2012 Jun;27(6):2303-11. doi: 10.1093/ndt/gfr677. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which Aranesp and EPOGEN are not approved). as a substitute for red blood cell transfusions in patients who require immediate correction of anemia. official website and that any information you provide is encrypted This suggests that the decision to transfuse was consistent with respect to Hb over the observation period (Fig. Examine each prefilled syringe for the expiration date. Mircera (methoxy polyethylene glycol / epoetin beta) dosing - Medscape New anemia therapies: translating novel strategies from bench to bedside. 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). Internal You are now leaving AnemiaHub.com. 1: 21% of the excluded patients had died or were lost to follow-up during the post-switch period; 45% were no longer receiving PEG-Epo by Months +6 and +7 post-switch; and 34% had no Hb value reported for one or both EPs. A primary growth factor for erythroid development, erythropoietin is produced in the kidney and released into the bloodstream in response to hypoxia. History of serious or severe allergic reactions to Mircera (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). PubMed - , . <>
Discard any unused portion. 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. Excluding patients receiving a transfusion within 90days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). Mircera Dosage Guide - Drugs.com Brand: Mircera. The initial conversion factor was 200:1. Of 302 patients enrolled, 206 had data available for DCR analysis. However, healthcare-resource utilization and cost data were not collected in this study, preventing comparison of these variables between the pre-switch and post-switch periods. Epoetin alfa (Procrit, Epogen) acts like the hormone we have in our body, whereas Mircera . stream
For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. 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. 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. Data were collected from 7months before until 7months after switching treatment. MIRCERA can be administered once every 2 weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA. Adverse reactions ( 10%) in Aranesp clinical studies in patients with CKD were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Lancet. Nephrol Dial Transplant. Epoetin beta and methoxy polyethylene glycol may increase tumor growth or decrease survival time in people with certain types of cancer. Action Stimulates erythropoesis (production of red blood cells). 1986;327:30710. ?Ij{JVv:oC*#]}V#$M_T.zC>~] L%lq[Tn`QbWB./@ClVgrk)U-j#(0(D All patients who fulfilled pre-specified criteria for completeness of Hb and dosing data were included in the DCR analysis: i.e., those who had received DA or PEG-Epo as the only ESA in the 1month prior to and during the pre- or post-switch EPs, respectively, and who had dosing information and at least 1 Hb value in each of the evaluation periods. Nephrol Dial Transplant. More severe cases were recorded with long-acting agents (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta). 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. 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). Months 7 to 1 constituted the pre-switch period, with switch defined as the date of first administration of PEG-Epo, and Months +1 to +7 constituted the post-switch period. 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. 4! Composition: Methoxy Polyethylene Glycol-Epoetin Beta. Accessibility 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. Please click to see accompanying Aranesp full prescribing information and EPOGEN full prescribing information, including Boxed WARNINGS and Medication Guide. Excluding patients receiving a transfusion within 90 days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). What is the practical conversion dose when changing from epoetin alfa The .gov means its official. 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. 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. %
