Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. 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. as a substitute for red blood cell transfusions in patients who require immediate correction of anemia. OK 1. Matsumura K, Okumiya T, Sugiura T, Takahashi N, Yamamoto Y, Kikuchi S, Fujii K, Otagaki M, Shiojima I. BMC Nephrol. Changes in ESA dosing and number of transfusions post-switch may have important health-economic implications. 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. Correspondence to Studies of erythropoietin therapy in patients with chronic anemia of cancer as well as CIA document response rates ranging from ~60% to 85%. Regression analysis indicated a non-linear relationship between pre- and post-switch ESA doses; DCR decreased with increasing pre-switch DA dose. Aranesp (darbepoetin alfa) prescribing information, Amgen. Eligible patients had received hemodialysis for 12months and DA for 7months. 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. sharing sensitive information, make sure youre on a federal Show detailed description Study Design Go to Box 1557, 6301, Zug, Switzerland, Amgen (UK) Limited, 240 Cambridge Science Park, Milton Road, Cambridge, UK, You can also search for this author in When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. 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. Secondly, the DCR was calculated on a subset of patients which constituted approximately two-thirds of the total enrolled. 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. 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. Am J Nephrol. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) 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 . Medically reviewed by Drugs.com. 2002;162:14018. A motion conversion mechanism 123 includes a yoke 153 and a rotatable member 149, which causes the yoke 152, . Arch Intern Med. Individualize dosing and use the lowest dose of MIRCERA. 2001;38:803812. When administered subcutaneously, Mircera should be injected in the abdomen, arm or thigh. Mircera is packaged as single-dose prefilled syringes. 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. Preservation of anemia control and weekly ESA dosage after conversion from PEG-Epoetin beta to darbepoetin alfa in adult hemodialysis patients: the TRANSFORM study. Goodkin DA, Zhao J, Cases A, Nangaku M, Karaboyas A. Peter Choi, MB BChir, PhD, FRCP (UK), has received lecturing and consulting fees from Amgen, and has participated in advisory boards for Amgen. Response rates are defined in two ways: 1) Hgb levels > 12 g/dL or 2) an increase in Hgb of 2 g/dL from baseline. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study. The information provided in this site is intended only for healthcare professionals in the United States. Please click to see accompanying Aranesp full prescribing information and EPOGEN full prescribing information, including Boxed WARNINGS and Medication Guide. Adverse Reactions: Hypertension, diarrhea,. 33 Dose. Hymes J, Bickimer T, Jackson JH, Bookhart BK, Mody SH, Tak Piech C. Curr Med Res Opin. Anemia: an early complication of chronic renal insufficiency. The intravenous route is recommended for patients on hemodialysis because the intravenous route may be less immunogenic. 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. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. The study sample comprised adult patients (age 18years) with CKD who received maintenance hemodialysis between January 2008 and August 2011 and whose ESA treatment was switched from IV DA to IV PEG-Epo. 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. ARANESP (darbepoetine alfa) 1 injection/sem. Generic name: Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL Before 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. 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]. Examine each prefilled syringe for the expiration date. New anemia therapies: translating novel strategies from bench to bedside. 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. 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). This article does not contain any studies with human or animal subjects performed by any of the authors. 3. Empirical methods to calculate an erythropoiesis-stimulating agent dose conversion ratio in nondialyzed patients with chronic kidney disease. If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of MIRCERA. Anemia Associated with Chronic Renal Failure, Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL, Drug class: recombinant human erythropoietins. Mircera works like the human protein called erythropoietin to help your body make more RBCs. Aranesp (darbepoetin alfa) Summary of product characteristics. Due to the skewed nature of the dosing data, mean weekly ESA doses were reported using geometric means; these were derived by calculating the arithmetic mean of the data transformed on the natural logarithmic scale. 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. 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). 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 Mircera after the expiration date. Months 7 to 1 constituted the pre-switch period, with switch defined as the date of first administration of PEG-Epo, and Months +1 to +7 constituted the post-switch period. