doi: 10.1053/ajkd.2001.27699. ARANESP single-dose strengths can be combined 4,* You can more . 2002;17(Suppl 5):6670. This medicine is not used to treat anemia caused by cancer medicines. The regression analysis that examined the relationship between mean weekly ESA doses in the two evaluation periods indicated that the DCR is not linear; a significant (P=0.008) quadratic term was observed in the regression analysis, indicating that the predicted DCR decreased at higher pre-switch doses of DA (Fig. PubMed J Manag Care Pharm. When adjusting therapy, consider hemoglobin rate of rise, rate of decline, ESA responsiveness, and hemoglobin variability. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. The intravenous route is recommended for patients on hemodialysis because the intravenous route may be less immunogenic. MIRCERA has an approximate molecular weight of 60 kDa. endobj We comply with the HONcode standard for trustworthy health information. Locatelli F, Aljama P, Barany P, et al. Association of erythropoietin resistance and fibroblast growth factor 23 in dialysis patients: Results from the Japanese Dialysis Outcomes and Practice Patterns Study. Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. 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. As the study was entirely retrospective, ESA switching and dose conversion were performed without reference to a study protocol and there was no protocol-driven intervention in the clinical management of patients. 2008;23:365461. Please click to see accompanying Aranesp full prescribing information and EPOGEN full prescribing information, including Boxed WARNINGS and Medication Guide. MIRCERA is a registered trademark of F. Hoffmann-La Roche Ltd. All Vifor Pharma Groups intellectual rights, including copyright, are reserved by the Vifor Pharma Group. -, Macdougall IC. Mircera would also have competed with Aranesp and with Procrit . Available for Android and iOS devices. Eligible patients had received hemodialysis for 12months and DA for 7months. government site. 1. Epoetin beta and methoxy polyethylene glycol may increase tumor growth or decrease survival time in people with certain types of cancer. 5). 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. 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. Conclusion: A dose approximating 0. Mircera is used to reduce or avoid the need for RBC transfusions. Packaging Type: Injection. PDF Aranesp, Epogen, Mircera, Procrit, Retacrit - Cigna Conclusion: In patients on hemodialysis receiving ESAs, conversion from epoetin alfa to darbepoetin alfa was associated with an approximate and persistent reduction of 65% of the required dose. Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. Mircera with 1-step decrease as soon as Hgb is < 11.8 g/dL and last dose was administered 2 weeks ago or more. Low hemoglobin at hemodialysis initiation: an international study of anemia management and mortality in the early dialysis period. RETACRIT Dosage and Administration (epoetin alfa-epbx) Hymes J, Bickimer T, Jackson JH, Bookhart BK, Mody SH, Tak Piech C. Curr Med Res Opin. Excursions of Hb values above and below the range of 1012g/dL [9] were more common in the post-switch compared to the pre-switch period. 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. Conclusion: 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. Secondary outcomes included Hb concentrations and ESA use during the study period, and the incidence of red blood cell (RBC) transfusions. Mourad Farouk is an employee of Amgen with Amgen stock ownership. These adverse reactions included myocardial infarction and stroke. In the evaluation periods, the geometric mean weekly DA dose in the pre-switch EP was 24.1g (95% CI 21.3, 27.1) while the geometric mean weekly PEG-Epo dose in the post-switch EP was 28.6g (95% CI 26.0, 31.5). Each pre-filled syringe contains 0.3 ml or 0.6 ml. pure red cell aplasia (PRCA) that begins after treatment with MIRCERA or other erythropoietin protein drugs. The study comprised a 14-month observation period. If Hb increases by < 1 g/dL and remains < 10 g/dL after 6 weeks of therapy: If dosing QW, then increase dose to 4.5 mcg/kg/week. Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. 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]. 