[3] It is the first approved, chemically modified erythropoiesis-stimulating agent (ESA). PubMed afK ] T z"$qu9H$}W//~||!+iO7^Q)|F.j+m ZJ7CY\7\lO7OGPno? You may also report negative side effects of prescription drugs to the Food and Drug Administration (FDA). The .gov means its official. Horowitz J, Agarwal A, Huang F, Gitlin M, Gandra SR, Cangialose CB. Excluding patients receiving a transfusion within 90days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). 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. Tolman et al. Always store Mircera prefilled syringes in their original cartons. Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Adult Patients with CKD. Use caution in patients with coexistent cardiovascular disease and stroke. 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. Adv Ther 30, 10071017 (2013). Excursions of Hb values above and below the range of 1012g/dL [9] were more common in the post-switch compared to the pre-switch period. There was neither any requirement for a center to have been using DA as their sole long-acting ESA pre-switch, nor for every DA-treated patient to have been switched to PEG-Epo. Of 302 patients enrolled, 206 had data available for DCR analysis. Results: Anemia of end-stage renal disease (ESRD) Kidney Int. Anemia Associated with Chronic Renal Failure, Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL, Drug class: recombinant human erythropoietins. x]r9r}W#k Drugs. Mechanism of Action. No difference in conversion dosage could be determined between patients who were epoetin sensitive (<200 units/kg per week) or resistant (>200 units/kg per week, P = NS). aranesp to retacrit conversiontuto amigurumi grenouille au crochet. St. Gallen, Switzerland: Vifor (International) Inc.; June 2018. 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. The study comprised a 14-month observation period. The data from this study were analyzed using SAS Statistical Software v9.2 (SAS Institute Inc., Cary, NC, USA). doi: 10.1038/ki.1985.109. Mircera is used to reduce or avoid the need for RBC transfusions. Janet Addison is an employee of Amgen with Amgen stock options. The pre-transfusion Hb concentrations were similar for transfusions occurring both pre- and post-switch (Fig. 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. Am J Kidney Dis. Changes in ESA dosing and number of transfusions post-switch may have important health-economic implications. MIRCERA has an approximate molecular weight of 60 kDa. 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. Pharmacokinetic studies have shown that the meanSD terminal half-life of DA is 217.5h when administered intravenously (IV) [7]. New anemia therapies: translating novel strategies from bench to bedside. Conversion from Another ESA: dosed once every 4 weeks based on total Recombinant human erythropoietin is effective in official website and that any information you provide is encrypted When adjusting therapy, consider hemoglobin rate of rise, rate of decline, ESA responsiveness, and hemoglobin variability. 2 0 obj randomized patients to darbepoetin or epoetin beta once weekly after the patients had been treated with epoetin beta three times weekly. - 94.130.71.173. Values are means (arithmetic for hemoglobin, geometric for dose) with 95% confidence intervals. Tables2 and 3 also summarize the proportion of patients in different Hb categories by study month. endobj 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. Do not increase the dose more frequently than once every 4 weeks. Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. Support for this assistance was funded by Amgen. Provided by the Springer Nature SharedIt content-sharing initiative, Over 10 million scientific documents at your fingertips, Not logged in 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. A BlandAltman analysis [10] was also performed to assess the agreement between ESA doses in the evaluation periods. Medically reviewed by Drugs.com. ESAs resulted in decreased locoregional control/progression-free survival and/or overall survival. The number of transfusions and units transfused increased approximately threefold from the pre-switch to the post-switch period. Mircera ceiling is 200 mcg every two weeks (or 3.0 mcg/kg/2 weeks, whichever is lower). Report to the Judicial Council. Aranesp (darbepoetin alfa) Summary of product characteristics. Composition: Methoxy Polyethylene Glycol-Epoetin Beta. darbepoetin alfa (Aransep) pre-filled syringe, injectable vial epoetin alfa (Epogen; Procrit) injectable methoxy polyethylene glycol-epoetin beta (Mircera) pre-filled syringe Conditions Medications Dialysis patients can . Dialysis centers were expected to adhere to European Best Practice Guidelines for iron repletion [9]. 3. Bland JM, Altman DG. A single hemoglobin excursion may not require a dosing change. Decreases in dose can occur more frequently. 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]. Eschbach JW, Adamson JW. 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. In controlled clinical trials of patients with CKD comparing higher hemoglobin targets (13 to 14 g/dL) to lower targets (9 to 11.3 g/dL), ESAs increased the risk of death, myocardial infarction, stroke, congestive heart failure, thrombosis of hemodialysis vascular access, and other thromboembolic events in the higher target groups. Anemia of chronic kidney disease (CKD) becomes increasingly prevalent and severe as kidney function declines [1], with over 90% of patients who require renal replacement therapy becoming anemic [2]. 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. Use the lowest Mircera dose sufficient to reduce the need for red blood cell (RBC) transfusions. 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. Mircera belongs to a class of drugs called Hematopoietic Growth Factors. MIRCERA comes in pre-filled syringes with laminated plunger stopper and tip cap with one needle 27G1/2. J Manag Care Pharm. Internal You are now leaving AnemiaHub.com. Kidney Int. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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. Eligible patients were randomized, either to continue on the previous regimen of Epoetin, or to receive Darbepoetin alfa or continuous erythropoietin receptor activator (C.E.R.A) for a total period of 40 weeks. Adverse Reactions: Hypertension, diarrhea,. 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery. Anyone you share the following link with will be able to read this content: Sorry, a shareable link is not currently available for this article. 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. St. Gallen, Switzerland: Vifor (International) Inc.; June 2018. Please know that Amgen, the sponsor of this site, is not responsible for the content on the site you are about to enter. Active ingredient: methoxy polyethylene glycol-epoetin beta Inactive ingredients: mannitol, methionine, poloxamer 188, sodium phosphate monobasic monohydrate, and sodium sulfate. 1: 21% of the excluded patients had died or were lost to follow-up during the post-switch period; 45% were no longer receiving PEG-Epo by Months +6 and +7 post-switch; and 34% had no Hb value reported for one or both EPs. Epub 2020 Aug 20. 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). 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. Aranesp and EPOGEN increase the risk of seizures in patients with CKD. BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (n=205). A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks. 2. This suggests that the decision to transfuse was consistent with respect to Hb over the observation period (Fig. Individual patients could contribute multiple transfusions to these analyses. Article MIRCERA is a registered trademark of F. Hoffmann-La Roche Ltd. All Vifor Pharma Groups intellectual rights, including copyright, are, The information provided in this site is intended only for healthcare. Strength: 100 mcg / 0.3ml. ?Ij{JVv:oC*#]}V#$M_T.zC>~] L%lq[Tn`QbWB./@ClVgrk)U-j#(0(D CAS This was particularly evident in patients whose pre-switch EP weekly DA dose was higher than 100g. MIRCERA can be administered once every 2 weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA. pediatric patients 5 to 17 years of age on hemodialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA.