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. Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with Aranesp or EPOGEN. This medicine is not for treating anemia caused by cancer chemotherapy. 4! 1985;28:15. EPOGEN from multidose vials contains benzyl alcohol and is contraindicated in neonates, infants, pregnant women, and lactating women. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) 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]. 5) shows that most transfusions occurred in the first 4months post-switch.
Methoxy polyethylene glycol-epoetin beta - Wikipedia Mircera is a prescription medicine used to treat the symptoms of Anemia associated with Chronic Renal Failure. Nephrol Dial Transplant. When a patient with a darbepoetin (Aranesp) or erythropoietin order switches to . For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. 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%.
MIRCERA- methoxy polyethylene glycol-epoetin beta RETACRIT Dosage and Administration (epoetin alfa-epbx) Decreases in dose can occur more frequently. Macdougall IC. Red blood cell transfusions pre- and post-switch were quantified. Summary of the last hemoglobin concentrations recorded within 14days prior to red blood cell transfusions pre- and post-switch. In CKD, anemia results primarily from decreased production of endogenous erythropoietin (EPO) by the kidney [3]. Individualize dosing and use the lowest dose of Mircera sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) Hymes J, Bickimer T, Jackson JH, Bookhart BK, Mody SH, Tak Piech C. Curr Med Res Opin. NCI CPTC Antibody Characterization Program, Astor BC, Muntner P, Levin A, Eustace JA, Coresh J.
Aranesp (darbepoetin alfa) | Dosing Considerations Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (19881994). 3. Do not use the prefilled syringe more than once. 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 MIRCERA has an approximate molecular weight of 60 kDa. Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. Anemia: an early complication of chronic renal insufficiency. 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). This site needs JavaScript to work properly. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Peter Choi, MB BChir, PhD, FRCP (UK), has received lecturing and consulting fees from Amgen, and has participated in advisory boards for Amgen. An official website of the United States government. The dose of Mircera, given as a single intravenous or subcutaneous injection, should be based on the 33 Dose. 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. MIRCERA [prescribing information]. 1:1 reference line indicates equal PEG-Epo and darbepoetin alfa doses. 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. ^D[5j@%e The PATRONUS study, in which stable hemodialysis patients receiving IV DA were randomized either to QM PEG-Epo or to Q2W DA for 26weeks [11], described an increase in post-switch dose requirement. Brand: Mircera. The intravenous route is recommended for patients on hemodialysis because the intravenous route may be less immunogenic. The data from this study were analyzed using SAS Statistical Software v9.2 (SAS Institute Inc., Cary, NC, USA). If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of MIRCERA. 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.
About ARANESP (darbepoetin alfa) | Amgen ESA | HCP (PDF) Amgen Business Review - library.corporate-ir.netlibrary.corporate American Society of Hematology Self-Assessment Program (Adam - Scribd Dose conversion ratio in hemodialysis patients switched from - 94.130.71.173. 1MIRCERA [prescribing information]. 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. 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].
PDF Mircera, INN: methoxy polyethylene glycol-epoetin beta MIRCERA Interactions: May require increased anticoagulation (heparin) during hemodialysis. 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). 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 (darbepoetin alfa) prescribing information, Amgen. MIRCERA Classification: Erythropoiesis stimulating protein. 5). Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Each dosage strength of MIRCERA is designated by a unique syringe plunger color. Randomized clinical studies have reported data on switching from DA to PEG-Epo (Stabilizing haemoglobin TaRgets in dialysis following IV C.E.R.A. 1986;327:30710. Dialysis centers were expected to adhere to European Best Practice Guidelines for iron repletion [9]. endobj
RBC transfusions were reported in terms of number of transfusions and number of units transfused, using descriptive statistics. Eligible patients had received hemodialysis for 12 months and DA for 7 months. Hb hemoglobin. The .gov means its official. 2002;17(Suppl 5):6670. Regression analysis indicated a non-linear relationship between pre- and post-switch ESA doses; DCR decreased with increasing pre-switch DA dose. Inflammation and Erythropoiesis-Stimulating Agent Response in Hemodialysis Patients: A Self-matched Longitudinal Study of Anemia Management in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Do you wish to proceed? 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. 10PAGE BROCHURE
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. 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. Do not pool unused portions from the prefilled syringes. A primary growth factor for erythroid development, erythropoietin is produced in the kidney and released into the bloodstream in response to hypoxia. Conversion from darbepoetin or erythropoietin to Mircera 1. Conversion from Epoetin alfa or Darbepoetin alfa to MIRCERA in Pediatric Patients with CKD on Hemodialysis. before initiating Mircera [see Warnings and Precautions (5.9)]. 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. For Adult Patients with CKD not on dialysis: Refer patients who self-administer Mircera to the Instructions for Use [see Patient Counseling Information (17)]. Dose Conversion Ratio in Hemodialysis Patients Switched from Darbepoetin Alfa to PEG-Epoetin Beta: AFFIRM Study. Results: 2001;38:803812. Eschbach JW, Adamson JW. Mircera would also have competed with Aranesp and with Procrit . FOIA 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. A BlandAltman analysis [10] was also performed to assess the agreement between ESA doses in the evaluation periods. 2019 Jul 5;13(3):425-433. doi: 10.1093/ckj/sfz065. PubMed }"nUEcJumC0ooF 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. doi: 10.1001/archinte.162.12.1401. Mircera is packaged as single-dose prefilled syringes. This article does not contain any studies with human or animal subjects performed by any of the authors. Part of Springer Nature. Packaging Type: Injection. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events. Fewer than half of the patients achieved Hb in the 1012g/dL range by 7months post-switch. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. 2008;23:365461. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Kidney Med. 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. 1. Of 302 patients enrolled, 206 had data available for DCR analysis. afK ] T z"$qu9H$}W//~||!+iO7^Q)|F.j+m
ZJ7CY\7\lO7OGPno? Epoetin beta and methoxy polyethylene glycol may increase tumor growth or decrease survival time in people with certain types of cancer.