Decreases in dose can occur more frequently. 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 . Results: 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. 1MIRCERA [prescribing information]. 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. This analysis indicated that the concordance decreased with increasing dose. Methoxy polyethylene glycol-epoetin beta injection causes the . 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. 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 Mircera at Best Price in India - IndiaMART Epub 2022 Apr 22. History of serious or severe allergic reactions to Mircera (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). 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. 6); the mean (SD) Hb within 14days prior to transfusion in these periods was 8.8 (1.41) and 8.3 (1.26), respectively. 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. More severe cases were recorded with long-acting agents (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta). Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (19881994) Arch Intern Med. 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. 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 . Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. The intravenous route is recommended for patients on hemodialysis because the intravenous route may be less immunogenic. Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. American Society of Hematology Self-Assessment Program (Adam - Scribd DCR geometric mean maintenance dose conversion ratio, EP evaluation period, ESA erythropoiesis-stimulating agent, Hb hemoglobin, PEG-Epo methoxy polyethylene glycol-epoetin beta. 2. -, Macdougall IC. endobj Administer Mircera either intravenously or subcutaneously in adult patients and only intravenously in pediatric patients. Table 1 Mircera Starting Doses for Adult Patients Currently Receiving an ESA, Table 2 Mircera Starting Doses for Pediatric Patients Currently Receiving an ESA. Geometric mean weekly PEG-Epo dose at Month 1 post-switch was 26.7g (95% CI 24.4, 29.3), rising to 29g (95% CI 26.2, 32.2) by Month 7 post-switch. 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). EPOGEN from multidose vials contains benzyl alcohol and is contraindicated in neonates, infants, pregnant women, and lactating women. This medicine is not used to treat anemia caused by cancer medicines. The primary outcome measure, the geometric mean maintenance DCR, was calculated to be 1.17 (95% CI 1.05, 1.29). . 2002;17(Suppl 5):6670. Most frequent adverse reactions (5%) in adult patients with CKD treated with MIRCERA. RBC transfusions were reported in terms of number of transfusions and number of units transfused, using descriptive statistics. Editorial assistance in the preparation of this manuscript was provided by W. Mark Roberts, PhD, Montreal, Canada. 2001;38:80312. (PDF) Amgen Business Review - library.corporate-ir.netlibrary.corporate Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. 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. Google Scholar. risks. Conversion from Another ESA: dosed once every 4 weeks based on total Nick Manamley, MSc, is an employee of Amgen with Amgen stock ownership. 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. Secondly, the DCR was calculated on a subset of patients which constituted approximately two-thirds of the total enrolled. 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. 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. Active ingredient: methoxy polyethylene glycol-epoetin beta Inactive ingredients: mannitol, methionine, poloxamer 188, sodium phosphate monobasic monohydrate, and sodium sulfate. For lack or loss of hemoglobin response to Aranesp or EPOGEN, initiate a search for causative 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). endobj Mircera (methoxy polyethylene glycol-epoetin beta) 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. Amgen Business Review November 7, 2008 Strategic Outlook Kevin Sharer CEO 3 Provided November 7, 2008 as part of an oral presentation and is qualified by such, contains forward-looking | DOWNLOAD SIZE: MIRCERA Interactions: May require increased anticoagulation (heparin) during hemodialysis. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. . Am J Kidney Dis. Red blood cell transfusions pre- and post-switch were quantified. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Brand: Mircera. Visit. 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. Excluding patients receiving a transfusion within 90 days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). Mircera (methoxy polyethylene glycol-epoetin beta) Summary of product characteristics. The .gov means its official. 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]. Do not pool unused portions from the prefilled syringes. Accessed 18 October 2013. 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). [3] It is the first approved, chemically modified erythropoiesis-stimulating agent (ESA). 1985;28:15. Show detailed description Study Design Go to 2013;28:10929. 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). MIRCERA [prescribing information]. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. In responding to hypoxia, erythropoietin interacts with erythroid progenitor . The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). )E]$&m"t "N5LQmgh-QZi`T0 hacpBYKUYRw@aMB/|n|'Y#h$8]#|zf. Tel: +1-650-344-3898 | Fax: +1-888-256-8883 | Email: info@palace-travel.com | | | LOG IN Report to the Judicial Council. 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. 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. m+KqXAXOkS@,1C0VgzXzeWU},4 Values are means (arithmetic for hemoglobin, geometric for dose) with 95% confidence intervals. Differentiating factors between erythropoiesis-stimulating agents: an update to selection for anaemia of chronic kidney disease. 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. Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. Article adult patients on dialysis and adult patients not on dialysis. 10PAGE BROCHURE Goodkin DA, Zhao J, Cases A, Nangaku M, Karaboyas A. 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. The geometric mean weekly ESA doses were 24.1 g DA in the pre-switch EP and 28.6 g PEG-Epo in the post-switch EP. Methoxy polyethylene glycol-epoetin (Mircera ) will be increased and decreased in 1-step or 2-step increments, based on scale above. 1. Accounting for the effect of transfusion, the DCR was 1.21 (95% CI 1.09, 1.35). 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. 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. The data from this study were analyzed using SAS Statistical Software v9.2 (SAS Institute Inc., Cary, NC, USA). 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). Nephrol Dial Transplant. Mircera will be administered IV to HD patients, and SC to PD patients. eCollection 2020 Jun. National Library of Medicine All groups were assessed at the end of the study for safety and efficacy parameters. FDA approves Mircera for anemia associated with chronic kidney disease 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. 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. In controlled clinical trials of patients with CKD comparing higher hemoglobin targets (13 to 14 g/dL) to lower targets (9 to 11.3 g/dL), ESAs increased the risk of death, myocardial infarction, stroke, congestive heart failure, thrombosis of hemodialysis vascular access, and other thromboembolic events in the higher target groups. 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. For patients who do not respond adequately over a 12-week escalation period, increasing the MIRCERA, Evaluate other causes of anemia. The dose of Mircera, given as a single intravenous or subcutaneous injection, should be based on the 2002;17(Suppl 5):6670. What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? 1986;327:30710. Do not pool unused portions from the prefilled syringes. Dose Conversion Ratio in Hemodialysis Patients Switched from Darbepoetin Alfa to PEG-Epoetin Beta: AFFIRM Study, https://doi.org/10.1007/s12325-013-0063-y, CERA conversion to darbepoetin alfa in 154 hemodialysis patients, Long-term maintenance of hemoglobin levels in hemodialysis patients treated with bi-weekly epoetin beta pegol switched from darbepoetin alfa: a single-center, 12-month observational study in Japan, Efficacy, tolerability and safety of darbepoetin alfa injection for the treatment of anemia associated with chronic kidney disease (CKD) undergoing dialysis: a randomized, phase-III trial, Safety of Roxadustat Versus Erythropoiesis-Stimulating Agents in Patients with Anemia of Non-dialysis-Dependent or Incident-to-Dialysis Chronic Kidney Disease: Pooled Analysis of Four Phase 3 Studies, Initial responsiveness to darbepoetin alfa and its contributing factors in non-dialysis chronic kidney disease patients in Japan, Comparison of darbepoetin alpha and recombinant human erythropoietin for treatment of anemia in pediatric chronic kidney disease: a non-inferiority trial from India, Comparative Safety of Originator and Biosimilar Epoetin Alfa Drugs: An Observational Prospective Multicenter Study, In Search of Predictors of Switching Between Erythropoiesis-Stimulating Agents in Clinical Practice: A Multi-Regional Cohort Study, Mixed hemodiafiltration reduces erythropoiesis stimulating agents requirement in dialysis patients: a prospective randomized study, http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000332/WC500026149.pdf, http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000739/WC500033672.pdf, https://creativecommons.org/licenses/by/2.0. Pure red cell aplasia (PRCA) that begins after treatment with Mircera or other erythropoietin protein drugs. Adverse reactions ( 10%) in Aranesp clinical studies in patients with CKD were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension. 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). In pediatric patients, Mircera is administered by intravenous injection only (2.2). ?z_IxD1&S&L)@g7NI\H |a_,I17KFu[7+n h?b}xqm5Ed]N8+3ei^Rh/0up20]S=NoPAN$Z$L+u'Hp5v;'QyBQT 8}"{=xVqe)gR&yOs^sfT#B cf#xF`=bXMdCV?s&KS|`q9HT=,[='q6s1UE J$KxBE hg*~'ct'p|YTs1c->uLd_614J)q)g>QR`~*B9GewhNBPs j "It(Y%kRz}=!ayvw^`c]n986kR+LBZ:l~(hf !|p)-b=@|] aRQ:SIRwn$Ip 8v-S"-j0G;r:@ElyDkDE#4H~n{x4P*jS '.P4F lZhBW0t*1b`&wIU_=(>|@"1A`. Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. NCI CPTC Antibody Characterization Program, Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. 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. Mircera is administered by subcutaneous (SC) or intravenous (IV) injection (2.2). 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. Mircera | European Medicines Agency Article 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 . 3. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Erythropoiesis-stimulating agents (epoetin alfa, beta, theta and zeta Introduction: In CKD, anemia results primarily from decreased production of endogenous erythropoietin (EPO) by the kidney [3]. 2). and transmitted securely. 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. Peter Choi. Methoxy polyethylene glycol-epoetin beta, the active substance of MIRCERA, is a continuous erythropoietin receptor activator that shows a different activity at the receptor level characterized by a slower association to and faster dissociation from the receptor, a reduced specific activity in vitro with an increased activity in vivo, as well as an increased half-life, in contrast to . PDF Methoxy polyethylene glycol-epoetin beta (Mircera ) Protocol Strength: 100 mcg / 0.3ml. Dose conversion ratio in hemodialysis patients switched from Careers. MIRCERA is indicated for the treatment of anemia associated with CKD in adult patients on dialysis and adult patients not on dialysis. BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (. as a substitute for red blood cell transfusions in patients who require immediate correction of anemia. Randomized clinical studies have reported data on switching from DA to PEG-Epo (Stabilizing haemoglobin TaRgets in dialysis following IV C.E.R.A. <> The introduction of exogenous erythropoiesis-stimulating agents (ESAs) to clinical practice has transformed the care of patients with CKD, by ameliorating anemia, reducing transfusion requirements, and improving quality of life [4]. darbepoetin alfa (Aransep) pre-filled syringe, injectable vial epoetin alfa (Epogen; Procrit) injectable methoxy polyethylene glycol-epoetin beta (Mircera) pre-filled syringe Conditions Medications Dialysis patients can . 