2014 Dec 8;2014(12):CD010590. Product Information and Dosing | Mircera 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. <>/Metadata 444 0 R/ViewerPreferences 445 0 R>> Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events. Mircera works like the human protein called erythropoietin to help your body make more RBCs. 2023Vifor (International) Inc. All rights reserved. Do not use Mircera after the expiration date. Macdougall IC, Obrador GT, El Nahas M. How important is transfusion avoidance in 2013? New anemia therapies: translating novel strategies from bench to bedside. Hb hemoglobin. Aranesp Dosing and Conversion Brochure | Amgen Anemia Hub Data quality and completeness were aided by automatic edit checks built into the database software. Please see full Prescribing Information including Boxed WARNING, and Medication Guide for MIRCERA (methoxy polyethylene glycol-epoetin beta) Injection, for Intravenous or Subcutaneous Use. EXTON, Pa., July 31, 2018 /PRNewswire/ -- Plagued by regulatory delays, the FDA finally granted approval for Retacrit in May 2018, making it the first biosimilar erythropoietin-stimulating agent (ESA) to become available in the US market. Not all pack sizes may be marketed. The Cost-Effectiveness of Continuous Erythropoiesis Receptor - Hindawi Inflammation and Erythropoiesis-Stimulating Agent Response in Hemodialysis Patients: A Self-matched Longitudinal Study of Anemia Management in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Changes in ESA dosing and number of transfusions post-switch may have important health-economic implications. 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. \ab/`IR 4%jI ^w7qQNA Tq Wz.oVfCVBT{h*>\\3u#P@"wW7|pIMB7 Janet Addison is an employee of Amgen with Amgen stock options. 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. The geometric mean DCR of PEG-Epo to DA was 1.17, rising to 1.21 when the effect of RBC transfusions was taken into account. Mircera solution for injection in pre-filled syringe - Summary of aMutually exclusive categories; patients are censored in the following order: first at death post-switch, then at loss to follow-up post-switch, then at receipt of an ESA other than PEG-Epo, and finally lack of an Hb measurement in either or both EPs. 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. Logistic regression analysis showed a higher likelihood of a transfusion during the post-switch period among patients with a dose ratio at switching of <1. 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. 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. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these Mircera | definition of Mircera by Medical dictionary 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. 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. The mean (95% CI) monthly Hb immediately prior to switch, in Month 1 post-switch, and in Month 7 post-switch was 11.5g/dL (11.3, 11.7), 11.7g/dL (11.5, 11.9), and 11.4g/dL (11.3, 11.6), respectively. Values are means (arithmetic for hemoglobin, geometric for dose) with 95% confidence intervals. Please know that Amgen, the sponsor of this site, is not responsible for the content on the site you are about to enter. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. If you are a healthcare professional outside of the US, please, visit www.mircera.global, The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion, and, Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal, For adverse event reports, please contact us at, You may also report negative side effects of prescription drugs to, the Food and Drug Administration (FDA). Of 302 patients enrolled, 206 had data available for DCR analysis. Disposition of patients. 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). The information provided in this site is intended only for healthcare professionals in the United States. Conversion from Epoetin alfa or Darbepoetin alfa to MIRCERA in Pediatric Patients with CKD on Hemodialysis. Aranesp and EPOGEN increase the risk of seizures in patients with CKD. 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. History of serious or severe allergic reactions to Mircera (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). I certify that I am a healthcare professional in the US. MIRCERA- methoxy polyethylene glycol-epoetin beta 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). See this image and copyright information in PMC. Aranesp (darbepoetin alfa) prescribing information, Amgen. 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%. 2021 Jan;26(1):46-53. doi: 10.1111/nep.13765. PMC Studies of erythropoietin therapy in patients with chronic anemia of cancer as well as CIA document response rates ranging from ~60% to 85%. The number of transfusions and units transfused increased approximately threefold from the pre-switch to the post-switch period. MIRCERA is a registered trademark of F. Hoffmann-La Roche Ltd. All Vifor Pharma Groups intellectual rights, including copyright, are, The information provided in this site is intended only for healthcare. Publication management support was provided by Caterina Hatzifoti, PhD, of Amgen Europe GmbH. Dose Conversion Ratio in Hemodialysis Patients Switched from 2002;162:14011408. PubMed 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. Therapeutic effects . Careers. Dr. Gerald Diaz @GeraldMD. 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. 2 0 obj Mircera belongs to a class of drugs called Hematopoietic Growth Factors.