Do not mix Mircera with any parenteral solution. Epub 2020 Aug 20. Cochrane Database Syst Rev. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) PEG-Epo was approved in 2009 for administration Q2W or once a month (QM) to patients on dialysis [5, 8]. Methoxy polyethylene glycol-epoetin (Mircera ) will be increased and decreased in 1-step or 2-step increments, based on scale above. Nephrol Dial Transplant. Le bilan martial est dpendant de l'tat inflammatoire et la protine C ractive (CRP) est galement suivi tous les 3 mois pour cela. MIRCERA (methoxy polyethylene glycol-epoetin beta) is the first erythropoiesis-stimulating agent (ESA) approved by FDA for once-monthly administration. 2002;17(Suppl 5):6670. Individual patients could contribute multiple transfusions to these analyses. Pure red cell aplasia (PRCA) that begins after treatment with Mircera or other erythropoietin protein drugs. in the treatment of anemia due to cancer chemotherapy. Conclusion: No difference in conversion dosage could be determined between patients who were epoetin sensitive (<200 units/kg per week) or resistant (>200 units/kg per week, P = NS). history of serious or severe allergic reactions to MIRCERA (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). The https:// ensures that you are connecting to the 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. There were 16 transfusion events in the pre-switch period and 48 post-switch, with a total of 34 units transfused pre-switch and 95 units in the post-switch period (Fig. Canaud B, Mingardi G, Braun J, et al. An observational cohort study of extended dosing (once every 2 weeks or once monthly) regimens with darbepoetin alfa in patients with chronic kidney disease not on dialysis: the EXTEND study. 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. Article Matsumura K, Okumiya T, Sugiura T, Takahashi N, Yamamoto Y, Kikuchi S, Fujii K, Otagaki M, Shiojima I. BMC Nephrol. <> However, the relationship between the pre- and post-switch ESA doses during the two evaluation periods was non-linear. This was particularly evident in patients whose pre-switch EP weekly DA dose was higher than 100g. Monitor patients closely for new-onset seizures, premonitory symptoms, or change in seizure frequency. Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. randomized patients to darbepoetin or epoetin beta once weekly after the patients had been treated with epoetin beta three times weekly. MIRCERA is indicated for the treatment of anemia associated with CKD in adult patients on dialysis and adult patients not on dialysis. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. 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. 6). Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Initial Treatment: 0.6 mcg/kg body weight administered once every two weeks (2.2). Eligible patients had received hemodialysis for 12months and DA for 7months. 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. Bethesda, MD 20894, Web Policies Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 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. MIRCERA comes in pre-filled syringes with laminated plunger stopper and tip cap with one needle 27G1/2. This medicine is not used to treat anemia caused by cancer medicines. Differentiating factors between erythropoiesis-stimulating agents: an update to selection for anaemia of chronic kidney disease. 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. 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. Am J Nephrol. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. %PDF-1.7 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. Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp #Pharmacology #Hematology #Nephrology. Changes in ESA dosing and number of transfusions post-switch may have important health-economic implications. 2023Vifor (International) Inc. All rights reserved. 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. 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. 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. Mean Hb was 11.5g/dL in the pre-switch EP and 11.4g/dL in the post-switch EP. Aranesp and EPOGEN have not been shown to improve quality of life, fatigue, or patient well-being. Eligible patients had received hemodialysis for 12 months and DA for 7 months. 2012 Jun;27(6):2303-11. doi: 10.1093/ndt/gfr677. 2002;162:14011408. 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). Provided by the Springer Nature SharedIt content-sharing initiative, Over 10 million scientific documents at your fingertips, Not logged in 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. Methoxy polyethylene glycol-epoetin beta, sold under the brand name Mircera, is a long-acting erythropoietin receptor activator (CERA) used for the treatment of anaemia associated with chronic kidney disease. Aranesp and EPOGEN increase the risk of seizures in patients with CKD. Resistance to Erythropoiesis-Stimulating Agents among Patients on Hemodialysis Is Typically Transient. OK Locatelli F, Aljama P, Barany P, et al. government site. 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. St. Gallen, Switzerland: Vifor (International) Inc.; June 2018. Choi, P., Farouk, M., Manamley, N. et al. 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. Would you like email updates of new search results? 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. m+KqXAXOkS@,1C0VgzXzeWU},4 Slider with three articles shown per slide. 