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. Am J Kidney Dis. m+KqXAXOkS@,1C0VgzXzeWU},4 For Pediatric Patients with CKD on hemodialysis: Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Pediatric Patients with CKD Treated with Hemodialysis. Association of erythropoietin resistance and fibroblast growth factor 23 in dialysis patients: Results from the Japanese Dialysis Outcomes and Practice Patterns Study. species. A BlandAltman analysis [10] was also performed to assess the agreement between ESA doses in the evaluation periods. 1 0 obj
Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. MIRCERA can be administered once every 2 weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA. Learn about Mircera, potential side effects, proper use and dosing, and popular alternatives. Canaud B, Mingardi G, Braun J, et al. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) 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. A motion conversion mechanism 123 includes a yoke 153 and a rotatable member 149, which causes the yoke 152, . pee`T"c+l_WB,`km^;6#j(*m`&E`l${F6Q`&^=e`f(6]8ZE[VHNx-FRIhE&iJKvW`Vz^p@?Yk+S.DgR1rrB6yq2N$| . All groups were assessed at the end of the study for safety and efficacy parameters. 2004;19(Suppl 2):ii1631. 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. 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). When a patient with a darbepoetin (Aranesp) or erythropoietin order switches to . 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 . -, Macdougall IC. doi: 10.1093/ndt/17.suppl_5.66. Epoetin alfa (Procrit, Epogen) acts like the hormone we have in our body, whereas Mircera . Data were also manually reviewed prior to final analysis. The study comprised a 14-month observation period. MIRCERA Interactions: May require increased anticoagulation (heparin) during hemodialysis. The data from this study were analyzed using SAS Statistical Software v9.2 (SAS Institute Inc., Cary, NC, USA). Introduction: Results: 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. Descriptions. 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. Kazmi WH, Kausz AT, Khan S, et al. Hrl WH. It is not known if Mircera is safe and effective in children younger than 5 years of age. Macdougall IC. doi: 10.1053/j.ajkd.2011.11.013. 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. A primary growth factor for erythroid development, erythropoietin is produced in the kidney and released into the bloodstream in response to hypoxia. 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). 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. 10PAGE BROCHURE
Show detailed description Study Design Go to 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. 1986;327:30710. Control hypertension prior to initiating and during treatment with Aranesp or EPOGEN. Pharmacokinetic studies have shown that the meanSD terminal half-life of DA is 217.5h when administered intravenously (IV) [7]. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. OK
Part of Springer Nature. *Data from a multicenter, randomized, open-label study comparing epoetin, given 1, 2, or 3 times weekly IV or SC, with ARANESP , at a reduced dose frequency, in dialysis patients (N = 522).Dose adjustments were made as necessary and per study protocol to maintain individual patients' Hb within a target range of -1.0 to +1.5 g/dL of their baseline Hb and between 9 g/dL and 13 g/dL for up . Open Access This article is distributed under the terms of the Creative Commons Attribution 2.0 International License (https://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Secondly, the DCR was calculated on a subset of patients which constituted approximately two-thirds of the total enrolled. Please know that Amgen, the sponsor of this site, is not responsible for the content on the site you are about to enter. This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these
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 . Amgen Business Review November 7, 2008 Strategic Outlook Kevin Sharer CEO 3 Provided November 7, 2008 as part of an oral presentation and is qualified by such, contains forward-looking Shortened red blood cell age in patients with end-stage renal disease who were receiving haemodialysis: a cross-sectional study. Statistical methods for assessing agreement between two methods of clinical measurement. and transmitted securely. OZZ Peter Choi. 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). 3. Hb concentrations were reported as arithmetic means for each month. DA can be administered once a week (QW) or once every 2weeks (Q2W) to hemodialysis patients. 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. Decreases in dose can occur more frequently. 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]. ^D[5j@%e 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. Data were collected from 7months before until 7months after switching treatment. 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. EXTON, Pa., July 31, 2018 /PRNewswire/ -- Plagued by regulatory delays, the FDA finally granted approval for Retacrit in May 2018, making it the first biosimilar erythropoietin-stimulating agent (ESA) to become available in the US market. For the purposes of this policy, a conversion factor of 3 should be used to estimate hematocrit when only the hemoglobin is measured, e.g., hemoglobin of 10 g/dL is approximately equal to a hematocrit of 30%, a hemoglobin of 11 g/dL is . %
