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. Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. 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. RETACRIT Dosage and Administration (epoetin alfa-epbx) Data quality and completeness were aided by automatic edit checks built into the database software. 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]. This study and the article processing charges were funded by Amgen Europe GmbH, Zug, Switzerland. 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). 2023 Springer Nature Switzerland AG. All calculations should be confirmed before use. Dose by Weight Chart - Resourcehub Epogen Dosage Guide - Drugs.com Epogen, Procrit (epoetin alfa) dosing, indications, interactions Conversion from epoetin beta to darbepoetin: what is the equivalent Show detailed description Study Design Go to 2008;23:365461. . randomized patients to darbepoetin or epoetin beta once weekly after the patients had been treated with epoetin beta three times weekly. eCollection 2020 May-Jun. ?Ij{JVv:oC*#]}V#$M_T.zC>~] L%lq[Tn`QbWB./@ClVgrk)U-j#(0(D RETACRIT Dosage Forms and Strengths (epoetin alfa-epbx) 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). [citation needed] Methoxy polyethylene glycol-epoetin (Mircera ) will be increased and decreased in 1-step or 2-step increments, based on scale above. Decreases in dose can occur more frequently. Resistance to Erythropoiesis-Stimulating Agents among Patients on Hemodialysis Is Typically Transient. 3 DOSAGE FORMS AND STRENGTHS. 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. 3 0 obj Karaboyas A, Morgenstern H, Fleischer NL, Vanholder RC, Dhalwani NN, Schaeffner E, Schaubel DE, Akizawa T, James G, Sinsakul MV, Pisoni RL, Robinson BM. Aranesp Dosing and Conversion Brochure | Amgen Anemia Hub Erythropoietins: A common mechanism of action - Academia.edu Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. Among patients switched from DA to PEG-Epo, the mean monthly PEG-Epo dose was increased from 159g at the switch to 263g at Week 26 and 273g at Month 1112 [11]. 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 . Hrl WH. 1: 21% of the excluded patients had died or were lost to follow-up during the post-switch period; 45% were no longer receiving PEG-Epo by Months +6 and +7 post-switch; and 34% had no Hb value reported for one or both EPs. 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. Evaluation of Iron Stores and Nutritional Factors. doi: 10.1093/ndt/17.suppl_5.66. Treatment: Treat to anemia in people with chronic kidney disease. This site needs JavaScript to work properly. Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. FDA approves Mircera for anemia associated with chronic kidney disease 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. 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]. Carrera F, Lok CE, de Francisco A, et al. Am J Kidney Dis. Aztec notes.docx - The kidneys are the primary organ of the 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). 2001;38:80312. Section III: Treatment of renal anaemia. 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. Nephrol Dial Transplant. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. and transmitted securely. 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. The remaining enrolment was at four sites divided between three other countries. 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. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Not all pack sizes may be marketed. Donck J, Gonzalez-Tabares L, Chanliau J, Martin H, Stamatelou K, Manamley N, Farouk M, Addison J. Adv Ther. : | , 2021 Jan;26(1):46-53. doi: 10.1111/nep.13765. Lancet. ARANESP single-dose strengths can be combined 4,* You can more . PDF Limitations of Use Mircera is not indicated and is not recommended for Of the 302 patients enrolled, 206 (68%) were included in the DCR analysis. The number of RBC transfusions and units transfused in the post-switch period was approximately threefold higher compared to the pre-switch period. The number of transfusions and units transfused increased approximately threefold from the pre-switch to the post-switch period. 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. 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). Dose conversion ratio in hemodialysis patients switched from 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. 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. 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. 6); the mean (SD) Hb within 14days prior to transfusion in these periods was 8.8 (1.41) and 8.3 (1.26), respectively. MIRCERA (methoxy polyethylene glycol-epoetin beta) is the first erythropoiesis-stimulating agent (ESA) approved by FDA for once-monthly administration. Recombinant human erythropoietins: very rare risk of severe cutaneous volume30,pages 10071017 (2013)Cite this article. Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp #Pharmacology #Hematology #Nephrology. What is the practical conversion dose when changing from epoetin alfa 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. PDF Aranesp, Epogen, Mircera, Procrit, Retacrit - Cigna Mircera is a prescription medicine used to treat the symptoms of Anemia associated with Chronic Renal Failure. 