A single hemoglobin excursion may not require a dosing change. 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. Mircera Injection (Methoxy Polyethylene Glycol-Epoetin Beta ) 6,610/ Piece Get Latest Price. 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. Aranesp (darbepoetin alfa) Summary of product characteristics. Anemia: an early complication of chronic renal insufficiency. Adverse reactions ( 10%) in Aranesp clinical studies in patients with CKD were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension. eCollection 2020 May-Jun. Correspondence to Low hemoglobin at hemodialysis initiation: an international study of anemia management and mortality in the early dialysis period. Secondary outcomes included Hb concentrations and ESA use during the study period, and the incidence of red blood cell (RBC) transfusions. Conversion from darbepoetin or erythropoietin to Mircera 1. 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. 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]. Anemia: an early complication of chronic renal insufficiency. The geometric mean weekly ESA dose for those included in the DCR analysis is shown in Fig. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. In an additional analysis performed to assess the sensitivity of this result to the effects of transfusion by excluding those patients who received an RBC transfusion within 90days prior to or during either evaluation period, the DCR was 1.21 (95% CI 1.09, 1.35). A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these 2008;23:365461. Mircera would also have competed with Aranesp and with Procrit . Accessibility When a patient with a darbepoetin (Aranesp) or erythropoietin order switches to . [3] It is the first approved, chemically modified erythropoiesis-stimulating agent (ESA). 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. MIRCERA Interactions: May require increased anticoagulation (heparin) during hemodialysis. The distribution of transfusions (Fig. 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%. Conversion d'une EPO l'autre Conversion potine en darbpotine avec un facteur de conversion 200 UI = 1 g Bilan martial Suivi ferritine et taux de saturation de la transferrine (TSAT) tous les 3 mois. Unauthorized use of these marks is strictly prohibited. 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. -, Eschbach JW, Adamson JW. 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. In the first month after switch, these proportions were 10.2%, 48.5% and 37.4%, respectively. A primary growth factor for erythroid development, erythropoietin is produced in the kidney and released into the bloodstream in response to hypoxia. 4. Examine each prefilled syringe for the expiration date. 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 is indicated for the treatment of anemia associated with CKD in adult patients on dialysis and adult patients not on dialysis. Bland JM, Altman DG. pee`T"c+l_WB,`km^;6#j(*m`&E`l${F6Q`&^=e`f(6]8ZE[VHNx-FRIhE&iJKvW`Vz^p@?Yk+S.DgR1rrB6yq2N$| 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 Aranesp, Serious and fatal reactions including gasping syndrome can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including EPOGEN. This article does not contain any studies with human or animal subjects performed by any of the authors. Internal You are now leaving AnemiaHub.com. Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. Aranesp (darbepoetin alfa) and EPOGEN (epoetin alfa) are contraindicated in patients with: Pure red cell aplasia (PRCA) that begins after treatment with Aranesp, EPOGEN, or other erythropoietin protein drugs, Serious allergic reactions to Aranesp or EPOGEN. Fewer than half of the patients achieved Hb in the 1012g/dL range by 7months post-switch. MIRCERA can be administered once every 2 weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA. 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. Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. Values are means (arithmetic for hemoglobin, geometric for dose) with 95% confidence intervals. Drugs. This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited. Nick Manamley, MSc, is an employee of Amgen with Amgen stock ownership. The primary finding of the study is that the DCR of PEG-Epo to DA was 1.17 (95% CI 1.05, 1.29). endobj Discard any unused portion. 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. Am J Kidney Dis. . Mircera is used to treat anemia caused by chronic kidney disease in adults, or in children at least 5 years old who are on hemodialysis. Mircera contains no preservatives. Kazmi WH, Kausz AT, Khan S, et al. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. 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 . The primary outcome measure, the geometric mean maintenance DCR, was calculated to be 1.17 (95% CI 1.05, 1.29). Methods: 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. There is no evidence that Mircera alters the metabolism of other medicinal products. 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. Please click the OK button below to continue. Mircera with 1-step decrease as soon as Hgb is < 11.8 g/dL and last dose was administered 2 weeks ago or more. For recommended dose equivalency, see Tables A and B (below). 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. A BlandAltman analysis [10] was also performed to assess the agreement between ESA doses in the evaluation periods. 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. Control hypertension prior to initiating and during treatment with Aranesp or EPOGEN. 2010;25:400917. Mircera is administered by subcutaneous (SC) or intravenous (IV) injection (2.2). doi: 10.1038/ki.1985.109. Conversion Dosing Guide: From epoetin alfa to Aranesp in patients with anemia due to CKD on dialysis. If severe anemia and low reticulocyte count develop during treatment with Aranesp or EPOGEN, withhold Aranesp or EPOGEN and evaluate patients for neutralizing antibodies to erythropoietin. 2020 Mar 26;2(3):286-296. doi: 10.1016/j.xkme.2020.01.007. Packaging Size: 0.3 ml. Eschbach JW, Adamson JW. Conversion from Epoetin alfa or Darbepoetin alfa to MIRCERA in Pediatric Patients with CKD on Hemodialysis. 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery. 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. Show detailed description Study Design Go to Am J Kidney Dis. 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. Publication management support was provided by Caterina Hatzifoti, PhD, of Amgen Europe GmbH. It is not known if Mircera is safe and effective in children younger than 5 years of age. stream 5) shows that most transfusions occurred in the first 4months post-switch. DA can be administered once a week (QW) or once every 2weeks (Q2W) to hemodialysis patients. Accounting for the effect of transfusion, the DCR was 1.21 (95% CI 1.09, 1.35). 