mircera to aranesp conversion

Carrera F, Lok CE, de Francisco A, et al. 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. 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]. Contributed by. 2001;38:80312. Drug class: Recombinant human erythropoietins. Excursions of Hb values above and below the range of 1012g/dL [9] were more common in the post-switch compared to the pre-switch period. 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. 1985;28:15. 2012;59:444451. 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). Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. 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 dose of MIRCERA , given as a single intravenous or subcutaneous injection, should be based on the total weekly ESA dose at the time of conversion. afK ] T z"$qu9H$}W//~||!+iO7^Q)|F.j+m ZJ7CY\7\lO7OGPno? ONLY administer MIRCERA intravenously in pediatric patients. The number of transfusions and units transfused increased approximately threefold from the pre-switch to the post-switch period. Of 302 patients enrolled, 206 had data available for DCR analysis. Use the lowest Mircera dose sufficient to reduce the need for red blood cell (RBC) transfusions. 6); the mean (SD) Hb within 14days prior to transfusion in these periods was 8.8 (1.41) and 8.3 (1.26), respectively. 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. Palmer SC, Saglimbene V, Mavridis D, Salanti G, Craig JC, Tonelli M, Wiebe N, Strippoli GF. Treatment: Treat to anemia in people with chronic kidney disease. Donck J, Gonzalez-Tabares L, Chanliau J, Martin H, Stamatelou K, Manamley N, Farouk M, Addison J. Adv Ther. Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Adult Patients with CKD Mircera can be administered once every two weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA (see Table 1). This article does not contain any studies with human or animal subjects performed by any of the authors. Do not mix Mircera with any parenteral solution. Methods: 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. pee`T"c+l_WB,`km^;6#j(*m`&E`l${F6Q`&^=e`f(6]8ZE[VHNx-FRIhE&iJKvW`Vz^p@?Yk+S.DgR1rrB6yq2N$| Not all pack sizes may be marketed. Figure4 also displays the mean monthly Hb for those included in the DCR analysis over the study period. For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Once Every Two Weeks (mcg/every two weeks). -, Kazmi WH, Kausz AT, Khan S, et al. For recommended dose equivalency, see Tables A and B (below). 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. Open Access This article is distributed under the terms of the Creative Commons Attribution 2.0 International License (https://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Use caution in patients with coexistent cardiovascular disease and stroke. The geometric mean DCR was 1.17 (95% CI 1.05, 1.29). Strength: 100 mcg / 0.3ml. The site is secure. -, Macdougall IC. Adverse Reactions: Hypertension, diarrhea,. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. Publication management support was provided by Caterina Hatzifoti, PhD, of Amgen Europe GmbH. Descriptions. 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 In the evaluation periods, the geometric mean weekly DA dose in the pre-switch EP was 24.1g (95% CI 21.3, 27.1) while the geometric mean weekly PEG-Epo dose in the post-switch EP was 28.6g (95% CI 26.0, 31.5). <> 2010;25:400917. Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. 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]. 2004;19(Suppl 2):ii1631. Conversion from Epoetin alfa or Darbepoetin alfa to MIRCERA in Pediatric Patients with CKD on Hemodialysis. The long-acting r-HuEPO methoxy polyethylene glycol-epoetin beta (Mircera) has been associated with a risk of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) following a. Visit. Composition: Methoxy Polyethylene Glycol-Epoetin Beta. Accessed 18 October 2013. <>/Font<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> An observational cohort study of extended dosing (once every 2 weeks or once monthly) regimens with darbepoetin alfa in patients with chronic kidney disease not on dialysis: the EXTEND study. Red blood cell transfusions pre- and post-switch were quantified. New anemia therapies: translating novel strategies from bench to bedside. Federal government websites often end in .gov or .mil. Mircera (methoxy polyethylene glycol-epoetin beta) Summary of product characteristics. HQ-MIR-1900027 Site last modified: January 2023. 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. 2019 Jul 5;13(3):425-433. doi: 10.1093/ckj/sfz065. Matsumura K, Okumiya T, Sugiura T, Takahashi N, Yamamoto Y, Kikuchi S, Fujii K, Otagaki M, Shiojima I. BMC Nephrol. Fewer than half of the patients achieved Hb in the 1012g/dL range by 7months post-switch. J Manag Care Pharm. in the treatment of anemia due to cancer chemotherapy. Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with Aranesp or EPOGEN. For lack or loss of hemoglobin response to Aranesp or EPOGEN, initiate a search for causative factors. MIRCERA has an approximate molecular weight of 60 kDa. before initiating Mircera [see Warnings and Precautions (5.9)]. doi: 10.1038/ki.1985.109. The initial conversion factor was 200:1. If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of MIRCERA. Dose by Weight Chart - Resourcehub Epogen Dosage Guide - Drugs.com Epogen, Procrit (epoetin alfa) dosing, indications, interactions Do not pool unused portions from the prefilled syringes. There is limited information published on switching erythropoiesis-stimulating agent (ESA) treatment for anemia associated with chronic kidney disease (CKD) from darbepoetin alfa (DA) to methoxy polyethylene glycol-epoetin beta (PEG-Epo) outside the protocol of interventional clinical studies. ESAs resulted in decreased locoregional control/progression-free survival and/or overall survival. 1 0 obj Pure red cell aplasia (PRCA) that begins after treatment with MIRCERA, History of serious or severe allergic reactions to MIRCERA. 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. Each pre-filled syringe contains 0.3 ml or 0.6 ml. Although the reasons for transfusion were not recorded, the pre-transfusion Hb concentrations within 14days prior to transfusion remained similar for transfusions occurring both pre- and post-switch. 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. Amgen Europe B.V., Breda, The Netherlands, 29 August 2013. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000332/WC500026149.pdf. This medicine is not used to treat anemia caused by cancer medicines. 2023 Springer Nature Switzerland AG. Unauthorized use of these marks is strictly prohibited. When administered subcutaneously, Mircera should be injected in the abdomen, arm or thigh. Am J Kidney Dis. 6). See Instructions for Use for complete instructions on the preparation and administration of MIRCERA, If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of MIRCERA. Examine each prefilled syringe for the expiration date. Low hemoglobin at hemodialysis initiation: an international study of anemia management and mortality in the early dialysis period. 5) shows that most transfusions occurred in the first 4months post-switch. Please click the OK button below to continue. 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. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. Methoxy polyethylene glycol-epoetin beta, the active substance of MIRCERA, is a continuous erythropoietin receptor activator that shows a different activity at the receptor level characterized by a slower association to and faster dissociation from the receptor, a reduced specific activity in vitro with an increased activity in vivo, as well as an increased half-life, in contrast to . 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 Kidney Med. The geometric mean weekly ESA dose for those included in the DCR analysis is shown in Fig. Secondary outcomes included Hb concentrations and ESA use during the study period, and the incidence of red blood cell (RBC) transfusions. MIRCERA is indicated for the treatment of anemia associated with CKD in adult patients on dialysis and adult patients not on dialysis. Methoxy polyethylene glycol-epoetin beta injection causes the . Packaging Size: 0.3 ml. The https:// ensures that you are connecting to the 3 DOSAGE FORMS AND STRENGTHS. Brand: Mircera. 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. Do not pool unused portions from the prefilled syringes. Dialysis centers were expected to adhere to European Best Practice Guidelines for iron repletion [9]. reaction occurs. Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (19881994) Arch Intern Med. If Hgb remains >= 12 g/dL for more than 2 months, return to regular Hgb testing policy. Before FOIA See this image and copyright information in PMC. 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. Asterisk Not all transfusions had an associated hemoglobin concentration in the 14-day period before transfusion. . BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (n=205). The MHRA is aware of very rare cases of severe cutaneous adverse reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, in patients treated with erythropoietins; some cases were fatal. Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. Tolman et al. 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. Summary of the last hemoglobin concentrations recorded within 14days prior to red blood cell transfusions pre- and post-switch. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. 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. PMC CAS 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). PubMed 2012;59:44451. Mircera is used to reduce or avoid the need for RBC transfusions. EP evaluation period, PEG-Epo methoxy polyethylene glycol-epoetin beta. Eligible patients had received hemodialysis for 12 months and DA for 7 months. Careers. 2002;17(Suppl 5):6670. 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). "BG0RjI G78 Each dosage strength of MIRCERA is designated by a unique syringe plunger color. 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. Generic name: Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL Recombinant human erythropoietin is effective in 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. Differentiating factors between erythropoiesis-stimulating agents: an update to selection for anaemia of chronic kidney disease. More severe cases were recorded with long-acting agents (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta). 