mircera to aranesp conversion

Brand: Mircera. Article This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. On June 7, 2018, the Food and Drug Administration approved methoxy polyethylene glycol-epoetin beta (Mircera, Vifor Pharma Inc.) for the treatment of pediatric patients 5 to 17 years of age on. Methoxy polyethylene glycol-epoetin beta, sold under the brand name Mircera, is a long-acting erythropoietin receptor activator (CERA) used for the treatment of anaemia associated with chronic kidney disease. The long-acting r-HuEPO methoxy polyethylene glycol-epoetin beta (Mircera) has been associated with a risk of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) following a. Following initiation of therapy and after each dose adjustment, monitor hemoglobin weekly until the hemoglobin level is stable and sufficient to minimize the need for RBC transfusion. A primary growth factor for erythroid development, erythropoietin is produced in the kidney and released into the bloodstream in response to hypoxia. J Manag Care Pharm. ONLY administer MIRCERA intravenously in pediatric patients. 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). Karaboyas A, Morgenstern H, Waechter S, Fleischer NL, Vanholder R, Jacobson SH, Sood MM, Schaubel DE, Inaba M, Pisoni RL, Robinson BM. 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. Galle JC, Claes K, Kiss I, Winearls CG, Herlitz H, Guerin A, Di Giulio S, Suranyi MG, Bridges I, Addison J, Farouk M. Nephrol Dial Transplant. 1MIRCERA [prescribing information]. See Instructions for Use for complete instructions on the preparation and administration of Mircera. Le bilan martial est dpendant de l'tat inflammatoire et la protine C ractive (CRP) est galement suivi tous les 3 mois pour cela. When adjusting therapy, consider hemoglobin rate of rise, rate of decline, ESA responsiveness, and hemoglobin variability. The recommended RETACRIT regimens are: 300 Units/kg per day subcutaneously for 15 days total: administered daily for 10 days before surgery, on the day of surgery, and for 4 days after surgery. Low hemoglobin at hemodialysis initiation: an international study of anemia management and mortality in the early dialysis period. Am J Nephrol. ?z_IxD1&S&L)@g7NI\H |a_,I17KFu[7+n h?b}xqm5Ed]N8+3ei^Rh/0up20]S=NoPAN$Z$L+u'Hp5v;'QyBQT 8}"{=xVqe)gR&yOs^sfT#B cf#xF`=bXMdCV?s&KS|`q9HT=,[='q6s1UE J$KxBE hg*~'ct'p|YTs1c->uLd_614J)q)g>QR`~*B9GewhNBPs j "It(Y%kRz}=!ayvw^`c]n986kR+LBZ:l~(hf !|p)-b=@|] aRQ:SIRwn$Ip 8v-S"-j0G;r:@ElyDkDE#4H~n{x4P*jS '.P4F lZhBW0t*1b`&wIU_=(>|@"1A`. <>/Font<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Kidney Med. 10PAGE BROCHURE Tables2 and 3 also summarize the proportion of patients in different Hb categories by study month. Accessed 18 October 2013. When administered subcutaneously, Mircera should be injected in the abdomen, arm or thigh. 2 0 obj 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. m+KqXAXOkS@,1C0VgzXzeWU},4 Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp GrepMed. 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 . Google Scholar. Nephrol Dial Transplant. 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. ou toutes les 2 semaines (ou par mois en prdialyse) la dose requise Avant 1 an : non indiqu 11 ans : comme chez l'adulte MIRCERA (potine bta - MPG [mthoxy-polythylne glycol]) 1 injection mensuelle la dose requise Non indiqu What is the practical conversion dose when changing from epoetin alfa Examine each prefilled syringe for the expiration date. The https:// ensures that you are connecting to the Cancel, Aranesp (darbepoetin alfa) Prescribing Information, EPOGEN (epoetin alfa) Prescribing Information, Aranesp and EPOGEN Important Safety Information, Prescribing Information, Important Safety Information, Dosing Information and Indications, DOWNLOAD ARANESP PRESCRIBING INFORMATION. A single hemoglobin excursion may not require a dosing change. doi: 10.1002/14651858.CD010590.pub2. Article Pfizer's Retacrit, the First Erythropoietin Stimulating - BioSpace Waiting game continues with Mircera launch | Evaluate Unable to load your collection due to an error, Unable to load your delegates due to an error. Macdougall IC, Obrador GT, El Nahas M. How important is transfusion avoidance in 2013? There are significant negative consequences associated with increased transfusion requirement in dialysis patients, including production of sensitizing anti-human leukocyte antigen (HLA) antibodies which, despite advances in immunosuppressant therapy [13], may impair or prevent transplantation in patients otherwise eligible for receipt of a kidney graft. PDF Erythropoiesis-Stimulating Agents - Commercial Medical Benefit Drug Policy 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. Randomized clinical studies have reported data on switching from DA to PEG-Epo (Stabilizing haemoglobin TaRgets in dialysis following IV C.E.R.A. In CKD, anemia results primarily from decreased production of endogenous erythropoietin (EPO) by the kidney [3]. Conversion Dosing Guide: From epoetin alfa to Aranesp in patients with anemia due to CKD on dialysis. Mircera solution for injection in pre-filled syringe - Summary of 2022;53(5):333-342. doi: 10.1159/000523947. Janet Addison is an employee of Amgen with Amgen stock options. PubMedGoogle Scholar. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events [see Boxed Warning and Clinical Studies (14)]. New anemia therapies: translating novel strategies from bench to bedside. Use caution in patients with coexistent cardiovascular disease and stroke. Mircera Dosage Guide - Drugs.com BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (. HHS Vulnerability Disclosure, Help This article does not contain any studies with human or animal subjects performed by any of the authors. 2002;17(Suppl 5):6670. It is not known if Mircera is safe and effective in children younger than 5 years of age. 3. Differentiating factors between erythropoiesis-stimulating agents: an update to selection for anaemia of chronic kidney disease. 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 geometric mean DCR was 1.17 (95% CI 1.05, 1.29). Packaging Size: 0.3 ml. a Mutually exclusive categories; patients are censored in the following, Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. 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). This article does not contain any studies with human or animal subjects performed by any of the authors. 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. Secondly, the DCR was calculated on a subset of patients which constituted approximately two-thirds of the total enrolled. Usui T, Zhao J, Fuller DS, Hanafusa N, Hasegawa T, Fujino H, Nomura T, Zee J, Young E, Robinson BM, Nangaku M. Nephrology (Carlton). 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. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. AFFIRM demonstrated non-linearity of the dose relationship curve, with DCR decreasing as pre-switch DA dose increased. Am J Kidney Dis. Aranesp (darbepoetin alfa) and EPOGEN (epoetin alfa) are contraindicated in patients with: Pure red cell aplasia (PRCA) that begins after treatment with Aranesp, EPOGEN, or other erythropoietin protein drugs, Serious allergic reactions to Aranesp or EPOGEN. - , . -, Kazmi WH, Kausz AT, Khan S, et al. Mircera: Basics, Side Effects & Reviews - GoodRx No test of statistical significance was performed on any of the clinical characteristics. 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. By Month 7 post-switch, the proportions of patients with Hb in these ranges were 9.7%, 48.1%, and 30.1%, respectively. 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. Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (19881994) Arch Intern Med. Excluding patients receiving a transfusion within 90days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). Anemia: an early complication of chronic renal insufficiency. A decade in the anaemia market - 10 products seen top . <>/Metadata 444 0 R/ViewerPreferences 445 0 R>> Bookshelf Each pre-filled syringe contains 0.3 ml or 0.6 ml. 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. Methods: *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 . Use the lowest Mircera dose sufficient to reduce the need for red blood cell (RBC) transfusions. Bland JM, Altman DG. PDF Highlights of Prescribing Information ----------------------- Dosage Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. Last updated on Jul 26, 2022. PDF Anemia response to Methoxy Polyethylene Glycol-Epoetin Beta (Mircera Clin Kidney J. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. Once Every Two Weeks (mcg/every two weeks). A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks. Nephrol Dial Transplant. MIRCERA- methoxy polyethylene glycol-epoetin beta 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 The majority of patients with CKD will require supplemental iron during the course of ESA therapy. FOIA 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]. Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Adult Patients with CKD. Slider with three articles shown per slide. Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (19881994). For adverse event reports, please contact us at safety@viforpharma.com,mircera@viforpharma.com or at 1-800-576-8295. 2014 Nov;31(11):1155-68. doi: 10.1007/s12325-014-0161-5. The number of transfusions and units transfused increased approximately threefold from the pre-switch to the post-switch period. All calculations should be confirmed before use. Comparison Among Erythropoietin Stimulating Agents Although the reasons for transfusion were not recorded, the pre-transfusion Hb concentrations within 14days prior to transfusion remained similar for transfusions occurring both pre- and post-switch. species. 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. _____ (if . What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? Publication management support was provided by Caterina Hatzifoti, PhD, of Amgen Europe GmbH. The distribution of transfusions (Fig. 2001;38:80312. 6); the mean (SD) Hb within 14days prior to transfusion in these periods was 8.8 (1.41) and 8.3 (1.26), respectively. The data from this study were analyzed using SAS Statistical Software v9.2 (SAS Institute Inc., Cary, NC, USA). endobj Mircera is used to treat anemia caused by chronic kidney disease in adults, or in children at least 5 years old who are on hemodialysis. The primary finding of the study is that the DCR of PEG-Epo to DA was 1.17 (95% CI 1.05, 1.29). For more information, please see the full Prescribing Information, including Boxed WARNING, and Medication Guide(English, Espaol) for MIRCERA. There were 16 transfusions and 34 units transfused in the pre-switch period, versus 48 transfusions and 95 units transfused post-switch. Treatment for Anaemia [STRIATA] [8] and comPArator sTudy of C.E.R.A. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Hb hemoglobin. Mircera (methoxy polyethylene glycol / epoetin beta) dosing, indications, interactions, adverse effects, and more Drugs & Diseases methoxy polyethylene glycol / epoetin beta (Rx) Brand and. Mircera is packaged as single-dose prefilled syringes. Mean Hb was 11.5g/dL in the pre-switch EP and 11.4g/dL in the post-switch EP. However, the relationship between the pre- and post-switch ESA doses during the two evaluation periods was non-linear. Provided by the Springer Nature SharedIt content-sharing initiative, Over 10 million scientific documents at your fingertips, Not logged in Control hypertension prior to initiating and during treatment with Aranesp or EPOGEN. Mircera at Best Price in India - IndiaMART pee`T"c+l_WB,`km^;6#j(*m`&E`l${F6Q`&^=e`f(6]8ZE[VHNx-FRIhE&iJKvW`Vz^p@?Yk+S.DgR1rrB6yq2N$| 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. ^D[5j@%e By definition, the DCR could not be calculated for patients ineligible for the DCR analysis as these did not have the necessary parameters recorded in both EPs. % doi: 10.1093/ndt/17.suppl_5.66. Please know that the sponsors of this site are not responsible for content on the site you are about to enter. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Mircera works like the human protein called erythropoietin to help your body make more RBCs. Am J Kidney Dis. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Values are means (arithmetic for hemoglobin, geometric for dose) with 95% confidence intervals. 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. endobj Google Scholar. RETACRIT Dosage Forms and Strengths (epoetin alfa-epbx) -, Macdougall IC. history of serious or severe allergic reactions to MIRCERA (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). Hb concentrations were reported as arithmetic means for each month. doi: 10.1001/archinte.162.12.1401. Am J Kidney Dis. Use the Previous and Next buttons to navigate the slides or the slide controller buttons at the end to navigate through each slide. Arch Intern Med. 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. Methoxy polyethylene glycol-epoetin beta - Wikipedia PEG-Epo was approved in 2009 for administration Q2W or once a month (QM) to patients on dialysis [5, 8]. Peter Choi. Data were also manually reviewed prior to final analysis. 