Nephrol Dial Transplant. For Pediatric Patients with CKD on hemodialysis: Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Pediatric Patients with CKD Treated with Hemodialysis. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Google Scholar. Dr. Peter Choi is the guarantor for this article, and takes responsibility for the integrity of the work as a whole. The relationship between the DA and PEG-Epo doses during the evaluation periods was explored through linear and quadratic regression. 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. Please see full Prescribing Information including Boxed WARNING, and Medication Guide for MIRCERA (methoxy polyethylene glycol-epoetin beta) Injection, for Intravenous or Subcutaneous Use. New anemia therapies: translating novel strategies from bench to bedside. <>/Metadata 444 0 R/ViewerPreferences 445 0 R>> 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 . Over the last 25years, several originator and biosimilar ESAs have been introduced for the management of CKD anemia, starting with the first generation short-acting recombinant erythropoietin agents (epoetin alfa and beta) and latterly with two longer-acting molecules, darbepoetin alfa (DA) and methoxy polyethylene glycol-epoetin beta (PEG-Epo), which combine a significantly increased half-life and lower binding affinity for the EPO receptor, allowing them to stimulate erythropoiesis for longer periods and to be administered less frequently [5, 6]. The number of transfusions and units transfused increased approximately threefold from the pre-switch to the post-switch period. Association of erythropoietin resistance and fibroblast growth factor 23 in dialysis patients: Results from the Japanese Dialysis Outcomes and Practice Patterns Study. Peter Choi. Do not use Mircera after the expiration date. 1:1 reference line indicates equal PEG-Epo and darbepoetin alfa doses. Adv Ther 30, 10071017 (2013). Use the lowest Mircera dose sufficient to reduce the need for red blood cell (RBC) transfusions. Conversion from darbepoetin or erythropoietin to Mircera 1. Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. 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. 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. For the purposes of this policy, a conversion factor of 3 should be used to estimate hematocrit when only the hemoglobin is measured, e.g., hemoglobin of 10 g/dL is approximately equal to a hematocrit of 30%, a hemoglobin of 11 g/dL is . <>/Font<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Le bilan martial est dpendant de l'tat inflammatoire et la protine C ractive (CRP) est galement suivi tous les 3 mois pour cela. 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. The intravenous route is recommended for patients on hemodialysis because the intravenous route may be less immunogenic. FOIA 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. 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. 6). pure red cell aplasia (PRCA) that begins after treatment with MIRCERA or other erythropoietin protein drugs. Last updated on Jul 26, 2022. 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. Aranesp and EPOGEN increase the risk of seizures in patients with CKD. Red blood cell transfusions pre- and post-switch were quantified. 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. ferrous sulfate, Aranesp, Procrit, Retacrit. Mircera is packaged as single-dose prefilled syringes. Accessibility 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. EP evaluation period, PEG-Epo methoxy polyethylene glycol-epoetin beta. This article does not contain any studies with human or animal subjects performed by any of the authors. Recombinant human erythropoietin is effective in 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. Once Every Two Weeks (mcg/every two weeks). 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 Composition: Methoxy Polyethylene Glycol-Epoetin Beta. doi: 10.1053/j.ajkd.2011.11.013. I certify that I am a healthcare professional in the US. Individualize dosing and use the lowest dose of Mircera sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. Eschbach JW, Adamson JW. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Active ingredient: methoxy polyethylene glycol-epoetin beta Inactive ingredients: mannitol, methionine, poloxamer 188, sodium phosphate monobasic monohydrate, and sodium sulfate. Kazmi WH, Kausz AT, Khan S, et al. Nick Manamley, MSc, is an employee of Amgen with Amgen stock ownership. A single hemoglobin excursion may not require a dosing change. 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). Therapeutic effects . However, the relationship between the pre- and post-switch ESA doses during the two evaluation periods was non-linear. eCollection 2020 Jun. Decreases in dose can occur more frequently. Report to the Judicial Council. For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. 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. \ab/`IR 4%jI ^w7qQNA Tq Wz.oVfCVBT{h*>\\3u#P@"wW7|pIMB7 Data were collected from 7months before until 7months after switching treatment. 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 . This study and the article processing charges were funded by Amgen Europe GmbH, Zug, Switzerland. }"nUEcJumC0ooF endobj For Adult Patients with CKD not on dialysis: Refer patients who self-administer Mircera to the Instructions for Use [see Patient Counseling Information (17)]. MIRCERA Classification: Erythropoiesis stimulating protein. Epoetin alfa was the first rhEPO produced and approved for pharmaceutical use, followed by several related products and by newer ESAs with the same mechanism but more prolonged action. 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). Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. The https:// ensures that you are connecting to the By Month 7 post-switch, the proportions of patients with Hb in these ranges were 9.7%, 48.1%, and 30.1%, respectively. Regression analysis indicated a non-linear relationship between pre- and post-switch ESA doses; DCR decreased with increasing pre-switch DA dose. Macdougall IC. Anemia of end-stage renal disease (ESRD). Use the Previous and Next buttons to navigate the slides or the slide controller buttons at the end to navigate through each slide. PubMed MIRCERA Interactions: May require increased anticoagulation (heparin) during hemodialysis. Pure red cell aplasia (PRCA) that begins after treatment with Mircera or other erythropoietin protein drugs. Summary of the last hemoglobin concentrations recorded within 14days prior to red blood cell transfusions pre- and post-switch. Methods: These adverse reactions included myocardial infarction and stroke. 