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. 1. Amgen's two anemia drugs, Epogen and Aranesp, had sales of $6.6 billion last year, nearly half the company's total revenue. Empirical methods to calculate an erythropoiesis-stimulating agent dose conversion ratio in nondialyzed patients with chronic kidney disease. Cost (BNF 60, March 2013) Aranesp (darbepoetin alfa) - 14.68-220.22 (10 micrograms syringe to 150 microgram syringe) NeoRecormon Mircera (methoxy polyethylene glycol-epoetin beta) - 44.05-220.22 (30 microgram syringe to 150 microgram syringe . Support for this assistance was funded by Amgen. Mircera works like the human protein called erythropoietin to help your body make more RBCs. The relationship between the DA and PEG-Epo doses during the evaluation periods was explored through linear and quadratic regression. This study and the article processing charges were funded by Amgen Europe GmbH, Zug, Switzerland. HHS Vulnerability Disclosure, Help 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 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. W\iA* 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. 2023 Springer Nature Switzerland AG. and darbepOetin alfa in patieNts Undergoing dialySis [PATRONUS] [9]); however, there is a lack of published literature on switching in patients receiving routine clinical care (i.e., outside interventional clinical trials). 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. Packaging Type: Injection. %PDF-1.7 Nephrol Dial Transplant. 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 \ab/`IR 4%jI ^w7qQNA Tq Wz.oVfCVBT{h*>\\3u#P@"wW7|pIMB7 https://doi.org/10.1007/s12325-013-0063-y, DOI: https://doi.org/10.1007/s12325-013-0063-y. Treatment: Treat to anemia in people with chronic kidney disease. Clin Kidney J. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Brand: Mircera. 2013;73:11730. Results of the BlandAltman analysis investigating the concordance between mean weekly ESA doses in both evaluation periods are presented in Fig. Goodkin DA, Zhao J, Cases A, Nangaku M, Karaboyas A. 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. Excluding patients receiving a transfusion within 90 days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). 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. Evaluate the iron status in all patients before and during treatment. before initiating MIRCERA. Am J Kidney Dis. 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. MIRCERA has an approximate molecular weight of 60 kDa. 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. sharing sensitive information, make sure youre on a federal 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. Mean Hb was 11.5 g/dL in the pre-switch EP and 11.4 g/dL in the post-switch EP. 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. Medically reviewed by Drugs.com. Please know that the sponsors of this site are not responsible for content on the site you are about to enter. volume30,pages 10071017 (2013)Cite this article. All groups were assessed at the end of the study for safety and efficacy parameters. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) Mircera is not the same as epoetin alfa (Procrit, Epogen). 33 Dose. 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. Canaud B, Mingardi G, Braun J, et al. Tables2 and 3 also summarize the proportion of patients in different Hb categories by study month. 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. Would you like email updates of new search results? Inflammation and Erythropoiesis-Stimulating Agent Response in Hemodialysis Patients: A Self-matched Longitudinal Study of Anemia Management in the Dialysis Outcomes and Practice Patterns Study (DOPPS). 1 0 obj 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. 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. 2022;53(5):333-342. doi: 10.1159/000523947. 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. Statistical methods for assessing agreement between two methods of clinical measurement. doi: 10.1053/j.ajkd.2011.11.013. For Adult Patients with CKD not on dialysis: Refer patients who self-administer Mircera to the Instructions for Use [see Patient Counseling Information (17)]. Action Stimulates erythropoesis (production of red blood cells). Do not increase the dose more frequently than once every 4 weeks. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. More severe cases were recorded with long-acting agents (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta). WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE. Pure red cell aplasia (PRCA) that begins after treatment with MIRCERA, History of serious or severe allergic reactions to MIRCERA. Excluding patients receiving a transfusion within 90days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). 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. In controlled clinical trials of patients with cancer, ESAs increased the risks for death and serious adverse cardiovascular reactions. 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. 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). BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (n=205). When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. The pre-transfusion Hb concentrations were similar for transfusions occurring both pre- and post-switch (Fig. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. Decreases in dose can occur more frequently. Descriptions. PubMed 2012;59:444451. randomized patients to darbepoetin or epoetin beta once weekly after the patients had been treated with epoetin beta three times weekly. Careers. 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. 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. 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. 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. 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. MIRCERA [prescribing information]. 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. 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 . Epub 2022 Apr 22. 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]. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. 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. Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. - 94.130.71.173. 2014 Dec 8;2014(12):CD010590. Please click to see accompanying Aranesp full prescribing information and EPOGEN full prescribing information, including Boxed WARNINGS and Medication Guide. 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.
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