Aranesp (darbepoetin alfa) Summary of product characteristics. Dissertation Les Fausses Confidences Stratagme, Les Fromagers De Thirache Horaires, Archange Gabriel Pouvoir, Adeline Franois Mari, Rdiger Un Rapport Sur Un lve En Difficult . endobj Dose Conversion Ratio in Hemodialysis Patients Switched from Darbepoetin Alfa to PEG-Epoetin Beta: AFFIRM Study. Red blood cell transfusions pre- and post-switch were quantified. 10PAGE BROCHURE 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. 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). EP evaluation period, PEG-Epo methoxy polyethylene glycol-epoetin beta. Control hypertension prior to initiating and during treatment with Aranesp or EPOGEN. Logistic regression analysis showed a higher likelihood of a transfusion during the post-switch period among patients with a dose ratio at switching of <1. Reasons for low Hb, e.g., acute intercurrent events such as bleeding, were not reported. 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. Revised European Best Practice Guidelines for the management of anaemia in patients with chronic renal failure. 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 . 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. Bethesda, MD 20894, Web Policies Reasons for exclusion of 96 enrolled patients from the DCR analysis are presented in Fig. Concerning RBC transfusions, 36 patients received a transfusion; 7 were transfused in the pre-switch period only, 4 received a transfusion both pre- and post-switch, and 25 had a transfusion in the post-switch period only. Each dosage strength of MIRCERA is designated by a unique syringe plunger color. There is no evidence that Mircera alters the metabolism of other medicinal products. Amgen Europe B.V., Breda, The Netherlands, 29 August 2013. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000332/WC500026149.pdf. 2002;17(Suppl 5):6670. Aranesp and EPOGEN increase the risk of seizures in patients with CKD. 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 Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (19881994). The aims of the Aranesp Efficiency Relative to Mircera (AFFIRM) study were primarily to estimate the maintenance dose conversion ratio (DCR) of PEG-Epo to DA in a population of European hemodialysis patients switched from DA to PEG-Epo and with comparable mean hemoglobin (Hb) in the pre- and post-switch periods, and secondarily to investigate parameters of clinical management of anemia in this group of patients, in real-world clinical practice. 2013;28:10929. _____ (if . Kazmi WH, Kausz AT, Khan S, et al. Do not pool unused portions from the prefilled syringes. Am J Kidney Dis. The study sample comprised adult patients (age 18years) with CKD who received maintenance hemodialysis between January 2008 and August 2011 and whose ESA treatment was switched from IV DA to IV PEG-Epo. NCI CPTC Antibody Characterization Program, Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. Do not use Mircera after the expiration date. 2 0 obj 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 . Adv Ther 30, 10071017 (2013). stream Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. Am J Nephrol. 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. The pre-transfusion Hb concentrations were similar for transfusions occurring both pre- and post-switch (Fig. 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. reaction occurs. Injection: 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, 10,000 Units/mL, and 40,000 Units/mL of RETACRIT as a clear and colorless liquid in single-dose vials. WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE. Anemia of end-stage renal disease (ESRD) Kidney Int. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of MIRCERA. In an additional analysis performed to assess the sensitivity of this result to the effects of transfusion by excluding those patients who received an RBC transfusion within 90days prior to or during either evaluation period, the DCR was 1.21 (95% CI 1.09, 1.35). 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. ^D[5j@%e Careers. PEG-Epo methoxy polyethylene glycol-epoetin beta. Conversion from Another ESA: dosed once every 4 weeks based on total history of serious or severe allergic reactions to MIRCERA (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). Mircera (methoxy polyethylene glycol / epoetin beta) dosing, indications, interactions, adverse effects, and more Drugs & Diseases methoxy polyethylene glycol / epoetin beta (Rx) Brand and. 2010;25:400917. Canaud B, Mingardi G, Braun J, et al. Hymes J, Bickimer T, Jackson JH, Bookhart BK, Mody SH, Tak Piech C. Curr Med Res Opin. 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 would also have competed with Aranesp and with Procrit . W\iA* as a substitute for red blood cell transfusions in patients who require immediate correction of anemia. Usui T, Zhao J, Fuller DS, Hanafusa N, Hasegawa T, Fujino H, Nomura T, Zee J, Young E, Robinson BM, Nangaku M. Nephrology (Carlton). Conversion from Another ESA: dosed once monthly or once every two weeks based on total weekly epoetin alfa or darbepoetin alfa dose at time of conversion (2.2). risks. 