Excluding patients receiving a transfusion within 90days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). MIRCERA (methoxy polyethylene glycol-epoetin beta) is the first erythropoiesis-stimulating agent (ESA) approved by FDA for once-monthly administration. Evaluate the iron status in all patients before and during treatment. In pediatric patients, Mircera is administered by intravenous injection only (2.2). Avoid frequent dose adjustments. Discard any unused portion. For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. Donck J, Gonzalez-Tabares L, Chanliau J, Martin H, Stamatelou K, Manamley N, Farouk M, Addison J. Adv Ther. Use caution in patients with coexistent cardiovascular disease and stroke. Unable to load your collection due to an error, Unable to load your delegates due to an error. Hb hemoglobin. Peter Choi, MB BChir, PhD, FRCP (UK), has received lecturing and consulting fees from Amgen, and has participated in advisory boards for Amgen. Eschbach JW, Adamson JW. Dose Conversion Ratio in Hemodialysis Patients Switched from Darbepoetin Alfa to PEG-Epoetin Beta: AFFIRM Study. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events. In responding to hypoxia, erythropoietin interacts with erythroid progenitor . Anemia of end-stage renal disease (ESRD). 10PAGE BROCHURE
Bookshelf What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? <>/Font<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>>
Aranesp (darbepoetin alfa) Summary of product characteristics. randomized patients to darbepoetin or epoetin beta once weekly after the patients had been treated with epoetin beta three times weekly. Conversion d'une EPO l'autre Conversion potine en darbpotine avec un facteur de conversion 200 UI = 1 g Bilan martial Suivi ferritine et taux de saturation de la transferrine (TSAT) tous les 3 mois. Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (19881994) Arch Intern Med. Do not mix Mircera with any parenteral solution. Please know that the sponsors of this site are not responsible for content on the site you are about to enter. 4 x previous weekly epoetin alfa dose (Units)/125, e.g., 4 x 1500 Units of epoetin alfa per week/125 = 48 mcg of Mircera once every 4 weeks, 4 x previous weekly darbepoetin alfa dose (mcg)/0.55, e.g., 4 x 20 mcg of darbepoetin alfa per week/0.55 = 145.5 mcg of Mircera once every 4 weeks. The number of RBC transfusions and units transfused in the post-switch period was approximately threefold higher compared to the pre-switch period. Am J Kidney Dis. 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. Shortened red blood cell age in patients with end-stage renal disease who were receiving haemodialysis: a cross-sectional study. This was particularly evident in patients whose pre-switch EP weekly DA dose was higher than 100g. Over the last 25years, several originator and biosimilar ESAs have been introduced for the management of CKD anemia, starting with the first generation short-acting recombinant erythropoietin agents (epoetin alfa and beta) and latterly with two longer-acting molecules, darbepoetin alfa (DA) and methoxy polyethylene glycol-epoetin beta (PEG-Epo), which combine a significantly increased half-life and lower binding affinity for the EPO receptor, allowing them to stimulate erythropoiesis for longer periods and to be administered less frequently [5, 6]. BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (. Epub 2011 Dec 2. At the moment forecasts for Mircera are $345m in 2015 rising to $552m in 2020, reflecting sales made outside the US. St. Gallen, Switzerland: Vifor (International) Inc.; June 2018. Data were also manually reviewed prior to final analysis. 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. Reasons for low Hb, e.g., acute intercurrent events such as bleeding, were not reported. Red blood cell transfusions pre- and post-switch, Summary of the last hemoglobin concentrations recorded within 14days prior to red blood cell transfusions pre- and post-switch. 2012 Jun;27(6):2303-11. doi: 10.1093/ndt/gfr677. Anemia Associated with Chronic Renal Failure, Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL, Drug class: recombinant human erythropoietins. Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. doi: 10.1053/j.ajkd.2011.11.013. This compares with a 35% decline in Epogen sales during the same period to $1.13bn, as competition from Mircera and biosimilars, like by Sandoz' Binocrit, reach the markets. Use the lowest Mircera dose sufficient to reduce the need for red blood cell (RBC) transfusions. The enrolling dialysis centers were situated in France, Germany, Spain and the UK, and each was expected to enroll a minimum of 20 patients into the study. 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. Carrera F, Lok CE, de Francisco A, et al. <>/Metadata 444 0 R/ViewerPreferences 445 0 R>>
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. The odds ratio for receiving a transfusion was twice as high in patients switched at a dose ratio less than 1 when compared to those switched at 1:1 or higher. Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. For adverse event reports, please contact us at safety@viforpharma.com,mircera@viforpharma.com or at 1-800-576-8295. More severe cases were recorded with long-acting agents (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta). Horowitz J, Agarwal A, Huang F, Gitlin M, Gandra SR, Cangialose CB. 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. Patients can also have iron-deficiency anemia and need iron replacement using one of the supplements listed in the previous Electrolytes and Minerals section of this lesson. Mean Hb was 11.5 g/dL in the pre-switch EP and 11.4 g/dL in the post-switch EP. official website and that any information you provide is encrypted 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. DA can be administered once a week (QW) or once every 2weeks (Q2W) to hemodialysis patients. 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 . Accounting for the effect of transfusion, the DCR was 1.21 (95% CI 1.09, 1.35). 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. Evaluation of Iron Stores and Nutritional Factors. | DOWNLOAD SIZE:
Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. - 94.130.71.173. doi: 10.1038/ki.1985.109. Methoxy polyethylene demonstrated that the dose efficiency after SC and IV ad- glycol-epoetin b (PEG-epoetin b; Mircera; F. Hoffmann- ministration was . The pre-transfusion Hb concentrations were similar for transfusions occurring both pre- and post-switch (Fig. 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]. Statistical methods for assessing agreement between two methods of clinical measurement. 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. Packaging Type: Injection. Article A BlandAltman analysis [10] was also performed to assess the agreement between ESA doses in the evaluation periods. Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (19881994). OZZ 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. adult patients on dialysis and adult patients not on dialysis. ^D[5j@%e Aranesp and EPOGEN increase the risk of seizures in patients with CKD. Epub 2014 Nov 1. Locatelli F, Aljama P, Barany P, et al. MIRCERA [prescribing information]. 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. Available for Android and iOS devices. A motion conversion mechanism 123 includes a yoke 153 and a rotatable member 149, which causes the yoke 152, . Nephrol Dial Transplant. 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. FOIA sharing sensitive information, make sure youre on a federal NCI CPTC Antibody Characterization Program, Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. The majority of patients with CKD will require supplemental iron during the course of ESA therapy.