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- However, the relationship between the pre- and post-switch ESA doses during the two evaluation periods was non-linear. 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. 3. 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 . 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 [prescribing information]. Internal You are now leaving AnemiaHub.com. 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. Patients can also have iron-deficiency anemia and need iron replacement using one of the supplements listed in the previous Electrolytes and Minerals section of this lesson. More severe cases were recorded with long-acting agents (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta). 1985;28:15. 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. 2 0 obj Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) In CKD, anemia results primarily from decreased production of endogenous erythropoietin (EPO) by the kidney [3]. 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. HQ-MIR-1900027 Site last modified: January 2023. 2012 Jun;27(6):2303-11. doi: 10.1093/ndt/gfr677. Eligible patients had received hemodialysis for 12months and DA for 7months. Revised European Best Practice Guidelines for the management of anaemia in patients with chronic renal failure. 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. - , . Secondary outcomes included Hb concentrations and ESA use during the study period, and the incidence of red blood cell (RBC) transfusions. 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. A decade in the anaemia market - 10 products seen top . The number of RBC transfusions and units transfused in the post-switch period was approximately threefold higher compared to the pre-switch period. The geometric mean weekly dose of DA was 23.2g (95% CI 20.6, 26.3) in the month prior to switch. https://doi.org/10.1007/s12325-013-0063-y, DOI: https://doi.org/10.1007/s12325-013-0063-y. Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. Use caution in patients with coexistent cardiovascular disease and stroke. 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 Conclusion: You may also report negative side effects of prescription drugs to the Food and Drug Administration (FDA). 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. -, Kazmi WH, Kausz AT, Khan S, et al. RBC transfusions were reported in terms of number of transfusions and number of units transfused, using descriptive statistics. Of 302 patients enrolled, 206 had data available for DCR analysis. Methoxy polyethylene glycol-epoetin (Mircera ) will be increased and decreased in 1-step or 2-step increments, based on scale above. Karaboyas A, Morgenstern H, Waechter S, Fleischer NL, Vanholder R, Jacobson SH, Sood MM, Schaubel DE, Inaba M, Pisoni RL, Robinson BM. National Library of Medicine The number of transfusions and units transfused increased approximately threefold from the pre-switch to the post-switch period. PubMedGoogle Scholar. official website and that any information you provide is encrypted The AFFIRM study was designed as a retrospective, longitudinal cohort analysis to estimate the DCR in a population of hemodialysis patients achieving comparable Hb after switching from IV DA to IV PEG-Epo in a real-world setting. Regression analysis indicated a non-linear relationship between pre- and post-switch ESA doses; DCR decreased with increasing pre-switch DA dose. Department of Nephrology, John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, 2305, Australia, Amgen (Europe) GmbH, Dammstrasse 23, P.O. 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. It is not known if Mircera is safe and effective in children younger than 5 years of age. 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. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. 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. Section III: Treatment of renal anaemia. Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. Nephrol Dial Transplant. 3. 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. Anemia of end-stage renal disease (ESRD). The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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. x]r9r}W#k We comply with the HONcode standard for trustworthy health information. 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. MIRCERA comes in pre-filled syringes with laminated plunger stopper and tip cap with one needle 27G1/2. Control hypertension prior to initiating and during treatment with Aranesp or EPOGEN. 2023Vifor (International) Inc. All rights reserved. If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of MIRCERA. 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. Avoid frequent dose adjustments. before initiating MIRCERA. eCollection 2020 Jun. New anemia therapies: translating novel strategies from bench to bedside. No difference in conversion dosage could be determined between patients who were epoetin sensitive (<200 units/kg per week) or resistant (>200 units/kg per week, P = NS). 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 . Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Adult Patients with CKD. 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). 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. Treatment: Treat to anemia in people with chronic kidney disease. 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. 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). W\iA* DA can be administered once a week (QW) or once every 2weeks (Q2W) to hemodialysis patients. Unable to load your collection due to an error, Unable to load your delegates due to an error. Of the 29 patients transfused during the post-switch period, 20 had a dose ratio at switch <1, and 9 had a dose ratio at switch 1 (odds ratio 2.39, 95% CI 1.05, 5.44; P=0.038). 