mircera to aranesp conversion mircera to aranesp conversion

4! Methoxy polyethylene glycol-epoetin beta injection causes the . The .gov means its official. -, Macdougall IC. Kidney Med. 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. See Instructions for Use for complete instructions on the preparation and administration of Mircera. Adverse reactions ( 10%) in Aranesp clinical studies in patients with CKD were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension. Nephrol Dial Transplant. 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). 1. MIRCERA can be administered once every 2 weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA. In pediatric patients, Mircera is administered by intravenous injection only (2.2). OZZ All patients who fulfilled pre-specified criteria for completeness of Hb and dosing data were included in the DCR analysis: i.e., those who had received DA or PEG-Epo as the only ESA in the 1month prior to and during the pre- or post-switch EPs, respectively, and who had dosing information and at least 1 Hb value in each of the evaluation periods. Amgen's two anemia drugs, Epogen and Aranesp, had sales of $6.6 billion last year, nearly half the company's total revenue. 3. https://doi.org/10.1007/s12325-013-0063-y, DOI: https://doi.org/10.1007/s12325-013-0063-y. Am J Kidney Dis. Data were also manually reviewed prior to final analysis. Dose Conversion Ratio in Hemodialysis Patients Switched from Darbepoetin Alfa to PEG-Epoetin Beta: AFFIRM Study, https://doi.org/10.1007/s12325-013-0063-y, CERA conversion to darbepoetin alfa in 154 hemodialysis patients, Long-term maintenance of hemoglobin levels in hemodialysis patients treated with bi-weekly epoetin beta pegol switched from darbepoetin alfa: a single-center, 12-month observational study in Japan, Efficacy, tolerability and safety of darbepoetin alfa injection for the treatment of anemia associated with chronic kidney disease (CKD) undergoing dialysis: a randomized, phase-III trial, Safety of Roxadustat Versus Erythropoiesis-Stimulating Agents in Patients with Anemia of Non-dialysis-Dependent or Incident-to-Dialysis Chronic Kidney Disease: Pooled Analysis of Four Phase 3 Studies, Initial responsiveness to darbepoetin alfa and its contributing factors in non-dialysis chronic kidney disease patients in Japan, Comparison of darbepoetin alpha and recombinant human erythropoietin for treatment of anemia in pediatric chronic kidney disease: a non-inferiority trial from India, Comparative Safety of Originator and Biosimilar Epoetin Alfa Drugs: An Observational Prospective Multicenter Study, In Search of Predictors of Switching Between Erythropoiesis-Stimulating Agents in Clinical Practice: A Multi-Regional Cohort Study, Mixed hemodiafiltration reduces erythropoiesis stimulating agents requirement in dialysis patients: a prospective randomized study, http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000332/WC500026149.pdf, http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000739/WC500033672.pdf, https://creativecommons.org/licenses/by/2.0. The long-acting r-HuEPO methoxy polyethylene glycol-epoetin beta (Mircera) has been associated with a risk of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) following a. If Hb exceeds a level needed to avoid RBC transfusions, withhold dose until Hb approaches a level where RBC transfusions may be required and reinitiate at a dose 40% below the previous dose. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp #Pharmacology #Hematology #Nephrology. Conclusion: A dose approximating 0. Most frequent adverse reactions (5%) in adult patients with CKD treated with MIRCERA. 1MIRCERA [prescribing information]. 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. 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. What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? St. Gallen, Switzerland: Vifor (International) Inc.; June 2018. Epoetin alfa (Procrit, Epogen) acts like the hormone we have in our body, whereas Mircera . Values are means (arithmetic for hemoglobin, geometric for dose) with 95% confidence intervals. In CKD, anemia results primarily from decreased production of endogenous erythropoietin (EPO) by the kidney [3]. Accessibility This study and the article processing charges were funded by Amgen Europe GmbH, Zug, Switzerland. The intravenous route is recommended for patients on hemodialysis because the intravenous route may be less immunogenic. Google Scholar. See this image and copyright information in PMC. government site. reverse transcriptase polymerase chain reaction (RT-PCR) Amplification of RNA sequences by conversion to cDNA by nucleic acid hybridization A technique of nucleic acid reverse transcriptase, followed by the polymerase chain reac-analy sis via association of complementary single- stranded tion. 