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Each pre-filled syringe contains 0.3 ml or 0.6 ml. 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. Red blood cell transfusions pre- and post-switch were quantified. The study comprised a 14-month observation period. 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. ESA erythropoiesis-stimulating agent, Hb hemoglobin. Horowitz J, Agarwal A, Huang F, Gitlin M, Gandra SR, Cangialose CB. endobj afK ] T z"$qu9H$}W//~||!+iO7^Q)|F.j+m ZJ7CY\7\lO7OGPno? In pediatric patients, Mircera is administered by intravenous injection only (2.2). J Manag Care Pharm. The number of transfusions and units transfused increased approximately threefold from the pre-switch to the post-switch period. NCI CPTC Antibody Characterization Program, Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. Data were also manually reviewed prior to final analysis. 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. Publication management support was provided by Caterina Hatzifoti, PhD, of Amgen Europe GmbH. Anemia of end-stage renal disease (ESRD) Kidney Int. Usui T, Zhao J, Fuller DS, Hanafusa N, Hasegawa T, Fujino H, Nomura T, Zee J, Young E, Robinson BM, Nangaku M. Nephrology (Carlton). For Adult Patients with CKD not on dialysis: Refer patients who self-administer Mircera to the Instructions for Use [see Patient Counseling Information (17)]. 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. Descriptions. At the moment forecasts for Mircera are $345m in 2015 rising to $552m in 2020, reflecting sales made outside 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. risks. 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. 3 0 obj ^D[5j@%e Nephrol Dial Transplant. BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (. Nick Manamley, MSc, is an employee of Amgen with Amgen stock ownership. For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. Eligible patients had received hemodialysis for 12 months and DA for 7 months. 2). A decade in the anaemia market - 10 products seen top . In controlled clinical trials of patients with cancer, ESAs increased the risks for death and serious adverse cardiovascular reactions. Peter Choi. Epub 2022 Apr 22. Article PEG-Epo methoxy polyethylene glycol-epoetin beta. Of 302 patients enrolled, 206 had data available for DCR analysis. Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. Disposition of patients. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. -, Macdougall IC. Differentiating factors between erythropoiesis-stimulating agents: an update to selection for anaemia of chronic kidney disease. eCollection 2020 May-Jun. 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. [citation needed] official website and that any information you provide is encrypted 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. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. There are limitations in generalizing the findings of this study to the broader hemodialysis population. 2002;17(Suppl 5):6670. 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. An official website of the United States government. Last updated on Jul 26, 2022. Kazmi WH, Kausz AT, Khan S, et al. 2012;59:444451. 1985;28:15. The geometric mean DCR was 1.17 (95% CI 1.05, 1.29). 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery. doi: 10.1002/14651858.CD010590.pub2. Introduction: Once the hemoglobin has been stabilized, MIRCERA, If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of MIRCERA. Mircera belongs to a class of drugs called Hematopoietic Growth Factors. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Composition: Methoxy Polyethylene Glycol-Epoetin Beta. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. HHS Vulnerability Disclosure, Help You may also report negative side effects of prescription drugs to the Food and Drug Administration (FDA). PEG-Epo was approved in 2009 for administration Q2W or once a month (QM) to patients on dialysis [5, 8]. <> We comply with the HONcode standard for trustworthy health information. The .gov means its official. 5) shows that most transfusions occurred in the first 4months post-switch. Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp #Pharmacology #Hematology #Nephrology. Action Stimulates erythropoesis (production of red blood cells). The pre-transfusion Hb concentrations were similar for transfusions occurring both pre- and post-switch (Fig. Clipboard, Search History, and several other advanced features are temporarily unavailable. 2019 Jul 5;13(3):425-433. doi: 10.1093/ckj/sfz065. <>/Font<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> | DOWNLOAD SIZE: When adjusting therapy, consider hemoglobin rate of rise, rate of decline, ESA responsiveness, and hemoglobin variability. 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. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. 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. 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]. before initiating MIRCERA. This article does not contain any studies with human or animal subjects performed by any of the authors. Use the Previous and Next buttons to navigate the slides or the slide controller buttons at the end to navigate through each slide. Mircera (methoxy polyethylene glycol-epoetin beta) is an erythropoiesis-stimulating agent (ESA). Epub 2014 Nov 1. MIRCERA is contraindicated in patients with: Please seefull Prescribing Information including Boxed WARNING, and Medication Guide(English, Espaol)for MIRCERA (methoxy polyethylene glycol-epoetin beta) Injection, for Intravenous or Subcutaneous Use. Section III: Treatment of renal anaemia. 