Do not use the prefilled syringe more than once. 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. - , . Mircera (methoxy polyethylene glycol / epoetin beta) dosing, indications, interactions, adverse effects, and more Drugs & Diseases methoxy polyethylene glycol / epoetin beta (Rx) Brand and. 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. 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 ESA erythropoiesis-stimulating agent, Hb hemoglobin. Am J Nephrol. Disposition of patients. 2013;28:10929. Support for this assistance was funded by Amgen. 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. 2014 Nov;31(11):1155-68. doi: 10.1007/s12325-014-0161-5. A single hemoglobin excursion may not require a dosing change. Asterisk Not all transfusions had an associated hemoglobin concentration in the 14-day period before transfusion. Methoxy polyethylene glycol-epoetin beta injection is used to treat anemia in adults with chronic kidney disease (CKD) who may or may not be on dialysis or in children with CKD who are on dialysis. This medicine is not used to treat anemia caused by cancer medicines. 4. Use caution in patients with coexistent cardiovascular disease and stroke. Accessed 18 October 2013. History of serious or severe allergic reactions to Mircera (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp GrepMed. Nephrol Dial Transplant. 3 0 obj
before initiating Mircera [see Warnings and Precautions (5.9)]. HHS Vulnerability Disclosure, Help For Adult Patients with CKD not on dialysis: Refer patients who self-administer Mircera to the Instructions for Use [see Patient Counseling Information (17)]. Google Scholar. Bland JM, Altman DG. When adjusting therapy, consider hemoglobin rate of rise, rate of decline, ESA responsiveness, and hemoglobin variability. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. MIRCERA [prescribing information]. Read reviews from GoodRx users who have taken Mircera and find the latest news on the drug. 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]. See this image and copyright information in PMC. However, the relationship between the pre- and post-switch ESA doses during the two evaluation periods was non-linear. }"nUEcJumC0ooF The .gov means its official. Generic name: Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL 4! https://doi.org/10.1007/s12325-013-0063-y, DOI: https://doi.org/10.1007/s12325-013-0063-y. 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. Discontinue MIRCERA, When administered subcutaneously, MIRCERA. 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. There are limitations in generalizing the findings of this study to the broader hemodialysis population. The primary outcome measure, the geometric mean maintenance DCR, was calculated to be 1.17 (95% CI 1.05, 1.29). Further exploration of the relationship between DA and PEG-Epo doses using the BlandAltman method [10], which circumvents the limitations of the regression method in this type of investigation, indicated that the variability in the dose differences increased as doses increased, while the level of concordance decreased with increasing ESA dose. In responding to hypoxia, erythropoietin interacts with erythroid progenitor . Anemia of end-stage renal disease (ESRD) Kidney Int. -, Macdougall IC. New anemia therapies: translating novel strategies from bench to bedside. Examine each prefilled syringe for the expiration date. . 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. Cochrane Database Syst Rev. Eligible patients had received hemodialysis for 12months and DA for 7months. For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. 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. adult patients on dialysis and adult patients not on dialysis. Secondary outcomes included Hb concentrations and ESA use during the study period, and the incidence of red blood cell (RBC) transfusions. 2002;162:14011408. Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. You may also report negative side effects of prescription drugs to the Food and Drug Administration (FDA). Kidney Int. 3. The geometric mean DCR was 1.17 (95% CI 1.05, 1.29). 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). 2012 Jun;27(6):2303-11. doi: 10.1093/ndt/gfr677. Randomized clinical studies have reported data on switching from DA to PEG-Epo (Stabilizing haemoglobin TaRgets in dialysis following IV C.E.R.A. No test of statistical significance was performed on any of the clinical characteristics. [3] It is the first approved, chemically modified erythropoiesis-stimulating agent (ESA).