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. Do not use Mircera after the expiration date. 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. doi: 10.1002/14651858.CD010590.pub2. For adverse event reports, please contact us at safety@viforpharma.com,mircera@viforpharma.com or at 1-800-576-8295. A total of 302 eligible patients were enrolled at 14 European hemodialysis centers, with 57% of patients enrolled at 10 French sites, 18% at 2 Spanish sites, 17% at 1 UK site, and 8% at 1 German site. Individualize dosing and use the lowest dose of Mircera sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. 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). 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. )E]$&m"t "N5LQmgh-QZi`T0 hacpBYKUYRw@aMB/|n|'Y#h$8]#|zf. Accessed 18 October 2013. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. Red blood cell transfusions pre- and post-switch were quantified. A BlandAltman analysis [10] was also performed to assess the agreement between ESA doses in the evaluation periods. Administer MIRCERA intravenously once every 4 More ways to get app. Bland JM, Altman DG. 4. 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 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]. See Instructions for Use for complete instructions on the preparation and administration of Mircera. Epoetin alfa (Procrit, Epogen) acts like the hormone we have in our body, whereas Mircera . The distribution of transfusions (Fig. 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). Preservation of anemia control and weekly ESA dosage after conversion from PEG-Epoetin beta to darbepoetin alfa in adult hemodialysis patients: the TRANSFORM study. volume30,pages 10071017 (2013)Cite this article. Medically reviewed by Drugs.com. A primary growth factor for erythroid development, erythropoietin is produced in the kidney and released into the bloodstream in response to hypoxia. Janet Addison is an employee of Amgen with Amgen stock options. For lack or loss of hemoglobin response to Aranesp or EPOGEN, initiate a search for causative factors. Treatment for Anaemia [STRIATA] [8] and comPArator sTudy of C.E.R.A. 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. Am J Kidney Dis. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Learn about Mircera, potential side effects, proper use and dosing, and popular alternatives. Pure red cell aplasia (PRCA) that begins after treatment with Mircera or other erythropoietin protein drugs. Locatelli F, Aljama P, Barany P, et al. pee`T"c+l_WB,`km^;6#j(*m`&E`l${F6Q`&^=e`f(6]8ZE[VHNx-FRIhE&iJKvW`Vz^p@?Yk+S.DgR1rrB6yq2N$| 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. MIRCERA has an approximate molecular weight of 60 kDa. Mircera belongs to a class of drugs called Hematopoietic Growth Factors. 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. Accounting for the effect of transfusion, the DCR was 1.21 (95% CI 1.09, 1.35). PEG-Epo methoxy polyethylene glycol-epoetin beta. 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]. Discontinue MIRCERA, When administered subcutaneously, MIRCERA. 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. ESA erythropoiesis-stimulating agent, Hb hemoglobin. history of serious or severe allergic reactions to MIRCERA (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). Recombinant human erythropoietin is effective in When a patient with a darbepoetin (Aranesp) or erythropoietin order switches to . 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. Once Every Two Weeks (mcg/every two weeks). Tables2 and 3 also summarize the proportion of patients in different Hb categories by study month. Please click to see accompanying Aranesp full prescribing information and EPOGEN full prescribing information, including Boxed WARNINGS and Medication Guide. Administer Mircera either intravenously or subcutaneously in adult patients and only intravenously in pediatric patients. Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp #Pharmacology #Hematology #Nephrology. Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Google Scholar. Mechanism of Action. Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. 2002;162:14018. ARANESP (darbepoetine alfa) 1 injection/sem. ONLY administer MIRCERA intravenously in pediatric patients. This was particularly evident in patients whose pre-switch EP weekly DA dose was higher than 100g. Therapeutic effects . 3 0 obj Conversion from Epoetin alfa or Darbepoetin alfa to MIRCERA in Pediatric Patients with CKD on Hemodialysis. This study and the article processing charges were funded by Amgen Europe GmbH, Zug, Switzerland. 1986;327:30710. OZZ m+KqXAXOkS@,1C0VgzXzeWU},4 Part of Springer Nature. Mircera Injection (Methoxy Polyethylene Glycol-Epoetin Beta ) 6,610/ Piece Get Latest Price. Careers. endobj Karaboyas A, Morgenstern H, Fleischer NL, Vanholder RC, Dhalwani NN, Schaeffner E, Schaubel DE, Akizawa T, James G, Sinsakul MV, Pisoni RL, Robinson BM. Aranesp (darbepoetin alfa) Summary of product characteristics. 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). FOIA The dose of Mircera, given as a single intravenous or subcutaneous injection, should be based on the 2008;23:365461. 2020 Sep 29;21(1):418. doi: 10.1186/s12882-020-02078-z. Data were collected from 7months before until 7months after switching treatment. Dose Conversion Ratio in Hemodialysis Patients Switched from Darbepoetin Alfa to PEG-Epoetin Beta: AFFIRM Study. A motion conversion mechanism 123 includes a yoke 153 and a rotatable member 149, which causes the yoke 152, . PMC Accessed 18 October 2013. Mean Hb was 11.5 g/dL in the pre-switch EP and 11.4 g/dL in the post-switch EP. Canaud B, Mingardi G, Braun J, et al. Secondly, the DCR was calculated on a subset of patients which constituted approximately two-thirds of the total enrolled.
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