Treatment for Anaemia [STRIATA] [8] and comPArator sTudy of C.E.R.A. 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. Table 1 Mircera Starting Doses for Adult Patients Currently Receiving an ESA, Table 2 Mircera Starting Doses for Pediatric Patients Currently Receiving an ESA. Hb hemoglobin. Nephrol Dial Transplant. Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp GrepMed. 2022;53(5):333-342. doi: 10.1159/000523947. Aranesp and EPOGEN increase the risk of seizures in patients with CKD. J Manag Care Pharm. An additional analysis was performed to explore the effect of transfusions on the DCR, by exclusion of patients with a transfusion within 90days prior to or during either EP from the analysis. It is not known if Mircera is safe and effective in children younger than 5 years of age. Fewer than half of the patients achieved Hb in the 1012g/dL range by 7months post-switch. Data quality and completeness were aided by automatic edit checks built into the database software. Mircera: Basics, Side Effects & Reviews - GoodRx Administer Mircera either intravenously or subcutaneously in adult patients and only intravenously in pediatric patients. Medically reviewed by Drugs.com. Read reviews from GoodRx users who have taken Mircera and find the latest news on the drug. 2012;59:44451. 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. 6). Contributed by. Empirical methods to calculate an erythropoiesis-stimulating agent dose conversion ratio in nondialyzed patients with chronic kidney disease. 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. NCI CPTC Antibody Characterization Program, Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. Yves Dimitrov, Julie Rieger, Thierry Hannedouche, Toru Kawai, Yoshie Kusano, Takao Masaki, Shubhadeep D. Sinha, Vamsi Krishna Bandi, Santosh Durugkar, Jonathan Barratt, Frank Dellanna, Michael Reusch, Terumasa Hayashi, Hideki Kato, Ichiei Narita, Rufaida Mazahir, Kanav Anand & P. K. Pruthi, Giovanna Stoppa, Carmen DAmore, ESAVIEW Study Group, Ylenia Ingrasciotta, Valeria Belleudi, On behalf of the Italian Biosimilars Network (I-BioNetwork), Luciano A. Pedrini, Mario Comelli, Stefano Stuard, Advances in Therapy The MHRA is aware of very rare cases of severe cutaneous adverse reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, in patients treated with erythropoietins; some cases were fatal. 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. W\iA* Dose Conversion Ratio in Hemodialysis Patients Switched from OZZ Studies of erythropoietin therapy in patients with chronic anemia of cancer as well as CIA document response rates ranging from ~60% to 85%. A single hemoglobin excursion may not require a dosing change. 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. 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Erythropoiesis-stimulating agents (epoetin alfa, beta, theta and zeta Epoetin zeta | Drugs | BNF | NICE This medicine is not for treating anemia caused by cancer chemotherapy. EP evaluation period, PEG-Epo methoxy polyethylene glycol-epoetin beta. Although the reasons for transfusion were not recorded, the pre-transfusion Hb concentrations within 14days prior to transfusion remained similar for transfusions occurring both pre- and post-switch. Anyone you share the following link with will be able to read this content: Sorry, a shareable link is not currently available for this article. If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of MIRCERA. PubMed % 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. EPOGEN (epoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis to decrease the need for red blood cell (RBC) transfusion. 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. Mircera contains no preservatives. Please know that Amgen, the sponsor of this site, is not responsible for the content on the site you are about to enter. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events. 1. Disposition of patients. Mircera (methoxy polyethylene glycol-epoetin beta) Summary of product characteristics. 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. Injection: 30 mcg, 50 mcg, 75 mcg, 100 mcg, 120 mcg, 150 mcg, 200 mcg, or 250 mcg in 0.3 mL solution in single- Conversion from epoetin beta to darbepoetin: what is the equivalent Waiting game continues with Mircera launch | Evaluate 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. Anemia Associated with Chronic Renal Failure, Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL, Drug class: recombinant human erythropoietins. There was neither any requirement for a center to have been using DA as their sole long-acting ESA pre-switch, nor for every DA-treated patient to have been switched to PEG-Epo. Part of Springer Nature. Randomized clinical studies have reported data on switching from DA to PEG-Epo (Stabilizing haemoglobin TaRgets in dialysis following IV C.E.R.A. doi: 10.1001/archinte.162.12.1401. afK ] T z"$qu9H$}W//~||!+iO7^Q)|F.j+m ZJ7CY\7\lO7OGPno? See this image and copyright information in PMC. 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. Composition: Methoxy Polyethylene Glycol-Epoetin Beta. 2021 Jan;26(1):46-53. doi: 10.1111/nep.13765. Conclusion: mircera to aranesp conversion - palace-travel.com Epoetin alfa (Procrit, Epogen) acts like the hormone we have in our body, whereas Mircera . Mourad Farouk is an employee of Amgen with Amgen stock ownership. WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE. MIRCERA is indicated for the treatment of anemia associated with CKD in adult patients on dialysis and adult patients not on dialysis. 