EP evaluation period, PEG-Epo methoxy polyethylene glycol-epoetin beta. adult patients on dialysis and adult patients not on dialysis. Google Scholar. 2002;17(Suppl 5):6670. Mircera would also have competed with Aranesp and with Procrit . Do you wish to proceed? Tolman et al. Hb concentrations were reported as arithmetic means for each month. Generic name: Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL as a substitute for red blood cell transfusions in patients who require immediate correction of anemia. Macdougall IC. A primary growth factor for erythroid development, erythropoietin is produced in the kidney and released into the bloodstream in response to hypoxia. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. The geometric mean DCR of PEG-Epo to DA was 1.17, rising to 1.21 when the effect of RBC transfusions was taken into account. Always store Mircera prefilled syringes in their original cartons. National Library of Medicine Action Stimulates erythropoesis (production of red blood cells). <>/Font<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Table 1 Mircera Starting Doses for Adult Patients Currently Receiving an ESA, Table 2 Mircera Starting Doses for Pediatric Patients Currently Receiving an ESA. RETACRIT Dosage and Administration (epoetin alfa-epbx) Shortened red blood cell age in patients with end-stage renal disease who were receiving haemodialysis: a cross-sectional study. 6). Section III: Treatment of renal anaemia. The geometric mean DCR was 1.17 (95% CI 1.05, 1.29). eCollection 2020 May-Jun. 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- This study and the article processing charges were funded by Amgen Europe GmbH, Zug, Switzerland. 2020 Sep 29;21(1):418. doi: 10.1186/s12882-020-02078-z. Results of the BlandAltman analysis investigating the concordance between mean weekly ESA doses in both evaluation periods are presented in Fig. Donck J, Gonzalez-Tabares L, Chanliau J, Martin H, Stamatelou K, Manamley N, Farouk M, Addison J. Adv Ther. Google Scholar. - , . 33 Dose. W\iA* 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. PMC When administered subcutaneously, Mircera should be injected in the abdomen, arm or thigh. The number of transfusions and units transfused increased approximately threefold from the pre-switch to the post-switch period. Arch Intern Med. 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. Nephrol Dial Transplant. Amgen Europe B.V., Breda, The Netherlands, 29 August 2013. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000332/WC500026149.pdf. Methods: 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). before initiating Mircera [see Warnings and Precautions (5.9)]. sharing sensitive information, make sure youre on a federal Dr. Peter Choi is the guarantor for this article, and takes responsibility for the integrity of the work as a whole. The .gov means its official. If Hgb remains >= 12 g/dL for more than 2 months, return to regular Hgb testing policy. . Medically reviewed by Drugs.com. St. Gallen, Switzerland: Vifor (International) Inc.; June 2018. - 94.130.71.173. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these The pre-transfusion Hb concentrations were similar for transfusions occurring both pre- and post-switch (Fig. The long-acting r-HuEPO methoxy polyethylene glycol-epoetin beta (Mircera) has been associated with a risk of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) following a. Brand: Mircera. MIRCERA is indicated for the treatment of anemia associated with CKD in adult patients on dialysis and adult patients not on dialysis. Aranesp (darbepoetin alfa) | Dosing Considerations 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. (PDF) Amgen Business Review - library.corporate-ir.netlibrary.corporate Firstly, the study sample was drawn largely from a single country (France), which contributed over 70% of the patients and 10 of the 14 study sites. Of the 302 patients enrolled, 206 (68%) were included in the DCR analysis. 2014 Dec 8;2014(12):CD010590. 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. Data were collected from 7 months before until 7 months after switching treatment. 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. Erythropoiesis-stimulating agents (epoetin alfa, beta, theta and zeta Mircera solution for injection in pre-filled syringe - Summary of Do not pool unused portions from the prefilled syringes. Disclaimer. The study comprised a 14-month observation period. Administer Mircera as an intravenous injection at the dose (in micrograms) based on the total weekly ESA dose at the time of conversion (see Table 2). 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. Mircera (methoxy polyethylene glycol / epoetin beta) dosing - Medscape 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. Results: Recombinant human erythropoietin is effective in volume30,pages 10071017 (2013)Cite this article. Do not use the prefilled syringe more than once. Horowitz J, Agarwal A, Huang F, Gitlin M, Gandra SR, Cangialose CB. 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. 