and transmitted securely. before initiating Mircera [see Warnings and Precautions (5.9)]. WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE. This article does not contain any studies with human or animal subjects performed by any of the authors. 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). ARANESP (darbepoetine alfa) 1 injection/sem. ?Ij{JVv:oC*#]}V#$M_T.zC>~] L%lq[Tn`QbWB./@ClVgrk)U-j#(0(D Bland JM, Altman DG. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. Locatelli F, Aljama P, Barany P, et al. PEG-Epo was approved in 2009 for administration Q2W or once a month (QM) to patients on dialysis [5, 8]. Mircera (methoxy polyethylene glycol / epoetin beta) dosing - Medscape Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Mircera is not the same as epoetin alfa (Procrit, Epogen). MIRCERA is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia associated with chronic kidney disease (CKD) in: MIRCERA is not indicated and is not recommended for use: MIRCERA has not been shown to improve quality of life, fatigue, or patient well-being. 2012;59:44451. Patients were excluded if they had participated in any interventional study within 30days before the 7-month period preceding the switch or at any subsequent time up to 7months after the switch. In recent years, the trend has been to use higher doses of epoetin alfa (eg, 60,000 U once per week), recognizing that MDS RBC precursors may have relative intrinsic resistance to EPO. Lancet. doi: 10.1002/14651858.CD010590.pub2. The primary outcome measure, the geometric mean maintenance DCR, was calculated to be 1.17 (95% CI 1.05, 1.29). doi: 10.1053/j.ajkd.2011.11.013. Do not mix Mircera with any parenteral solution. 1985;28:15. endobj For Pediatric Patients with CKD on hemodialysis: Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Pediatric Patients with CKD Treated with Hemodialysis. The pre-transfusion Hb concentrations were similar for transfusions occurring both pre- and post-switch (Fig. [citation needed] 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. 3 DOSAGE FORMS AND STRENGTHS. Procrit dosing calculator | Math Applications 10PAGE BROCHURE doi: 10.1053/ajkd.2001.27699. Karaboyas A, Morgenstern H, Fleischer NL, Vanholder RC, Dhalwani NN, Schaeffner E, Schaubel DE, Akizawa T, James G, Sinsakul MV, Pisoni RL, Robinson BM. volume30,pages 10071017 (2013)Cite this article. Packaging Type: Injection. 1986;327:30710. _____ (if . m+KqXAXOkS@,1C0VgzXzeWU},4 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. 2013;73:11730. Mircera solution for injection in pre-filled syringe - Summary of The geometric mean DCR was 1.17 (95% CI 1.05, 1.29). Aranesp (darbepoetin alfa) Summary of product characteristics. Box 1557, 6301, Zug, Switzerland, Amgen (UK) Limited, 240 Cambridge Science Park, Milton Road, Cambridge, UK, You can also search for this author in Mircera ceiling is 200 mcg every two weeks (or 3.0 mcg/kg/2 weeks, whichever is lower). Dosage form: injection, solution ESA erythropoiesis-stimulating agent, Hb hemoglobin. Prise en charge anmie rnale - Nephro.blog 1 0 obj American Society of Hematology Self-Assessment Program (Adam - Scribd Nephrol Dial Transplant. 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). Mircera Dosage Guide - Drugs.com Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. FDA approves Mircera for anemia associated with chronic kidney disease 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 species. Each dosage strength of MIRCERA is designated by a unique syringe plunger color. PDF Highlights of Prescribing Information ----------------------- Dosage Vigorous shaking or prolonged exposure to light should be avoided. Values are means (arithmetic for hemoglobin, geometric for dose) with 95% confidence intervals. Table 1 Mircera Starting Doses for Adult Patients Currently Receiving an ESA, Table 2 Mircera Starting Doses for Pediatric Patients Currently Receiving an ESA. 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. There were 16 transfusions and 34 units transfused in the pre-switch period, versus 48 transfusions and 95 units transfused post-switch. Pure red cell aplasia (PRCA) that begins after treatment with MIRCERA, History of serious or severe allergic reactions to MIRCERA. Mircera | European Medicines Agency 6). 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. Anemia: an early complication of chronic renal insufficiency. Mircera would also have competed with Aranesp and with Procrit . Anemia of chronic kidney disease (CKD) becomes increasingly prevalent and severe as kidney function declines [1], with over 90% of patients who require renal replacement therapy becoming anemic [2]. Mircera is used to reduce or avoid the need for RBC transfusions. MIRCERA Dosage & Rx Info | Uses, Side Effects - MPR Epub 2011 Dec 2. Epoetin beta and methoxy polyethylene glycol may increase tumor growth or decrease survival time in people with certain types of cancer. Visit. 