1:1 reference line indicates equal PEG-Epo and darbepoetin alfa doses. Please click to see accompanying Aranesp full prescribing information and EPOGEN full prescribing information, including Boxed WARNINGS and Medication Guide. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. Clipboard, Search History, and several other advanced features are temporarily unavailable. The dose of Mircera, given as a single intravenous or subcutaneous injection, should be based on the Before Aranesp (darbepoetin alfa) prescribing information, Amgen. 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. For patients who do not respond adequately over a 12-week escalation period, increasing the MIRCERA, Evaluate other causes of anemia. Excluding patients receiving a transfusion within 90 days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). Visit. Epub 2020 Aug 20. 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. 2012;59:44451. Administer Mircera as an intravenous injection at the dose (in micrograms) based on the total weekly ESA dose at the time of conversion (see Table 2). 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. Matsumura K, Okumiya T, Sugiura T, Takahashi N, Yamamoto Y, Kikuchi S, Fujii K, Otagaki M, Shiojima I. BMC Nephrol. official website and that any information you provide is encrypted 2002;162:14011408. . Kidney Med. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) The distribution of transfusions (Fig. MIRCERA has an approximate molecular weight of 60 kDa. Table 1 Mircera Starting Doses for Adult Patients Currently Receiving an ESA, Table 2 Mircera Starting Doses for Pediatric Patients Currently Receiving an ESA. 2014 Dec 8;2014(12):CD010590. m+KqXAXOkS@,1C0VgzXzeWU},4 Hb hemoglobin. 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 . Mircera may be used alone or with other medications. Slider with three articles shown per slide. Dose Conversion Ratio in Hemodialysis Patients Switched from Darbepoetin Alfa to PEG-Epoetin Beta: AFFIRM Study, https://doi.org/10.1007/s12325-013-0063-y, CERA conversion to darbepoetin alfa in 154 hemodialysis patients, Long-term maintenance of hemoglobin levels in hemodialysis patients treated with bi-weekly epoetin beta pegol switched from darbepoetin alfa: a single-center, 12-month observational study in Japan, Efficacy, tolerability and safety of darbepoetin alfa injection for the treatment of anemia associated with chronic kidney disease (CKD) undergoing dialysis: a randomized, phase-III trial, Safety of Roxadustat Versus Erythropoiesis-Stimulating Agents in Patients with Anemia of Non-dialysis-Dependent or Incident-to-Dialysis Chronic Kidney Disease: Pooled Analysis of Four Phase 3 Studies, Initial responsiveness to darbepoetin alfa and its contributing factors in non-dialysis chronic kidney disease patients in Japan, Comparison of darbepoetin alpha and recombinant human erythropoietin for treatment of anemia in pediatric chronic kidney disease: a non-inferiority trial from India, Comparative Safety of Originator and Biosimilar Epoetin Alfa Drugs: An Observational Prospective Multicenter Study, In Search of Predictors of Switching Between Erythropoiesis-Stimulating Agents in Clinical Practice: A Multi-Regional Cohort Study, Mixed hemodiafiltration reduces erythropoiesis stimulating agents requirement in dialysis patients: a prospective randomized study, http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000332/WC500026149.pdf, http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000739/WC500033672.pdf, https://creativecommons.org/licenses/by/2.0. J Manag Care Pharm. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 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. 4. Nephrol Dial Transplant. - , . doi: 10.1001/archinte.162.12.1401. 5). This medicine is not for treating anemia caused by cancer chemotherapy. The geometric mean DCR was 1.17 (95% CI 1.05, 1.29). Injection: 30 mcg, 50 mcg, 75 mcg, 100 mcg, 120 mcg, 150 mcg, 200 mcg, or 250 mcg in 0.3 mL solution in single- -, Macdougall IC. MIRCERA [prescribing information]. 2023Vifor (International) Inc. All rights reserved. Correspondence to 6). Brand: 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. In pediatric patients on hemodialysis, all reported adverse reactions regardless of causality (more than 5% incidence) were headache, nasopharyngitis, hypertension, vomiting, bronchitis, abdominal pain, arteriovenous fistula thrombosis, cough, device related infection, hyperkalemia, pharyngitis, pyrexia, thrombocytopenia, and thrombosis in device. Secondary outcomes included Hb concentrations and ESA use during the study period, and the incidence of red blood cell (RBC) transfusions. Hb concentrations were reported as arithmetic means for each month. This medicine is not used to treat anemia caused by cancer medicines. Horowitz J, Agarwal A, Huang F, Gitlin M, Gandra SR, Cangialose CB. doi: 10.1053/ajkd.2001.27699. HQ-MIR-1900027 Site last modified: January 2023. MIRCERA (methoxy polyethylene glycol-epoetin beta) is the first erythropoiesis-stimulating agent (ESA) approved by FDA for once-monthly administration. Secondly, the DCR was calculated on a subset of patients which constituted approximately two-thirds of the total enrolled. }"nUEcJumC0ooF Empirical methods to calculate an erythropoiesis-stimulating agent dose conversion ratio in nondialyzed patients with chronic kidney disease. 