1 0 obj Lancet. doi: 10.1053/j.ajkd.2011.11.013. history of serious or severe allergic reactions to MIRCERA (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). For Pediatric Patients with CKD on hemodialysis: Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Pediatric Patients with CKD Treated with Hemodialysis. 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. 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 Mourad Farouk is an employee of Amgen with Amgen stock ownership. Evaluate the iron status in all patients before and during treatment. Secondary outcomes included Hb concentrations and ESA use during the study period, and the incidence of red blood cell (RBC) transfusions. Monitor patients closely for new-onset seizures, premonitory symptoms, or change in seizure frequency. 20,000 Units/2 mL (10,000 Units/mL) and 20,000 Units/mL of RETACRIT as a clear and colorless liquid in multiple-dose vials (contains benzyl alcohol). 1MIRCERA [prescribing information]. pee`T"c+l_WB,`km^;6#j(*m`&E`l${F6Q`&^=e`f(6]8ZE[VHNx-FRIhE&iJKvW`Vz^p@?Yk+S.DgR1rrB6yq2N$| What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? The baseline (i.e., at time of switch) demographic and clinical characteristics of enrolled patients and those included in and excluded from the DCR analysis are displayed in Table1. Excluding patients receiving a transfusion within 90 days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). 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. Do not pool unused portions from the prefilled syringes. 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 . 2002;162:14011408. Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. 2010;25:400917. PMC 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 Methoxy polyethylene glycol-epoetin beta injection causes the . Recombinant human erythropoietin is effective in Methoxy polyethylene demonstrated that the dose efficiency after SC and IV ad- glycol-epoetin b (PEG-epoetin b; Mircera; F. Hoffmann- ministration was . 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. Decreases in dose can occur more frequently. 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). Mechanism of Action. MIRCERA Classification: Erythropoiesis stimulating protein. The geometric mean DCR was 1.17 (95% CI 1.05, 1.29). 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)]. PubMed Article Kidney Med. doi: 10.1093/ndt/17.suppl_5.66. Eschbach JW, Adamson JW. 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. 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. A single hemoglobin excursion may not require a dosing change. Please click to see accompanying Aranesp full prescribing information and EPOGEN full prescribing information, including Boxed WARNINGS and Medication Guide. Most frequent adverse reactions (5%) in adult patients with CKD treated with MIRCERA. 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. ferrous sulfate, Aranesp, Procrit, Retacrit. 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]. MIRCERA Interactions: May require increased anticoagulation (heparin) during hemodialysis. Mircera (methoxy polyethylene glycol-epoetin beta) Summary of product characteristics. Accessed 18 October 2013. Article Aranesp (darbepoetin alfa) Epogen (epoetin alfa) Mircera . Red blood cell transfusions pre- and post-switch were quantified. 3. 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. Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. OZZ Cochrane Database Syst Rev. Strength: 100 mcg / 0.3ml. Administer Mircera either intravenously or subcutaneously in adult patients and only intravenously in pediatric patients. 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). 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. Mircera will be administered IV to HD patients, and SC to PD patients. Tolman et al. Macdougall IC. The https:// ensures that you are connecting to the Google Scholar. 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. MIRCERA (methoxy polyethylene glycol-epoetin beta) is the first erythropoiesis-stimulating agent (ESA) approved by FDA for once-monthly administration. 4 x previous weekly epoetin alfa dose (Units)/125, e.g., 4 x 1500 Units of epoetin alfa per week/125 = 48 mcg of Mircera once every 4 weeks, 4 x previous weekly darbepoetin alfa dose (mcg)/0.55, e.g., 4 x 20 mcg of darbepoetin alfa per week/0.55 = 145.5 mcg of Mircera once every 4 weeks. Janet Addison is an employee of Amgen with Amgen stock options. 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- Amgen's two anemia drugs, Epogen and Aranesp, had sales of $6.6 billion last year, nearly half the company's total revenue. 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). -, Kazmi WH, Kausz AT, Khan S, et al. 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.
Illinois Baseball Coaches, Aau Basketball Essex County Nj, Kmel Summer Jam 1998 Lineup, What Was Monks Mound Used For, How Many Grammy Awards Does Nba Youngboy Have, Articles M