Please click the OK button below to continue. . 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. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Aranesp (darbepoetin alfa), Dynepo (epoetin delta), Mircera (methyoxy polyethylene glycol-epoetin beta), Hematide, MRK-2578, INS-22, Retacrit (epoetin zeta), Neorecormon (epoetin beta), Silapo (epoetin zeta), Binocrit . DCR geometric mean maintenance dose conversion ratio, EP evaluation period, ESA erythropoiesis-stimulating agent, Hb hemoglobin, PEG-Epo methoxy polyethylene glycol-epoetin beta. Anemia Associated with Chronic Renal Failure, Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL, Drug class: recombinant human erythropoietins. The enrolling dialysis centers were situated in France, Germany, Spain and the UK, and each was expected to enroll a minimum of 20 patients into the study. 2010;25:400917. Bookshelf 3. National Library of Medicine Nephrol Dial Transplant. Descriptions. 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). Low hemoglobin at hemodialysis initiation: an international study of anemia management and mortality in the early dialysis period. 33 Dose. 2023 Springer Nature Switzerland AG. methoxypolyethylene glycol-epoetin beta (meh-thok-see-pah-lee-eh-thih-leen gly-kol ee-poh-eh-tin bay-ta) , Mircera (trade name) Classification Therapeutic: antianemics Pharmacologic: hormones Pregnancy Category: C Indications Anemia due to chronic renal failure. Control hypertension prior to initiating and during treatment with Aranesp or EPOGEN. 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. New anemia therapies: translating novel strategies from bench to bedside. 2021 Jan;26(1):46-53. doi: 10.1111/nep.13765. HQ-MIR-1900027 Site last modified: January 2023. doi: 10.1038/ki.1985.109. The number of RBC transfusions and units transfused in the post-switch period was approximately threefold higher compared to the pre-switch period. 2001;38:803812. 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. NCI CPTC Antibody Characterization Program, Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. As the study was entirely retrospective, ESA switching and dose conversion were performed without reference to a study protocol and there was no protocol-driven intervention in the clinical management of patients. The pre-transfusion Hb concentrations were similar for transfusions occurring both pre- and post-switch (Fig. Am J Kidney Dis. <>/Metadata 444 0 R/ViewerPreferences 445 0 R>> 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. 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. Pharmacokinetic studies have shown that the meanSD terminal half-life of DA is 217.5h when administered intravenously (IV) [7]. When a patient with a darbepoetin (Aranesp) or erythropoietin order switches to . The mean (95% CI) monthly Hb immediately prior to switch, in Month 1 post-switch, and in Month 7 post-switch was 11.5g/dL (11.3, 11.7), 11.7g/dL (11.5, 11.9), and 11.4g/dL (11.3, 11.6), respectively. Data 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. Canaud B, Mingardi G, Braun J, et al. 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. MIRCERA (methoxy polyethylene glycol-epoetin beta) is the first erythropoiesis-stimulating agent (ESA) approved by FDA for once-monthly administration. DA can be administered once a week (QW) or once every 2weeks (Q2W) to hemodialysis patients. Anemia response to Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) versus Epoetin Alfa (Eprex) in patients with chronic Kidney disease on Hemodialysis Published: September 05, 2017 42/47 is common in patients with a GFR below 30 ml/min/1.73m2 and contributes to many of the speciic symptoms of CKD. 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. HHS Vulnerability Disclosure, Help aranesp to retacrit conversiontuto amigurumi grenouille au crochet. 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. aMutually exclusive categories; patients are censored in the following order: first at death post-switch, then at loss to follow-up post-switch, then at receipt of an ESA other than PEG-Epo, and finally lack of an Hb measurement in either or both EPs. 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. - 94.130.71.173. Initial Treatment: 0.6 mcg/kg body weight administered once every two weeks (2.2). 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). St. Gallen, Switzerland: Vifor (International) Inc.; June 2018. and transmitted securely. 2002;17(Suppl 5):6670. Nephrol Dial Transplant. Values are means (arithmetic for hemoglobin, geometric for dose) with 95% confidence intervals. 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)]. species. Pure red cell aplasia (PRCA) that begins after treatment with Mircera or other erythropoietin protein drugs. Mourad Farouk is an employee of Amgen with Amgen stock ownership. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. %PDF-1.7 Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Do not use the prefilled syringe more than once. Mircera will be administered IV to HD patients, and SC to PD patients. Mircera belongs to a class of drugs called Hematopoietic Growth Factors. 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. Anemia: an early complication of chronic renal insufficiency. Packaging Type: Injection. 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 . 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. 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. 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. Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit. 