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. 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. For adverse event reports, please contact us at safety@viforpharma.com,mircera@viforpharma.com or at 1-800-576-8295. Composition: Methoxy Polyethylene Glycol-Epoetin Beta. pediatric patients 5 to 17 years of age on hemodialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA. 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]. Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in patients treated with Aranesp or EPOGEN. Hymes J, Bickimer T, Jackson JH, Bookhart BK, Mody SH, Tak Piech C. Curr Med Res Opin. 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 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). Please click the OK button below to continue. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. 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. 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 [3] It is the first approved, chemically modified erythropoiesis-stimulating agent (ESA). 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. Learn about Mircera, potential side effects, proper use and dosing, and popular alternatives. The relationship between the DA and PEG-Epo doses during the evaluation periods was explored through linear and quadratic regression. 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. Figure4 also displays the mean monthly Hb for those included in the DCR analysis over the study period. Janet Addison is an employee of Amgen with Amgen stock options. 2. 2020 Sep 29;21(1):418. doi: 10.1186/s12882-020-02078-z. About ARANESP (darbepoetin alfa) | Amgen ESA | HCP Mircera solution for injection in pre-filled syringe - Summary of Aranesp (darbepoetin alfa) Summary of product characteristics. Mircera (methoxy polyethylene glycol-epoetin beta) Summary of product characteristics. eCollection 2020 Jun. Nick Manamley, MSc, is an employee of Amgen with Amgen stock ownership. 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. Conversion from darbepoetin or erythropoietin to Mircera 1. These adverse reactions included myocardial infarction and stroke. Immediately and permanently discontinue Aranesp or EPOGEN if a serious allergic Studies of erythropoietin therapy in patients with chronic anemia of cancer as well as CIA document response rates ranging from ~60% to 85%. A motion conversion mechanism 123 includes a yoke 153 and a rotatable member 149, which causes the yoke 152, . A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks. Mean Hb was 11.5 g/dL in the pre-switch EP and 11.4 g/dL in the post-switch EP. 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. 2002;17(Suppl 5):6670. In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL. 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. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study. Aranesp Dosing Calculator75 mcg/kg as an IV or SC injection once every This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. species. before initiating MIRCERA. 2010;25:400917. Conclusion: Locatelli F, Aljama P, Barany P, et al. Dosage form: injection, solution Do not pool unused portions from the prefilled syringes. 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. Conversion Dosing Guide: From epoetin alfa to Aranesp in patients with anemia due to CKD on dialysis. before initiating Mircera [see Warnings and Precautions (5.9)]. -, Macdougall IC. Methoxy polyethylene glycol-epoetin beta | Drugs | BNF | NICE There are limitations in generalizing the findings of this study to the broader hemodialysis population. Procrit dosing calculator | Math Applications No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. 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. AFFIRM demonstrated non-linearity of the dose relationship curve, with DCR decreasing as pre-switch DA dose increased. Each pre-filled syringe contains 0.3 ml or 0.6 ml. 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. 1 0 obj ESAs resulted in decreased locoregional control/progression-free survival and/or overall survival. The site is secure. Please know that the sponsors of this site are not responsible for content on the site you are about to enter. Mean Hb was 11.5g/dL in the pre-switch EP and 11.4g/dL in the post-switch EP. In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL. Bethesda, MD 20894, Web Policies Pfizer's Retacrit, the First Erythropoietin Stimulating - BioSpace 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. In CKD, anemia results primarily from decreased production of endogenous erythropoietin (EPO) by the kidney [3]. Contributed by. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which Aranesp and EPOGEN are not approved). Regression analysis indicated a non-linear relationship between pre- and post-switch ESA doses; DCR decreased with increasing pre-switch DA dose. The geometric mean DCR was 1.17 (95% CI 1.05, 1.29). Do not use the prefilled syringe more than once. Brand: Mircera. Changes in ESA dosing and number of transfusions post-switch may have important health-economic implications. Mircera is not the same as epoetin alfa (Procrit, Epogen). 