mircera to aranesp conversion

2001;38:80312. EPOGEN (epoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis to decrease the need for red blood cell (RBC) transfusion. Preservation of anemia control and weekly ESA dosage after conversion from PEG-Epoetin beta to darbepoetin alfa in adult hemodialysis patients: the TRANSFORM study. Low hemoglobin at hemodialysis initiation: an international study of anemia management and mortality in the early dialysis period. Google Scholar. Bethesda, MD 20894, Web Policies Discard any unused portion. 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 Matsumura K, Okumiya T, Sugiura T, Takahashi N, Yamamoto Y, Kikuchi S, Fujii K, Otagaki M, Shiojima I. BMC Nephrol. 2002;162:14011408. The geometric mean weekly ESA doses were 24.1 g DA in the pre-switch EP and 28.6 g PEG-Epo in the post-switch EP. Each pre-filled syringe contains 0.3 ml or 0.6 ml. sharing sensitive information, make sure youre on a federal 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. . Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. Results of the BlandAltman analysis investigating the concordance between mean weekly ESA doses in both evaluation periods are presented in Fig. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events. Mourad Farouk is an employee of Amgen with Amgen stock ownership. 33 Dose. Internal You are now leaving AnemiaHub.com. https://doi.org/10.1007/s12325-013-0063-y, DOI: https://doi.org/10.1007/s12325-013-0063-y. 2023 Springer Nature Switzerland AG. 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. PubMedGoogle Scholar. Fewer than half of the patients achieved Hb in the 1012g/dL range by 7months post-switch. Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Adult Patients with CKD. Summary of the last hemoglobin concentrations recorded within 14days prior to red blood cell transfusions pre- and post-switch. 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. When administered subcutaneously, Mircera should be injected in the abdomen, arm or thigh. 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. Brand: Mircera. 2 0 obj [3] It is the first approved, chemically modified erythropoiesis-stimulating agent (ESA). There are limitations in generalizing the findings of this study to the broader hemodialysis population. Randomized clinical studies have reported data on switching from DA to PEG-Epo (Stabilizing haemoglobin TaRgets in dialysis following IV C.E.R.A. Do not mix Mircera with any parenteral solution. 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). Of 302 patients enrolled, 206 had data available for DCR analysis. 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. 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 In controlled clinical trials of patients with cancer, ESAs increased the risks for death and serious adverse cardiovascular reactions. 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. Federal government websites often end in .gov or .mil. The pre-transfusion Hb concentrations were similar for transfusions occurring both pre- and post-switch (Fig. More severe cases were recorded with long-acting agents (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta). Report to the Judicial Council. Packaging Type: Injection. Mircera is packaged as single-dose prefilled syringes. Box 1557, 6301, Zug, Switzerland, Amgen (UK) Limited, 240 Cambridge Science Park, Milton Road, Cambridge, UK, You can also search for this author in The recommended RETACRIT regimens are: 300 Units/kg per day subcutaneously for 15 days total: administered daily for 10 days before surgery, on the day of surgery, and for 4 days after surgery. 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. Hymes J, Bickimer T, Jackson JH, Bookhart BK, Mody SH, Tak Piech C. Curr Med Res Opin. <> 1 0 obj Conversion d'une EPO l'autre Conversion potine en darbpotine avec un facteur de conversion 200 UI = 1 g Bilan martial Suivi ferritine et taux de saturation de la transferrine (TSAT) tous les 3 mois. Aranesp (darbepoetin alfa) prescribing information, Amgen. Control hypertension prior to initiating and during treatment with Aranesp or EPOGEN. 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 . MIRCERA (methoxy polyethylene glycol-epoetin beta) is the first erythropoiesis-stimulating agent (ESA) approved by FDA for once-monthly administration. 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. Data were collected from 7 months before until 7 months after switching treatment. Section III: Treatment of renal anaemia. 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. Dose by Weight Chart - Resourcehub Epogen Dosage Guide - Drugs.com Epogen, Procrit (epoetin alfa) dosing, indications, interactions MIRCERA is indicated for the treatment of anemia associated with CKD in adult patients on dialysis and adult patients not on dialysis. Although the reasons for transfusion were not recorded, the pre-transfusion Hb concentrations within 14days prior to transfusion remained similar for transfusions occurring both pre- and post-switch. Adverse Reactions: Hypertension, diarrhea,. Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit. For lack or loss of hemoglobin response to Aranesp or EPOGEN, initiate a search for causative factors. Mircera works like the human protein called erythropoietin to help your body make more RBCs. ribosome A ribonuclear protein complex that binds to mRNA nucleotide A basic . 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. 1. 3. 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. m+KqXAXOkS@,1C0VgzXzeWU},4 Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Nephrol Dial Transplant. Google Scholar. 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. Publication management support was provided by Caterina Hatzifoti, PhD, of Amgen Europe GmbH. a Mutually exclusive categories; patients are censored in the following, Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. 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). No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Goodkin DA, Zhao J, Cases A, Nangaku M, Karaboyas A. MIRCERA comes in pre-filled syringes with laminated plunger stopper and tip cap with one needle 27G1/2. 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. The data from this study were analyzed using SAS Statistical Software v9.2 (SAS Institute Inc., Cary, NC, USA). Lancet. Article For recommended dose equivalency, see Tables A and B (below). Once Every Two Weeks (mcg/every two weeks). Bland JM, Altman DG. Strength: 100 mcg / 0.3ml. endobj The remaining enrolment was at four sites divided between three other countries. Accessibility . Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with Aranesp or EPOGEN. Action Stimulates erythropoesis (production of red blood cells). -, Kazmi WH, Kausz AT, Khan S, et al. If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of MIRCERA. Secondly, the DCR was calculated on a subset of patients which constituted approximately two-thirds of the total enrolled. Do you wish to proceed? Le bilan martial est dpendant de l'tat inflammatoire et la protine C ractive (CRP) est galement suivi tous les 3 mois pour cela. RBC transfusions were reported in terms of number of transfusions and number of units transfused, using descriptive statistics. 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. Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. Dr. Gerald Diaz @GeraldMD. Generic name: Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL The distribution of transfusions (Fig. Nephrol Dial Transplant. 4. When a patient with a darbepoetin (Aranesp) or erythropoietin order switches to . [citation needed] Do not pool unused portions from the prefilled syringes. Locatelli F, Aljama P, Barany P, et al. Clipboard, Search History, and several other advanced features are temporarily unavailable. There is no evidence that Mircera alters the metabolism of other medicinal products. In responding to hypoxia, erythropoietin interacts with erythroid progenitor . 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. doi: 10.1038/ki.1985.109. Mircera may be used alone or with other medications. This medicine is not for treating anemia caused by cancer chemotherapy. Choi, P., Farouk, M., Manamley, N. et al. 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. Unable to load your collection due to an error, Unable to load your delegates due to an error. Discontinue MIRCERA, When administered subcutaneously, MIRCERA. The https:// ensures that you are connecting to the 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. AFFIRM demonstrated non-linearity of the dose relationship curve, with DCR decreasing as pre-switch DA dose increased. as a substitute for red blood cell transfusions in patients who require immediate correction of anemia. WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE. In the absence of PRCA, follow dosing recommendations for management of patients with an insufficient response to MIRCERA, 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 the postmarketing setting in patients treated with MIRCERA, PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which MIRCERA, If severe anemia and low reticulocyte count develop during treatment with MIRCERA, Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, tachycardia, pruritus, skin rash and urticaria have been reported in patients treated with MIRCERA, Blistering and skin exfoliation reactions including Erythema multiforme and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with ESAs (including MIRCERA, Patients may require adjustments in their dialysis prescription after initiation of MIRCERA, Most frequent adverse reactions ( 5%) in adult patients with CKD treated with MIRCERA. Mircera (methoxy polyethylene glycol / epoetin beta) dosing, indications, interactions, adverse effects, and more Drugs & Diseases methoxy polyethylene glycol / epoetin beta (Rx) Brand and. 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. Kidney Int. Kazmi WH, Kausz AT, Khan S, et al. Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. risks. 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. Please know that Amgen, the sponsor of this site, is not responsible for the content on the site you are about to enter.