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. 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. Anemia of end-stage renal disease (ESRD) Kidney Int. Mircera with 1-step decrease as soon as Hgb is < 11.8 g/dL and last dose was administered 2 weeks ago or more. See this image and copyright information in PMC. -. 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). Avoid frequent dose adjustments. doi: 10.1038/ki.1985.109. Drugs. Methoxy polyethylene glycol-epoetin (Mircera ) will be increased and decreased in 1-step or 2-step increments, based on scale above. Immediately and permanently discontinue Aranesp or EPOGEN if a serious allergic 3. 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. Drug class: Recombinant human erythropoietins. Patients were required to fulfill the following criteria for study entry: switched from treatment with DA to treatment with PEG-Epo at least 7months before study enrollment; receipt of hemodialysis for at least 12months prior to switching; receipt of IV DA for at least 7months immediately prior to switching; receipt of at least 1 dose of PEG-Epo after switching; and provision of informed consent, according to local requirements. 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. A single hemoglobin excursion may not require a dosing change. Department of Nephrology, John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, 2305, Australia, Amgen (Europe) GmbH, Dammstrasse 23, P.O. In conclusion, this study has shown that in a cohort of European hemodialysis patients who converted from DA to PEG-Epo (and who completed 67months treatment with PEG-Epo post-conversion), there was an approximately 20% increase in the g dose required to achieve a comparable Hb profile. in the treatment of anemia due to cancer chemotherapy. Mircera Injection: Uses, Dosing & Side Effects - Drugs.com Due to the skewed nature of the dosing data, mean weekly ESA doses were reported using geometric means; these were derived by calculating the arithmetic mean of the data transformed on the natural logarithmic scale. 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. 20,000 Units/2 mL (10,000 Units/mL) and 20,000 Units/mL of RETACRIT as a clear and colorless liquid in multiple-dose vials (contains benzyl alcohol). Do not use Mircera after the expiration date. PDF Anmie chez l'insuffisant rnal : comment utiliser les agents stimulant An additional analysis was performed to explore the effect of transfusions on the DCR, by exclusion of patients with a transfusion within 90days prior to or during either EP from the analysis. 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. When a patient with a darbepoetin (Aranesp) or erythropoietin order switches to . . Peter Choi, MB BChir, PhD, FRCP (UK), has received lecturing and consulting fees from Amgen, and has participated in advisory boards for Amgen. Monitor patients closely for new-onset seizures, premonitory symptoms, or change in seizure frequency. Dialysis centers were expected to adhere to European Best Practice Guidelines for iron repletion [9]. Mircera | European Medicines Agency Patients were then switched to fortnightly darbepoetin alfa dosing treatments; the existing weekly dose being doubled and Hb levels fell from 125 to 110 g/L (P < 0.0001), despite an increase in the mean dose from 44.9 to 47.5 . Discontinue MIRCERA, When administered subcutaneously, MIRCERA. In controlled clinical trials of patients with cancer, ESAs increased the risks for death and serious adverse cardiovascular reactions. MIRCERA can be administered once every 2 weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA. Conclusion: A dose approximating 0. For recommended dose equivalency, see Tables A and B (below). 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. PubMed Internal You are now leaving AnemiaHub.com. The relationship between the DA and PEG-Epo doses during the evaluation periods was explored through linear and quadratic regression. (PDF) Conversion from epoetin beta to darbepoetin: What is the 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. Aranesp (darbepoetin alfa) prescribing information, Amgen. I certify that I am a healthcare professional in the US. Locatelli F, Aljama P, Barany P, et al.

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