Conversion - Epoetin alfa (Procrit) to Darbepoetin | GrepMed Box 1557, 6301, Zug, Switzerland, Amgen (UK) Limited, 240 Cambridge Science Park, Milton Road, Cambridge, UK, You can also search for this author in Karaboyas A, Morgenstern H, Waechter S, Fleischer NL, Vanholder R, Jacobson SH, Sood MM, Schaubel DE, Inaba M, Pisoni RL, Robinson BM. For Adult Patients with CKD not on dialysis: Refer patients who self-administer Mircera to the Instructions for Use [see Patient Counseling Information (17)]. Therapeutic effects . See Instructions for Use for complete instructions on the preparation and administration of MIRCERA, If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of MIRCERA. 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. Longer-acting PEG-Epo contains a chemical bond between an amino group present in epoetin beta and methoxy polyethylene glycol (PEG) butanoic acid; the addition of PEG is responsible for an increase in serum half-life of epoetin beta, and in CKD patients on dialysis the terminal half-life of PEG-Epo after IV administration is 134h [6, 8]. Patients were excluded if they had participated in any interventional study within 30days before the 7-month period preceding the switch or at any subsequent time up to 7months after the switch. 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. ONLY administer MIRCERA intravenously in pediatric patients. in the treatment of anemia due to cancer chemotherapy. Indication 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.Limitations of Use Aranesp has not been shown to improve quality of life, fatigue, or patient well-being. Careers. Support for this assistance was funded by Amgen. 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). For Pediatric Patients with CKD on hemodialysis: Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Pediatric Patients with CKD Treated with Hemodialysis. 5). Of the 302 patients enrolled, 206 (68%) were included in the DCR analysis. 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. You may also report negative side effects of prescription drugs to the Food and Drug Administration (FDA). PDF Highlights of Prescribing Information ----------------------- Dosage eCollection 2020 May-Jun. More severe cases were recorded with long-acting agents (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta). 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. The site is secure. 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. ARANESP (darbepoetine alfa) 1 injection/sem. 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. A single hemoglobin excursion may not require a dosing change. (PDF) Amgen Business Review - library.corporate-ir.netlibrary.corporate 2021 Jan;26(1):46-53. doi: 10.1111/nep.13765. Recombinant human erythropoietins: very rare risk of severe cutaneous PDF Anmie chez l'insuffisant rnal : comment utiliser les agents stimulant Palmer SC, Saglimbene V, Mavridis D, Salanti G, Craig JC, Tonelli M, Wiebe N, Strippoli GF. However, healthcare-resource utilization and cost data were not collected in this study, preventing comparison of these variables between the pre-switch and post-switch periods. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Treatment: Treat to anemia in people with chronic kidney disease. PubMedGoogle Scholar. doi: 10.1038/ki.1985.109. Red blood cell transfusions pre- and post-switch were quantified. Cochrane Database Syst Rev. Methoxy polyethylene glycol-epoetin (Mircera ) will be increased and decreased in 1-step or 2-step increments, based on scale above. Unable to load your collection due to an error, Unable to load your delegates due to an error. Amgen's two anemia drugs, Epogen and Aranesp, had sales of $6.6 billion last year, nearly half the company's total revenue. history of serious or severe allergic reactions to MIRCERA (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). Action Stimulates erythropoesis (production of red blood cells). chemotherapy, MDS or MF, continued therapy) Please provide a hemoglobin level (g/dL) for your patient taken within the first 12 weeks of therapy with epoetin and include the date the lab was drawn. Galle JC, Claes K, Kiss I, Winearls CG, Herlitz H, Guerin A, Di Giulio S, Suranyi MG, Bridges I, Addison J, Farouk M. Nephrol Dial Transplant. Mourad Farouk is an employee of Amgen with Amgen stock ownership. 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. Am J Kidney Dis. Mircera with 1-step decrease as soon as Hgb is < 11.8 g/dL and last dose was administered 2 weeks ago or more. Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. Mircera at Best Price in India - IndiaMART Aranesp (darbepoetin alfa) | Dosing Considerations This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Accessed 18 October 2013. 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. 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]. pure red cell aplasia (PRCA) that begins after treatment with MIRCERA or other erythropoietin protein drugs. Eschbach JW, Adamson JW. Control hypertension prior to initiating and during treatment with Aranesp or EPOGEN. MIRCERA, methoxy polyethylene glycol-epoetin beta, is an ESA which differs from erythropoietin through formation of a chemical bond between an amino group present in erythropoietin beta and methoxy polyethylene glycol (PEG) butanoic acid. randomized patients to darbepoetin or epoetin beta once weekly after the patients had been treated with epoetin beta three times weekly. Please click the OK button below to continue. 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 . Secondly, the DCR was calculated on a subset of patients which constituted approximately two-thirds of the total enrolled. Nephrol Dial Transplant. https://doi.org/10.1007/s12325-013-0063-y, DOI: https://doi.org/10.1007/s12325-013-0063-y. Prise en charge anmie rnale - Nephro.blog 3. Dose Conversion Ratio in Hemodialysis Patients Switched from Darbepoetin Alfa to PEG-Epoetin Beta: AFFIRM Study. PEG-Epo was approved in 2009 for administration Q2W or once a month (QM) to patients on dialysis [5, 8]. Anemia of end-stage renal disease (ESRD). 1. 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 . Randomized clinical studies have reported data on switching from DA to PEG-Epo (Stabilizing haemoglobin TaRgets in dialysis following IV C.E.R.A. In particular, the likelihood of a transfusion during the post-switch period was significantly higher in patients with a dose ratio below 1 at switch. Pharmacokinetic studies have shown that the meanSD terminal half-life of DA is 217.5h when administered intravenously (IV) [7]. Mircera contains no preservatives. 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. Do not increase the dose more frequently than once every 4 weeks. Shortened red blood cell age in patients with end-stage renal disease who were receiving haemodialysis: a cross-sectional study. Mircera | European Medicines Agency Available for Android and iOS devices. There were 16 transfusions and 34 units transfused in the pre-switch period, versus 48 transfusions and 95 units transfused post-switch. 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). Procrit dosing calculator | Math Applications Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 2002;17(Suppl 5):6670.