MIRCERA Classification: Erythropoiesis stimulating protein. 2001;38:803812. Methoxy polyethylene glycol-epoetin beta injection causes the . 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]. doi: 10.1053/ajkd.2001.27699. Mircera: Basics, Side Effects & Reviews - GoodRx 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. Google Scholar. Nephrol Dial Transplant. Do not use the prefilled syringe more than once. 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. Cochrane Database Syst Rev. 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. [3] It is the first approved, chemically modified erythropoiesis-stimulating agent (ESA). 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. 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. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Tolman et al. Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp #Pharmacology #Hematology #Nephrology. Clin Kidney J. Discontinue MIRCERA, When administered subcutaneously, MIRCERA. )E]$&m"t "N5LQmgh-QZi`T0 hacpBYKUYRw@aMB/|n|'Y#h$8]#|zf. MIRCERA comes in pre-filled syringes with laminated plunger stopper and tip cap with one needle 27G1/2. Kazmi WH, Kausz AT, Khan S, et al. Would you like email updates of new search results? Mircera: Uses, Taking, Side Effects, Warnings - Medicine.com This medicine is not for treating anemia caused by cancer chemotherapy. 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%. Support for this assistance was funded by Amgen. 2021 Jan;26(1):46-53. doi: 10.1111/nep.13765. For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. Unable to load your collection due to an error, Unable to load your delegates due to an error. aranesp to retacrit conversion For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. For lack or loss of hemoglobin response to Aranesp or EPOGEN, initiate a search for causative factors. Conversion from epoetin beta to darbepoetin: what is the equivalent 2 0 obj Slider with three articles shown per slide. 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. Mircera at Best Price in India - IndiaMART Bookshelf 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. Anemia response to Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) versus Epoetin Alfa (Eprex) in patients with chronic Kidney disease on Hemodialysis Published: September 05, 2017 42/47 is common in patients with a GFR below 30 ml/min/1.73m2 and contributes to many of the speciic symptoms of CKD. There is no evidence that Mircera alters the metabolism of other medicinal products. Drug class: Recombinant human erythropoietins. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. CAS Recombinant human erythropoietin is effective in The mean (95% CI) monthly Hb immediately prior to switch, in Month 1 post-switch, and in Month 7 post-switch was 11.5g/dL (11.3, 11.7), 11.7g/dL (11.5, 11.9), and 11.4g/dL (11.3, 11.6), respectively. Intravenous C.E.R.A. Mean Hb was 11.5 g/dL in the pre-switch EP and 11.4 g/dL in the post-switch EP. Mircera | European Medicines Agency Pharmacokinetic studies have shown that the meanSD terminal half-life of DA is 217.5h when administered intravenously (IV) [7]. Prise en charge anmie rnale - Nephro.blog The introduction of exogenous erythropoiesis-stimulating agents (ESAs) to clinical practice has transformed the care of patients with CKD, by ameliorating anemia, reducing transfusion requirements, and improving quality of life [4]. Do not use Mircera after the expiration date. In the first month after switch, these proportions were 10.2%, 48.5% and 37.4%, respectively. Use caution in patients with coexistent cardiovascular disease and stroke. Procrit dosing calculator | Math Applications Red blood cell transfusions pre- and post-switch, Summary of the last hemoglobin concentrations recorded within 14days prior to red blood cell transfusions pre- and post-switch. OK 2014 Dec 8;2014(12):CD010590. Not all pack sizes may be marketed. MIRCERA- methoxy polyethylene glycol-epoetin beta Macdougall IC. Dosage form: injection, solution official website and that any information you provide is encrypted 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). Individualize dosing and use the lowest dose of MIRCERA. Donck J, Gonzalez-Tabares L, Chanliau J, Martin H, Stamatelou K, Manamley N, Farouk M, Addison J. Adv Ther. m+KqXAXOkS@,1C0VgzXzeWU},4 Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. [citation needed] The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Mircera will be administered IV to HD patients, and SC to PD patients. Last updated on Jul 26, 2022. In the evaluation periods, the geometric mean weekly DA dose in the pre-switch EP was 24.1g (95% CI 21.3, 27.1) while the geometric mean weekly PEG-Epo dose in the post-switch EP was 28.6g (95% CI 26.0, 31.5). 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. Aranesp (darbepoetin alfa) | Dosing Considerations volume30,pages 10071017 (2013)Cite this article. If Hgb remains >= 12 g/dL for more than 2 months, return to regular Hgb testing policy. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which Aranesp and EPOGEN are not approved). When administered subcutaneously, Mircera should be injected in the abdomen, arm or thigh. Adverse reactions ( 5%) in EPOGEN clinical studies in patients with CKD were hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection. Patients included in the analysis were less likely to be diabetic (32% vs. 40%), more likely to be receiving DA at a longer dosing interval (60% vs. 73% at QW; 19% vs. 3% less frequently than Q2W), and received a lower geometric mean weekly dose of DA during the pre-switch EP (24.1 vs. 37.7g). Conversion Dosing Guide: from Epoetin Alfa to Aranesp in Patients with AFFIRM may therefore help to guide expectations around potential differences in ESA dose requirements when switching hemodialysis patients from DA to PEG-Epo, although the reported mean maintenance DCR is not intended to predict the dose conversion ratio at the individual patient level. 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. 6). National Library of Medicine Individual patients could contribute multiple transfusions to these analyses. See this image and copyright information in PMC. Goodkin DA, Zhao J, Cases A, Nangaku M, Karaboyas A. Erythropoiesis-stimulating agents (epoetin alfa, beta, theta and zeta Janet Addison is an employee of Amgen with Amgen stock options. 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). Disclaimer. (PDF) Conversion from epoetin beta to darbepoetin: What is the 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. Each dosage strength of MIRCERA is designated by a unique syringe plunger color. Conversion from Epoetin alfa or Darbepoetin alfa to MIRCERA in Pediatric Patients with CKD on Hemodialysis. The conversion from EpoB to CERA (methoxy polyethylene glycol-epoetin beta; Mircera; Hoffmann-La Roche Ltd., Basel, Switzerland) once monthly was already decided by the health care payer policy, who is the provider of erythropoietin stimulating agents for all patients, and was planned after a period of 6 months.