2012 Jun;27(6):2303-11. doi: 10.1093/ndt/gfr677. MIRCERA (methoxy polyethylene glycol-epoetin beta) is the first erythropoiesis-stimulating agent (ESA) approved by FDA for once-monthly administration. The primary finding of the study is that the DCR of PEG-Epo to DA was 1.17 (95% CI 1.05, 1.29). Hb concentrations were reported as arithmetic means for each month. Individualize dosing and use the lowest dose of MIRCERA. Prise en charge anmie rnale - Nephro.blog Mircera is packaged as single-dose prefilled syringes. MIRCERA is indicated for the treatment of anemia associated with CKD in adult patients on dialysis and adult patients not on dialysis. Summary of the last hemoglobin concentrations recorded within 14days prior to red blood cell transfusions pre- and post-switch. Nephrol Dial Transplant. Red blood cell transfusions pre- and post-switch were quantified. In particular, the likelihood of a transfusion during the post-switch period was significantly higher in patients with a dose ratio below 1 at switch. *Data from a multicenter, randomized, open-label study comparing epoetin, given 1, 2, or 3 times weekly IV or SC, with ARANESP , at a reduced dose frequency, in dialysis patients (N = 522).Dose adjustments were made as necessary and per study protocol to maintain individual patients' Hb within a target range of -1.0 to +1.5 g/dL of their baseline Hb and between 9 g/dL and 13 g/dL for up . In the absence of PRCA, follow dosing recommendations for management of patients with an insufficient response to MIRCERA, 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 the postmarketing setting in patients treated with MIRCERA, PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which MIRCERA, If severe anemia and low reticulocyte count develop during treatment with MIRCERA, Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, tachycardia, pruritus, skin rash and urticaria have been reported in patients treated with MIRCERA, 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 MIRCERA, Patients may require adjustments in their dialysis prescription after initiation of MIRCERA, Most frequent adverse reactions ( 5%) in adult patients with CKD treated with MIRCERA. Epub 2011 Dec 2. 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. before initiating Mircera [see Warnings and Precautions (5.9)]. Mircera (methoxy polyethylene glycol / epoetin beta) dosing, indications, interactions, adverse effects, and more Drugs & Diseases methoxy polyethylene glycol / epoetin beta (Rx) Brand and. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. RETACRIT Dosage and Administration (epoetin alfa-epbx) Asterisk Not all transfusions had an associated hemoglobin concentration in the 14-day period before transfusion. 33 Dose. RBC transfusions were reported in terms of number of transfusions and number of units transfused, using descriptive statistics. %PDF-1.7 in the treatment of anemia due to cancer chemotherapy. 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. 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. This site needs JavaScript to work properly. 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. Section III: Treatment of renal anaemia. Do you wish to proceed? Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. Each pre-filled syringe contains 0.3 ml or 0.6 ml. If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of MIRCERA. Treatment: Treat to anemia in people with chronic kidney disease. 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. Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. The initial conversion factor was 200:1. The Cost-Effectiveness of Continuous Erythropoiesis Receptor - Hindawi Read reviews from GoodRx users who have taken Mircera and find the latest news on the drug. . ESAs resulted in decreased locoregional control/progression-free survival and/or overall survival. All groups were assessed at the end of the study for safety and efficacy parameters. Individual patients could contribute multiple transfusions to these analyses. The study comprised a 14-month observation period. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) 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. MIRCERA is available, for all strengths, in pack sizes of 1 and also pack size of 3 for the strengths 30, 50, 75 micrograms/0.3ml. Association of erythropoietin resistance and fibroblast growth factor 23 in dialysis patients: Results from the Japanese Dialysis Outcomes and Practice Patterns Study. MIRCERA Classification: Erythropoiesis stimulating protein. Mircera may be used alone or with other medications. Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. Tel: +1-650-344-3898 | Fax: +1-888-256-8883 | Email: info@palace-travel.com | | | LOG IN Dose by Weight Chart - Resourcehub Epogen Dosage Guide - Drugs.com Epogen, Procrit (epoetin alfa) dosing, indications, interactions There is no evidence that Mircera alters the metabolism of other medicinal products. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. official website and that any information you provide is encrypted 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. 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. PubMed (0.6MB), Anemia Assessment and Management Brochure, Pathophysiology of Anemia in Patients with CKD, * Case studies and patient profiles are hypothetical, WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE. When administered subcutaneously, Mircera should be injected in the abdomen, arm or thigh. -, Macdougall IC. 2012;59:44451. 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. Karaboyas A, Morgenstern H, Fleischer NL, Vanholder RC, Dhalwani NN, Schaeffner E, Schaubel DE, Akizawa T, James G, Sinsakul MV, Pisoni RL, Robinson BM. Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. Methoxy Polyethylene Glycol-Epoetin Beta (Injection Route) 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. Accessed 18 October 2013. 2014 Nov;31(11):1155-68. doi: 10.1007/s12325-014-0161-5. 3 DOSAGE FORMS AND STRENGTHS. Aranesp Dosing and Conversion Brochure | Amgen Anemia Hub Reasons for low Hb, e.g., acute intercurrent events such as bleeding, were not reported. Low hemoglobin at hemodialysis initiation: an international study of anemia management and mortality in the early dialysis 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. Evaluate the iron status in all patients before and during treatment. Please click to see accompanying Aranesp full prescribing information and EPOGEN full prescribing information, including Boxed WARNINGS and Medication Guide. Last updated on Jul 26, 2022. Palmer SC, Saglimbene V, Mavridis D, Salanti G, Craig JC, Tonelli M, Wiebe N, Strippoli GF. -, Eschbach JW, Adamson JW. 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%. Hrl WH. [citation needed] This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. doi: 10.1038/ki.1985.109. eCollection 2020 May-Jun. . RETACRIT Dosage Forms and Strengths (epoetin alfa-epbx) )E]$&m"t "N5LQmgh-QZi`T0 hacpBYKUYRw@aMB/|n|'Y#h$8]#|zf. 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. For lack or loss of hemoglobin response to Aranesp or EPOGEN, initiate a search for causative factors. A BlandAltman analysis [10] was also performed to assess the agreement between ESA doses in the evaluation periods. PDF Mircera, INN: methoxy polyethylene glycol-epoetin beta Composition: Methoxy Polyethylene Glycol-Epoetin Beta. . 2). 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. Mean Hb was 11.5g/dL in the pre-switch EP and 11.4g/dL in the post-switch EP. a Mutually exclusive categories; patients are censored in the following, Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. endobj sharing sensitive information, make sure youre on a federal The majority of patients with CKD will require supplemental iron during the course of ESA therapy.