Do not use the prefilled syringe more than once. Choi, P., Farouk, M., Manamley, N. et al. Janet Addison is an employee of Amgen with Amgen stock options. _____ (if . MIRCERA is a registered trademark of F. Hoffmann-La Roche Ltd. All Vifor Pharma Groups intellectual rights, including copyright, are, The information provided in this site is intended only for healthcare. MIRCERA (methoxy polyethylene glycol-epoetin beta) is the first erythropoiesis-stimulating agent (ESA) approved by FDA for once-monthly administration. Studies of erythropoietin therapy in patients with chronic anemia of cancer as well as CIA document response rates ranging from ~60% to 85%. 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. In the first month after switch, these proportions were 10.2%, 48.5% and 37.4%, respectively. Hb concentrations were reported as arithmetic means for each month. It is not known if Mircera is safe and effective in children younger than 5 years of age. There were 16 transfusions and 34 units transfused in the pre-switch period, versus 48 transfusions and 95 units transfused post-switch. Dissertation Les Fausses Confidences Stratagme, Les Fromagers De Thirache Horaires, Archange Gabriel Pouvoir, Adeline Franois Mari, Rdiger Un Rapport Sur Un lve En Difficult . 6). 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 geometric mean weekly dose of DA was 23.2g (95% CI 20.6, 26.3) in the month prior to switch. 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. Macdougall IC. 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. 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. Epub 2020 Aug 20. 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. Disclaimer. Cost (BNF 60, March 2013) Aranesp (darbepoetin alfa) - 14.68-220.22 (10 micrograms syringe to 150 microgram syringe) NeoRecormon Mircera (methoxy polyethylene glycol-epoetin beta) - 44.05-220.22 (30 microgram syringe to 150 microgram syringe . pure red cell aplasia (PRCA) that begins after treatment with MIRCERA or other erythropoietin protein drugs. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. The site is secure. Nephrol Dial Transplant. Of the 302 patients enrolled, 206 (68%) were included in the DCR analysis. Pure red cell aplasia (PRCA) that begins after treatment with MIRCERA, History of serious or severe allergic reactions to MIRCERA. endobj 2002;17(Suppl 5):6670. volume30,pages 10071017 (2013)Cite this article. 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. Examine each prefilled syringe for the expiration date. Secondly, the DCR was calculated on a subset of patients which constituted approximately two-thirds of the total enrolled. Macdougall IC, Obrador GT, El Nahas M. How important is transfusion avoidance in 2013? After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. 2020 Mar 26;2(3):286-296. doi: 10.1016/j.xkme.2020.01.007. Results: https://doi.org/10.1007/s12325-013-0063-y, DOI: https://doi.org/10.1007/s12325-013-0063-y. 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. Hrl WH. There are limitations in generalizing the findings of this study to the broader hemodialysis population. 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. 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. 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. I certify that I am a healthcare professional in the US. 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. For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. . MIRCERA Classification: Erythropoiesis stimulating protein. This was particularly evident in patients whose pre-switch EP weekly DA dose was higher than 100g. 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. \ab/`IR 4%jI ^w7qQNA Tq Wz.oVfCVBT{h*>\\3u#P@"wW7|pIMB7 In order to compare stable clinical scenarios for the purposes of DCR calculation, data evaluation periods (EPs) were utilized: Months 2 and 1 were defined as the pre-switch EP and Months +6 and +7 were defined as the post-switch EP. OZZ -, Macdougall IC. 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. Mircera will be administered IV to HD patients, and SC to PD patients. Yves Dimitrov, Julie Rieger, Thierry Hannedouche, Toru Kawai, Yoshie Kusano, Takao Masaki, Shubhadeep D. Sinha, Vamsi Krishna Bandi, Santosh Durugkar, Jonathan Barratt, Frank Dellanna, Michael Reusch, Terumasa Hayashi, Hideki Kato, Ichiei Narita, Rufaida Mazahir, Kanav Anand & P. K. Pruthi, Giovanna Stoppa, Carmen DAmore, ESAVIEW Study Group, Ylenia Ingrasciotta, Valeria Belleudi, On behalf of the Italian Biosimilars Network (I-BioNetwork), Luciano A. Pedrini, Mario Comelli, Stefano Stuard, Advances in Therapy Slider with three articles shown per slide. PubMedGoogle Scholar. )E]$&m"t "N5LQmgh-QZi`T0 hacpBYKUYRw@aMB/|n|'Y#h$8]#|zf. Figure4 also displays the mean monthly Hb for those included in the DCR analysis over the study period. 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. 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. 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]. CAS When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. Mircera (methoxy polyethylene glycol / epoetin beta) dosing, indications, interactions, adverse effects, and more Drugs & Diseases methoxy polyethylene glycol / epoetin beta (Rx) Brand and. Last updated on Jul 26, 2022. 2023 Springer Nature Switzerland AG. There is no evidence that Mircera alters the metabolism of other medicinal products. 2009 Nov-Dec;15(9):741-50. doi: 10.18553/jmcp.2009.15.9.741. Each dosage strength of MIRCERA is designated by a unique syringe plunger color. Please see full Prescribing Information including Boxed WARNING, and Medication Guide for MIRCERA (methoxy polyethylene glycol-epoetin beta) Injection, for Intravenous or Subcutaneous Use. This study and the article processing charges were funded by Amgen Europe GmbH, Zug, Switzerland. Secondary outcomes included Hb concentrations and ESA use during the study period, and the incidence of red blood cell (RBC) transfusions. Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (19881994). -, Eschbach JW, Adamson JW. Mechanism of Action. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. history of serious or severe allergic reactions to MIRCERA (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). 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- The study comprised a 14-month observation period. ARANESP single-dose strengths can be combined 4,* You can more . Please click the OK button below to continue. These adverse reactions included myocardial infarction and stroke. We comply with the HONcode standard for trustworthy health information. 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. 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. Disposition of patients. Once Every Two Weeks (mcg/every two weeks). Aranesp (darbepoetin alfa) Summary of product characteristics. Please know that Amgen, the sponsor of this site, is not responsible for the content on the site you are about to enter. 1. Reasons for low Hb, e.g., acute intercurrent events such as bleeding, were not reported. MIRCERA is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia associated with chronic kidney disease (CKD) in: MIRCERA is not indicated and is not recommended for use: MIRCERA has not been shown to improve quality of life, fatigue, or patient well-being. 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. Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. Packaging Type: Injection. Full Prescribing Information, including Boxed WARNING, full Prescribing Information including Boxed WARNING, How to Use the MIRCERA Prefilled Syringe, Healthcare Provider and Patient Resources, full Prescribing Information, including Boxed WARNING. *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 . DCR geometric mean maintenance dose conversion ratio, EP evaluation period, ESA erythropoiesis-stimulating agent, Hb hemoglobin, PEG-Epo methoxy polyethylene glycol-epoetin beta. -, Macdougall IC. If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of MIRCERA. Epub 2022 Apr 22. For adverse event reports, please contact us at safety@viforpharma.com,mircera@viforpharma.com or at 1-800-576-8295. sharing sensitive information, make sure youre on a federal Dr. Gerald Diaz @GeraldMD. <> 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. More severe cases were recorded with long-acting agents (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta). In CKD, anemia results primarily from decreased production of endogenous erythropoietin (EPO) by the kidney [3]. 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. 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. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. %PDF-1.7 Accessed 18 October 2013. Avoid frequent dose adjustments. Use caution in patients with coexistent cardiovascular disease and stroke. MIRCERA [prescribing information]. Red blood cell transfusions pre- and post-switch were quantified. 33 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. Do not use the prefilled syringe more than once. 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. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Donck J, Gonzalez-Tabares L, Chanliau J, Martin H, Stamatelou K, Manamley N, Farouk M, Addison J. Adv Ther. Horowitz J, Agarwal A, Huang F, Gitlin M, Gandra SR, Cangialose CB. MIRCERA has an approximate molecular weight of 60 kDa. Please know that the sponsors of this site are not responsible for content on the site you are about to enter. Therapeutic effects . (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. FOIA 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. In pediatric patients, Mircera is administered by intravenous injection only (2.2). MIRCERA is a registered trademark of F. Hoffmann-La Roche Ltd. All Vifor Pharma Groups intellectual rights, including copyright, are reserved by the Vifor Pharma Group. 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. x]r9r}W#k Nephrol Dial Transplant. 10PAGE BROCHURE Initial Treatment: 0.6 mcg/kg body weight administered once every two weeks (2.2). Carrera F, Lok CE, de Francisco A, et al. The number of RBC transfusions and units transfused in the post-switch period was approximately threefold higher compared to the pre-switch period. 2012;59:44451. 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 Recombinant human erythropoietin is effective in Mircera contains no preservatives. 5). The geometric mean weekly ESA dose for those included in the DCR analysis is shown in Fig. Data were also manually reviewed prior to final analysis. 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. Anyone you share the following link with will be able to read this content: Sorry, a shareable link is not currently available for this article. 2004;19(Suppl 2):ii1631. aMutually exclusive categories; patients are censored in the following order: first at death post-switch, then at loss to follow-up post-switch, then at receipt of an ESA other than PEG-Epo, and finally lack of an Hb measurement in either or both EPs. Evaluate the iron status in all patients before and during treatment.
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