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. Drug class: Recombinant human erythropoietins. Initial Treatment: 0.6 mcg/kg body weight administered once every two weeks (2.2). 2022;53(5):333-342. doi: 10.1159/000523947. These adverse reactions included myocardial infarction and stroke. Administer Mircera intravenously once every 4 weeks to pediatric patients (ages 5 to 17 years) whose hemoglobin level has been stabilized by treatment with an ESA. This paper presents the findings of a retrospective, multi-center, observational study of hemodialysis patients switched from DA to PEG-Epo for the treatment of anemia. Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. ARANESP single-dose strengths can be combined 4,* You can more . Palmer SC, Saglimbene V, Mavridis D, Salanti G, Craig JC, Tonelli M, Wiebe N, Strippoli GF. Do not pool unused portions from the prefilled syringes. 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 patients treated with Aranesp or EPOGEN. Part of Springer Nature. ou toutes les 2 semaines (ou par mois en prdialyse) la dose requise Avant 1 an : non indiqu 11 ans : comme chez l'adulte MIRCERA (potine bta - MPG [mthoxy-polythylne glycol]) 1 injection mensuelle la dose requise Non indiqu 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 . endobj Support for this assistance was funded by Amgen. MIRCERA is indicated for the treatment of anemia associated with CKD in adult patients on dialysis and adult patients not on dialysis. Disposition of patients. Evaluate the iron status in all patients before and during treatment. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. ?z_IxD1&S&L)@g7NI\H |a_,I17KFu[7+n h?b}xqm5Ed]N8+3ei^Rh/0up20]S=NoPAN$Z$L+u'Hp5v;'QyBQT 8}"{=xVqe)gR&yOs^sfT#B cf#xF`=bXMdCV?s&KS|`q9HT=,[='q6s1UE J$KxBE hg*~'ct'p|YTs1c->uLd_614J)q)g>QR`~*B9GewhNBPs j "It(Y%kRz}=!ayvw^`c]n986kR+LBZ:l~(hf !|p)-b=@|] aRQ:SIRwn$Ip 8v-S"-j0G;r:@ElyDkDE#4H~n{x4P*jS '.P4F lZhBW0t*1b`&wIU_=(>|@"1A`. Red blood cell transfusions pre- and post-switch were quantified. Canaud B, Mingardi G, Braun J, et al. pee`T"c+l_WB,`km^;6#j(*m`&E`l${F6Q`&^=e`f(6]8ZE[VHNx-FRIhE&iJKvW`Vz^p@?Yk+S.DgR1rrB6yq2N$| 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. National Library of Medicine The geometric mean weekly ESA doses were 24.1g DA in the pre-switch EP and 28.6g PEG-Epo in the post-switch EP. 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. 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. 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. The initial conversion factor was 200:1. Evaluate the iron status in all patients before and during treatment. Differentiating factors between erythropoiesis-stimulating agents: an update to selection for anaemia of chronic kidney disease. doi: 10.1001/archinte.162.12.1401. 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. Adverse Reactions: Hypertension, diarrhea,. Mean Hb was 11.5g/dL in the pre-switch EP and 11.4g/dL in the post-switch EP. Conversion Dosing Guide: From epoetin alfa to Aranesp in patients with anemia due to CKD on dialysis. As the study was entirely retrospective, ESA switching and dose conversion were performed without reference to a study protocol and there was no protocol-driven intervention in the clinical management of patients. pure red cell aplasia (PRCA) that begins after treatment with MIRCERA or other erythropoietin protein drugs. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. Unauthorized use of these marks is strictly prohibited. %PDF-1.7 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery. 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%. Administer Mircera either intravenously or subcutaneously in adult patients and only intravenously in pediatric patients. Drugs. 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. 2014 Dec 8;2014(12):CD010590. Visit. Janet Addison is an employee of Amgen with Amgen stock options. New anemia therapies: translating novel strategies from bench to bedside. An official website of the United States government. 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. Macdougall IC, Obrador GT, El Nahas M. How important is transfusion avoidance in 2013? Carrera F, Lok CE, de Francisco A, et al. in the treatment of anemia due to cancer chemotherapy. Conversion from darbepoetin or erythropoietin to Mircera 1. 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). Of 302 patients enrolled, 206 had data available for DCR analysis. New anemia therapies: translating novel strategies from bench to bedside. history of serious or severe allergic reactions to MIRCERA (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). . 