Accessed 18 October 2013. 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. 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. 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. This was particularly evident in patients whose pre-switch EP weekly DA dose was higher than 100g. Part of Springer Nature. - , . 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. The initial conversion factor was 200:1. | DOWNLOAD SIZE: 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 parameters of clinical management of anemia in this group of patients, in real-world clinical practice. -, Kazmi WH, Kausz AT, Khan S, et al. Table 1 Mircera Starting Doses for Adult Patients Currently Receiving an ESA, Table 2 Mircera Starting Doses for Pediatric Patients Currently Receiving an ESA. When adjusting therapy, consider hemoglobin rate of rise, rate of decline, ESA responsiveness, and hemoglobin variability. 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). The intravenous route is recommended for patients on hemodialysis because the intravenous route may be less immunogenic. Am J Kidney Dis. The data from this study were analyzed using SAS Statistical Software v9.2 (SAS Institute Inc., Cary, NC, USA). Macdougall IC. 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. Avoid frequent dose adjustments. 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). Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. \ab/`IR 4%jI ^w7qQNA Tq Wz.oVfCVBT{h*>\\3u#P@"wW7|pIMB7 Evaluation of Iron Stores and Nutritional Factors. Secondary outcomes included Hb concentrations and ESA use during the study period, and the incidence of red blood cell (RBC) transfusions. Please know that the sponsors of this site are not responsible for content on the site you are about to enter. 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 . Kidney Med. PMC 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. An official website of the United States government. in the treatment of anemia due to cancer chemotherapy. Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (19881994) Arch Intern Med. 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. 4 0 obj 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. Mircera may be used alone or with other medications. Anemia: an early complication of chronic renal insufficiency. 3 DOSAGE FORMS AND STRENGTHS. 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. Dr. Peter Choi is the guarantor for this article, and takes responsibility for the integrity of the work as a whole. Individualize dosing and use the lowest dose of MIRCERA. Am J Nephrol. Aranesp (darbepoetin alfa) Epogen (epoetin alfa) Mircera . 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). 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. Report to the Judicial Council. AFFIRM demonstrated non-linearity of the dose relationship curve, with DCR decreasing as pre-switch DA dose increased. Tables2 and 3 also summarize the proportion of patients in different Hb categories by study month. Article 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. Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. EP evaluation period, PEG-Epo methoxy polyethylene glycol-epoetin beta. Active ingredient: methoxy polyethylene glycol-epoetin beta Inactive ingredients: mannitol, methionine, poloxamer 188, sodium phosphate monobasic monohydrate, and sodium sulfate. }"nUEcJumC0ooF Figure4 also displays the mean monthly Hb for those included in the DCR analysis over the study period. Goodkin DA, Zhao J, Cases A, Nangaku M, Karaboyas A. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. Adverse reactions ( 10%) in Aranesp clinical studies in patients with CKD were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension. Dosage form: injection, solution A motion conversion mechanism 123 includes a yoke 153 and a rotatable member 149, which causes the yoke 152, . Internal You are now leaving AnemiaHub.com. Before ESAs resulted in decreased locoregional control/progression-free survival and/or overall survival. 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. Matsumura K, Okumiya T, Sugiura T, Takahashi N, Yamamoto Y, Kikuchi S, Fujii K, Otagaki M, Shiojima I. BMC Nephrol. For recommended dose equivalency, see Tables A and B (below). Disposition of 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. The .gov means its official. Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. DA can be administered once a week (QW) or once every 2weeks (Q2W) to hemodialysis patients. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events. 2004;19(Suppl 2):ii1631. This site needs JavaScript to work properly. Do not pool unused portions from the prefilled syringes. 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. Please click the OK button below to continue. Learn about Mircera, potential side effects, proper use and dosing, and popular alternatives. Treatment: Treat to anemia in people with chronic kidney disease. Statistical methods for assessing agreement between two methods of clinical measurement. Provided by the Springer Nature SharedIt content-sharing initiative, Over 10 million scientific documents at your fingertips, Not logged in Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. 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. See this image and copyright information in PMC. Dose Conversion Ratio in Hemodialysis Patients Switched from Darbepoetin Alfa to PEG-Epoetin Beta: AFFIRM Study. aranesp to retacrit conversiontuto amigurumi grenouille au crochet. 1. Am J Kidney Dis. 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. J Manag Care Pharm. HHS Vulnerability Disclosure, Help When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. Red blood cell transfusions pre- and post-switch were quantified. endobj Nephrol Dial Transplant. Mircera (methoxy polyethylene glycol-epoetin beta) Summary of product characteristics. 1985;28:15. Appropriately control hypertension prior to initiation of and during treatment with MIRCERA, Seizures have occurred in patients participating in MIRCERA, For lack or loss of hemoglobin response to MIRCERA, If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. Department of Nephrology, John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, 2305, Australia, Amgen (Europe) GmbH, Dammstrasse 23, P.O. Methoxy polyethylene glycol-epoetin (Mircera ) will be increased and decreased in 1-step or 2-step increments, based on scale above. x]r9r}W#k A single hemoglobin excursion may not require a dosing change. 5). Mircera with 1-step decrease as soon as Hgb is < 11.8 g/dL and last dose was administered 2 weeks ago or more. 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. m+KqXAXOkS@,1C0VgzXzeWU},4 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). 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]. Pure red cell aplasia (PRCA) that begins after treatment with Mircera or other erythropoietin protein drugs. 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. For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. sharing sensitive information, make sure youre on a federal
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