Macdougall IC. Locatelli F, Aljama P, Barany P, et al. Adverse reactions ( 10%) in Aranesp clinical studies in patients with CKD were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension. Peter Choi. 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. 2). . x]r9r}W#k Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. Before Support for this assistance was funded by Amgen. Each dosage strength of MIRCERA is designated by a unique syringe plunger color. 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. By Month 7 post-switch, the proportions of patients with Hb in these ranges were 9.7%, 48.1%, and 30.1%, respectively. For recommended dose equivalency, see Tables A and B (below). doi: 10.1001/archinte.162.12.1401. Recombinant human erythropoietin is effective in However, the relationship between the pre- and post-switch ESA doses during the two evaluation periods was non-linear. Mircera (methoxy polyethylene glycol-epoetin beta) Summary of product characteristics. Packaging Type: Injection. Publication management support was provided by Caterina Hatzifoti, PhD, of Amgen Europe GmbH. The study comprised a 14-month observation period. 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)]. PDF Aranesp, Epogen, Mircera, Procrit, Retacrit - Cigna Pure red cell aplasia (PRCA) that begins after treatment with MIRCERA, History of serious or severe allergic reactions to MIRCERA. These adverse reactions included myocardial infarction and stroke. Mircera (methoxy polyethylene glycol-epoetin beta) Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) The distribution of transfusions (Fig. Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with Aranesp or EPOGEN. 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. What is the practical conversion dose when changing from epoetin alfa The data from this study were analyzed using SAS Statistical Software v9.2 (SAS Institute Inc., Cary, NC, USA). 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. Amgen's two anemia drugs, Epogen and Aranesp, had sales of $6.6 billion last year, nearly half the company's total revenue. Insertion mechanism for drug delivery device - AMGEN INC. The introduction of exogenous erythropoiesis-stimulating agents (ESAs) to clinical practice has transformed the care of patients with CKD, by ameliorating anemia, reducing transfusion requirements, and improving quality of life [4]. <>/Font<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Cancel, Aranesp (darbepoetin alfa) Prescribing Information, EPOGEN (epoetin alfa) Prescribing Information, Aranesp and EPOGEN Important Safety Information, Prescribing Information, Important Safety Information, Dosing Information and Indications, DOWNLOAD ARANESP PRESCRIBING INFORMATION. Mircera solution for injection in pre-filled syringe Over the last 25years, several originator and biosimilar ESAs have been introduced for the management of CKD anemia, starting with the first generation short-acting recombinant erythropoietin agents (epoetin alfa and beta) and latterly with two longer-acting molecules, darbepoetin alfa (DA) and methoxy polyethylene glycol-epoetin beta (PEG-Epo), which combine a significantly increased half-life and lower binding affinity for the EPO receptor, allowing them to stimulate erythropoiesis for longer periods and to be administered less frequently [5, 6]. PDF Mircera, INN: methoxy polyethylene glycol-epoetin beta Choi, P., Farouk, M., Manamley, N. et al. Erythropoiesis-stimulating agents (epoetin alfa, beta, theta and zeta Epub 2011 Dec 2. Methoxy Polyethylene Glycol-Epoetin Beta (Injection Route) The remaining enrolment was at four sites divided between three other countries. Accessed 18 October 2013. ?z_IxD1&S&L)@g7NI\H |a_,I17KFu[7+n h?b}xqm5Ed]N8+3ei^Rh/0up20]S=NoPAN$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`. PDF Methoxy polyethylene glycol-epoetin beta (Mircera ) Protocol Conversion from Another ESA: dosed once every 4 weeks based on total A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks. 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. 1MIRCERA [prescribing information]. Am J Kidney Dis. Article 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). When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. 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. doi: 10.1002/14651858.CD010590.pub2. Values are means (arithmetic for hemoglobin, geometric for dose) with 95% confidence intervals. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Eligible patients had received hemodialysis for 12months and DA for 7months. Carrera F, Lok CE, de Francisco A, et al. The primary outcome measure, the geometric mean maintenance DCR, was calculated to be 1.17 (95% CI 1.05, 1.29). Conversion from darbepoetin or erythropoietin to Mircera 1. 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. Evaluate the iron status in all patients before and during treatment. Accounting for the effect of transfusion, the DCR was 1.21 (95% CI 1.09, 1.35). - 94.130.71.173. Individualize dosing and use the lowest dose of Mircera sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. PDF Limitations of Use Mircera is not indicated and is not recommended for Dosage form: injection, solution 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. 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. 2022;53(5):333-342. doi: 10.1159/000523947. Pharmacotherapy Update - Automatic Therapeutic Interchange Program In pediatric patients, Mircera is administered by intravenous injection only (2.2). MIRCERA- methoxy polyethylene glycol-epoetin beta 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. 2008;23:365461. -, Macdougall IC. Matsumura K, Okumiya T, Sugiura T, Takahashi N, Yamamoto Y, Kikuchi S, Fujii K, Otagaki M, Shiojima I. BMC Nephrol. reaction occurs. )E]$&m"t "N5LQmgh-QZi`T0 hacpBYKUYRw@aMB/|n|'Y#h$8]#|zf. This site needs JavaScript to work properly. Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. Epoetin beta and methoxy polyethylene glycol may increase tumor growth or decrease survival time in people with certain types of cancer. Red blood cell transfusions pre- and post-switch were quantified. W\iA* 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). Eligible patients had received hemodialysis for 12 months and DA for 7 months. 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. Control hypertension prior to initiating and during treatment with Aranesp or EPOGEN. For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (19881994). 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]. 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.
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