Mircera belongs to a class of drugs called Hematopoietic Growth Factors. 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). 4. as a substitute for red blood cell transfusions in patients who require immediate correction of anemia. 4! 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. 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). <> Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. Hrl WH. Disclaimer. This medicine is not used to treat anemia caused by cancer medicines. 2022;53(5):333-342. doi: 10.1159/000523947. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Individualize dosing and use the lowest dose of MIRCERA. Regression analysis indicated a non-linear relationship between pre- and post-switch ESA doses; DCR decreased with increasing pre-switch DA dose. Unauthorized use of these marks is strictly prohibited. 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. There were 16 transfusions and 34 units transfused in the pre-switch period, versus 48 transfusions and 95 units transfused post-switch. Statistical methods for assessing agreement between two methods of clinical measurement. Monitor patients closely for new-onset seizures, premonitory symptoms, or change in seizure frequency. 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. Accounting for the effect of transfusion, the DCR was 1.21 (95% CI 1.09, 1.35). Nephrol Dial Transplant. Kazmi WH, Kausz AT, Khan S, et al. 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. eCollection 2020 Jun. 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. Excursions of Hb values above and below the range of 1012g/dL [9] were more common in the post-switch compared to the pre-switch period. Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. All groups were assessed at the end of the study for safety and efficacy parameters. Before doi: 10.1053/j.ajkd.2011.11.013. 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 . Mircera is packaged as single-dose prefilled syringes. 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. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. AFFIRM demonstrated non-linearity of the dose relationship curve, with DCR decreasing as pre-switch DA dose increased. However, the relationship between the pre- and post-switch ESA doses during the two evaluation periods was non-linear. ?Ij{JVv:oC*#]}V#$M_T.zC>~] L%lq[Tn`QbWB./@ClVgrk)U-j#(0(D Not all pack sizes may be marketed. 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. 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. MIRCERA is indicated for the treatment of anemia associated with CKD in adult patients on dialysis and adult patients not on dialysis. Mircera contains no preservatives. Article Mircera works like the human protein called erythropoietin to help your body make more RBCs. Aranesp and EPOGEN have not been shown to improve quality of life, fatigue, or patient well-being. Article Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp #Pharmacology #Hematology #Nephrology. For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. RBC transfusions were reported in terms of number of transfusions and number of units transfused, using descriptive statistics. 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. The study comprised a 14-month observation period. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. Am J Kidney Dis. 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). 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. Regardless of possible differences in their clinical characteristics it should be borne in mind that patients were not selected for inclusion in the DCR analysis on the basis of their fulfilling any clinical, Hb or ESA dose requirements: all patients who had Hb measurements in both EPs, a DA dose in the pre-switch EP and a PEG-Epo dose in the post-switch EP were eligible for inclusion. 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. 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. Epub 2014 Nov 1. Anemia of end-stage renal disease (ESRD) Kidney Int. Tolman et al. Accessed 18 October 2013. What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? This compares with a 35% decline in Epogen sales during the same period to $1.13bn, as competition from Mircera and biosimilars, like by Sandoz' Binocrit, reach the markets. I certify that I am a healthcare professional in the US. Disposition of patients. ARANESP (darbepoetine alfa) 1 injection/sem. Do not pool unused portions from the prefilled syringes. Of the 29 patients transfused during the post-switch period, 20 had a dose ratio at switch <1, and 9 had a dose ratio at switch 1 (odds ratio 2.39, 95% CI 1.05, 5.44; P=0.038). maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study. 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]. Methods: 2002;17(Suppl 5):6670. There were 16 transfusions and 34 units transfused in the pre-switch period, versus 48 transfusions and 95 units transfused post-switch. 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]. A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks. Anemia Associated with Chronic Renal Failure, Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL, Drug class: recombinant human erythropoietins. For adverse event reports, please contact us at safety@viforpharma.com,mircera@viforpharma.com or at 1-800-576-8295. ESA erythropoiesis-stimulating agent, Hb hemoglobin. Of 302 patients enrolled, 206 had data available for DCR analysis. Figure4 also displays the mean monthly Hb for those included in the DCR analysis over the study period. Preservation of anemia control and weekly ESA dosage after conversion from PEG-Epoetin beta to darbepoetin alfa in adult hemodialysis patients: the TRANSFORM study. Initial Treatment: 0.6 mcg/kg body weight administered once every two weeks (2.2). For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. Excluding patients receiving a transfusion within 90days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). Each pre-filled syringe contains 0.3 ml or 0.6 ml. 