircera with 1-step decrease as soon as Hgb is < 11.8 g/dL and last dose was administered 2 weeks ago or more. HQ-MIR-1900027 Site last modified: January 2023. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. Lancet. 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. Data were also manually reviewed prior to final analysis. Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit. In the first month after switch, these proportions were 10.2%, 48.5% and 37.4%, respectively. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events. Immediately and permanently discontinue Aranesp or EPOGEN if a serious allergic
Slider with three articles shown per slide. Mircera will be administered IV to HD patients, and SC to PD patients. Mircera (methoxy polyethylene glycol-epoetin beta) Summary of product characteristics. MIRCERA is indicated for the treatment of anemia associated with CKD in adult patients on dialysis and adult patients not on dialysis. 4! 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. Mean Hb was 11.5g/dL in the pre-switch EP and 11.4g/dL in the post-switch EP. Donck J, Gonzalez-Tabares L, Chanliau J, Martin H, Stamatelou K, Manamley N, Farouk M, Addison J. Adv Ther. 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. 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. 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. Recombinant human erythropoietins: very rare risk of severe cutaneous 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. Learn about Mircera, potential side effects, proper use and dosing, and popular alternatives. 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. endobj
Action Stimulates erythropoesis (production of red blood cells). Hb hemoglobin. MIRCERA comes in pre-filled syringes with laminated plunger stopper and tip cap with one needle 27G1/2. . as a substitute for red blood cell transfusions in patients who require immediate correction of anemia. Mircera is used to reduce or avoid the need for RBC transfusions. (PDF) Conversion from epoetin beta to darbepoetin: What is the EP evaluation period, PEG-Epo methoxy polyethylene glycol-epoetin beta. PDF Erythropoiesis-Stimulating Agents - Commercial Medical Benefit Drug Policy 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. 2013;28:10929. "BG0RjI G78 Prise en charge anmie rnale - Nephro.blog ?Ij{JVv:oC*#]}V#$M_T.zC>~] L%lq[Tn`QbWB./@ClVgrk)U-j#(0(D 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. Report to the Judicial Council. The WHO has set the daily-defined dose (DDD) for epoetin beta and darbepoetin at 1000 U and 4.5 g respectively, which gives a conversion factor of 222:1 . 4. Use the Previous and Next buttons to navigate the slides or the slide controller buttons at the end to navigate through each slide. The site is secure. HHS Vulnerability Disclosure, Help Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. Pure red cell aplasia (PRCA) that begins after treatment with MIRCERA, History of serious or severe allergic reactions to MIRCERA. Anemia Associated with Chronic Renal Failure, Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL, Drug class: recombinant human erythropoietins. The primary finding of the study is that the DCR of PEG-Epo to DA was 1.17 (95% CI 1.05, 1.29). 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. Use caution in patients with coexistent cardiovascular disease and stroke. Regardless of possible differences in their clinical characteristics it should be borne in mind that patients were not selected for inclusion in the DCR analysis on the basis of their fulfilling any clinical, Hb or ESA dose requirements: all patients who had Hb measurements in both EPs, a DA dose in the pre-switch EP and a PEG-Epo dose in the post-switch EP were eligible for inclusion. Monitor patients closely for new-onset seizures, premonitory symptoms, or change in seizure frequency. aranesp to retacrit conversion ESAs resulted in decreased locoregional control/progression-free survival and/or overall survival. Brand: Mircera. This article does not contain any studies with human or animal subjects performed by any of the authors. 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. OK
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. Mircera | European Medicines Agency Federal government websites often end in .gov or .mil. 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) OZZ 2012;59:444451. 1. A single hemoglobin excursion may not require a dosing change. PDF Anemia response to Methoxy Polyethylene Glycol-Epoetin Beta (Mircera Composition: Methoxy Polyethylene Glycol-Epoetin Beta. [3] It is the first approved, chemically modified erythropoiesis-stimulating agent (ESA). NCI CPTC Antibody Characterization Program, Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. Mircera is not the same as epoetin alfa (Procrit, Epogen). The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records.