BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (. a Mutually exclusive categories; patients are censored in the following, Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. This paper presents the findings of a retrospective, multi-center, observational study of hemodialysis patients switched from DA to PEG-Epo for the treatment of anemia. ESA erythropoiesis-stimulating agent, Hb hemoglobin. 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. 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. 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. Galle JC, Claes K, Kiss I, Winearls CG, Herlitz H, Guerin A, Di Giulio S, Suranyi MG, Bridges I, Addison J, Farouk M. Nephrol Dial Transplant. Logistic regression analysis showed a higher likelihood of a transfusion during the post-switch period among patients with a dose ratio at switching of <1.
RETACRIT Dosage and Administration (epoetin alfa-epbx) Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. reaction occurs. Evaluation of Iron Stores and Nutritional Factors. The dose of Mircera, given as a single intravenous or subcutaneous injection, should be based on the Slider with three articles shown per slide. adult patients on dialysis and adult patients not on dialysis. volume30,pages 10071017 (2013)Cite this article. There are limitations in generalizing the findings of this study to the broader hemodialysis population. Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. Hb hemoglobin.
Recombinant human erythropoietins: very rare risk of severe cutaneous Mourad Farouk is an employee of Amgen with Amgen stock ownership. By Month 7 post-switch, the proportions of patients with Hb in these ranges were 9.7%, 48.1%, and 30.1%, respectively. 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 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). 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. The site is secure.
Switch from epoetin to darbepoetin alfa in hemodialysis: dose Learn about Mircera, potential side effects, proper use and dosing, and popular alternatives. Dr. Peter Choi is the guarantor for this article, and takes responsibility for the integrity of the work as a whole. 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. Mircera contains no preservatives. CAS Of 302 patients enrolled, 206 had data available for DCR analysis. Clin Kidney J. Conclusion: A dose approximating 0. )E]$&m"t "N5LQmgh-QZi`T0 hacpBYKUYRw@aMB/|n|'Y#h$8]#|zf. Individual patients could contribute multiple transfusions to these analyses. An official website of the United States government. Individualize dosing and use the lowest dose of MIRCERA.
PDF Mircera, INN: methoxy polyethylene glycol-epoetin beta Anemia response to Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) versus Epoetin Alfa (Eprex) in patients with chronic Kidney disease on Hemodialysis Published: September 05, 2017 42/47 is common in patients with a GFR below 30 ml/min/1.73m2 and contributes to many of the speciic symptoms of CKD. Am J Kidney Dis. <>/Font<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>>
Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Adult Patients with CKD 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). MIRCERA is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia associated with chronic kidney disease (CKD) in: MIRCERA is not indicated and is not recommended for use: MIRCERA has not been shown to improve quality of life, fatigue, or patient well-being. Fewer than half of the patients achieved Hb in the 1012g/dL range by 7months post-switch. . 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. Revised European Best Practice Guidelines for the management of anaemia in patients with chronic renal failure. Action Stimulates erythropoesis (production of red blood cells). Data quality and completeness were aided by automatic edit checks built into the database software. Conclusion: In patients on hemodialysis receiving ESAs, conversion from epoetin alfa to darbepoetin alfa was associated with an approximate and persistent reduction of 65% of the required dose. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). See this image and copyright information in PMC. 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. 2004;19(Suppl 2):ii1631. 6); the mean (SD) Hb within 14days prior to transfusion in these periods was 8.8 (1.41) and 8.3 (1.26), respectively. Publication management support was provided by Caterina Hatzifoti, PhD, of Amgen Europe GmbH. All patients who fulfilled pre-specified criteria for completeness of Hb and dosing data were included in the DCR analysis: i.e., those who had received DA or PEG-Epo as the only ESA in the 1month prior to and during the pre- or post-switch EPs, respectively, and who had dosing information and at least 1 Hb value in each of the evaluation periods.
Mircera: Uses, Taking, Side Effects, Warnings - Medicine.com This medicine is not used to treat anemia caused by cancer medicines. A decade in the anaemia market - 10 products seen top . 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. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these
Waiting game continues with Mircera launch | Evaluate 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)]. 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).
Methoxy Polyethylene Glycol-Epoetin Beta (Injection Route) 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 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. For more information, please see the full Prescribing Information, including Boxed WARNING, and Medication Guide(English, Espaol) for MIRCERA.
Comparison Among Erythropoietin Stimulating Agents There is no evidence that Mircera alters the metabolism of other medicinal products. 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. Control hypertension prior to initiating and during treatment with Aranesp or EPOGEN. Am J Kidney Dis. The initial conversion factor was 200:1. 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. 2020 Mar 26;2(3):286-296. doi: 10.1016/j.xkme.2020.01.007. Before Careers. Use caution in patients with coexistent cardiovascular disease and stroke. _____ (if . endobj
Dr. Gerald Diaz @GeraldMD. Adverse reactions ( 5%) in EPOGEN clinical studies in patients with CKD were hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection.
Procrit dosing calculator | Math Applications In conclusion, this study has shown that in a cohort of European hemodialysis patients who converted from DA to PEG-Epo (and who completed 67months treatment with PEG-Epo post-conversion), there was an approximately 20% increase in the g dose required to achieve a comparable Hb profile. 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. The mean (95% CI) monthly Hb immediately prior to switch, in Month 1 post-switch, and in Month 7 post-switch was 11.5g/dL (11.3, 11.7), 11.7g/dL (11.5, 11.9), and 11.4g/dL (11.3, 11.6), respectively. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. methoxypolyethylene glycol-epoetin beta (meh-thok-see-pah-lee-eh-thih-leen gly-kol ee-poh-eh-tin bay-ta) , Mircera (trade name) Classification Therapeutic: antianemics Pharmacologic: hormones Pregnancy Category: C Indications Anemia due to chronic renal failure. Use the Previous and Next buttons to navigate the slides or the slide controller buttons at the end to navigate through each slide. Do not use the prefilled syringe more than once. Goodkin DA, Zhao J, Cases A, Nangaku M, Karaboyas A. Please know that Amgen, the sponsor of this site, is not responsible for the content on the site you are about to enter.
PDF Drug Name: Erythropoietin Stimulating Agents (ESAs) Clinical Indication Drugs. Results:
Mircera (methoxy polyethylene glycol / epoetin beta) dosing - Medscape Horowitz J, Agarwal A, Huang F, Gitlin M, Gandra SR, Cangialose CB. 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). Eligible patients were randomized, either to continue on the previous regimen of Epoetin, or to receive Darbepoetin alfa or continuous erythropoietin receptor activator (C.E.R.A) for a total period of 40 weeks. The pre-transfusion Hb concentrations were similar for transfusions occurring both pre- and post-switch (Fig. 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.
Aranesp (darbepoetin alfa) | Dosing Considerations Examine each prefilled syringe for the expiration date. Epub 2022 Apr 22. sharing sensitive information, make sure youre on a federal In responding to hypoxia, erythropoietin interacts with erythroid progenitor . No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Methoxy polyethylene glycol-epoetin (Mircera ) will be increased and decreased in 1-step or 2-step increments, based on scale above. Learn how to combine multiple dosing options for precise titration and individualize anemia management.1. stream
-, Macdougall IC. See Instructions for Use for complete instructions on the preparation and administration of Mircera. St. Gallen, Switzerland: Vifor (International) Inc.; June 2018. 2022;53(5):333-342. doi: 10.1159/000523947. 1MIRCERA [prescribing information]. WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE. 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. 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. Packaging Type: Injection. A single hemoglobin excursion may not require a dosing change. 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. For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. W\iA* 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.