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. Federal government websites often end in .gov or .mil. Most frequent adverse reactions (5%) in adult patients with CKD treated with MIRCERA. Red blood cell transfusions pre- and post-switch, Summary of the last hemoglobin concentrations recorded within 14days prior to red blood cell transfusions pre- and post-switch. EP evaluation period, PEG-Epo methoxy polyethylene glycol-epoetin beta. BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (. If Hb increases by < 1 g/dL and remains < 10 g/dL after 6 weeks of therapy: If dosing QW, then increase dose to 4.5 mcg/kg/week. 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. Individual patients could contribute multiple transfusions to these analyses. A total of 302 eligible patients were enrolled at 14 European hemodialysis centers, with 57% of patients enrolled at 10 French sites, 18% at 2 Spanish sites, 17% at 1 UK site, and 8% at 1 German site. A motion conversion mechanism 123 includes a yoke 153 and a rotatable member 149, which causes the yoke 152, . OK If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of MIRCERA. 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). Therapeutic effects . Discard any unused portion. Discontinue MIRCERA, When administered subcutaneously, MIRCERA. Descriptions. PubMedGoogle Scholar. 1. MIRCERA is a registered trademark of F. Hoffmann-La Roche Ltd. All Vifor Pharma Groups intellectual rights, including copyright, are, The information provided in this site is intended only for healthcare. Strength: 100 mcg / 0.3ml. - , . PMC Article 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. - 94.130.71.173. Please click to see accompanying Aranesp full prescribing information and EPOGEN full prescribing information, including Boxed WARNINGS and Medication Guide. Excluding patients receiving a transfusion within 90 days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. Mean Hb was 11.5 g/dL in the pre-switch EP and 11.4 g/dL in the post-switch EP. Pharmacokinetic studies have shown that the meanSD terminal half-life of DA is 217.5h when administered intravenously (IV) [7]. Nephrol Dial Transplant. For recommended dose equivalency, see Tables A and B (below). <> The remaining enrolment was at four sites divided between three other countries. The primary outcome measure, the geometric mean maintenance DCR, was calculated to be 1.17 (95% CI 1.05, 1.29). 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. 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. species. Aranesp (darbepoetin alfa) prescribing information, Amgen. 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. https://doi.org/10.1007/s12325-013-0063-y, DOI: https://doi.org/10.1007/s12325-013-0063-y. <>/Metadata 444 0 R/ViewerPreferences 445 0 R>> endobj At the moment forecasts for Mircera are $345m in 2015 rising to $552m in 2020, reflecting sales made outside the US. A brochure to help you understand how to dose and administer Aranesp, and to convert from epoetin alfa to Aranesp in patients with anemia due to CKD. 2021 Jan;26(1):46-53. doi: 10.1111/nep.13765. 2012 Jun;27(6):2303-11. doi: 10.1093/ndt/gfr677. Red blood cell transfusions pre- and post-switch were quantified. Reasons for exclusion of 96 enrolled patients from the DCR analysis are presented in Fig. 2). 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. Epoetin alfa (Procrit, Epogen) acts like the hormone we have in our body, whereas Mircera . 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. Evaluate the iron status in all patients before and during treatment. Secondary outcomes included Hb concentrations and ESA use during the study period, and the incidence of red blood cell (RBC) transfusions. Mircera will be administered IV to HD patients, and SC to PD patients. 2012;59:444451. Control hypertension prior to initiating and during treatment with Aranesp or EPOGEN. Anemia: an early complication of chronic renal insufficiency. Anemia: an early complication of chronic renal insufficiency. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Use the Previous and Next buttons to navigate the slides or the slide controller buttons at the end to navigate through each slide. 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. The conversion from EpoB to CERA (methoxy polyethylene glycol-epoetin beta; Mircera; Hoffmann-La Roche Ltd., Basel, Switzerland) once monthly was already decided by the health care payer policy, who is the provider of erythropoietin stimulating agents for all patients, and was planned after a period of 6 months. MIRCERA comes in pre-filled syringes with laminated plunger stopper and tip cap with one needle 27G1/2. 1:1 reference line indicates equal PEG-Epo and darbepoetin alfa doses. Pure red cell aplasia (PRCA) that begins after treatment with MIRCERA, History of serious or severe allergic reactions to MIRCERA. 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. For Adult Patients with CKD not on dialysis: Refer patients who self-administer Mircera to the Instructions for Use [see Patient Counseling Information (17)]. No test of statistical significance was performed on any of the clinical characteristics. 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. Department of Nephrology, John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, 2305, Australia, Amgen (Europe) GmbH, Dammstrasse 23, P.O. 5). 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. Examine each prefilled syringe for the expiration date. Methoxy polyethylene glycol-epoetin beta injection causes the . Disposition of patients. The geometric mean weekly dose of DA was 23.2g (95% CI 20.6, 26.3) in the month prior to switch. This was particularly evident in patients whose pre-switch EP weekly DA dose was higher than 100g. This medicine is not for treating anemia caused by cancer chemotherapy. The data from this study were analyzed using SAS Statistical Software v9.2 (SAS Institute Inc., Cary, NC, USA). afK ] T z"$qu9H$}W//~||!+iO7^Q)|F.j+m ZJ7CY\7\lO7OGPno? Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. 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). Decreases in dose can occur more frequently. Hb concentrations were reported as arithmetic means for each month. The conversion rate was 354:1 in patients requiring high (>200 IU/kg/week) doses of epoetin and 291:1 in patients requiring low doses. Recombinant human erythropoietin is effective in Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Adult Patients with CKD. reaction occurs. NCI CPTC Antibody Characterization Program, Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. 