Mircera Injection (Methoxy Polyethylene Glycol-Epoetin Beta ) 6,610/ Piece Get Latest Price. Figure4 also displays the mean monthly Hb for those included in the DCR analysis over the study period. Accessed 18 October 2013. Once Every Two Weeks (mcg/every two weeks). 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. Please know that the sponsors of this site are not responsible for content on the site you are about to enter. Correspondence to "BG0RjI G78 before initiating MIRCERA. 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. 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. Am J Kidney Dis. For the purposes of this policy, a conversion factor of 3 should be used to estimate hematocrit when only the hemoglobin is measured, e.g., hemoglobin of 10 g/dL is approximately equal to a hematocrit of 30%, a hemoglobin of 11 g/dL is . 2022;53(5):333-342. doi: 10.1159/000523947. The WHO has set the daily-defined dose (DDD) for epoetin beta and darbepoetin at 1000 U and 4.5 g respectively, which gives a conversion factor of 222:1 . 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. ^D[5j@%e Donck J, Gonzalez-Tabares L, Chanliau J, Martin H, Stamatelou K, Manamley N, Farouk M, Addison J. Adv Ther. Careers. Use the lowest Mircera dose sufficient to reduce the need for red blood cell (RBC) transfusions. The remaining enrolment was at four sites divided between three other countries. W\iA* Mircera | European Medicines Agency 2 0 obj
Aranesp and EPOGEN increase the risk of seizures in patients with CKD. Methoxy polyethylene demonstrated that the dose efficiency after SC and IV ad- glycol-epoetin b (PEG-epoetin b; Mircera; F. Hoffmann- ministration was . Disposition of patients. Secondary outcomes included Hb concentrations and ESA use during the study period, and the incidence of red blood cell (RBC) transfusions. 2002;162:14018. doi: 10.1002/14651858.CD010590.pub2. eCollection 2020 May-Jun. OZZ Box 1557, 6301, Zug, Switzerland, Amgen (UK) Limited, 240 Cambridge Science Park, Milton Road, Cambridge, UK, You can also search for this author in 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). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Aranesp Dosing Calculator75 mcg/kg as an IV or SC injection once every In pediatric patients, Mircera is administered by intravenous injection only (2.2). Epub 2022 Apr 22. 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. - 94.130.71.173. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Provided by the Springer Nature SharedIt content-sharing initiative, Over 10 million scientific documents at your fingertips, Not logged in This was particularly evident in patients whose pre-switch EP weekly DA dose was higher than 100g. The geometric mean DCR was 1.17 (95% CI 1.05, 1.29). The geometric mean weekly dose of DA was 23.2g (95% CI 20.6, 26.3) in the month prior to switch. Of 302 patients enrolled, 206 had data available for DCR analysis. PEG-Epo methoxy polyethylene glycol-epoetin beta. Once the hemoglobin has been stabilized, MIRCERA, If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of MIRCERA. Conversion from darbepoetin or erythropoietin to Mircera 1. 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. Preservation of anemia control and weekly ESA dosage after conversion from PEG-Epoetin beta to darbepoetin alfa in adult hemodialysis patients: the TRANSFORM study. The site is secure. The distribution of transfusions (Fig. Dialysis centers were expected to adhere to European Best Practice Guidelines for iron repletion [9]. Patients included in the analysis were less likely to be diabetic (32% vs. 40%), more likely to be receiving DA at a longer dosing interval (60% vs. 73% at QW; 19% vs. 3% less frequently than Q2W), and received a lower geometric mean weekly dose of DA during the pre-switch EP (24.1 vs. 37.7g). No test of statistical significance was performed on any of the clinical characteristics. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. 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. There are limitations in generalizing the findings of this study to the broader hemodialysis population. Amgen's two anemia drugs, Epogen and Aranesp, had sales of $6.6 billion last year, nearly half the company's total revenue. In controlled clinical trials of patients with CKD comparing higher hemoglobin targets (13 to 14 g/dL) to lower targets (9 to 11.3 g/dL), ESAs increased the risk of death, myocardial infarction, stroke, congestive heart failure, thrombosis of hemodialysis vascular access, and other thromboembolic events in the higher target groups. Administer Mircera intravenously once every 4 weeks to pediatric patients (ages 5 to 17 years) whose hemoglobin level has been stabilized by treatment with an ESA. The relationship between the DA and PEG-Epo doses during the evaluation periods was explored through linear and quadratic regression. Mircera belongs to a class of drugs called Hematopoietic Growth Factors. Choi, P., Farouk, M., Manamley, N. et al. Patients stable on intravenous (iv) epoetin alfa will be randomized either to receive standard of care therapy (epoetin alfa (iv) 3 times weekly), or to receive Mircera 120-360 micrograms (iv), monthly. For adverse event reports, please contact us at safety@viforpharma.com,mircera@viforpharma.com or at 1-800-576-8295. 