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. In CKD, anemia results primarily from decreased production of endogenous erythropoietin (EPO) by the kidney [3]. <> 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. 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. 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. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Evaluation of Iron Stores and Nutritional Factors. 2008;23:365461. When administered subcutaneously, Mircera should be injected in the abdomen, arm or thigh. Dr. Gerald Diaz @GeraldMD. 2001;38:80312. A BlandAltman analysis [10] was also performed to assess the agreement between ESA doses in the evaluation periods. ?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`. 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. Each pre-filled syringe contains 0.3 ml or 0.6 ml. 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. ribosome A ribonuclear protein complex that binds to mRNA nucleotide A basic . The MHRA is aware of very rare cases of severe cutaneous adverse reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, in patients treated with erythropoietins; some cases were fatal. Mircera Injection (Methoxy Polyethylene Glycol-Epoetin Beta ) 6,610/ Piece Get Latest Price. Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Pediatric Patients with CKD Treated with Hemodialysis 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. In pediatric patients, Mircera is administered by intravenous injection only (2.2). Methods: 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. . 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]. Do not increase the dose more frequently than once every 4 weeks. Mircera (methoxy polyethylene glycol-epoetin beta) is an erythropoiesis-stimulating agent (ESA). Drugs. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) 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). Conclusion: In patients on hemodialysis receiving ESAs, conversion from epoetin alfa to darbepoetin alfa was associated with an approximate and persistent reduction of 65% of the required dose. <> For adverse event reports, please contact us at safety@viforpharma.com,mircera@viforpharma.com or at 1-800-576-8295. 2023 Springer Nature Switzerland AG. 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. | DOWNLOAD SIZE: 2. Statistical methods for assessing agreement between two methods of clinical measurement. Mircera with 1-step decrease as soon as Hgb is < 11.8 g/dL and last dose was administered 2 weeks ago or more. Indication 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.Limitations of Use Aranesp has not been shown to improve quality of life, fatigue, or patient well-being. . This analysis indicated that the concordance decreased with increasing dose. Differentiating factors between erythropoiesis-stimulating agents: an update to selection for anaemia of chronic kidney disease. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 2022;53(5):333-342. doi: 10.1159/000523947. 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. PubMed Mean Hb was 11.5g/dL in the pre-switch EP and 11.4g/dL in the post-switch EP. % Nephrol Dial Transplant. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp GrepMed. 1MIRCERA [prescribing information]. EXTON, Pa., July 31, 2018 /PRNewswire/ -- Plagued by regulatory delays, the FDA finally granted approval for Retacrit in May 2018, making it the first biosimilar erythropoietin-stimulating agent (ESA) to become available in the US market. Macdougall IC, Obrador GT, El Nahas M. How important is transfusion avoidance in 2013? A primary growth factor for erythroid development, erythropoietin is produced in the kidney and released into the bloodstream in response to hypoxia. Mourad Farouk is an employee of Amgen with Amgen stock ownership. The number of RBC transfusions and units transfused in the post-switch period was approximately threefold higher compared to the pre-switch period. For recommended dose equivalency, see Tables A and B (below). Am J Kidney Dis. 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). 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)]. Provided by the Springer Nature SharedIt content-sharing initiative, Over 10 million scientific documents at your fingertips, Not logged in Conversion Dosing Guide: From epoetin alfa to Aranesp in patients with anemia due to CKD on dialysis. Active ingredient: methoxy polyethylene glycol-epoetin beta Inactive ingredients: mannitol, methionine, poloxamer 188, sodium phosphate monobasic monohydrate, and sodium sulfate. Treatment for Anaemia [STRIATA] [8] and comPArator sTudy of C.E.R.A. and transmitted securely. 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. Publication management support was provided by Caterina Hatzifoti, PhD, of Amgen Europe GmbH. 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. 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. 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. 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. Eligible patients had received hemodialysis for 12 months and DA for 7 months. 33 Dose. 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. Anemia Associated with Chronic Renal Failure, Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL, Drug class: recombinant human erythropoietins. There are limitations in generalizing the findings of this study to the broader hemodialysis population. Methoxy polyethylene glycol-epoetin beta, the active substance of MIRCERA, is a continuous erythropoietin receptor activator that shows a different activity at the receptor level characterized by a slower association to and faster dissociation from the receptor, a reduced specific activity in vitro with an increased activity in vivo, as well as an increased half-life, in contrast to . Cochrane Database Syst Rev. 1985;28:15. 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). doi: 10.1038/ki.1985.109. 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. MIRCERA, methoxy polyethylene glycol-epoetin beta, is an ESA which differs from erythropoietin through formation of a chemical bond between an amino group present in erythropoietin beta and methoxy polyethylene glycol (PEG) butanoic acid. Of 302 patients enrolled, 206 had data available for DCR analysis. Dialysis centers were expected to adhere to European Best Practice Guidelines for iron repletion [9]. PMC No difference in conversion dosage could be determined between patients who were epoetin sensitive (<200 units/kg per week) or resistant (>200 units/kg per week, P = NS). 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. Mircera belongs to a class of drugs called Hematopoietic Growth Factors. 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. Use the lowest Mircera dose sufficient to reduce the need for red blood cell (RBC) transfusions. 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. Mircera (methoxy polyethylene glycol-epoetin beta) Summary of product characteristics. Data were collected from 7months before until 7months after switching treatment. 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. Nephrol Dial Transplant. Department of Nephrology, John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, 2305, Australia, Amgen (Europe) GmbH, Dammstrasse 23, P.O. Epub 2022 Apr 22. Low hemoglobin at hemodialysis initiation: an international study of anemia management and mortality in the early dialysis period. 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. This site needs JavaScript to work properly. Disclaimer. A single hemoglobin excursion may not require a dosing change. Epub 2014 Nov 1. St. Gallen, Switzerland: Vifor (International) Inc.; June 2018. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. Finally, our study indicates that the risk of transfusion was higher in the post-switch compared with the pre-switch period, with an approximate threefold rise observed in the number of transfusions and units transfused post-switch. 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. Part of Springer Nature. The site is secure. Evaluate the iron status in all patients before and during treatment. 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. Anemia response to Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) versus Epoetin Alfa (Eprex) in patients with chronic Kidney disease on Hemodialysis Published: September 05, 2017 42/47 is common in patients with a GFR below 30 ml/min/1.73m2 and contributes to many of the speciic symptoms of CKD. Mircera is used to reduce or avoid the need for RBC transfusions. Hrl WH. See Instructions for Use for complete instructions on the preparation and administration of Mircera. History of serious or severe allergic reactions to Mircera (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). 2013;73:11730. Randomized clinical studies have reported data on switching from DA to PEG-Epo (Stabilizing haemoglobin TaRgets in dialysis following IV C.E.R.A. Use the Previous and Next buttons to navigate the slides or the slide controller buttons at the end to navigate through each slide. Do not use the prefilled syringe more than once. DCR geometric mean maintenance dose conversion ratio, EP evaluation period, ESA erythropoiesis-stimulating agent, Hb hemoglobin, PEG-Epo methoxy polyethylene glycol-epoetin beta. Peter Choi, MB BChir, PhD, FRCP (UK), has received lecturing and consulting fees from Amgen, and has participated in advisory boards for Amgen. 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. Dosage form: injection, solution What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? Goodkin DA, Zhao J, Cases A, Nangaku M, Karaboyas A. Nephrol Dial Transplant. BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (.
Where Is Jerry Lewis Buried,
Is Sparkling An Onomatopoeia,
Articles M