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. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Macdougall IC, Obrador GT, El Nahas M. How important is transfusion avoidance in 2013? Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Evaluation of Iron Stores and Nutritional Factors. 8600 Rockville Pike Control hypertension prior to initiating and during treatment with Aranesp or EPOGEN. A primary growth factor for erythroid development, erythropoietin is produced in the kidney and released into the bloodstream in response to hypoxia. Once the hemoglobin has been stabilized, MIRCERA, If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of MIRCERA. EPOGEN from multidose vials contains benzyl alcohol and is contraindicated in neonates, infants, pregnant women, and lactating women. Horowitz J, Agarwal A, Huang F, Gitlin M, Gandra SR, Cangialose CB. 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. 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. More severe cases were recorded with long-acting agents (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta). Results: 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. MIRCERA (methoxy polyethylene glycol-epoetin beta) is the first erythropoiesis-stimulating agent (ESA) approved by FDA for once-monthly administration. New anemia therapies: translating novel strategies from bench to bedside. 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). 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. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. species. ESA erythropoiesis-stimulating agent, Hb hemoglobin. BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (. 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. 2023Vifor (International) Inc. All rights reserved. Secondly, the DCR was calculated on a subset of patients which constituted approximately two-thirds of the total enrolled. You may also report negative side effects of prescription drugs to the Food and Drug Administration (FDA). Nephrol Dial Transplant. 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. MIRCERA Interactions: May require increased anticoagulation (heparin) during hemodialysis. This study and the article processing charges were funded by Amgen Europe GmbH, Zug, Switzerland. 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. 2002;162:14011408. Article The geometric mean weekly ESA doses were 24.1 g DA in the pre-switch EP and 28.6 g PEG-Epo in the post-switch EP. For adverse event reports, please contact us at safety@viforpharma.com,mircera@viforpharma.com or at 1-800-576-8295. 33 Dose. Aranesp (darbepoetin alfa), Dynepo (epoetin delta), Mircera (methyoxy polyethylene glycol-epoetin beta), Hematide, MRK-2578, INS-22, Retacrit (epoetin zeta), Neorecormon (epoetin beta), Silapo (epoetin zeta), Binocrit . There is limited information published on switching erythropoiesis-stimulating agent (ESA) treatment for anemia associated with chronic kidney disease (CKD) from darbepoetin alfa (DA) to methoxy polyethylene glycol-epoetin beta (PEG-Epo) outside the protocol of interventional clinical studies. This suggests that the decision to transfuse was consistent with respect to Hb over the observation period (Fig. - 94.130.71.173. 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. 1:1 reference line indicates equal PEG-Epo and darbepoetin alfa doses. 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. aranesp to retacrit conversiontuto amigurumi grenouille au crochet. Disclaimer. Mircera will be administered IV to HD patients, and SC to PD patients. MIRCERA [prescribing information]. -. 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. In controlled clinical trials of patients with cancer, ESAs increased the risks for death and serious adverse cardiovascular reactions. 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. This medicine is not for treating anemia caused by cancer chemotherapy. 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. Provided by the Springer Nature SharedIt content-sharing initiative, Over 10 million scientific documents at your fingertips, Not logged in ferrous sulfate, Aranesp, Procrit, Retacrit. Data quality and completeness were aided by automatic edit checks built into the database software. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. The geometric mean DCR was 1.17 (95% CI 1.05, 1.29). Dose Conversion Ratio in Hemodialysis Patients Switched from Darbepoetin Alfa to PEG-Epoetin Beta: AFFIRM Study. Report to the Judicial Council. Vigorous shaking or prolonged exposure to light should be avoided. 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). 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. 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. <> No test of statistical significance was performed on any of the clinical characteristics. 5). volume30,pages 10071017 (2013)Cite this article. PEG-Epo was approved in 2009 for administration Q2W or once a month (QM) to patients on dialysis [5, 8]. Mircera contains no preservatives. <>/Metadata 444 0 R/ViewerPreferences 445 0 R>> The majority of patients with CKD will require supplemental iron during the course of ESA therapy.

Amina And Sarah Said Funeral, North Manchester General Hospital Volunteer Work, Rhetorical Devices In Antony's Speech Quizlet, Articles M