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. In the month immediately prior to switch, the proportions of patients who had Hb below 10, 1012, and above 12g/dL were 7.3%, 54.4%, and 25.7%, respectively, with 12.6% missing. Clin Kidney J. 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. -, Kazmi WH, Kausz AT, Khan S, et al. 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. Mechanism of Action. 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. When administered subcutaneously, Mircera should be injected in the abdomen, arm or thigh. Conversion from Another ESA: dosed once every 4 weeks based on total [citation needed] endobj . Data were collected from 7months before until 7months after switching treatment. Do you wish to proceed? Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with Aranesp or EPOGEN. BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (n=205). Google Scholar. 8600 Rockville Pike Karaboyas A, Morgenstern H, Waechter S, Fleischer NL, Vanholder R, Jacobson SH, Sood MM, Schaubel DE, Inaba M, Pisoni RL, Robinson BM. A single hemoglobin excursion may not require a dosing change. Editorial assistance in the preparation of this manuscript was provided by W. Mark Roberts, PhD, Montreal, Canada. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. Each dosage strength of MIRCERA is designated by a unique syringe plunger color. This suggests that the decision to transfuse was consistent with respect to Hb over the observation period (Fig. 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. 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). Treatment: Treat to anemia in people with chronic kidney disease. 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. 2013;28:10929. 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. Bookshelf Packaging Type: Injection. 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. 10PAGE BROCHURE Donck J, Gonzalez-Tabares L, Chanliau J, Martin H, Stamatelou K, Manamley N, Farouk M, Addison J. Adv Ther. . Table 1 Mircera Starting Doses for Adult Patients Currently Receiving an ESA, Table 2 Mircera Starting Doses for Pediatric Patients Currently Receiving an ESA. Please know that Amgen, the sponsor of this site, is not responsible for the content on the site you are about to enter. Kidney Med. 2002;17(Suppl 5):6670. 1985;28:15. Macdougall IC. Mircera may be used alone or with other medications. The aims of the Aranesp Efficiency Relative to Mircera (AFFIRM) study were primarily to estimate the maintenance dose conversion ratio (DCR) of PEG-Epo to DA in a population of European hemodialysis patients switched from DA to PEG-Epo and with comparable mean hemoglobin (Hb) in the pre- and post-switch periods, and secondarily to investigate (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. 1MIRCERA [prescribing information]. Patients included in the analysis were less likely to be diabetic (32% vs. 40%), more likely to be receiving DA at a longer dosing interval (60% vs. 73% at QW; 19% vs. 3% less frequently than Q2W), and received a lower geometric mean weekly dose of DA during the pre-switch EP (24.1 vs. 37.7g). Would you like email updates of new search results? 2009 Nov-Dec;15(9):741-50. doi: 10.18553/jmcp.2009.15.9.741. Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. ARANESP single-dose strengths can be combined 4,* You can more . Results of the BlandAltman analysis investigating the concordance between mean weekly ESA doses in both evaluation periods are presented in Fig. Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. 2014 Dec 8;2014(12):CD010590. Choi, P., Farouk, M., Manamley, N. et al. MIRCERA (methoxy polyethylene glycol-epoetin beta) is the first erythropoiesis-stimulating agent (ESA) approved by FDA for once-monthly administration. -. ONLY administer MIRCERA intravenously in pediatric patients. 1986;327:30710. Am J Kidney Dis. Adverse reactions ( 10%) in Aranesp clinical studies in patients with CKD were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension. 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. 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. endobj 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. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. . Pure red cell aplasia (PRCA) that begins after treatment with Mircera or other erythropoietin protein drugs. 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). Mircera is a prescription medicine used to treat the symptoms of Anemia associated with Chronic Renal Failure. Regression analysis indicated a non-linear relationship between pre- and post-switch ESA doses; DCR decreased with increasing pre-switch DA dose. 3 0 obj 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). CAS Unable to load your collection due to an error, Unable to load your delegates due to an error. 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. Learn how to combine multiple dosing options for precise titration and individualize anemia management.1. 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). By Month 7 post-switch, the proportions of patients with Hb in these ranges were 9.7%, 48.1%, and 30.1%, respectively. 2010;25:400917. 2023Vifor (International) Inc. All rights reserved. Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. 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. Dosage form: injection, solution Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Read reviews from GoodRx users who have taken Mircera and find the latest news on the drug. )E]$&m"t "N5LQmgh-QZi`T0 hacpBYKUYRw@aMB/|n|'Y#h$8]#|zf. The geometric mean DCR was 1.17 (95% CI 1.05, 1.29). The geometric mean DCR was 1.17 (95% CI 1.05, 1.29). before initiating Mircera [see Warnings and Precautions (5.9)]. Adv Ther 30, 10071017 (2013). Correspondence to Slider with three articles shown per slide. 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 Do not pool unused portions from the prefilled syringes.