Janet Addison is an employee of Amgen with Amgen stock options. Arch Intern Med. Drug class: Recombinant human erythropoietins. Aranesp and EPOGEN have 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. Please know that the sponsors of this site are not responsible for content on the site you are about to enter. Mircera ceiling is 200 mcg every two weeks (or 3.0 mcg/kg/2 weeks, whichever is lower). Conclusion: Revised European Best Practice Guidelines for the management of anaemia in patients with chronic renal failure. MIRCERA Classification: Erythropoiesis stimulating protein. Among patients switched from DA to PEG-Epo, the mean monthly PEG-Epo dose was increased from 159g at the switch to 263g at Week 26 and 273g at Month 1112 [11]. 33 Dose. Learn how to combine multiple dosing options for precise titration and individualize anemia management.1. Conversion d'une EPO l'autre Conversion potine en darbpotine avec un facteur de conversion 200 UI = 1 g Bilan martial Suivi ferritine et taux de saturation de la transferrine (TSAT) tous les 3 mois. This study and the article processing charges were funded by Amgen Europe GmbH, Zug, Switzerland. <>/Metadata 444 0 R/ViewerPreferences 445 0 R>>
https://doi.org/10.1007/s12325-013-0063-y, DOI: https://doi.org/10.1007/s12325-013-0063-y. Lancet. Strength: 100 mcg / 0.3ml. 2014 Dec 8;2014(12):CD010590. When administered subcutaneously, Mircera should be injected in the abdomen, arm or thigh. Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. 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. 2). eCollection 2020 May-Jun. See Instructions for Use for complete instructions on the preparation and administration of Mircera. -, Eschbach JW, Adamson JW. 1:1 reference line, BlandAltman analysis of agreement between, BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose ( n, Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period., Red blood cell transfusions pre- and post-switch, Summary of the last hemoglobin concentrations recorded within 14 days prior to red, MeSH A BlandAltman analysis [10] was also performed to assess the agreement between ESA doses in the evaluation periods. 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). Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Adult Patients with CKD. MIRCERA is indicated for the treatment of anemia associated with CKD in adult patients on dialysis and adult patients not on dialysis. Use caution in patients with coexistent cardiovascular disease and stroke. ferrous sulfate, Aranesp, Procrit, Retacrit. I certify that I am a healthcare professional in the US. If Hb increases by < 1 g/dL and remains < 10 g/dL after 6 weeks of therapy: If dosing QW, then increase dose to 4.5 mcg/kg/week. sharing sensitive information, make sure youre on a federal 2023Vifor (International) Inc. All rights reserved. Asterisk Not all transfusions had an associated hemoglobin concentration in the 14-day period before transfusion. Epub 2014 Nov 1. For adverse event reports, please contact us at safety@viforpharma.com,mircera@viforpharma.com or at 1-800-576-8295. Nephrol Dial Transplant. 2009 Nov-Dec;15(9):741-50. doi: 10.18553/jmcp.2009.15.9.741. MIRCERA comes in pre-filled syringes with laminated plunger stopper and tip cap with one needle 27G1/2. 2 0 obj
Mechanism of Action. 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. 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. If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of MIRCERA. Secondly, the DCR was calculated on a subset of patients which constituted approximately two-thirds of the total enrolled. as a substitute for red blood cell transfusions in patients who require immediate correction of anemia. Data were collected from 7 months before until 7 months after switching treatment. \ab/`IR 4%jI ^w7qQNA Tq Wz.oVfCVBT{h*>\\3u#P@"wW7|pIMB7 2002;162:14011408. 2012;59:444451. Anemia of chronic kidney disease (CKD) becomes increasingly prevalent and severe as kidney function declines [1], with over 90% of patients who require renal replacement therapy becoming anemic [2]. Statistical methods for assessing agreement between two methods of clinical measurement. Of 302 patients enrolled, 206 had data available for DCR analysis. 2002;17(Suppl 5):6670. Pharmacokinetic studies have shown that the meanSD terminal half-life of DA is 217.5h when administered intravenously (IV) [7]. 4. 2008;23:365461. Inflammation and Erythropoiesis-Stimulating Agent Response in Hemodialysis Patients: A Self-matched Longitudinal Study of Anemia Management in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Locatelli F, Aljama P, Barany P, et al. Packaging Type: Injection. Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp #Pharmacology #Hematology #Nephrology. History of serious or severe allergic reactions to Mircera (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). 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. 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. Visit. More severe cases were recorded with long-acting agents (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta). 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. Matsumura K, Okumiya T, Sugiura T, Takahashi N, Yamamoto Y, Kikuchi S, Fujii K, Otagaki M, Shiojima I. BMC Nephrol. A decade in the anaemia market - 10 products seen top . St. Gallen, Switzerland: Vifor (International) Inc.; June 2018. Canaud B, Mingardi G, Braun J, et al. PMC _____ (if . 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. Mircera with 1-step decrease as soon as Hgb is < 11.8 g/dL and last dose was administered 2 weeks ago or more. Summary of the last hemoglobin concentrations recorded within 14days prior to red blood cell transfusions pre- and post-switch. Macdougall IC, Obrador GT, El Nahas M. How important is transfusion avoidance in 2013? Treatment: Treat to anemia in people with chronic kidney disease. Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. 2014 Nov;31(11):1155-68. doi: 10.1007/s12325-014-0161-5. Internal You are now leaving AnemiaHub.com. Epoetin beta and methoxy polyethylene glycol may increase tumor growth or decrease survival time in people with certain types of cancer. 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). -, Kazmi WH, Kausz AT, Khan S, et al. Individualize dosing and use the lowest dose of Mircera sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. stream
Horowitz J, Agarwal A, Huang F, Gitlin M, Gandra SR, Cangialose CB. Results: The remaining enrolment was at four sites divided between three other countries. 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. 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. afK ] T z"$qu9H$}W//~||!+iO7^Q)|F.j+m
ZJ7CY\7\lO7OGPno? Macdougall IC. The geometric mean weekly ESA dose for those included in the DCR analysis is shown in Fig. All calculations should be confirmed before use. Intravenous C.E.R.A. 1985;28:15. Nephrol Dial Transplant. reaction occurs. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. 6); the mean (SD) Hb within 14days prior to transfusion in these periods was 8.8 (1.41) and 8.3 (1.26), respectively. Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. Discard any unused portion. WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE CHRONIC KIDNEY DISEASE: Please see full Prescribing Information including Boxed WARNING, and Medication Guide(English, Espaol) for MIRCERA (methoxy polyethylene glycol-epoetin beta) Injection, for Intravenous or Subcutaneous Use. risks. 2002;17(Suppl 5):6670. -, Macdougall IC. Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. 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. 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). Anemia of end-stage renal disease (ESRD) Kidney Int. 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. 1986;327:30710. . Correspondence to Unauthorized use of these marks is strictly prohibited. Nephrol Dial Transplant. HHS Vulnerability Disclosure, Help 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. Mircera (methoxy polyethylene glycol / epoetin beta) dosing, indications, interactions, adverse effects, and more Drugs & Diseases methoxy polyethylene glycol / epoetin beta (Rx) Brand and. . Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. In responding to hypoxia, erythropoietin interacts with erythroid progenitor . Epub 2011 Dec 2. Use caution in patients with coexistent cardiovascular disease and stroke. For Pediatric Patients with CKD on hemodialysis: Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Pediatric Patients with CKD Treated with Hemodialysis. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events. }"nUEcJumC0ooF You may also report negative side effects of prescription drugs to the Food and Drug Administration (FDA). 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 . -. Introduction: Please click to see accompanying Aranesp full prescribing information and EPOGEN full prescribing information, including Boxed WARNINGS and Medication Guide. 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. DCR geometric mean maintenance dose conversion ratio, EP evaluation period, ESA erythropoiesis-stimulating agent, Hb hemoglobin, PEG-Epo methoxy polyethylene glycol-epoetin beta. Adverse reactions ( 10%) in Aranesp clinical studies in patients with CKD were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension. doi: 10.1038/ki.1985.109. 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). Mircera is a prescription medicine used to treat the symptoms of Anemia associated with Chronic Renal Failure. species. WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE. Mircera may be used alone or with other medications. 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. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. In controlled clinical trials of patients with cancer, ESAs increased the risks for death and serious adverse cardiovascular reactions. Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (19881994). Disclaimer. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Choi, P., Farouk, M., Manamley, N. et al. Anemia of end-stage renal disease (ESRD). Do not pool unused portions from the prefilled syringes. -, Macdougall IC. BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (n=205). 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. 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. Cochrane Database Syst Rev. 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. Support for this assistance was funded by Amgen. Please know that Amgen, the sponsor of this site, is not responsible for the content on the site you are about to enter. Examine each prefilled syringe for the expiration date. EPOGEN (epoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis to decrease the need for red blood cell (RBC) transfusion. 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. a Mutually exclusive categories; patients are censored in the following, Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. 8600 Rockville Pike There were 16 transfusions and 34 units transfused in the pre-switch period, versus 48 transfusions and 95 units transfused post-switch. Show detailed description Study Design Go to doi: 10.1002/14651858.CD010590.pub2. ^D[5j@%e Administer MIRCERA intravenously once every 4 More ways to get app. 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. Donck J, Gonzalez-Tabares L, Chanliau J, Martin H, Stamatelou K, Manamley N, Farouk M, Addison J. Adv Ther. 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. The information provided in this site is intended only for healthcare professionals in the United States. 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. Goodkin DA, Zhao J, Cases A, Nangaku M, Karaboyas A. This medicine is not used to treat anemia caused by cancer medicines. 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. Bland JM, Altman DG. Kazmi WH, Kausz AT, Khan S, et al. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. eCollection 2020 Jun. Recombinant human erythropoietin is effective in