Mircera will be administered IV to HD patients, and SC to PD patients. (0.6MB), Anemia Assessment and Management Brochure, Pathophysiology of Anemia in Patients with CKD, * Case studies and patient profiles are hypothetical, WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE. Mircera Injection: Uses, Dosing & Side Effects - Drugs.com <> }"nUEcJumC0ooF 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). 1. Do not pool unused portions from the prefilled syringes. 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. The geometric mean weekly dose of DA was 23.2g (95% CI 20.6, 26.3) in the month prior to switch. Methoxy polyethylene glycol-epoetin (Mircera ) will be increased and decreased in 1-step or 2-step increments, based on scale above. -, Eschbach JW, Adamson JW. 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. Matsumura K, Okumiya T, Sugiura T, Takahashi N, Yamamoto Y, Kikuchi S, Fujii K, Otagaki M, Shiojima I. BMC Nephrol. Epoetin zeta | Drugs | BNF | NICE 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. 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 Epub 2022 Apr 22. You may also report negative side effects of prescription drugs to the Food and Drug Administration (FDA). in the treatment of anemia due to cancer chemotherapy. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. 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. - , . 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. A single hemoglobin excursion may not require a dosing change. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. This medicine is not used to treat anemia caused by cancer medicines. This paper presents the findings of a retrospective, multi-center, observational study of hemodialysis patients switched from DA to PEG-Epo for the treatment of anemia. 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. . Medically reviewed by Drugs.com. pure red cell aplasia (PRCA) that begins after treatment with MIRCERA or other erythropoietin protein drugs. 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. Administer Mircera either intravenously or subcutaneously in adult patients and only intravenously in pediatric patients. Methoxy Polyethylene Glycol-Epoetin Beta (Injection Route) Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. Red blood cell transfusions pre- and post-switch were quantified. Would you like email updates of new search results? Available for Android and iOS devices. 2002;162:14011408. before initiating Mircera [see Warnings and Precautions (5.9)]. 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. Mircera at Best Price in India - IndiaMART The introduction of exogenous erythropoiesis-stimulating agents (ESAs) to clinical practice has transformed the care of patients with CKD, by ameliorating anemia, reducing transfusion requirements, and improving quality of life [4]. There is no evidence that Mircera alters the metabolism of other medicinal products. 1MIRCERA [prescribing information]. For lack or loss of hemoglobin response to Aranesp or EPOGEN, initiate a search for causative factors. Please know that Amgen, the sponsor of this site, is not responsible for the content on the site you are about to enter. 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. Each pre-filled syringe contains 0.3 ml or 0.6 ml. 2001;38:803812. Initial Treatment: 0.6 mcg/kg body weight administered once every two weeks (2.2). 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. 1. Mircera solution for injection in pre-filled syringe The initial conversion factor was 200:1. Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (19881994). 2010;25:400917. 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]. 33 Dose. 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. PDF Anmie chez l'insuffisant rnal : comment utiliser les agents stimulant Nephrol Dial Transplant. Dose Conversion Ratio in Hemodialysis Patients Switched from For recommended dose equivalency, see Tables A and B (below). Not all pack sizes may be marketed. Recombinant human erythropoietin is effective in The number of transfusions and units transfused increased approximately threefold from the pre-switch to the post-switch period. 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). 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. Adverse Reactions: Hypertension, diarrhea,. Recombinant human erythropoietins: very rare risk of severe cutaneous Internal You are now leaving AnemiaHub.com. Bookshelf . Patients were excluded if they had participated in any interventional study within 30days before the 7-month period preceding the switch or at any subsequent time up to 7months after the switch. Pfizer's Retacrit, the First Erythropoietin Stimulating - BioSpace Aztec notes.docx - The kidneys are the primary organ of the Google Scholar. Table 1 Mircera Starting Doses for Adult Patients Currently Receiving an ESA, Table 2 Mircera Starting Doses for Pediatric Patients Currently Receiving an ESA. Please know that the sponsors of this site are not responsible for content on the site you are about to enter. Eligible patients were randomized, either to continue on the previous regimen of Epoetin, or to receive Darbepoetin alfa or continuous erythropoietin receptor activator (C.E.R.A) for a total period of 40 weeks. 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: 10.1053/j.ajkd.2011.11.013. Individualize dosing and use the lowest dose of Mircera sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. MIRCERA [prescribing information]. 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. 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. Differentiating factors between erythropoiesis-stimulating agents: an update to selection for anaemia of chronic kidney disease. Palmer SC, Saglimbene V, Mavridis D, Salanti G, Craig JC, Tonelli M, Wiebe N, Strippoli GF. There were 16 transfusion events in the pre-switch period and 48 post-switch, with a total of 34 units transfused pre-switch and 95 units in the post-switch period (Fig. and darbepOetin alfa in patieNts Undergoing dialySis [PATRONUS] [9]); however, there is a lack of published literature on switching in patients receiving routine clinical care (i.e., outside interventional clinical trials). 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. Therapeutic effects . 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. 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. Conversion - Epoetin alfa (Procrit) to Darbepoetin | GrepMed endobj The remaining enrolment was at four sites divided between three other countries. Action Stimulates erythropoesis (production of red blood cells). 1985;28:15. DCR was calculated for patients with Hb and ESA data available in both evaluation periods (EP; Months 1 and 2 were defined as the pre-switch EP, and Months 6 and 7 as the post-switch EP). Fewer than half of the patients achieved Hb in the 1012g/dL range by 7months post-switch. Do not use the prefilled syringe more than once. Epoetin alfa was the first rhEPO produced and approved for pharmaceutical use, followed by several related products and by newer ESAs with the same mechanism but more prolonged action. Careers. Aranesp Dosing Calculator75 mcg/kg as an IV or SC injection once every Conversion from epoetin beta to darbepoetin: what is the equivalent Mircera is administered by subcutaneous (SC) or intravenous (IV) injection (2.2). BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (n=205). Regardless of possible differences in their clinical characteristics it should be borne in mind that patients were not selected for inclusion in the DCR analysis on the basis of their fulfilling any clinical, Hb or ESA dose requirements: all patients who had Hb measurements in both EPs, a DA dose in the pre-switch EP and a PEG-Epo dose in the post-switch EP were eligible for inclusion. 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. Statistical methods for assessing agreement between two methods of clinical measurement. Please enable it to take advantage of the complete set of features! These findings were observed in studies of patients with advanced head and neck cancer receiving radiation therapy, in patients receiving chemotherapy for metastatic breast cancer or lymphoid malignancy, and in patients with non-small cell lung cancer or various malignancies who were not receiving chemotherapy or radiotherapy. "BG0RjI G78 1986;327:30710. 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. A single hemoglobin excursion may not require a dosing change. Prise en charge anmie rnale - Nephro.blog We comply with the HONcode standard for trustworthy health information. PMC MIRCERA can be administered once every 2 weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA. 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery. Do not increase the dose more frequently than once every 4 weeks. 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.