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. DA, launched in 2001 [5, 7], contains 5 N-linked oligosaccharide chains, rather than the 3 contained in short-acting epoetins, which confer an approximately threefold longer serum half-life and mean residence time, allowing extended inter-dosing intervals [6]. For Pediatric Patients with CKD on hemodialysis: Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Pediatric Patients with CKD Treated with Hemodialysis. There are limitations in generalizing the findings of this study to the broader hemodialysis population. risks. Mircera (methoxy polyethylene glycol / epoetin beta) dosing, indications, interactions, adverse effects, and more Drugs & Diseases methoxy polyethylene glycol / epoetin beta (Rx) Brand and. This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited. For recommended dose equivalency, see Tables A and B (below). Editorial assistance in the preparation of this manuscript was provided by W. Mark Roberts, PhD, Montreal, Canada. 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. Monitor patients closely for new-onset seizures, premonitory symptoms, or change in seizure frequency. 3 0 obj 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery. Methods: A total of 302 eligible patients were enrolled at 14 European hemodialysis centers, with 57% of patients enrolled at 10 French sites, 18% at 2 Spanish sites, 17% at 1 UK site, and 8% at 1 German site. 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). 2002;162:14018. . 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. https://doi.org/10.1007/s12325-013-0063-y, DOI: https://doi.org/10.1007/s12325-013-0063-y. The study comprised a 14-month observation period. Kazmi WH, Kausz AT, Khan S, et al. Use the Previous and Next buttons to navigate the slides or the slide controller buttons at the end to navigate through each slide. . 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. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Eligible patients had received hemodialysis for 12 months and DA for 7 months. 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. Use caution in patients with coexistent cardiovascular disease and stroke. Pharmacokinetic studies have shown that the meanSD terminal half-life of DA is 217.5h when administered intravenously (IV) [7]. Geometric mean weekly PEG-Epo dose at Month 1 post-switch was 26.7g (95% CI 24.4, 29.3), rising to 29g (95% CI 26.2, 32.2) by Month 7 post-switch. 4 0 obj ONLY administer MIRCERA intravenously in pediatric patients. 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). Locatelli F, Aljama P, Barany P, et al. Figure4 also displays the mean monthly Hb for those included in the DCR analysis over the study period. 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. Mircera is used to treat anemia caused by chronic kidney disease in adults, or in children at least 5 years old who are on hemodialysis. Of the 302 patients enrolled, 206 (68%) were included in the DCR analysis. Karaboyas A, Morgenstern H, Waechter S, Fleischer NL, Vanholder R, Jacobson SH, Sood MM, Schaubel DE, Inaba M, Pisoni RL, Robinson BM. doi: 10.1093/ndt/17.suppl_5.66. 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. In the first month after switch, these proportions were 10.2%, 48.5% and 37.4%, respectively. Mircera belongs to a class of drugs called Hematopoietic Growth Factors. MIRCERA has an approximate molecular weight of 60 kDa. Use the lowest Mircera dose sufficient to reduce the need for red blood cell (RBC) transfusions. Amgen Wins Patent Battle Over Roche's Anemia Drug 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. When adjusting therapy, consider hemoglobin rate of rise, rate of decline, ESA responsiveness, and hemoglobin variability. For Adult Patients with CKD not on dialysis: Refer patients who self-administer Mircera to the Instructions for Use [see Patient Counseling Information (17)]. PDF beta (Mircera ) Protocol - Northwest Kidney Centers 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. Evaluate the iron status in all patients before and during treatment. 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). | DOWNLOAD SIZE: What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? The information provided in this site is intended only for healthcare professionals in the United States. Nephrol Dial Transplant. 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. 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. Strength: 100 mcg / 0.3ml. Bethesda, MD 20894, Web Policies Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. See Instructions for Use for complete instructions on the preparation and administration of Mircera. Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. 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. Usui T, Zhao J, Fuller DS, Hanafusa N, Hasegawa T, Fujino H, Nomura T, Zee J, Young E, Robinson BM, Nangaku M. Nephrology (Carlton). eCollection 2020 May-Jun. Tables2 and 3 also summarize the proportion of patients in different Hb categories by study month. 2002;162:14011408. Product Information and Dosing | Mircera ESAs resulted in decreased locoregional control/progression-free survival and/or overall survival. 2013;73:11730. 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). MIRCERA (methoxy polyethylene glycol-epoetin beta) is the first erythropoiesis-stimulating agent (ESA) approved by FDA for once-monthly administration. 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). 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 . doi: 10.1053/j.ajkd.2011.11.013. 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. 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. -, Eschbach JW, Adamson JW. Use caution in patients with coexistent cardiovascular disease and stroke. The geometric mean weekly ESA dose for those included in the DCR analysis is shown in Fig.
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