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. AFFIRM may therefore help to guide expectations around potential differences in ESA dose requirements when switching hemodialysis patients from DA to PEG-Epo, although the reported mean maintenance DCR is not intended to predict the dose conversion ratio at the individual patient level. Dr. Peter Choi is the guarantor for this article, and takes responsibility for the integrity of the work as a whole. 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. MIRCERA is contraindicated in patients with: Please seefull Prescribing Information including Boxed WARNING, and Medication Guide(English, Espaol)for MIRCERA (methoxy polyethylene glycol-epoetin beta) Injection, for Intravenous or Subcutaneous Use. History of serious or severe allergic reactions to Mircera (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). before initiating MIRCERA. official website and that any information you provide is encrypted More severe cases were recorded with long-acting agents (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta). 2 0 obj 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). Nephrol Dial Transplant. afK ] T z"$qu9H$}W//~||!+iO7^Q)|F.j+m ZJ7CY\7\lO7OGPno? 1:1 reference line indicates equal PEG-Epo and darbepoetin alfa doses. OZZ Excluding patients receiving a transfusion within 90days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). Do not use Mircera after the expiration date. doi: 10.1001/archinte.162.12.1401. Patients included in the analysis were less likely to be diabetic (32% vs. 40%), more likely to be receiving DA at a longer dosing interval (60% vs. 73% at QW; 19% vs. 3% less frequently than Q2W), and received a lower geometric mean weekly dose of DA during the pre-switch EP (24.1 vs. 37.7g). ?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`. before initiating Mircera [see Warnings and Precautions (5.9)]. 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. x]r9r}W#k Editorial assistance in the preparation of this manuscript was provided by W. Mark Roberts, PhD, Montreal, Canada. 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. 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. 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. 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. Control hypertension prior to initiating and during treatment with Aranesp or EPOGEN. 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). The geometric mean weekly ESA dose for those included in the DCR analysis is shown in Fig. Decreases in dose can occur more frequently. 8600 Rockville Pike Values are means (arithmetic for hemoglobin, geometric for dose) with 95% confidence intervals. Eschbach JW, Adamson JW. 3. Methoxy polyethylene glycol-epoetin beta injection causes the . 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. <>/Font<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> The initial conversion factor was 200:1. Dose Conversion Ratio in Hemodialysis Patients Switched from Darbepoetin Alfa to PEG-Epoetin Beta: AFFIRM Study. Do not use the prefilled syringe more than once. In pediatric patients on hemodialysis, all reported adverse reactions regardless of causality (more than 5% incidence) were headache, nasopharyngitis, hypertension, vomiting, bronchitis, abdominal pain, arteriovenous fistula thrombosis, cough, device related infection, hyperkalemia, pharyngitis, pyrexia, thrombocytopenia, and thrombosis in device. When a patient with a darbepoetin (Aranesp) or erythropoietin order switches to . 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) dosing, indications, interactions, adverse effects, and more Drugs & Diseases methoxy polyethylene glycol / epoetin beta (Rx) Brand and. 1 0 obj Treatment: Treat to anemia in people with chronic kidney disease. Introduction: and darbepOetin alfa in patieNts Undergoing dialySis [PATRONUS] [9]); however, there is a lack of published literature on switching in patients receiving routine clinical care (i.e., outside interventional clinical trials). Internal You are now leaving AnemiaHub.com. MIRCERA Interactions: May require increased anticoagulation (heparin) during hemodialysis. Of 302 patients enrolled, 206 had data available for DCR analysis. . Evaluate the iron status in all patients before and during treatment. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Clipboard, Search History, and several other advanced features are temporarily unavailable. Available for Android and iOS devices. -. Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp GrepMed. 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. FOIA See this image and copyright information in PMC. ribosome A ribonuclear protein complex that binds to mRNA nucleotide A basic . Dosage form: injection, solution A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these % 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 Usui T, Zhao J, Fuller DS, Hanafusa N, Hasegawa T, Fujino H, Nomura T, Zee J, Young E, Robinson BM, Nangaku M. Nephrology (Carlton). In CKD, anemia results primarily from decreased production of endogenous erythropoietin (EPO) by the kidney [3]. Data were also manually reviewed prior to final analysis. A single hemoglobin excursion may not require a dosing change. 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. Donck J, Gonzalez-Tabares L, Chanliau J, Martin H, Stamatelou K, Manamley N, Farouk M, Addison J. Adv Ther. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly.