Follow me!">
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. . The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). You may also report negative side effects of prescription drugs to the Food and Drug Administration (FDA). Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp #Pharmacology #Hematology #Nephrology. 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. St. Gallen, Switzerland: Vifor (International) Inc.; June 2018. Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. Support for this assistance was funded by Amgen. Packaging Type: Injection. chemotherapy, MDS or MF, continued therapy) Please provide a hemoglobin level (g/dL) for your patient taken within the first 12 weeks of therapy with epoetin and include the date the lab was drawn. 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. Please know that Amgen, the sponsor of this site, is not responsible for the content on the site you are about to enter. Nephrol Dial Transplant. 3. The geometric mean weekly ESA dose for those included in the DCR analysis is shown in Fig. 2023 Springer Nature Switzerland AG. darbepoetin alfa (Aransep) pre-filled syringe, injectable vial epoetin alfa (Epogen; Procrit) injectable methoxy polyethylene glycol-epoetin beta (Mircera) pre-filled syringe Conditions Medications Dialysis patients can . Individual patients could contribute multiple transfusions to these analyses. Mircera is packaged as single-dose prefilled syringes. 2009 Nov-Dec;15(9):741-50. doi: 10.18553/jmcp.2009.15.9.741. Each pre-filled syringe contains 0.3 ml or 0.6 ml. Am J Kidney Dis. This site needs JavaScript to work properly. 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. Hrl WH. HQ-MIR-1900027 Site last modified: January 2023. x]r9r}W#k Resistance to Erythropoiesis-Stimulating Agents among Patients on Hemodialysis Is Typically Transient. For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. Nephrol Dial Transplant. Box 1557, 6301, Zug, Switzerland, Amgen (UK) Limited, 240 Cambridge Science Park, Milton Road, Cambridge, UK, You can also search for this author in Publication management support was provided by Caterina Hatzifoti, PhD, of Amgen Europe GmbH. New anemia therapies: translating novel strategies from bench to bedside. Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. Immediately and permanently discontinue Aranesp or EPOGEN if a serious allergic 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. In pediatric patients on hemodialysis, all reported adverse reactions regardless of causality (more than 5% incidence) were headache, nasopharyngitis, hypertension, vomiting, bronchitis, abdominal pain, arteriovenous fistula thrombosis, cough, device related infection, hyperkalemia, pharyngitis, pyrexia, thrombocytopenia, and thrombosis in device. Following initiation of therapy and after each dose adjustment, monitor hemoglobin weekly until the hemoglobin level is stable and sufficient to minimize the need for RBC transfusion. Studies of erythropoietin therapy in patients with chronic anemia of cancer as well as CIA document response rates ranging from ~60% to 85%. Monitor patients closely for new-onset seizures, premonitory symptoms, or change in seizure frequency. 2022;53(5):333-342. doi: 10.1159/000523947. Am J Nephrol. volume30,pages 10071017 (2013)Cite this article. sharing sensitive information, make sure youre on a federal Of the 302 patients enrolled, 206 (68%) were included in the DCR analysis. 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. Red blood cell transfusions pre- and post-switch were quantified. The dose of Mircera, given as a single intravenous or subcutaneous injection, should be based on the doi: 10.1038/ki.1985.109. A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks. https://doi.org/10.1007/s12325-013-0063-y, DOI: https://doi.org/10.1007/s12325-013-0063-y. 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. 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. 1MIRCERA [prescribing information]. Mircera contains no preservatives. Carrera F, Lok CE, de Francisco A, et al. Following initiation of therapy and after each dose adjustment, monitor hemoglobin weekly until the hemoglobin level is stable and sufficient to minimize the need for RBC transfusion. Amgen's two anemia drugs, Epogen and Aranesp, had sales of $6.6 billion last year, nearly half the company's total revenue. Eschbach JW, Adamson JW. 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]. -. Contributed by. The distribution of transfusions (Fig. Treatment: Treat to anemia in people with chronic kidney disease. Article Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. Further exploration of the relationship between DA and PEG-Epo doses using the BlandAltman method [10], which circumvents the limitations of the regression method in this type of investigation, indicated that the variability in the dose differences increased as doses increased, while the level of concordance decreased with increasing ESA dose. Learn how to combine multiple dosing options for precise titration and individualize anemia management.1. The geometric mean DCR was 1.17 (95% CI 1.05, 1.29). FOIA The information provided in this site is intended only for healthcare professionals in the United States. Accessed 18 October 2013. 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 ESA erythropoiesis-stimulating agent, Hb hemoglobin. Not all pack sizes may be marketed. Decreases in dose can occur more frequently. Randomized clinical studies have reported data on switching from DA to PEG-Epo (Stabilizing haemoglobin TaRgets in dialysis following IV C.E.R.A. 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 : EPAR - Conditions imposed on member states for safe and effective use - Annex IV (PDF/15.49 KB) First published: 02/08/2007 Last updated: 02/08/2007 Pharmacotherapeutic group Antianemic preparations Therapeutic indication Treatment of symptomatic anaemia associated with chronic kidney disease (CKD). Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. OZZ Mircera (methoxy polyethylene glycol-epoetin beta) is an erythropoiesis-stimulating agent (ESA). )E]$&m"t "N5LQmgh-QZi`T0 hacpBYKUYRw@aMB/|n|'Y#h$8]#|zf. Careers. Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Adult Patients with CKD. See Instructions for Use for complete instructions on the preparation and administration of Mircera. 2. before initiating Mircera [see Warnings and Precautions (5.9)]. species. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. This suggests that the decision to transfuse was consistent with respect to Hb over the observation period (Fig. For patients who do not respond adequately over a 12-week escalation period, increasing the MIRCERA, Evaluate other causes of anemia. . Appropriately control hypertension prior to initiation of and during treatment with MIRCERA, Seizures have occurred in patients participating in MIRCERA, For lack or loss of hemoglobin response to MIRCERA, If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. 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. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Epub 2014 Nov 1. 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 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. Read reviews from GoodRx users who have taken Mircera and find the latest news on the drug. MIRCERA comes in pre-filled syringes with laminated plunger stopper and tip cap with one needle 27G1/2. Anemia: an early complication of chronic renal insufficiency. - 94.130.71.173. Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Pediatric Patients with CKD Treated with Hemodialysis 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. Do not increase the dose more frequently than once every 4 weeks. 2012;59:44451. DA, launched in 2001 [5, 7], contains 5 N-linked oligosaccharide chains, rather than the 3 contained in short-acting epoetins, which confer an approximately threefold longer serum half-life and mean residence time, allowing extended inter-dosing intervals [6]. Please see full Prescribing Information including Boxed WARNING, and Medication Guide for MIRCERA (methoxy polyethylene glycol-epoetin beta) Injection, for Intravenous or Subcutaneous Use. 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. Am J Kidney Dis. 1:1 reference line indicates equal PEG-Epo and darbepoetin alfa doses. Eligible patients had received hemodialysis for 12 months and DA for 7 months. 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. Data were collected from 7months before until 7months after switching treatment. Conclusion: Nephrol Dial Transplant. Red blood cell transfusions pre- and post-switch, Summary of the last hemoglobin concentrations recorded within 14days prior to red blood cell transfusions pre- and post-switch. Correspondence to *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 . reaction occurs. Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. 2002;162:14018. 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. Karaboyas A, Morgenstern H, Fleischer NL, Vanholder RC, Dhalwani NN, Schaeffner E, Schaubel DE, Akizawa T, James G, Sinsakul MV, Pisoni RL, Robinson BM. OK Red blood cell transfusions pre- and post-switch were quantified. Epoetin beta and methoxy polyethylene glycol may increase tumor growth or decrease survival time in people with certain types of cancer. The conversion from EpoB to CERA (methoxy polyethylene glycol-epoetin beta; Mircera; Hoffmann-La Roche Ltd., Basel, Switzerland) once monthly was already decided by the health care payer policy, who is the provider of erythropoietin stimulating agents for all patients, and was planned after a period of 6 months. Results of the BlandAltman analysis investigating the concordance between mean weekly ESA doses in both evaluation periods are presented in Fig. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. Adverse reactions ( 10%) in Aranesp clinical studies in patients with CKD were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension. MIRCERA Interactions: May require increased anticoagulation (heparin) during hemodialysis. For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. DA can be administered once a week (QW) or once every 2weeks (Q2W) to hemodialysis patients. 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. A single hemoglobin excursion may not require a dosing change. Evaluate the iron status in all patients before and during treatment. risks. Secondly, the DCR was calculated on a subset of patients which constituted approximately two-thirds of the total enrolled. Aranesp (darbepoetin alfa) Summary of product characteristics. Empirical methods to calculate an erythropoiesis-stimulating agent dose conversion ratio in nondialyzed patients with chronic kidney disease. Therapeutic effects . 5). For Adult Patients with CKD not on dialysis: Refer patients who self-administer Mircera to the Instructions for Use [see Patient Counseling Information (17)]. Initial Treatment: 0.6 mcg/kg body weight administered once every two weeks (2.2). Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit. \ab/`IR 4%jI ^w7qQNA Tq Wz.oVfCVBT{h*>\\3u#P@"wW7|pIMB7 Fewer than half of the patients achieved Hb in the 1012g/dL range by 7months 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. The pre-transfusion Hb concentrations were similar for transfusions occurring both pre- and post-switch (Fig. Use the lowest Mircera dose sufficient to reduce the need for red blood cell (RBC) transfusions. The intravenous route is recommended for patients on hemodialysis because the intravenous route may be less immunogenic. Epub 2020 Aug 20. 2012 Jun;27(6):2303-11. doi: 10.1093/ndt/gfr677. If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of MIRCERA. It is not known if Mircera is safe and effective in children younger than 5 years of age. Nick Manamley, MSc, is an employee of Amgen with Amgen stock ownership. Pure red cell aplasia (PRCA) that begins after treatment with MIRCERA, History of serious or severe allergic reactions to MIRCERA. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. history of serious or severe allergic reactions to MIRCERA (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). 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. This medicine is not used to treat anemia caused by cancer medicines. Administer Mircera as an intravenous injection at the dose (in micrograms) based on the total weekly ESA dose at the time of conversion (see Table 2). | DOWNLOAD SIZE: adult patients on dialysis and adult patients not on dialysis. Unable to load your collection due to an error, Unable to load your delegates due to an error. 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. 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). Disposition of patients. In CKD, anemia results primarily from decreased production of endogenous erythropoietin (EPO) by the kidney [3]. ^D[5j@%e Nephrol Dial Transplant. 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 [prescribing information]. 2 0 obj Roche Registration Ltd., Welwyn Garden City, UK, 19 June 2012. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000739/WC500033672.pdf. Data were collected from 7 months before until 7 months after switching treatment. Evaluation of Iron Stores and Nutritional Factors. This was particularly evident in patients whose pre-switch EP weekly DA dose was higher than 100g. Evaluate the iron status in all patients before and during treatment. PubMed Mircera (methoxy polyethylene glycol-epoetin beta) Summary of product characteristics. 2020 Mar 26;2(3):286-296. doi: 10.1016/j.xkme.2020.01.007. MIRCERA can be administered once every 2 weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA. 2002;162:14011408. ARANESP single-dose strengths can be combined 4,* You can more . 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. 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. This medicine is not for treating anemia caused by cancer chemotherapy. 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. government site. Show detailed description Study Design Go to The number of transfusions and units transfused increased approximately threefold from the pre-switch to the post-switch period. EP evaluation period, PEG-Epo methoxy polyethylene glycol-epoetin beta. 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. 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. 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. For Pediatric Patients with CKD on hemodialysis: Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Pediatric Patients with CKD Treated with Hemodialysis. Mircera Injection (Methoxy Polyethylene Glycol-Epoetin Beta ) 6,610/ Piece Get Latest Price. Accessed 18 October 2013. Association of erythropoietin resistance and fibroblast growth factor 23 in dialysis patients: Results from the Japanese Dialysis Outcomes and Practice Patterns Study. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 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. Goodkin DA, Zhao J, Cases A, Nangaku M, Karaboyas A. BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (. pee`T"c+l_WB,`km^;6#j(*m`&E`l${F6Q`&^=e`f(6]8ZE[VHNx-FRIhE&iJKvW`Vz^p@?Yk+S.DgR1rrB6yq2N$| Mircera belongs to a class of drugs called Hematopoietic Growth Factors. Mircera may be used alone or with other medications. Janet Addison is an employee of Amgen with Amgen stock options. Cochrane Database Syst Rev. A motion conversion mechanism 123 includes a yoke 153 and a rotatable member 149, which causes the yoke 152, . 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. Longer-acting PEG-Epo contains a chemical bond between an amino group present in epoetin beta and methoxy polyethylene glycol (PEG) butanoic acid; the addition of PEG is responsible for an increase in serum half-life of epoetin beta, and in CKD patients on dialysis the terminal half-life of PEG-Epo after IV administration is 134h [6, 8]. Anemia: an early complication of chronic renal insufficiency. Accessibility Excluding patients receiving a transfusion within 90 days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). Changes in ESA dosing and number of transfusions post-switch may have important health-economic implications. 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. Do you wish to proceed? Do not pool unused portions from the prefilled syringes. 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. 1. Internal You are now leaving AnemiaHub.com. Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. 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. 2019 Jul 5;13(3):425-433. doi: 10.1093/ckj/sfz065. Control hypertension prior to initiating and during treatment with Aranesp or EPOGEN. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events [see Boxed Warning and Clinical Studies (14)]. Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (19881994). }"nUEcJumC0ooF Google Scholar. 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. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. stream 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. If Hb exceeds a level needed to avoid RBC transfusions, withhold dose until Hb approaches a level where RBC transfusions may be required and reinitiate at a dose 40% below the previous dose. Dialysis centers were expected to adhere to European Best Practice Guidelines for iron repletion [9]. Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations.
Why Did Laura Barns Kill Herself,
Michael Voss Obituary,
Articles M
Follow me!