4. J Manag Care Pharm. Conclusion: m+KqXAXOkS@,1C0VgzXzeWU},4 DA can be administered once a week (QW) or once every 2weeks (Q2W) to hemodialysis patients. The study comprised a 14-month observation period. Amgen Business Review November 7, 2008 Strategic Outlook Kevin Sharer CEO 3 Provided November 7, 2008 as part of an oral presentation and is qualified by such, contains forward-looking -, Macdougall IC. Aranesp (darbepoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis. reaction occurs. pee`T"c+l_WB,`km^;6#j(*m`&E`l${F6Q`&^=e`f(6]8ZE[VHNx-FRIhE&iJKvW`Vz^p@?Yk+S.DgR1rrB6yq2N$| x]r9r}W#k Data on clinical and laboratory parameters relating to CKD management were abstracted from patient records and entered into an anonymized study-specific central database by study center staff. Shortened red blood cell age in patients with end-stage renal disease who were receiving haemodialysis: a cross-sectional study. Canaud B, Mingardi G, Braun J, et al. afK ] T z"$qu9H$}W//~||!+iO7^Q)|F.j+m
ZJ7CY\7\lO7OGPno? Please see full Prescribing Information including Boxed WARNING, and Medication Guide for MIRCERA (methoxy polyethylene glycol-epoetin beta) Injection, for Intravenous or Subcutaneous Use. If you are a healthcare professional outside of the US, please, visit www.mircera.global, The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion, and, Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal, For adverse event reports, please contact us at, You may also report negative side effects of prescription drugs to, the Food and Drug Administration (FDA). The majority of patients who were transfused during the pre- and post-switch observation periods had Hb 10g/dL within the 14days prior to transfusion; only 1 patient during each period had Hb >11g/dL within the 14-day pre-transfusion interval. MIRCERA Classification: Erythropoiesis stimulating protein. The Cost-Effectiveness of Continuous Erythropoiesis Receptor - Hindawi randomized patients to darbepoetin or epoetin beta once weekly after the patients had been treated with epoetin beta three times weekly. Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. eCollection 2020 Jun. )E]$&m"t "N5LQmgh-QZi`T0 hacpBYKUYRw@aMB/|n|'Y#h$8]#|zf. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study. Revised European Best Practice Guidelines for the management of anaemia in patients with chronic renal failure. The number of transfusions and units transfused increased approximately threefold from the pre-switch to the post-switch period. FOIA Firstly, the study sample was drawn largely from a single country (France), which contributed over 70% of the patients and 10 of the 14 study sites. OK
Resistance to Erythropoiesis-Stimulating Agents among Patients on Hemodialysis Is Typically Transient. . ferrous sulfate, Aranesp, Procrit, Retacrit. As shown in Tables2 and 3, the mean (standard error) monthly Hb remained stable across the observation period, with mean monthly concentration ranging from 11.42 (0.09) g/dL (Month 4) to 11.60 (0.09) g/dL (Month 2) pre-switch, and from 11.26 (0.10) g/dL (Month 4) to 11.67 (0.09) g/dL (Month 1) post-switch. Mean Hb was 11.5g/dL in the pre-switch EP and 11.4g/dL in the post-switch EP. Treatment for Anaemia [STRIATA] [8] and comPArator sTudy of C.E.R.A. Disclaimer. Part of Springer Nature. Data were collected from 7 months before until 7 months after switching treatment. Dr. Gerald Diaz @GeraldMD. In responding to hypoxia, erythropoietin interacts with erythroid progenitor . 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. Studies of erythropoietin therapy in patients with chronic anemia of cancer as well as CIA document response rates ranging from ~60% to 85%. Peter Choi, MB BChir, PhD, FRCP (UK), has received lecturing and consulting fees from Amgen, and has participated in advisory boards for Amgen. endobj
A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these
Dose conversion ratio in hemodialysis patients switched from Slider with three articles shown per slide. PDF Anmie chez l'insuffisant rnal : comment utiliser les agents stimulant About ARANESP (darbepoetin alfa) | Amgen ESA | HCP Available for Android and iOS devices. Bookshelf aranesp to retacrit conversion Erythropoiesis-stimulating agents (epoetin alfa, beta, theta and zeta In contrast, in the STRIATA study where stable hemodialysis patients receiving IV DA were randomized to Q2W PEG-Epo (outside current label guidance) or to continue on DA QW or Q2W, median PEG-Epo doses were described as stable across the 52-week post-switch period, although mean dose data were not reported [12]. 2002;17(Suppl 5):6670. 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. MIRCERA is indicated for the treatment of anemia associated with CKD in adult patients on dialysis and adult patients not on dialysis. Immediately and permanently discontinue Aranesp or EPOGEN if a serious allergic
Disposition of patients. 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.