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Geometric mean weekly PEG-Epo dose at Month 1 post-switch was 26.7g (95% CI 24.4, 29.3), rising to 29g (95% CI 26.2, 32.2) by Month 7 post-switch. 5). Locatelli F, Aljama P, Barany P, et al. PubMed Matsumura K, Okumiya T, Sugiura T, Takahashi N, Yamamoto Y, Kikuchi S, Fujii K, Otagaki M, Shiojima I. BMC Nephrol. 6). doi: 10.1001/archinte.162.12.1401. The primary finding of the study is that the DCR of PEG-Epo to DA was 1.17 (95% CI 1.05, 1.29). 2019 Jul 5;13(3):425-433. doi: 10.1093/ckj/sfz065. Aranesp and EPOGEN have not been shown to improve quality of life, fatigue, or patient well-being. Mircera is administered by subcutaneous (SC) or intravenous (IV) injection (2.2). 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]. Values are means (arithmetic for hemoglobin, geometric for dose) with 95% confidence intervals. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. 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. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. 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. 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. Peter Choi, MB BChir, PhD, FRCP (UK), has received lecturing and consulting fees from Amgen, and has participated in advisory boards for Amgen. Please click the OK button below to continue. In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL. volume30,pages 10071017 (2013)Cite this article. The majority of patients who were transfused during the pre- and post-switch observation periods had Hb 10g/dL within the 14days prior to transfusion; only 1 patient during each period had Hb >11g/dL within the 14-day pre-transfusion interval. The pre-transfusion Hb concentrations were similar for transfusions occurring both pre- and post-switch (Fig. . 2023Vifor (International) Inc. All rights reserved. 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. The number of RBC transfusions and units transfused in the post-switch period was approximately threefold higher compared to the pre-switch period. An official website of the United States government. MIRCERA Classification: Erythropoiesis stimulating protein. Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. This suggests that the decision to transfuse was consistent with respect to Hb over the observation period (Fig. All calculations should be confirmed before use. Macdougall IC. Results of the BlandAltman analysis investigating the concordance between mean weekly ESA doses in both evaluation periods are presented in 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. Aranesp (darbepoetin alfa) Epogen (epoetin alfa) Mircera . [citation needed] Aranesp and EPOGEN increase the risk of seizures in patients with CKD. 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. Aranesp (darbepoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis. 6); the mean (SD) Hb within 14days prior to transfusion in these periods was 8.8 (1.41) and 8.3 (1.26), respectively. Changes in ESA dosing and number of transfusions post-switch may have important health-economic implications. Federal government websites often end in .gov or .mil. Do not pool unused portions from the prefilled syringes. 2012;59:444451. 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. aranesp to retacrit conversiontuto amigurumi grenouille au crochet. MIRCERA (methoxy polyethylene glycol-epoetin beta) is the first erythropoiesis-stimulating agent (ESA) approved by FDA for once-monthly administration. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Before You may also report negative side effects of prescription drugs to the Food and Drug Administration (FDA). 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. 2009 Nov-Dec;15(9):741-50. doi: 10.18553/jmcp.2009.15.9.741. 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 . 33 Dose. Asterisk Not all transfusions had an associated hemoglobin concentration in the 14-day period before transfusion. Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. 2002;162:14011408. Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp #Pharmacology #Hematology #Nephrology. Conclusion: A dose approximating 0. 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. Excluding patients receiving a transfusion within 90 days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). doi: 10.1053/j.ajkd.2011.11.013. Epoetin alfa was the first rhEPO produced and approved for pharmaceutical use, followed by several related products and by newer ESAs with the same mechanism but more prolonged action. randomized patients to darbepoetin or epoetin beta once weekly after the patients had been treated with epoetin beta three times weekly. Use caution in patients with coexistent cardiovascular disease and stroke. The WHO has set the daily-defined dose (DDD) for epoetin beta and darbepoetin at 1000 U and 4.5 g respectively, which gives a conversion factor of 222:1 . Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. Shortened red blood cell age in patients with end-stage renal disease who were receiving haemodialysis: a cross-sectional study. 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. Regression analysis indicated a non-linear relationship between pre- and post-switch ESA doses; DCR decreased with increasing pre-switch DA dose. Please see full Prescribing Information including Boxed WARNING, and Medication Guide for MIRCERA (methoxy polyethylene glycol-epoetin beta) Injection, for Intravenous or Subcutaneous Use. For Adult Patients with CKD not on dialysis: Refer patients who self-administer Mircera to the Instructions for Use [see Patient Counseling Information (17)]. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) Each pre-filled syringe contains 0.3 ml or 0.6 ml. There were 16 transfusions and 34 units transfused in the pre-switch period, versus 48 transfusions and 95 units transfused post-switch. Secondary outcomes included Hb concentrations and ESA use during the study period, and the incidence of red blood cell (RBC) transfusions. 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. Vigorous shaking or prolonged exposure to light should be avoided. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. 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. ^D[5j@%e Conversion from Epoetin alfa or Darbepoetin alfa to MIRCERA in Pediatric Patients with CKD on Hemodialysis. Decreases in dose can occur more frequently. 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. Hymes J, Bickimer T, Jackson JH, Bookhart BK, Mody SH, Tak Piech C. Curr Med Res Opin. If you are a healthcare professional outside of the US, please, visit www.mircera.global, The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion, and, Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal, For adverse event reports, please contact us at, You may also report negative side effects of prescription drugs to, the Food and Drug Administration (FDA). Eligible patients had received hemodialysis for 12 months and DA for 7 months. DA can be administered once a week (QW) or once every 2weeks (Q2W) to hemodialysis patients. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. Statistical methods for assessing agreement between two methods of clinical measurement. Am J Kidney Dis. 2023 Springer Nature Switzerland AG. Please know that Amgen, the sponsor of this site, is not responsible for the content on the site you are about to enter. Do not use the prefilled syringe more than once. Initial Treatment: 0.6 mcg/kg body weight administered once every two weeks (2.2). -, Kazmi WH, Kausz AT, Khan S, et al. 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. Choi, P., Farouk, M., Manamley, N. et al. Each dosage strength of MIRCERA is designated by a unique syringe plunger color. Not all pack sizes may be marketed. By definition, the DCR could not be calculated for patients ineligible for the DCR analysis as these did not have the necessary parameters recorded in both EPs. 8600 Rockville Pike Resistance to Erythropoiesis-Stimulating Agents among Patients on Hemodialysis Is Typically Transient. Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. Epub 2011 Dec 2. Dissertation Les Fausses Confidences Stratagme, Les Fromagers De Thirache Horaires, Archange Gabriel Pouvoir, Adeline Franois Mari, Rdiger Un Rapport Sur Un lve En Difficult . Accessed 18 October 2013. Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with Aranesp or EPOGEN. Macdougall IC, Obrador GT, El Nahas M. How important is transfusion avoidance in 2013? When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. In an additional analysis performed to assess the sensitivity of this result to the effects of transfusion by excluding those patients who received an RBC transfusion within 90days prior to or during either evaluation period, the DCR was 1.21 (95% CI 1.09, 1.35). Read reviews from GoodRx users who have taken Mircera and find the latest news on the drug. | DOWNLOAD SIZE: <>/Metadata 444 0 R/ViewerPreferences 445 0 R>> Would you like email updates of new search results? ferrous sulfate, Aranesp, Procrit, Retacrit. Slider with three articles shown per slide. <> Examine each prefilled syringe for the expiration date. 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 <>/Font<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. 3. Generic name: Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL 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). Nephrol Dial Transplant. MIRCERA Interactions: May require increased anticoagulation (heparin) during hemodialysis. Drugs. 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). 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. Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. Over the last 25years, several originator and biosimilar ESAs have been introduced for the management of CKD anemia, starting with the first generation short-acting recombinant erythropoietin agents (epoetin alfa and beta) and latterly with two longer-acting molecules, darbepoetin alfa (DA) and methoxy polyethylene glycol-epoetin beta (PEG-Epo), which combine a significantly increased half-life and lower binding affinity for the EPO receptor, allowing them to stimulate erythropoiesis for longer periods and to be administered less frequently [5, 6]. 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%. 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. MIRCERA has an approximate molecular weight of 60 kDa. New anemia therapies: translating novel strategies from bench to bedside. Hb hemoglobin. Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. Fewer than half of the patients achieved Hb in the 1012g/dL range by 7months post-switch. Aranesp (darbepoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis. Peter Choi. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study. Recombinant human erythropoietin is effective in Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (19881994). When a patient with a darbepoetin (Aranesp) or erythropoietin order switches to . What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? For patients who do not respond adequately over a 12-week escalation period, increasing the MIRCERA, Evaluate other causes of anemia. Conclusion: 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. 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. Clin Kidney J. MIRCERA comes in pre-filled syringes with laminated plunger stopper and tip cap with one needle 27G1/2. 2. 1 0 obj 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. ARANESP single-dose strengths can be combined 4,* You can more . The relationship between the DA and PEG-Epo doses during the evaluation periods was explored through linear and quadratic regression. Always store Mircera prefilled syringes in their original cartons. 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. before initiating MIRCERA. Drug class: Recombinant human erythropoietins. This medicine is not used to treat anemia caused by cancer medicines. %PDF-1.7 Cost (BNF 60, March 2013) Aranesp (darbepoetin alfa) - 14.68-220.22 (10 micrograms syringe to 150 microgram syringe) NeoRecormon Mircera (methoxy polyethylene glycol-epoetin beta) - 44.05-220.22 (30 microgram syringe to 150 microgram syringe . 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. Epub 2022 Apr 22. Horowitz J, Agarwal A, Huang F, Gitlin M, Gandra SR, Cangialose CB. Control hypertension prior to initiating and during treatment with Aranesp or EPOGEN. The study comprised a 14-month observation period. Discontinue MIRCERA, When administered subcutaneously, MIRCERA. Bethesda, MD 20894, Web Policies [3] It is the first approved, chemically modified erythropoiesis-stimulating agent (ESA). Individualize dosing and use the lowest dose of Mircera sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. Please know that the sponsors of this site are not responsible for content on the site you are about to enter. stream A decade in the anaemia market - 10 products seen top . Mechanism of Action. 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. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Epoetin beta and methoxy polyethylene glycol may increase tumor growth or decrease survival time in people with certain types of cancer. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these Nephrol Dial Transplant. Treatment: Treat to anemia in people with chronic kidney disease. Tables2 and 3 also summarize the proportion of patients in different Hb categories by study month. 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 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. Aranesp (darbepoetin alfa) and EPOGEN (epoetin alfa) are contraindicated in patients with: Pure red cell aplasia (PRCA) that begins after treatment with Aranesp, EPOGEN, or other erythropoietin protein drugs, Serious allergic reactions to Aranesp or EPOGEN. doi: 10.1002/14651858.CD010590.pub2. 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). Editorial assistance in the preparation of this manuscript was provided by W. Mark Roberts, PhD, Montreal, Canada. In CKD, anemia results primarily from decreased production of endogenous erythropoietin (EPO) by the kidney [3]. Kidney Med. eCollection 2020 May-Jun. Discard any unused portion. The distribution of transfusions (Fig. There were 16 transfusions and 34 units transfused in the pre-switch period, versus 48 transfusions and 95 units transfused post-switch. Mourad Farouk is an employee of Amgen with Amgen stock ownership. NCI CPTC Antibody Characterization Program, Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. The .gov means its official. Eligible patients had received hemodialysis for 12months and DA for 7months. 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). 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. 4! MIRCERA is a registered trademark of F. Hoffmann-La Roche Ltd. All Vifor Pharma Groups intellectual rights, including copyright, are reserved by the Vifor Pharma Group. 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 . Aranesp (darbepoetin alfa) prescribing information, Amgen. By Month 7 post-switch, the proportions of patients with Hb in these ranges were 9.7%, 48.1%, and 30.1%, respectively. 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. The dose of Mircera, given as a single intravenous or subcutaneous injection, should be based on the 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. Mircera with 1-step decrease as soon as Hgb is < 11.8 g/dL and last dose was administered 2 weeks ago or more. pure red cell aplasia (PRCA) that begins after treatment with MIRCERA or other erythropoietin protein drugs. Packaging Size: 0.3 ml. This was particularly evident in patients whose pre-switch EP weekly DA dose was higher than 100g. For adverse event reports, please contact us at safety@viforpharma.com,mircera@viforpharma.com or at 1-800-576-8295. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events. a Mutually exclusive categories; patients are censored in the following, Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. Clipboard, Search History, and several other advanced features are temporarily unavailable. 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. Values are means (arithmetic for hemoglobin, geometric for dose) with 95% confidence intervals.