Shortened red blood cell age in patients with end-stage renal disease who were receiving haemodialysis: a cross-sectional study. 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]. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these - 94.130.71.173. For patients who do not respond adequately over a 12-week escalation period, increasing the MIRCERA, Evaluate other causes of anemia. Statistical methods for assessing agreement between two methods of clinical measurement. Evaluate the iron status in all patients before and during treatment. Do not pool unused portions from the prefilled syringes. Individualize dosing and use the lowest dose of MIRCERA. randomized patients to darbepoetin or epoetin beta once weekly after the patients had been treated with epoetin beta three times weekly. doi: 10.1038/ki.1985.109. Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (19881994) Arch Intern Med. Methoxy polyethylene glycol-epoetin beta injection causes the . 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. The site is secure. In pediatric patients, Mircera is administered by intravenous injection only (2.2). Reasons for low Hb, e.g., acute intercurrent events such as bleeding, were not reported. 33 Dose. Evaluation of Iron Stores and Nutritional Factors. 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 Kazmi WH, Kausz AT, Khan S, et al. There were 16 transfusion events in the pre-switch period and 48 post-switch, with a total of 34 units transfused pre-switch and 95 units in the post-switch period (Fig. This was particularly evident in patients whose pre-switch EP weekly DA dose was higher than 100g. The distribution of transfusions (Fig. Strength: 100 mcg / 0.3ml. Mircera ceiling is 200 mcg every two weeks (or 3.0 mcg/kg/2 weeks, whichever is lower). Epoetin beta and methoxy polyethylene glycol may increase tumor growth or decrease survival time in people with certain types of cancer. Mircera is packaged as single-dose prefilled syringes. For Adult Patients with CKD not on dialysis: Refer patients who self-administer Mircera to the Instructions for Use [see Patient Counseling Information (17)]. 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. 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. 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. 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. 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. Anemia: an early complication of chronic renal insufficiency. WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE CHRONIC KIDNEY DISEASE: Please see full Prescribing Information including Boxed WARNING, and Medication Guide(English, Espaol) for MIRCERA (methoxy polyethylene glycol-epoetin beta) Injection, for Intravenous or Subcutaneous Use. The .gov means its official. 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 the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of MIRCERA. Epub 2022 Apr 22. (0.6MB), Anemia Assessment and Management Brochure, Pathophysiology of Anemia in Patients with CKD, * Case studies and patient profiles are hypothetical, WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE. The study comprised a 14-month observation period. Last updated on Jul 26, 2022. Methoxy polyethylene glycol-epoetin (Mircera ) will be increased and decreased in 1-step or 2-step increments, based on scale above. 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. At the moment forecasts for Mircera are $345m in 2015 rising to $552m in 2020, reflecting sales made outside the US. )E]$&m"t "N5LQmgh-QZi`T0 hacpBYKUYRw@aMB/|n|'Y#h$8]#|zf. However, the relationship between the pre- and post-switch ESA doses during the two evaluation periods was non-linear. AFFIRM (Aranesp Efficiency Relative to Mircera) was a retrospective, multi-site, observational study designed to estimate the population mean maintenance dose conversion ratio [DCR; dose ratio achieving comparable hemoglobin level (Hb) between two evaluation periods] in European hemodialysis patients whose treatment was switched from DA to PEG-Epo. MIRCERA [prescribing information]. EPOGEN (epoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis to decrease the need for red blood cell (RBC) transfusion. Conversion from darbepoetin or erythropoietin to Mircera 1. Learn how to combine multiple dosing options for precise titration and individualize anemia management.1. There are limitations in generalizing the findings of this study to the broader hemodialysis population. Response rates are defined in two ways: 1) Hgb levels > 12 g/dL or 2) an increase in Hgb of 2 g/dL from baseline. sharing sensitive information, make sure youre on a federal ?z_IxD1&S&L)@g7NI\H |a_,I17KFu[7+n h?b}xqm5Ed]N8+3ei^Rh/0up20]S=NoPAN$Z$L+u'Hp5v;'QyBQT 8}"{=xVqe)gR&yOs^sfT#B cf#xF`=bXMdCV?s&KS|`q9HT=,[='q6s1UE J$KxBE hg*~'ct'p|YTs1c->uLd_614J)q)g>QR`~*B9GewhNBPs j "It(Y%kRz}=!ayvw^`c]n986kR+LBZ:l~(hf !