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. MIRCERA Interactions: May require increased anticoagulation (heparin) during hemodialysis. 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. 5) shows that most transfusions occurred in the first 4months post-switch. )E]$&m"t "N5LQmgh-QZi`T0 hacpBYKUYRw@aMB/|n|'Y#h$8]#|zf. ribosome A ribonuclear protein complex that binds to mRNA nucleotide A basic . Full Prescribing Information, including Boxed WARNING, full Prescribing Information including Boxed WARNING, How to Use the MIRCERA Prefilled Syringe, Healthcare Provider and Patient Resources, full Prescribing Information, including Boxed WARNING. 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. 20,000 Units/2 mL (10,000 Units/mL) and 20,000 Units/mL of RETACRIT as a clear and colorless liquid in multiple-dose vials (contains benzyl alcohol). All calculations should be confirmed before use. This medicine is not for treating anemia caused by cancer chemotherapy. ARANESP single-dose strengths can be combined 4,* You can more . Action Stimulates erythropoesis (production of red blood cells). 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). reverse transcriptase polymerase chain reaction (RT-PCR) Amplification of RNA sequences by conversion to cDNA by nucleic acid hybridization A technique of nucleic acid reverse transcriptase, followed by the polymerase chain reac-analy sis via association of complementary single- stranded tion. For Pediatric Patients with CKD on hemodialysis: Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Pediatric Patients with CKD Treated with Hemodialysis. 2013;28:10929. Locatelli F, Aljama P, Barany P, et al. The .gov means its official. }"nUEcJumC0ooF Nephrol Dial Transplant. 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). Following administration, remove the needle from the injection site and then release the plunger to allow the needle guard to move up until the entire needle is covered. Disclaimer. Secondly, the DCR was calculated on a subset of patients which constituted approximately two-thirds of the total enrolled. Janet Addison is an employee of Amgen with Amgen stock options. Carrera F, Lok CE, de Francisco A, et al. Mircera would also have competed with Aranesp and with Procrit . Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. More severe cases were recorded with long-acting agents (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta). 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%. 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. 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. Nephrol Dial Transplant. 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. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. Once Every Two Weeks (mcg/every two weeks). In CKD, anemia results primarily from decreased production of endogenous erythropoietin (EPO) by the kidney [3]. 1985;28:15. 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]. Epoetin alfa (Eprex [JanssenCilag], Binocrit [Sandoz], and epoetin zeta (Retacrit, - Hospira UK): the initial dose is 150 IU kg-1 given subcutaneously three times per week.5 -7 Alternatively, epoetin alfa can be administered at an initial dose of 450 IU kg 1 subcutaneously once weekly.5-7 The maximum recommended dose is 900 IU kg-1 See Instructions for Use for complete instructions on the preparation and administration of Mircera. Use the Previous and Next buttons to navigate the slides or the slide controller buttons at the end to navigate through each slide. Avoid frequent dose adjustments. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) Am J Kidney Dis. Mircera is a prescription medicine used to treat the symptoms of Anemia associated with Chronic Renal Failure. 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. 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. Methods: Please click to see accompanying Aranesp full prescribing information and EPOGEN full prescribing information, including Boxed WARNINGS and Medication Guide. Immediately and permanently discontinue Aranesp or EPOGEN if a serious allergic 2023Vifor (International) Inc. All rights reserved. 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. Once the hemoglobin has been stabilized, MIRCERA, If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of MIRCERA. 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. 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. Slider with three articles shown per slide. in the treatment of anemia due to cancer chemotherapy. W\iA* For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. Mircera (methoxy polyethylene glycol-epoetin beta) Summary of product characteristics. For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. Mircera is used to reduce or avoid the need for RBC transfusions. Vigorous shaking or prolonged exposure to light should be avoided. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Of the 302 patients enrolled, 206 (68%) were included in the DCR analysis. Adverse reactions ( 10%) in Aranesp clinical studies in patients with CKD were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension. 6); the mean (SD) Hb within 14days prior to transfusion in these periods was 8.8 (1.41) and 8.3 (1.26), respectively. a Mutually exclusive categories; patients are censored in the following, Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. history of serious or severe allergic reactions to MIRCERA (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). 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. 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. Association of erythropoietin resistance and fibroblast growth factor 23 in dialysis patients: Results from the Japanese Dialysis Outcomes and Practice Patterns Study. 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. Correspondence to Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Pediatric Patients with CKD Treated with Hemodialysis 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. Pure red cell aplasia (PRCA) that begins after treatment with MIRCERA, History of serious or severe allergic reactions 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 patients treated with Aranesp or EPOGEN. MIRCERA [prescribing information]. 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. Mircera Injection (Methoxy Polyethylene Glycol-Epoetin Beta ) 6,610/ Piece Get Latest Price. 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 Administer Mircera either intravenously or subcutaneously in adult patients and only intravenously in pediatric patients. 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. RBC transfusions were reported in terms of number of transfusions and number of units transfused, using descriptive statistics. ferrous sulfate, Aranesp, Procrit, Retacrit. Response rates are defined in two ways: 1) Hgb levels > 12 g/dL or 2) an increase in Hgb of 2 g/dL from baseline. Excluding patients receiving a transfusion within 90 days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). Am J Nephrol. 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 (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. The geometric mean weekly dose of DA was 23.2g (95% CI 20.6, 26.3) in the month prior to switch. 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. Preservation of anemia control and weekly ESA dosage after conversion from PEG-Epoetin beta to darbepoetin alfa in adult hemodialysis patients: the TRANSFORM study. Of 302 patients enrolled, 206 had data available for DCR analysis. 2002;162:14011408. CAS Macdougall IC. 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. Disposition of patients. 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. MIRCERA comes in pre-filled syringes with laminated plunger stopper and tip cap with one needle 27G1/2. 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. A motion conversion mechanism 123 includes a yoke 153 and a rotatable member 149, which causes the yoke 152, . More severe cases were recorded with long-acting agents (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta). Peter Choi, MB BChir, PhD, FRCP (UK), has received lecturing and consulting fees from Amgen, and has participated in advisory boards for Amgen. 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. The geometric mean DCR was 1.17 (95% CI 1.05, 1.29). WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE. Longer-acting PEG-Epo contains a chemical bond between an amino group present in epoetin beta and methoxy polyethylene glycol (PEG) butanoic acid; the addition of PEG is responsible for an increase in serum half-life of epoetin beta, and in CKD patients on dialysis the terminal half-life of PEG-Epo after IV administration is 134h [6, 8]. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. Anemia of end-stage renal disease (ESRD). Most frequent adverse reactions (5%) in adult patients with CKD treated with MIRCERA. Section III: Treatment of renal anaemia. The information provided in this site is intended only for healthcare professionals in the United States. Matsumura K, Okumiya T, Sugiura T, Takahashi N, Yamamoto Y, Kikuchi S, Fujii K, Otagaki M, Shiojima I. BMC Nephrol. -, Kazmi WH, Kausz AT, Khan S, et al. Tables2 and 3 also summarize the proportion of patients in different Hb categories by study month. The number of transfusions and units transfused increased approximately threefold from the pre-switch to the post-switch period. . Department of Nephrology, John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, 2305, Australia, Amgen (Europe) GmbH, Dammstrasse 23, P.O. 4! Support for this assistance was funded by Amgen. Eligible patients had received hemodialysis for 12 months and DA for 7 months. Secondary outcomes included Hb concentrations and ESA use during the study period, and the incidence of red blood cell (RBC) transfusions. 2004;19(Suppl 2):ii1631. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. There are limitations in generalizing the findings of this study to the broader hemodialysis population. 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. 2012 Jun;27(6):2303-11. doi: 10.1093/ndt/gfr677. Nephrol Dial Transplant. Careers. Epub 2011 Dec 2. Hb hemoglobin. Please know that the sponsors of this site are not responsible for content on the site you are about to enter. 1 0 obj Google Scholar. endobj stream 5). Macdougall IC. 2014 Nov;31(11):1155-68. doi: 10.1007/s12325-014-0161-5. Article 3. Dr. Gerald Diaz @GeraldMD. Tel: +1-650-344-3898 | Fax: +1-888-256-8883 | Email: info@palace-travel.com | | | LOG IN See this image and copyright information in PMC. 2). . Please click to see accompanying Aranesp full prescribing information and EPOGEN full prescribing information, including Boxed WARNINGS and Medication Guide. Red blood cell transfusions pre- and post-switch were quantified. Revised European Best Practice Guidelines for the management of anaemia in patients with chronic renal failure. Learn about Mircera, potential side effects, proper use and dosing, and popular alternatives. pure red cell aplasia (PRCA) that begins after treatment with MIRCERA or other erythropoietin protein drugs. Contributed by. At the moment forecasts for Mircera are $345m in 2015 rising to $552m in 2020, reflecting sales made outside the US. This medicine is not used to treat anemia caused by cancer medicines.