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. Nephrol Dial Transplant. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. Table 1 Mircera Starting Doses for Adult Patients Currently Receiving an ESA, Table 2 Mircera Starting Doses for Pediatric Patients Currently Receiving an ESA. When a patient with a darbepoetin (Aranesp) or erythropoietin order switches to . stream Logistic regression was used to estimate an odds ratio comparing the number of patients receiving an RBC transfusion in the post-switch period relative to their dose ratio at switch (<1 vs. 1). Mean Hb was 11.5g/dL in the pre-switch EP and 11.4g/dL in the post-switch EP. 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. Empirical methods to calculate an erythropoiesis-stimulating agent dose conversion ratio in nondialyzed patients with chronic kidney disease. Eligible patients had received hemodialysis for 12months and DA for 7months. [3] It is the first approved, chemically modified erythropoiesis-stimulating agent (ESA). Statistical methods for assessing agreement between two methods of clinical measurement. The geometric mean weekly ESA dose for those included in the DCR analysis is shown in Fig. WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE. 2020 Mar 26;2(3):286-296. doi: 10.1016/j.xkme.2020.01.007. volume30,pages 10071017 (2013)Cite this article. 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]. Article 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. Canaud B, Mingardi G, Braun J, et al. Do you wish to proceed? Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. 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. Kidney Int. This medicine is not used to treat anemia caused by cancer medicines. Packaging Size: 0.3 ml. reaction occurs. Dialysis centers were expected to adhere to European Best Practice Guidelines for iron repletion [9]. Action Stimulates erythropoesis (production of red blood cells). 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. ESAs resulted in decreased locoregional control/progression-free survival and/or overall survival. OK Anemia: an early complication of chronic renal insufficiency. Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. 8600 Rockville Pike maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study. Differentiating factors between erythropoiesis-stimulating agents: an update to selection for anaemia of chronic kidney disease. 2012;59:44451. Mircera ceiling is 200 mcg every two weeks (or 3.0 mcg/kg/2 weeks, whichever is lower). . PMC Brand: Mircera. . At the moment forecasts for Mircera are $345m in 2015 rising to $552m in 2020, reflecting sales made outside the US. Contributed by. Editorial assistance in the preparation of this manuscript was provided by W. Mark Roberts, PhD, Montreal, Canada. Am J Kidney Dis. Please click the OK button below to continue. Concerning RBC transfusions, 36 patients received a transfusion; 7 were transfused in the pre-switch period only, 4 received a transfusion both pre- and post-switch, and 25 had a transfusion in the post-switch period only. There were 16 transfusions and 34 units transfused in the pre-switch period, versus 48 transfusions and 95 units transfused post-switch. Each dosage strength of MIRCERA is designated by a unique syringe plunger color. )E]$&m"t "N5LQmgh-QZi`T0 hacpBYKUYRw@aMB/|n|'Y#h$8]#|zf. ESA erythropoiesis-stimulating agent, Hb hemoglobin. There is limited information published on switching erythropoiesis-stimulating agent (ESA) treatment for anemia associated with chronic kidney disease (CKD) from darbepoetin alfa (DA) to methoxy polyethylene glycol-epoetin beta (PEG-Epo) outside the protocol of interventional clinical studies. Generic name: Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. All calculations should be confirmed before use. The enrolling dialysis centers were situated in France, Germany, Spain and the UK, and each was expected to enroll a minimum of 20 patients into the study. DCR geometric mean maintenance dose conversion ratio, EP evaluation period, ESA erythropoiesis-stimulating agent, Hb hemoglobin, PEG-Epo methoxy polyethylene glycol-epoetin beta. Conclusion: A dose approximating 0. 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. eCollection 2020 May-Jun. 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). Reasons for low Hb, e.g., acute intercurrent events such as bleeding, were not reported. 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. Initial Treatment: 0.6 mcg/kg body weight administered once every two weeks (2.2). 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. PubMedGoogle Scholar. 1MIRCERA [prescribing information]. 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. Matsumura K, Okumiya T, Sugiura T, Takahashi N, Yamamoto Y, Kikuchi S, Fujii K, Otagaki M, Shiojima I. BMC Nephrol. Mircera belongs to a class of drugs called Hematopoietic Growth Factors. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. 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. There is no evidence that Mircera alters the metabolism of other medicinal products. Lancet. 10PAGE BROCHURE doi: 10.1002/14651858.CD010590.pub2. 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). The primary outcome measure, the geometric mean maintenance DCR, was calculated to be 1.17 (95% CI 1.05, 1.29). 2021 Jan;26(1):46-53. doi: 10.1111/nep.13765. a Mutually exclusive categories; patients are censored in the following, Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. 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. Methoxy polyethylene glycol-epoetin (Mircera ) will be increased and decreased in 1-step or 2-step increments, based on scale above. Epub 2022 Apr 22. 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. Please click to see accompanying Aranesp full prescribing information and EPOGEN full prescribing information, including Boxed WARNINGS and Medication Guide. Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Adult Patients with CKD. 2001;38:80312. 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.
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