|p)-b=@|] aRQ:SIRwn$Ip 8v-S"-j0G;r:@ElyDkDE#4H~n{x4P*jS '.P4F lZhBW0t*1b`&wIU_=(>|@"1A`. The number of transfusions and units transfused increased approximately threefold from the pre-switch to the post-switch 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. A motion conversion mechanism 123 includes a yoke 153 and a rotatable member 149, which causes the yoke 152, . The geometric mean weekly dose of DA was 23.2g (95% CI 20.6, 26.3) in the month prior to switch. BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (n=205). 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. Values are means (arithmetic for hemoglobin, geometric for dose) with 95% confidence intervals. OK Mircera contains no preservatives. Use the lowest Mircera dose sufficient to reduce the need for red blood cell (RBC) transfusions. 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. 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. Bland JM, Altman DG. The number of RBC transfusions and units transfused in the post-switch period was approximately threefold higher compared to the pre-switch period. This article does not contain any studies with human or animal subjects performed by any of the authors. Nephrol Dial Transplant. DCR was calculated for patients with Hb and ESA data available in both evaluation periods (EP; Months 1 and 2 were defined as the pre-switch EP, and Months 6 and 7 as the post-switch EP). <>/Font<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> The primary outcome (DCR) for each patient was calculated as the mean weekly dose of PEG-Epo during the post-switch EP divided by the mean weekly dose of DA during the pre-switch EP. 2010;25:400917. Article 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. Monitor patients closely for new-onset seizures, premonitory symptoms, or change in seizure frequency. 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]. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Choi, P., Farouk, M., Manamley, N. et al. Aranesp and EPOGEN have not been shown to improve quality of life, fatigue, or patient well-being. Tables2 and 3 also summarize the proportion of patients in different Hb categories by study month. Amgen's two anemia drugs, Epogen and Aranesp, had sales of $6.6 billion last year, nearly half the company's total revenue. Cochrane Database Syst Rev. Resistance to Erythropoiesis-Stimulating Agents among Patients on Hemodialysis Is Typically Transient. Publication management support was provided by Caterina Hatzifoti, PhD, of Amgen Europe GmbH. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. Most frequent adverse reactions (5%) in adult patients with CKD treated with MIRCERA. Regression analysis indicated a non-linear relationship between pre- and post-switch ESA doses; DCR decreased with increasing pre-switch DA dose. DA can be administered once a week (QW) or once every 2weeks (Q2W) to hemodialysis patients. Red blood cell transfusions pre- and post-switch were quantified. Nephrol Dial Transplant. 2009 Nov-Dec;15(9):741-50. doi: 10.18553/jmcp.2009.15.9.741. There is no evidence that Mircera alters the metabolism of other medicinal products. Lancet. 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 : 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). Epoetin alfa (Eprex [JanssenCilag], Binocrit [Sandoz], and epoetin zeta (Retacrit, - Hospira UK): the initial dose is 150 IU kg-1 given subcutaneously three times per week.5 -7 Alternatively, epoetin alfa can be administered at an initial dose of 450 IU kg 1 subcutaneously once weekly.5-7 The maximum recommended dose is 900 IU kg-1 Nephrol Dial Transplant. If Hgb remains >= 12 g/dL for more than 2 months, return to regular Hgb testing policy. 2002;17(Suppl 5):6670. -, Kazmi WH, Kausz AT, Khan S, et al. Hb hemoglobin. 1986;327:30710. See Instructions for Use for complete instructions on the preparation and administration of Mircera. 1MIRCERA [prescribing information]. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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. Anemia of end-stage renal disease (ESRD). Epoetin alfa (Procrit, Epogen) acts like the hormone we have in our body, whereas Mircera . Nephrol Dial Transplant. Article ARANESP (darbepoetine alfa) 1 injection/sem. before initiating Mircera [see Warnings and Precautions (5.9)]. and darbepOetin alfa in patieNts Undergoing dialySis [PATRONUS] [9]); however, there is a lack of published literature on switching in patients receiving routine clinical care (i.e., outside interventional clinical trials). Google Scholar. The odds ratio for receiving a transfusion was twice as high in patients switched at a dose ratio less than 1 when compared to those switched at 1:1 or higher. species. Tolman et al. }"nUEcJumC0ooF Google Scholar. <> afK ] T z"$qu9H$}W//~||!+iO7^Q)|F.j+m ZJ7CY\7\lO7OGPno? Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. Correspondence to Please know that the sponsors of this site are not responsible for content on the site you are about to enter. For recommended dose equivalency, see Tables A and B (below). For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%. 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. 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. In the first month after switch, these proportions were 10.2%, 48.5% and 37.4%, respectively. Do not use the prefilled syringe more than once. Nephrol Dial Transplant. W\iA* Federal government websites often end in .gov or .mil. In responding to hypoxia, erythropoietin interacts with erythroid progenitor . 2021 Jan;26(1):46-53. doi: 10.1111/nep.13765. Kidney Int. I certify that I am a healthcare professional in the US. as a substitute for red blood cell transfusions in patients who require immediate correction of anemia. Treatment: Treat to anemia in people with chronic kidney disease. Am J Kidney Dis. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp GrepMed. Mircera (methoxy polyethylene glycol-epoetin beta) Summary of product characteristics. Available for Android and iOS devices. Asterisk Not all transfusions had an associated hemoglobin concentration in the 14-day period before transfusion. In CKD, anemia results primarily from decreased production of endogenous erythropoietin (EPO) by the kidney [3]. 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 endobj CAS Hb concentrations were reported as arithmetic means for each month. Methods: Generic name: Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL For lack or loss of hemoglobin response to Aranesp or EPOGEN, initiate a search for causative factors. Once Every Two Weeks (mcg/every two weeks). 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. 2004;19(Suppl 2):ii1631. \ab/`IR 4%jI ^w7qQNA Tq Wz.oVfCVBT{h*>\\3u#P@"wW7|pIMB7 In conclusion, this study has shown that in a cohort of European hemodialysis patients who converted from DA to PEG-Epo (and who completed 67months treatment with PEG-Epo post-conversion), there was an approximately 20% increase in the g dose required to achieve a comparable Hb profile. in the treatment of anemia due to cancer chemotherapy. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) Anemia Associated with Chronic Renal Failure, Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL, Drug class: recombinant human erythropoietins. official website and that any information you provide is encrypted 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. 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. 3. 2012;59:44451. . 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. 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. 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. 1985;28:15. Individualize dosing and use the lowest dose of Mircera sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. Once the hemoglobin has been stabilized, MIRCERA, If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of MIRCERA. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. a Mutually exclusive categories; patients are censored in the following, Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. Adverse Reactions: Hypertension, diarrhea,. eCollection 2020 Jun. This medicine is not used to treat anemia caused by cancer medicines. Brand: Mircera. Conversion from Another ESA: dosed once monthly or once every two weeks based on total weekly epoetin alfa or darbepoetin alfa dose at time of conversion (2.2). In contrast, in the STRIATA study where stable hemodialysis patients receiving IV DA were randomized to Q2W PEG-Epo (outside current label guidance) or to continue on DA QW or Q2W, median PEG-Epo doses were described as stable across the 52-week post-switch period, although mean dose data were not reported [12]. Mourad Farouk is an employee of Amgen with Amgen stock ownership. 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. Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. ^D[5j@%e 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. Of 302 patients enrolled, 206 had data available for DCR analysis. 2 0 obj All groups were assessed at the end of the study for safety and efficacy parameters. 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 ribosome A ribonuclear protein complex that binds to mRNA nucleotide A basic . This suggests that the decision to transfuse was consistent with respect to Hb over the observation period (Fig. 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. These adverse reactions included myocardial infarction and stroke. pee`T"c+l_WB,`km^;6#j(*m`&E`l${F6Q`&^=e`f(6]8ZE[VHNx-FRIhE&iJKvW`Vz^p@?Yk+S.DgR1rrB6yq2N$| 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. 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. Regardless of possible differences in their clinical characteristics it should be borne in mind that patients were not selected for inclusion in the DCR analysis on the basis of their fulfilling any clinical, Hb or ESA dose requirements: all patients who had Hb measurements in both EPs, a DA dose in the pre-switch EP and a PEG-Epo dose in the post-switch EP were eligible for inclusion. 