doi: 10.1001/archinte.162.12.1401. Logistic regression was used to estimate an odds ratio comparing the number of patients receiving an RBC transfusion in the post-switch period relative to their dose ratio at switch (<1 vs. 1). 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery. (PDF) Conversion from epoetin beta to darbepoetin: What is the 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. OK Macdougall IC. Most frequent adverse reactions (5%) in adult patients with CKD treated with MIRCERA. A brochure to help you understand how to dose and administer Aranesp, and to convert from epoetin alfa to Aranesp in patients with anemia due to CKD. Amgen Wins Patent Battle Over Roche's Anemia Drug 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]. The information provided in this site is intended only for healthcare professionals in the United States. 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. 1985;28:15. There is no evidence that Mircera alters the metabolism of other medicinal products. Insertion mechanism for drug delivery device - AMGEN INC. (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. 2001;38:803812. Usui T, Zhao J, Fuller DS, Hanafusa N, Hasegawa T, Fujino H, Nomura T, Zee J, Young E, Robinson BM, Nangaku M. Nephrology (Carlton). 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. 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. 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. Table 1 Mircera Starting Doses for Adult Patients Currently Receiving an ESA, Table 2 Mircera Starting Doses for Pediatric Patients Currently Receiving an ESA. 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 Methoxy Polyethylene Glycol-Epoetin Beta (Injection Route) 1 0 obj PMC }"nUEcJumC0ooF Regression analysis indicated a non-linear relationship between pre- and post-switch ESA doses; DCR decreased with increasing pre-switch DA dose. More severe cases were recorded with long-acting agents (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta). 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 . American Society of Hematology Self-Assessment Program (Adam - Scribd 1. There was neither any requirement for a center to have been using DA as their sole long-acting ESA pre-switch, nor for every DA-treated patient to have been switched to PEG-Epo. The distribution of Hb values reported within the 14days prior to transfusion was described; if multiple Hb values were recorded, the value closest to the transfusion date was utilized. official website and that any information you provide is encrypted Cochrane Database Syst Rev. 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. PubMedGoogle Scholar. \ab/`IR 4%jI ^w7qQNA Tq Wz.oVfCVBT{h*>\\3u#P@"wW7|pIMB7 Nephrol Dial Transplant. Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. Tables2 and 3 also summarize the proportion of patients in different Hb categories by study month. Kazmi WH, Kausz AT, Khan S, et al. Macdougall IC. The geometric mean DCR was 1.17 (95% CI 1.05, 1.29). Mircera solution for injection in pre-filled syringe Red blood cell transfusions pre- and post-switch were quantified. Aztec notes.docx - The kidneys are the primary organ of the 2013;28:10929. Initial Treatment: 0.6 mcg/kg body weight administered once every two weeks (2.2). Hb hemoglobin. Excluding patients receiving a transfusion within 90 days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Before Mircera is packaged as single-dose prefilled syringes. 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. PDF Aranesp, Epogen, Mircera, Procrit, Retacrit - Cigna 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). RBC transfusions were reported in terms of number of transfusions and number of units transfused, using descriptive statistics. Horowitz J, Agarwal A, Huang F, Gitlin M, Gandra SR, Cangialose CB. Epoetin beta and methoxy polyethylene glycol may increase tumor growth or decrease survival time in people with certain types of cancer. What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. 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. 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). The data from this study were analyzed using SAS Statistical Software v9.2 (SAS Institute Inc., Cary, NC, USA). Packaging Type: Injection. Adverse reactions ( 5%) in EPOGEN clinical studies in patients with CKD were hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection. Use the Previous and Next buttons to navigate the slides or the slide controller buttons at the end to navigate through each slide. DCR geometric mean maintenance dose conversion ratio, EP evaluation period, ESA erythropoiesis-stimulating agent, Hb hemoglobin, PEG-Epo methoxy polyethylene glycol-epoetin beta. 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. In controlled clinical trials of patients with cancer, ESAs increased the risks for death and serious adverse cardiovascular reactions. Lancet. Intravenous C.E.R.A. MIRCERA comes in pre-filled syringes with laminated plunger stopper and tip cap with one needle 27G1/2. Please enable it to take advantage of the complete set of features! The distribution of transfusions (Fig. Revised European Best Practice Guidelines for the management of anaemia in patients with chronic renal failure. At the moment forecasts for Mircera are $345m in 2015 rising to $552m in 2020, reflecting sales made outside the US. 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. stream Conversion Dosing Guide: from Epoetin Alfa to Aranesp in Patients with Of the 302 patients enrolled, 206 (68%) were included in the DCR analysis. Provided by the Springer Nature SharedIt content-sharing initiative, Over 10 million scientific documents at your fingertips, Not logged in 2002;162:14011408. Report to the Judicial Council. and transmitted securely. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. eCollection 2020 Jun. Am J Nephrol. Therapeutic effects . 5). The number of RBC transfusions and units transfused in the post-switch period was approximately threefold higher compared to the pre-switch period. government site. 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) is an erythropoiesis-stimulating agent (ESA). J Manag Care Pharm. doi: 10.1038/ki.1985.109. 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. Kidney Med. 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). 2). Action Stimulates erythropoesis (production of red blood cells). 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. Unauthorized use of these marks is strictly prohibited. A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks. For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. Methoxy polyethylene glycol-epoetin beta - Wikipedia reverse transcriptase polymerase chain reaction (RT-PCR) Amplification of RNA sequences by conversion to cDNA by nucleic acid hybridization A technique of nucleic acid reverse transcriptase, followed by the polymerase chain reac-analy sis via association of complementary single- stranded tion. Brand: Mircera. Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. There are limitations in generalizing the findings of this study to the broader hemodialysis population. 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. The regression analysis that examined the relationship between mean weekly ESA doses in the two evaluation periods indicated that the DCR is not linear; a significant (P=0.008) quadratic term was observed in the regression analysis, indicating that the predicted DCR decreased at higher pre-switch doses of DA (Fig. 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. randomized patients to darbepoetin or epoetin beta once weekly after the patients had been treated with epoetin beta three times weekly. ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers. ARANESP single-dose strengths can be combined 4,* You can more . Randomized clinical studies have reported data on switching from DA to PEG-Epo (Stabilizing haemoglobin TaRgets in dialysis following IV C.E.R.A. 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. -, Eschbach JW, Adamson JW. EP evaluation period, PEG-Epo methoxy polyethylene glycol-epoetin beta. 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. Individualize dosing and use the lowest dose of MIRCERA. 4. Adv Ther 30, 10071017 (2013). Do not mix Mircera with any parenteral solution. a Mutually exclusive categories; patients are censored in the following, Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. Use the lowest Mircera dose sufficient to reduce the need for red blood cell (RBC) transfusions. CAS Accessibility Discard any unused portion. 3 0 obj About ARANESP (darbepoetin alfa) | Amgen ESA | HCP [citation needed] Active ingredient: methoxy polyethylene glycol-epoetin beta Inactive ingredients: mannitol, methionine, poloxamer 188, sodium phosphate monobasic monohydrate, and sodium sulfate. 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).