3 DOSAGE FORMS AND STRENGTHS. Google Scholar. Mircera Injection: Uses, Dosing & Side Effects - Drugs.com 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. RETACRIT Dosage Forms and Strengths (epoetin alfa-epbx) 2002;162:14018. Monitor patients closely for new-onset seizures, premonitory symptoms, or change in seizure frequency. Evaluation of Iron Stores and Nutritional Factors. Pharmacotherapy Update - Automatic Therapeutic Interchange Program 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. Anemia: an early complication of chronic renal insufficiency. PDF Anmie chez l'insuffisant rnal : comment utiliser les agents stimulant 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%. Kidney Int. Publication management support was provided by Caterina Hatzifoti, PhD, of Amgen Europe GmbH. 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. PubMed Resistance to Erythropoiesis-Stimulating Agents among Patients on Hemodialysis Is Typically Transient. No test of statistical significance was performed on any of the clinical characteristics. Mircera is not the same as epoetin alfa (Procrit, Epogen). This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (n=205). Slider with three articles shown per slide. Of the 302 patients enrolled, 206 (68%) were included in the DCR analysis. Before For recommended dose equivalency, see Tables A and B (below). Department of Nephrology, John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, 2305, Australia, Amgen (Europe) GmbH, Dammstrasse 23, P.O. 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 In the absence of PRCA, follow dosing recommendations for management of patients with an insufficient response to MIRCERA, 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 the postmarketing setting in patients treated with MIRCERA, PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which MIRCERA, If severe anemia and low reticulocyte count develop during treatment with MIRCERA, Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, tachycardia, pruritus, skin rash and urticaria have been reported in patients treated with MIRCERA, 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 MIRCERA, Patients may require adjustments in their dialysis prescription after initiation of MIRCERA, Most frequent adverse reactions ( 5%) in adult patients with CKD treated with MIRCERA. volume30,pages 10071017 (2013)Cite this article. Contributed by. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these eCollection 2020 May-Jun. Initial Treatment: 0.6 mcg/kg body weight administered once every two weeks (2.2). Cochrane Database Syst Rev. government site. Internal You are now leaving AnemiaHub.com. Data were also manually reviewed prior to final analysis. 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. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Mechanism of Action. Mircera may be used alone or with other medications. Studies of erythropoietin therapy in patients with chronic anemia of cancer as well as CIA document response rates ranging from ~60% to 85%. 2023Vifor (International) Inc. All rights reserved. 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. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Do not use the prefilled syringe more than once. pure red cell aplasia (PRCA) that begins after treatment with MIRCERA or other erythropoietin protein drugs. Descriptions. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Bookshelf Anemia of end-stage renal disease (ESRD) Kidney Int. You may also report negative side effects of prescription drugs to the Food and Drug Administration (FDA). 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. species. 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. The regression analysis that examined the relationship between mean weekly ESA doses in the two evaluation periods indicated that the DCR is not linear; a significant (P=0.008) quadratic term was observed in the regression analysis, indicating that the predicted DCR decreased at higher pre-switch doses of DA (Fig. Disposition of patients. Mircera: Basics, Side Effects & Reviews - GoodRx - , . This medicine is not for treating anemia caused by cancer chemotherapy. Mircera solution for injection in pre-filled syringe The geometric mean weekly ESA doses were 24.1g DA in the pre-switch EP and 28.6g PEG-Epo in the post-switch EP. 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. WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE. 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. Do you wish to proceed? Data quality and completeness were aided by automatic edit checks built into the database software. 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. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Each pre-filled syringe contains 0.3 ml or 0.6 ml. -, Eschbach JW, Adamson JW. Asterisk Not all transfusions had an associated hemoglobin concentration in the 14-day period before transfusion. Generic name: Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL in the treatment of anemia due to cancer chemotherapy. 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. Dose by Weight Chart - Resourcehub Epogen Dosage Guide - Drugs.com Epogen, Procrit (epoetin alfa) dosing, indications, interactions 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). Packaging Size: 0.3 ml. stream Recombinant human erythropoietins: very rare risk of severe cutaneous