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. . Would you like email updates of new search results? Canaud B, Mingardi G, Braun J, et al. Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. Cancel, Aranesp (darbepoetin alfa) Prescribing Information, EPOGEN (epoetin alfa) Prescribing Information, Aranesp and EPOGEN Important Safety Information, Prescribing Information, Important Safety Information, Dosing Information and Indications, DOWNLOAD ARANESP PRESCRIBING INFORMATION. Box 1557, 6301, Zug, Switzerland, Amgen (UK) Limited, 240 Cambridge Science Park, Milton Road, Cambridge, UK, You can also search for this author in Mircera Injection (Methoxy Polyethylene Glycol-Epoetin Beta ) 6,610/ Piece Get Latest Price. 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. Accessed 18 October 2013. Fewer than half of the patients achieved Hb in the 1012g/dL range by 7months post-switch. Each pre-filled syringe contains 0.3 ml or 0.6 ml. HHS Vulnerability Disclosure, Help 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. 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. The geometric mean weekly ESA doses were 24.1g DA in the pre-switch EP and 28.6g PEG-Epo in the post-switch EP. Vigorous shaking or prolonged exposure to light should be avoided. Immediately and permanently discontinue Aranesp or EPOGEN if a serious allergic Clipboard, Search History, and several other advanced features are temporarily unavailable. Conclusion: In patients on hemodialysis receiving ESAs, conversion from epoetin alfa to darbepoetin alfa was associated with an approximate and persistent reduction of 65% of the required dose. government site. The remaining enrolment was at four sites divided between three other countries. 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. This analysis indicated that the concordance decreased with increasing dose. . _____ (if . . PubMedGoogle Scholar. Aranesp (darbepoetin alfa) Summary of product characteristics. Mechanism of Action. Visit. 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. stream -, Macdougall IC. 2023Vifor (International) Inc. All rights reserved. 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. 2022;53(5):333-342. doi: 10.1159/000523947. 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. 2). Mircera may be used alone or with other medications. 2019 Jul 5;13(3):425-433. doi: 10.1093/ckj/sfz065. 1: 21% of the excluded patients had died or were lost to follow-up during the post-switch period; 45% were no longer receiving PEG-Epo by Months +6 and +7 post-switch; and 34% had no Hb value reported for one or both EPs. Examine each prefilled syringe for the expiration date. doi: 10.1001/archinte.162.12.1401. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. 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. For more information, please see the full Prescribing Information, including Boxed WARNING, and Medication Guide(English, Espaol) for MIRCERA. 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). Dose Conversion Ratio in Hemodialysis Patients Switched from Darbepoetin Alfa to PEG-Epoetin Beta: AFFIRM Study, https://doi.org/10.1007/s12325-013-0063-y, CERA conversion to darbepoetin alfa in 154 hemodialysis patients, Long-term maintenance of hemoglobin levels in hemodialysis patients treated with bi-weekly epoetin beta pegol switched from darbepoetin alfa: a single-center, 12-month observational study in Japan, Efficacy, tolerability and safety of darbepoetin alfa injection for the treatment of anemia associated with chronic kidney disease (CKD) undergoing dialysis: a randomized, phase-III trial, Safety of Roxadustat Versus Erythropoiesis-Stimulating Agents in Patients with Anemia of Non-dialysis-Dependent or Incident-to-Dialysis Chronic Kidney Disease: Pooled Analysis of Four Phase 3 Studies, Initial responsiveness to darbepoetin alfa and its contributing factors in non-dialysis chronic kidney disease patients in Japan, Comparison of darbepoetin alpha and recombinant human erythropoietin for treatment of anemia in pediatric chronic kidney disease: a non-inferiority trial from India, Comparative Safety of Originator and Biosimilar Epoetin Alfa Drugs: An Observational Prospective Multicenter Study, In Search of Predictors of Switching Between Erythropoiesis-Stimulating Agents in Clinical Practice: A Multi-Regional Cohort Study, Mixed hemodiafiltration reduces erythropoiesis stimulating agents requirement in dialysis patients: a prospective randomized study, http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000332/WC500026149.pdf, http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000739/WC500033672.pdf, https://creativecommons.org/licenses/by/2.0.