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). In CKD, anemia results primarily from decreased production of endogenous erythropoietin (EPO) by the kidney [3]. The primary outcome measure, the geometric mean maintenance DCR, was calculated to be 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. 2004;19(Suppl 2):ii1631. 2002;17(Suppl 5):6670. 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. The data from this study were analyzed using SAS Statistical Software v9.2 (SAS Institute Inc., Cary, NC, USA). St. Gallen, Switzerland: Vifor (International) Inc.; June 2018. Methoxy polyethylene glycol-epoetin beta - Wikipedia Macdougall IC. 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. Cochrane Database Syst Rev. Mircera | definition of Mircera by Medical dictionary RBC transfusions were reported in terms of number of transfusions and number of units transfused, using descriptive statistics. 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. A single hemoglobin excursion may not require a dosing change. The AFFIRM study was designed as a retrospective, longitudinal cohort analysis to estimate the DCR in a population of hemodialysis patients achieving comparable Hb after switching from IV DA to IV PEG-Epo in a real-world setting. 2021 Jan;26(1):46-53. doi: 10.1111/nep.13765. Anemia: an early complication of chronic renal insufficiency. In contrast, in the STRIATA study where stable hemodialysis patients receiving IV DA were randomized to Q2W PEG-Epo (outside current label guidance) or to continue on DA QW or Q2W, median PEG-Epo doses were described as stable across the 52-week post-switch period, although mean dose data were not reported [12]. An additional analysis was performed to explore the effect of transfusions on the DCR, by exclusion of patients with a transfusion within 90days prior to or during either EP from the analysis. -, Eschbach JW, Adamson JW. 1985;28:15. Most frequent adverse reactions (5%) in adult patients with CKD treated with MIRCERA. Accessed 18 October 2013. Aranesp and EPOGEN increase the risk of seizures in patients with CKD. Accessed 18 October 2013. afK ] T z"$qu9H$}W//~||!+iO7^Q)|F.j+m ZJ7CY\7\lO7OGPno? Mircera (methoxy polyethylene glycol-epoetin beta) Mircera belongs to a class of drugs called Hematopoietic Growth Factors. MIRCERA Dosage & Rx Info | Uses, Side Effects - MPR Changes in ESA dosing and number of transfusions post-switch may have important health-economic implications. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. doi: 10.1093/ndt/17.suppl_5.66. The primary finding of the study is that the DCR of PEG-Epo to DA was 1.17 (95% CI 1.05, 1.29). mircera to aranesp conversion - palace-travel.com Use the Previous and Next buttons to navigate the slides or the slide controller buttons at the end to navigate through each slide. FOIA 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). Please know that Amgen, the sponsor of this site, is not responsible for the content on the site you are about to enter. Janet Addison is an employee of Amgen with Amgen stock options. Report to the Judicial Council. Visit. 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. This article does not contain any studies with human or animal subjects performed by any of the authors. EPOGEN from multidose vials contains benzyl alcohol and is contraindicated in neonates, infants, pregnant women, and lactating women. Mircera: Uses, Taking, Side Effects, Warnings - Medicine.com Disposition of patients. 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. 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. Evaluate the iron status in all patients before and during treatment. A motion conversion mechanism 123 includes a yoke 153 and a rotatable member 149, which causes the yoke 152, . HHS Vulnerability Disclosure, Help 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). Aranesp Dosing and Conversion Brochure | Amgen Anemia Hub Unauthorized use of these marks is strictly prohibited. Mean Hb was 11.5 g/dL in the pre-switch EP and 11.4 g/dL in the post-switch EP. Dr. Gerald Diaz @GeraldMD. Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. Bethesda, MD 20894, Web Policies NCI CPTC Antibody Characterization Program, Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. Active ingredient: methoxy polyethylene glycol-epoetin beta Inactive ingredients: mannitol, methionine, poloxamer 188, sodium phosphate monobasic monohydrate, and sodium sulfate. -. Please enable it to take advantage of the complete set of features! Am J Kidney Dis. In responding to hypoxia, erythropoietin interacts with erythroid progenitor . maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study. BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (n=205). However, the relationship between the pre- and post-switch ESA doses during the two evaluation periods was non-linear. Bland JM, Altman DG. 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. Once the hemoglobin has been stabilized, MIRCERA, If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of MIRCERA. 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. 2 0 obj 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.
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