Eschbach JW, Adamson JW. 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. *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 . PubMed The geometric mean DCR was 1.17 (95% CI 1.05, 1.29). 4 0 obj
600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery. 2004;19(Suppl 2):ii1631. eCollection 2020 May-Jun. 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. 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. Nephrol Dial Transplant. In responding to hypoxia, erythropoietin interacts with erythroid progenitor . In the month immediately prior to switch, the proportions of patients who had Hb below 10, 1012, and above 12g/dL were 7.3%, 54.4%, and 25.7%, respectively, with 12.6% missing. Hb concentrations were reported as arithmetic means for each month. Epub 2011 Dec 2. pee`T"c+l_WB,`km^;6#j(*m`&E`l${F6Q`&^=e`f(6]8ZE[VHNx-FRIhE&iJKvW`Vz^p@?Yk+S.DgR1rrB6yq2N$| There is limited information published on switching erythropoiesis-stimulating agent (ESA) treatment for anemia associated with chronic kidney disease (CKD) from darbepoetin alfa (DA) to methoxy polyethylene glycol-epoetin beta (PEG-Epo) outside the protocol of interventional clinical studies. 2020 Mar 26;2(3):286-296. doi: 10.1016/j.xkme.2020.01.007. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. 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. 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. Avoid frequent dose adjustments. Administer Mircera either intravenously or subcutaneously in adult patients and only intravenously in pediatric patients. ^D[5j@%e 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 Shortened red blood cell age in patients with end-stage renal disease who were receiving haemodialysis: a cross-sectional study. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. For adverse event reports, please contact us at safety@viforpharma.com,mircera@viforpharma.com or at 1-800-576-8295. Tolman et al. 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). Regression analysis indicated a non-linear relationship between pre- and post-switch ESA doses; DCR decreased with increasing pre-switch DA dose. An official website of the United States government. In pediatric patients, Mircera is administered by intravenous injection only (2.2). Strength: 100 mcg / 0.3ml. Choi, P., Farouk, M., Manamley, N. et al. Epub 2014 Nov 1. National Library of Medicine The primary outcome measure, the geometric mean maintenance DCR, was calculated to be 1.17 (95% CI 1.05, 1.29). 3. BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (. 1986;327:30710. The geometric mean DCR of PEG-Epo to DA was 1.17, rising to 1.21 when the effect of RBC transfusions was taken into account. 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. Please know that the sponsors of this site are not responsible for content on the site you are about to enter. 2002;17(Suppl 5):6670. Nephrol Dial Transplant. %PDF-1.7
Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. 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. Google Scholar. History of serious or severe allergic reactions to Mircera (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). The https:// ensures that you are connecting to the 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%. Conversion Dosing Guide: From epoetin alfa to Aranesp in patients with anemia due to CKD on dialysis. Data were collected from 7months before until 7months after switching treatment. Always store Mircera prefilled syringes in their original cartons. Before For Adult Patients with CKD not on dialysis: Refer patients who self-administer Mircera to the Instructions for Use [see Patient Counseling Information (17)]. FOIA Lancet. MIRCERA can be administered once every 2 weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA. 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. Disclaimer. Please click to see accompanying Aranesp full prescribing information and EPOGEN full prescribing information, including Boxed WARNINGS and Medication Guide. The .gov means its official. 2012;59:444451. Adverse reactions ( 10%) in Aranesp clinical studies in patients with CKD were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension. This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited. Am J Kidney Dis. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Mircera is administered by subcutaneous (SC) or intravenous (IV) injection (2.2). Nephrol Dial Transplant. Arch Intern Med. 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. Show detailed description Study Design Go to Epoetin alfa (Eprex [JanssenCilag], Binocrit [Sandoz], and epoetin zeta (Retacrit, - Hospira UK): the initial dose is 150 IU kg-1 given subcutaneously three times per week.5 -7 Alternatively, epoetin alfa can be administered at an initial dose of 450 IU kg 1 subcutaneously once weekly.5-7 The maximum recommended dose is 900 IU kg-1 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. Federal government websites often end in .gov or .mil. 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. . and transmitted securely. 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. This was particularly evident in patients whose pre-switch EP weekly DA dose was higher than 100g. CAS There were 16 transfusions and 34 units transfused in the pre-switch period, versus 48 transfusions and 95 units transfused post-switch. 6); the mean (SD) Hb within 14days prior to transfusion in these periods was 8.8 (1.41) and 8.3 (1.26), respectively. Epub 2022 Apr 22. Anemia: an early complication of chronic renal insufficiency. risks. 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. Geometric mean weekly PEG-Epo dose at Month 1 post-switch was 26.7g (95% CI 24.4, 29.3), rising to 29g (95% CI 26.2, 32.2) by Month 7 post-switch. Accessed 18 October 2013. 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. Aranesp and EPOGEN have not been shown to improve quality of life, fatigue, or patient well-being. 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. Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Adult Patients with CKD 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). The geometric mean weekly dose of DA was 23.2g (95% CI 20.6, 26.3) in the month prior to switch. Most frequent adverse reactions (5%) in adult patients with CKD treated with MIRCERA. Statistical methods for assessing agreement between two methods of clinical measurement. Careers. doi: 10.1001/archinte.162.12.1401. pediatric patients 5 to 17 years of age on hemodialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA. Individualize dosing and use the lowest dose of Mircera sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. 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. There is limited information published on switching erythropoiesis-stimulating agent (ESA) treatment for anemia associated with chronic kidney disease (CKD) from darbepoetin alfa (DA) to methoxy polyethylene glycol-epoetin beta (PEG-Epo) outside the protocol of interventional clinical studies. 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- ?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`. Mircera with 1-step decrease as soon as Hgb is < 11.8 g/dL and last dose was administered 2 weeks ago or more. Use caution in patients with coexistent cardiovascular disease and stroke. By Month 7 post-switch, the proportions of patients with Hb in these ranges were 9.7%, 48.1%, and 30.1%, respectively. MIRCERA Classification: Erythropoiesis stimulating protein. Canaud B, Mingardi G, Braun J, et al. 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. Mircera would also have competed with Aranesp and with Procrit . 2014 Dec 8;2014(12):CD010590. 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. doi: 10.1093/ndt/17.suppl_5.66. Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. PubMed 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. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events. 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. Please enable it to take advantage of the complete set of features! Administer MIRCERA intravenously once every 4 More ways to get app. Once the hemoglobin has been stabilized, MIRCERA, If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of MIRCERA. Palmer SC, Saglimbene V, Mavridis D, Salanti G, Craig JC, Tonelli M, Wiebe N, Strippoli GF. Mircera works like the human protein called erythropoietin to help your body make more RBCs. 2009 Nov-Dec;15(9):741-50. doi: 10.18553/jmcp.2009.15.9.741.
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