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. Please know that the sponsors of this site are not responsible for content on the site you are about to enter. Internal You are now leaving AnemiaHub.com. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. Drug class: Recombinant human erythropoietins. Dr. Gerald Diaz @GeraldMD. WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE CHRONIC KIDNEY DISEASE: Please see full Prescribing Information including Boxed WARNING, and Medication Guide(English, Espaol) for MIRCERA (methoxy polyethylene glycol-epoetin beta) Injection, for Intravenous or Subcutaneous Use. Reasons for exclusion of 96 enrolled patients from the DCR analysis are presented in Fig. OZZ Mircera: Uses, Taking, Side Effects, Warnings - Medicine.com 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. Mircera belongs to a class of drugs called Hematopoietic Growth Factors. NCI CPTC Antibody Characterization Program, Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. Once the hemoglobin has been stabilized, MIRCERA, If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of MIRCERA. MIRCERA has an approximate molecular weight of 60 kDa. 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. Erythropoiesis-stimulating agents (epoetin alfa, beta, theta and zeta 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. Am J Kidney Dis. Mircera at Best Price in India - IndiaMART Please enable it to take advantage of the complete set of features! Packaging Size: 0.3 ml. risks. New anemia therapies: translating novel strategies from bench to bedside. Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. Intravenous C.E.R.A. I certify that I am a healthcare professional in the US. in the treatment of anemia due to cancer chemotherapy. Conversion from Another ESA: dosed once every 4 weeks based on total Conversion - Epoetin alfa (Procrit) to Darbepoetin | GrepMed 4 x previous weekly epoetin alfa dose (Units)/125, e.g., 4 x 1500 Units of epoetin alfa per week/125 = 48 mcg of Mircera once every 4 weeks, 4 x previous weekly darbepoetin alfa dose (mcg)/0.55, e.g., 4 x 20 mcg of darbepoetin alfa per week/0.55 = 145.5 mcg of Mircera once every 4 weeks. For more information, please see the full Prescribing Information, including Boxed WARNING, and Medication Guide(English, Espaol) for MIRCERA. MIRCERA- methoxy polyethylene glycol-epoetin beta The geometric mean weekly dose of DA was 23.2g (95% CI 20.6, 26.3) in the month prior to switch. RETACRIT Dosage and Administration (epoetin alfa-epbx) Conversion d'une EPO l'autre Conversion potine en darbpotine avec un facteur de conversion 200 UI = 1 g Bilan martial Suivi ferritine et taux de saturation de la transferrine (TSAT) tous les 3 mois. This paper presents the findings of a retrospective, multi-center, observational study of hemodialysis patients switched from DA to PEG-Epo for the treatment of anemia. Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (19881994). Eligible patients had received hemodialysis for 12months and DA for 7months. When adjusting therapy, consider hemoglobin rate of rise, rate of decline, ESA responsiveness, and hemoglobin variability. 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%. In CKD, anemia results primarily from decreased production of endogenous erythropoietin (EPO) by the kidney [3]. A primary growth factor for erythroid development, erythropoietin is produced in the kidney and released into the bloodstream in response to hypoxia. . Figure4 also displays the mean monthly Hb for those included in the DCR analysis over the study period. The site is secure. Epub 2014 Nov 1. Hb concentrations were reported as arithmetic means for each month. There is no evidence that Mircera alters the metabolism of other medicinal products. Mircera (Methoxy Polyethylene glycol-epoetin beta): Uses - RxList All calculations should be confirmed before use. Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. Am J Kidney Dis. This medicine is not used to treat anemia caused by cancer medicines. More severe cases were recorded with long-acting agents (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta). Individualize dosing and use the lowest dose of Mircera sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. Nephrol Dial Transplant. If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of MIRCERA. OK 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. 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). Conclusion: A dose approximating 0. . eCollection 2020 Jun. ?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`. Low hemoglobin at hemodialysis initiation: an international study of anemia management and mortality in the early dialysis period. Methoxy polyethylene glycol-epoetin beta - Wikipedia