For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. Dose conversion ratio in hemodialysis patients switched from All calculations should be confirmed before use. Of the 302 patients enrolled, 206 (68%) were included in the DCR analysis. Examine each prefilled syringe for the expiration date. St. Gallen, Switzerland: Vifor (International) Inc.; June 2018. Conclusion: A dose approximating 0. HQ-MIR-1900027 Site last modified: January 2023. 2013;73:11730. Anemia Associated with Chronic Renal Failure, Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL, Drug class: recombinant human erythropoietins. This study and the article processing charges were funded by Amgen Europe GmbH, Zug, Switzerland. 2012 Jun;27(6):2303-11. doi: 10.1093/ndt/gfr677. 4 x previous weekly epoetin alfa dose (Units)/125, e.g., 4 x 1500 Units of epoetin alfa per week/125 = 48 mcg of Mircera once every 4 weeks, 4 x previous weekly darbepoetin alfa dose (mcg)/0.55, e.g., 4 x 20 mcg of darbepoetin alfa per week/0.55 = 145.5 mcg of Mircera once every 4 weeks. Product Information and Dosing | Mircera MIRCERA comes in pre-filled syringes with laminated plunger stopper and tip cap with one needle 27G1/2. 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). 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. chemotherapy, MDS or MF, continued therapy) Please provide a hemoglobin level (g/dL) for your patient taken within the first 12 weeks of therapy with epoetin and include the date the lab was drawn. 1MIRCERA [prescribing information]. When administered subcutaneously, Mircera should be injected in the abdomen, arm or thigh. Peter Choi, MB BChir, PhD, FRCP (UK), has received lecturing and consulting fees from Amgen, and has participated in advisory boards for Amgen. MIRCERA Classification: Erythropoiesis stimulating protein. Contributed by. A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks. Association of erythropoietin resistance and fibroblast growth factor 23 in dialysis patients: Results from the Japanese Dialysis Outcomes and Practice Patterns Study. PDF Mircera, INN: methoxy polyethylene glycol-epoetin beta This article does not contain any studies with human or animal subjects performed by any of the authors. randomized patients to darbepoetin or epoetin beta once weekly after the patients had been treated with epoetin beta three times weekly. Brand: Mircera. Karaboyas A, Morgenstern H, Waechter S, Fleischer NL, Vanholder R, Jacobson SH, Sood MM, Schaubel DE, Inaba M, Pisoni RL, Robinson BM. Mircera is administered by subcutaneous (SC) or intravenous (IV) injection (2.2). Choi, P., Farouk, M., Manamley, N. et al. 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. Would you like email updates of new search results? 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. 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. Once the hemoglobin has been stabilized, MIRCERA, If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of MIRCERA. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. Each pre-filled syringe contains 0.3 ml or 0.6 ml. 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. Comparison Among Erythropoietin Stimulating Agents Am J Kidney Dis. 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. Do not use Mircera after the expiration date. 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. 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]. Erythropoiesis-stimulating agents (epoetin alfa, beta, theta and zeta St. Gallen, Switzerland: Vifor (International) Inc.; June 2018. 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). Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. endobj Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Adult Patients with CKD. RETACRIT Dosage Forms and Strengths (epoetin alfa-epbx) Table 1 Mircera Starting Doses for Adult Patients Currently Receiving an ESA, Table 2 Mircera Starting Doses for Pediatric Patients Currently Receiving an ESA. 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. 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. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Dose Conversion Ratio in Hemodialysis Patients Switched from Administer Mircera either intravenously or subcutaneously in adult patients and only intravenously in pediatric patients. The majority of patients who were transfused during the pre- and post-switch observation periods had Hb 10g/dL within the 14days prior to transfusion; only 1 patient during each period had Hb >11g/dL within the 14-day pre-transfusion interval. <>/Font<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Article Tolman et al. 2012;59:444451. Aranesp (darbepoetin alfa) prescribing information, Amgen. . Recombinant human erythropoietin is effective in 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. This medicine is not used to treat anemia caused by cancer medicines. 2022;53(5):333-342. doi: 10.1159/000523947. 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 . - 94.130.71.173. Conversion Dosing Guide: from Epoetin Alfa to Aranesp in Patients with Randomized clinical studies have reported data on switching from DA to PEG-Epo (Stabilizing haemoglobin TaRgets in dialysis following IV C.E.R.A. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Epub 2022 Apr 22. (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. MIRCERA has an approximate molecular weight of 60 kDa. Horowitz J, Agarwal A, Huang F, Gitlin M, Gandra SR, Cangialose CB. 2020 Mar 26;2(3):286-296. doi: 10.1016/j.xkme.2020.01.007. OZZ 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. Accounting for the effect of transfusion, the DCR was 1.21 (95% CI 1.09, 1.35). Asterisk Not all transfusions had an associated hemoglobin concentration in the 14-day period before transfusion. 1. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. official website and that any information you provide is encrypted The https:// ensures that you are connecting to the 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. Packaging Size: 0.3 ml. Changes in ESA dosing and number of transfusions post-switch may have important health-economic implications. Methoxy polyethylene glycol-epoetin beta injection causes the . 3 DOSAGE FORMS AND STRENGTHS. Clin Kidney J. 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 . Karaboyas A, Morgenstern H, Fleischer NL, Vanholder RC, Dhalwani NN, Schaeffner E, Schaubel DE, Akizawa T, James G, Sinsakul MV, Pisoni RL, Robinson BM. doi: 10.1038/ki.1985.109. Waiting game continues with Mircera launch | Evaluate Aranesp (darbepoetin alfa) | Dosing Considerations Usui T, Zhao J, Fuller DS, Hanafusa N, Hasegawa T, Fujino H, Nomura T, Zee J, Young E, Robinson BM, Nangaku M. Nephrology (Carlton). Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp GrepMed. 6); the mean (SD) Hb within 14days prior to transfusion in these periods was 8.8 (1.41) and 8.3 (1.26), respectively. Mircera (methoxy polyethylene glycol-epoetin beta) is an erythropoiesis-stimulating agent (ESA). in the treatment of anemia due to cancer chemotherapy. Anemia of chronic kidney disease (CKD) becomes increasingly prevalent and severe as kidney function declines [1], with over 90% of patients who require renal replacement therapy becoming anemic [2]. This was particularly evident in patients whose pre-switch EP weekly DA dose was higher than 100g. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) 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. <> MIRCERA Interactions: May require increased anticoagulation (heparin) during hemodialysis. 3 0 obj Slider with three articles shown per slide. Palmer SC, Saglimbene V, Mavridis D, Salanti G, Craig JC, Tonelli M, Wiebe N, Strippoli GF. 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 Cost-Effectiveness of Continuous Erythropoiesis Receptor - Hindawi Administer MIRCERA intravenously once every 4 More ways to get app. See this image and copyright information in PMC. Figure4 also displays the mean monthly Hb for those included in the DCR analysis over the study period. Initial Treatment: 0.6 mcg/kg body weight administered once every two weeks (2.2). Disclaimer. Results of the BlandAltman analysis investigating the concordance between mean weekly ESA doses in both evaluation periods are presented in Fig. 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. "BG0RjI G78 afK ] T z"$qu9H$}W//~||!+iO7^Q)|F.j+m ZJ7CY\7\lO7OGPno? PDF Anemia response to Methoxy Polyethylene Glycol-Epoetin Beta (Mircera sharing sensitive information, make sure youre on a federal This article does not contain any studies with human or animal subjects performed by any of the authors. 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). history of serious or severe allergic reactions to MIRCERA (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). 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.
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