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]. Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp GrepMed. Correspondence to History of serious or severe allergic reactions to Mircera (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). Aranesp and EPOGEN increase the risk of seizures in patients with CKD. Red blood cell transfusions pre- and post-switch were quantified. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Secondly, the DCR was calculated on a subset of patients which constituted approximately two-thirds of the total enrolled. 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. These findings were observed in studies of patients with advanced head and neck cancer receiving radiation therapy, in patients receiving chemotherapy for metastatic breast cancer or lymphoid malignancy, and in patients with non-small cell lung cancer or various malignancies who were not receiving chemotherapy or radiotherapy. methoxypolyethylene glycol-epoetin beta (meh-thok-see-pah-lee-eh-thih-leen gly-kol ee-poh-eh-tin bay-ta) , Mircera (trade name) Classification Therapeutic: antianemics Pharmacologic: hormones Pregnancy Category: C Indications Anemia due to chronic renal failure. The dose of Mircera, given as a single intravenous or subcutaneous injection, should be based on the Dr. Peter Choi is the guarantor for this article, and takes responsibility for the integrity of the work as a whole. In controlled clinical trials of patients with cancer, ESAs increased the risks for death and serious adverse cardiovascular reactions. Hb hemoglobin. The pre-transfusion Hb concentrations were similar for transfusions occurring both pre- and post-switch (Fig. 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. J Manag Care Pharm. 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. 2002;162:14011408. WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE. Last updated on Jul 26, 2022. 8600 Rockville Pike 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. Do not increase the dose more frequently than once every 4 weeks. The information provided in this site is intended only for healthcare professionals in the United States. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 2002;17(Suppl 5):6670. MIRCERA is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia associated with chronic kidney disease (CKD) in: MIRCERA is not indicated and is not recommended for use: MIRCERA has not been shown to improve quality of life, fatigue, or patient well-being. ferrous sulfate, Aranesp, Procrit, Retacrit. Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. -, Kazmi WH, Kausz AT, Khan S, et al. 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. endobj 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. Provided by the Springer Nature SharedIt content-sharing initiative, Over 10 million scientific documents at your fingertips, Not logged in Bethesda, MD 20894, Web Policies 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. In pediatric patients on hemodialysis, all reported adverse reactions regardless of causality (more than 5% incidence) were headache, nasopharyngitis, hypertension, vomiting, bronchitis, abdominal pain, arteriovenous fistula thrombosis, cough, device related infection, hyperkalemia, pharyngitis, pyrexia, thrombocytopenia, and thrombosis in device. Article Regression analysis indicated a non-linear relationship between pre- and post-switch ESA doses; DCR decreased with increasing pre-switch DA dose. 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 Tel: +1-650-344-3898 | Fax: +1-888-256-8883 | Email: info@palace-travel.com | | | LOG IN Hrl WH. If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of MIRCERA. Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. For patients who do not respond adequately over a 12-week escalation period, increasing the MIRCERA, Evaluate other causes of anemia. 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). Mircera is a prescription medicine used to treat the symptoms of Anemia associated with Chronic Renal Failure. HHS Vulnerability Disclosure, Help 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. 4. Logistic regression was used to estimate an odds ratio comparing the number of patients receiving an RBC transfusion in the post-switch period relative to their dose ratio at switch (<1 vs. 1). Peter Choi, MB BChir, PhD, FRCP (UK), has received lecturing and consulting fees from Amgen, and has participated in advisory boards for Amgen. If Hgb remains >= 12 g/dL for more than 2 months, return to regular Hgb testing policy. 3 0 obj }"nUEcJumC0ooF Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.)