1. Mircera Injection (Methoxy Polyethylene Glycol-Epoetin Beta ) 6,610/ Piece Get Latest Price. Packaging Type: Injection. Longer-acting PEG-Epo contains a chemical bond between an amino group present in epoetin beta and methoxy polyethylene glycol (PEG) butanoic acid; the addition of PEG is responsible for an increase in serum half-life of epoetin beta, and in CKD patients on dialysis the terminal half-life of PEG-Epo after IV administration is 134h [6, 8]. 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). Unauthorized use of these marks is strictly prohibited. FOIA 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). The PATRONUS study, in which stable hemodialysis patients receiving IV DA were randomized either to QM PEG-Epo or to Q2W DA for 26weeks [11], described an increase in post-switch dose requirement. The information provided in this site is intended only for healthcare professionals in the United States. Always store Mircera prefilled syringes in their original cartons. 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). Eschbach JW, Adamson JW. Mircera : EPAR - Conditions imposed on member states for safe and effective use - Annex IV (PDF/15.49 KB) First published: 02/08/2007 Last updated: 02/08/2007 Pharmacotherapeutic group Antianemic preparations Therapeutic indication Treatment of symptomatic anaemia associated with chronic kidney disease (CKD). Empirical methods to calculate an erythropoiesis-stimulating agent dose conversion ratio in nondialyzed patients with chronic kidney disease. randomized patients to darbepoetin or epoetin beta once weekly after the patients had been treated with epoetin beta three times weekly. <>/Font<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Treatment for Anaemia [STRIATA] [8] and comPArator sTudy of C.E.R.A. % maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study. 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). Generic name: Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL Mircera may be used alone or with other medications. https://doi.org/10.1007/s12325-013-0063-y, DOI: https://doi.org/10.1007/s12325-013-0063-y. Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. When a patient with a darbepoetin (Aranesp) or erythropoietin order switches to . 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. An official website of the United States government. Available for Android and iOS devices. The number of transfusions and units transfused increased approximately threefold from the pre-switch to the post-switch period. 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. 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). 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. 33 Dose. The geometric mean weekly ESA doses were 24.1 g DA in the pre-switch EP and 28.6 g PEG-Epo in the post-switch EP. Donck J, Gonzalez-Tabares L, Chanliau J, Martin H, Stamatelou K, Manamley N, Farouk M, Addison J. Adv Ther. Conclusion: Am J Kidney Dis. DA can be administered once a week (QW) or once every 2weeks (Q2W) to hemodialysis patients. Usui T, Zhao J, Fuller DS, Hanafusa N, Hasegawa T, Fujino H, Nomura T, Zee J, Young E, Robinson BM, Nangaku M. Nephrology (Carlton). Aranesp (darbepoetin alfa) prescribing information, Amgen. Descriptions. 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. Macdougall IC. 1985;28:15. 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. Active ingredient: methoxy polyethylene glycol-epoetin beta Inactive ingredients: mannitol, methionine, poloxamer 188, sodium phosphate monobasic monohydrate, and sodium sulfate. Hb hemoglobin. 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. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. 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. 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. 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. At the moment forecasts for Mircera are $345m in 2015 rising to $552m in 2020, reflecting sales made outside the US. . Accessibility Data were also manually reviewed prior to final analysis. 2019 Jul 5;13(3):425-433. doi: 10.1093/ckj/sfz065. Choi, P., Farouk, M., Manamley, N. et al. methoxypolyethylene glycol-epoetin beta (meh-thok-see-pah-lee-eh-thih-leen gly-kol ee-poh-eh-tin bay-ta) , Mircera (trade name) Classification Therapeutic: antianemics Pharmacologic: hormones Pregnancy Category: C Indications Anemia due to chronic renal failure. MIRCERA can be administered once every 2 weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA. Drugs. Roche Registration Ltd., Welwyn Garden City, UK, 19 June 2012. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000739/WC500033672.pdf. Palmer SC, Saglimbene V, Mavridis D, Salanti G, Craig JC, Tonelli M, Wiebe N, Strippoli GF. 2020 Sep 29;21(1):418. doi: 10.1186/s12882-020-02078-z. Nephrol Dial Transplant. 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. darbepoetin alfa (Aransep) pre-filled syringe, injectable vial epoetin alfa (Epogen; Procrit) injectable methoxy polyethylene glycol-epoetin beta (Mircera) pre-filled syringe Conditions Medications Dialysis patients can . A single hemoglobin excursion may not require a dosing change. eCollection 2020 Jun. Carrera F, Lok CE, de Francisco A, et al. Am J Kidney Dis. A brochure to help you understand how to dose and administer Aranesp, and to convert from epoetin alfa to Aranesp in patients with anemia due to CKD. See Instructions for Use for complete instructions on the preparation and administration of Mircera. These adverse reactions included myocardial infarction and stroke. MIRCERA Interactions: May require increased anticoagulation (heparin) during hemodialysis. 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. aranesp to retacrit conversiontuto amigurumi grenouille au crochet. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. 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 . MIRCERA is indicated for the treatment of anemia associated with CKD in adult patients on dialysis and adult patients not on dialysis. species. Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. Brand: Mircera. 1986;327:30710. Correspondence to See this image and copyright information in PMC. Am J Nephrol. Nick Manamley, MSc, is an employee of Amgen with Amgen stock ownership. Slider with three articles shown per slide. This study and the article processing charges were funded by Amgen Europe GmbH, Zug, Switzerland. ESA erythropoiesis-stimulating agent, Hb hemoglobin. Nephrol Dial Transplant. Learn how to combine multiple dosing options for precise titration and individualize anemia management.1. 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. 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. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Epoetin alfa (Eprex [JanssenCilag], Binocrit [Sandoz], and epoetin zeta (Retacrit, - Hospira UK): the initial dose is 150 IU kg-1 given subcutaneously three times per week.5 -7 Alternatively, epoetin alfa can be administered at an initial dose of 450 IU kg 1 subcutaneously once weekly.5-7 The maximum recommended dose is 900 IU kg-1 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. doi: 10.1093/ndt/17.suppl_5.66. Disposition of patients. a Mutually exclusive categories; patients are censored in the following, Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. endobj WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE. pure red cell aplasia (PRCA) that begins after treatment with MIRCERA or other erythropoietin protein drugs. 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. }"nUEcJumC0ooF as a substitute for red blood cell transfusions in patients who require immediate correction of anemia. Appropriately control hypertension prior to initiation of and during treatment with MIRCERA, Seizures have occurred in patients participating in MIRCERA, For lack or loss of hemoglobin response to MIRCERA, If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. Recombinant human erythropoietin is effective in MIRCERA comes in pre-filled syringes with laminated plunger stopper and tip cap with one needle 27G1/2. The geometric mean DCR was 1.17 (95% CI 1.05, 1.29). All calculations should be confirmed before use. 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. Discontinue MIRCERA, When administered subcutaneously, MIRCERA. This article does not contain any studies with human or animal subjects performed by any of the authors. Tables2 and 3 also summarize the proportion of patients in different Hb categories by study month. Nephrol Dial Transplant. Examine each prefilled syringe for the expiration date. Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. In the month immediately prior to switch, the proportions of patients who had Hb below 10, 1012, and above 12g/dL were 7.3%, 54.4%, and 25.7%, respectively, with 12.6% missing. Article A motion conversion mechanism 123 includes a yoke 153 and a rotatable member 149, which causes the yoke 152, . For patients who do not respond adequately over a 12-week escalation period, increasing the MIRCERA, Evaluate other causes of anemia. W\iA* Conversion from darbepoetin or erythropoietin to Mircera 1. In order to compare stable clinical scenarios for the purposes of DCR calculation, data evaluation periods (EPs) were utilized: Months 2 and 1 were defined as the pre-switch EP and Months +6 and +7 were defined as the post-switch EP.