2023Vifor (International) Inc. All rights reserved. Internal You are now leaving AnemiaHub.com. 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). Statistical methods for assessing agreement between two methods of clinical measurement. PubMedGoogle Scholar. When administered subcutaneously, Mircera should be injected in the abdomen, arm or thigh. 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). When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. aranesp to retacrit conversiontuto amigurumi grenouille au crochet. Mircera solution for injection in pre-filled syringe Patients can also have iron-deficiency anemia and need iron replacement using one of the supplements listed in the previous Electrolytes and Minerals section of this lesson. 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 . Always store Mircera prefilled syringes in their original cartons. sharing sensitive information, make sure youre on a federal For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. EP evaluation period, PEG-Epo methoxy polyethylene glycol-epoetin beta. This medicine is not used to treat anemia caused by cancer medicines. 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. If Hgb remains >= 12 g/dL for more than 2 months, return to regular Hgb testing policy. Please see full Prescribing Information including Boxed WARNING, and Medication Guide for MIRCERA (methoxy polyethylene glycol-epoetin beta) Injection, for Intravenous or Subcutaneous Use. Aranesp (darbepoetin alfa) Epogen (epoetin alfa) Mircera . Individualize dosing and use the lowest dose of MIRCERA. 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. Correspondence to 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. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events. 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. Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. (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. 10PAGE BROCHURE For Pediatric Patients with CKD on hemodialysis: Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Pediatric Patients with CKD Treated with Hemodialysis. Dr. Peter Choi is the guarantor for this article, and takes responsibility for the integrity of the work as a whole. A decade in the anaemia market - 10 products seen top . doi: 10.1002/14651858.CD010590.pub2. Recombinant human erythropoietin is effective in 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. MIRCERA- methoxy polyethylene glycol-epoetin beta 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. However, healthcare-resource utilization and cost data were not collected in this study, preventing comparison of these variables between the pre-switch and post-switch periods. 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). Do not increase the dose more frequently than once every 4 weeks. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. 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)]. Control hypertension prior to initiating and during treatment with Aranesp or EPOGEN. Reasons for exclusion of 96 enrolled patients from the DCR analysis are presented in 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%. Google Scholar. (PDF) Amgen Business Review - library.corporate-ir.netlibrary.corporate See this image and copyright information in PMC. Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. Intravenous C.E.R.A. Excluding patients receiving a transfusion within 90 days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). Conclusion: A dose approximating 0. 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. *Data from a multicenter, randomized, open-label study comparing epoetin, given 1, 2, or 3 times weekly IV or SC, with ARANESP , at a reduced dose frequency, in dialysis patients (N = 522).Dose adjustments were made as necessary and per study protocol to maintain individual patients' Hb within a target range of -1.0 to +1.5 g/dL of their baseline Hb and between 9 g/dL and 13 g/dL for up . PDF beta (Mircera ) Protocol - Northwest Kidney Centers Federal government websites often end in .gov or .mil. St. Gallen, Switzerland: Vifor (International) Inc.; June 2018. 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. Article Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Adult Patients with CKD. Packaging Type: Injection. Association of erythropoietin resistance and fibroblast growth factor 23 in dialysis patients: Results from the Japanese Dialysis Outcomes and Practice Patterns Study. Pure red cell aplasia (PRCA) that begins after treatment with Mircera or other erythropoietin protein drugs. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. 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. 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. PDF Anemia response to Methoxy Polyethylene Glycol-Epoetin Beta (Mircera Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. CAS 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. 4 0 obj Examine each prefilled syringe for the expiration date. No difference in conversion dosage could be determined between patients who were epoetin sensitive (<200 units/kg per week) or resistant (>200 units/kg per week, P = NS).
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