Pure red cell aplasia (PRCA) that begins after treatment with Mircera or other erythropoietin protein drugs. 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. Mircera with 1-step decrease as soon as Hgb is < 11.8 g/dL and last dose was administered 2 weeks ago or more. 2012;59:444451. Avoid frequent dose adjustments. Do not use the prefilled syringe more than once. National Library of Medicine Unable to load your collection due to an error, Unable to load your delegates due to an error. Mircera will be administered IV to HD patients, and SC to PD patients. In recent years, the trend has been to use higher doses of epoetin alfa (eg, 60,000 U once per week), recognizing that MDS RBC precursors may have relative intrinsic resistance to EPO. HQ-MIR-1900027 Site last modified: January 2023. In responding to hypoxia, erythropoietin interacts with erythroid progenitor . Action Stimulates erythropoesis (production of red blood cells). Anemia: an early complication of chronic renal insufficiency. Section III: Treatment of renal anaemia. Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. At the moment forecasts for Mircera are $345m in 2015 rising to $552m in 2020, reflecting sales made outside the US. However, the relationship between the pre- and post-switch ESA doses during the two evaluation periods was non-linear. Monitor patients closely for new-onset seizures, premonitory symptoms, or change in seizure frequency. Regression analysis indicated a non-linear relationship between pre- and post-switch ESA doses; DCR decreased with increasing pre-switch DA dose. <> The dose of Mircera, given as a single intravenous or subcutaneous injection, should be based on the total weekly ESA dose at the time of conversion. )E]$&m"t "N5LQmgh-QZi`T0 hacpBYKUYRw@aMB/|n|'Y#h$8]#|zf. In contrast, in the STRIATA study where stable hemodialysis patients receiving IV DA were randomized to Q2W PEG-Epo (outside current label guidance) or to continue on DA QW or Q2W, median PEG-Epo doses were described as stable across the 52-week post-switch period, although mean dose data were not reported [12]. ribosome A ribonuclear protein complex that binds to mRNA nucleotide A basic . Each dosage strength of MIRCERA is designated by a unique syringe plunger color. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. MIRCERA Interactions: May require increased anticoagulation (heparin) during hemodialysis. There were 16 transfusions and 34 units transfused in the pre-switch period, versus 48 transfusions and 95 units transfused post-switch. Do not increase the dose more frequently than once every 4 weeks. Figure4 also displays the mean monthly Hb for those included in the DCR analysis over the study period. NCI CPTC Antibody Characterization Program, Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. 2020 Sep 29;21(1):418. doi: 10.1186/s12882-020-02078-z. CAS MIRCERA is contraindicated in patients with: Please seefull Prescribing Information including Boxed WARNING, and Medication Guide(English, Espaol)for MIRCERA (methoxy polyethylene glycol-epoetin beta) Injection, for Intravenous or Subcutaneous Use. 2019 Jul 5;13(3):425-433. doi: 10.1093/ckj/sfz065. Mircera (methoxy polyethylene glycol / epoetin beta) dosing, indications, interactions, adverse effects, and more Drugs & Diseases methoxy polyethylene glycol / epoetin beta (Rx) Brand and. PubMed For patients who do not respond adequately over a 12-week escalation period, increasing the MIRCERA, Evaluate other causes of anemia. 2002;162:14018. government site. The AFFIRM study was designed as a retrospective, longitudinal cohort analysis to estimate the DCR in a population of hemodialysis patients achieving comparable Hb after switching from IV DA to IV PEG-Epo in a real-world setting. What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? 3 0 obj There is no evidence that Mircera alters the metabolism of other medicinal products. Administer Mircera either intravenously or subcutaneously in adult patients and only intravenously in pediatric patients. 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). 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. Initial Treatment: 0.6 mcg/kg body weight administered once every two weeks (2.2). Publication management support was provided by Caterina Hatzifoti, PhD, of Amgen Europe GmbH. Mircera is used to reduce or avoid the need for RBC transfusions. Aranesp (darbepoetin alfa) Epogen (epoetin alfa) Mircera . This was particularly evident in patients whose pre-switch EP weekly DA dose was higher than 100g. There are significant negative consequences associated with increased transfusion requirement in dialysis patients, including production of sensitizing anti-human leukocyte antigen (HLA) antibodies which, despite advances in immunosuppressant therapy [13], may impair or prevent transplantation in patients otherwise eligible for receipt of a kidney graft. 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 Aranesp, Serious and fatal reactions including gasping syndrome can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including EPOGEN. Cochrane Database Syst Rev. Evaluation of Iron Stores and Nutritional Factors. You may also report negative side effects of prescription drugs to the Food and Drug Administration (FDA). Canaud B, Mingardi G, Braun J, et al. Use caution in patients with coexistent cardiovascular disease and stroke. afK ] T z"$qu9H$}W//~||!+iO7^Q)|F.j+m ZJ7CY\7\lO7OGPno? Matsumura K, Okumiya T, Sugiura T, Takahashi N, Yamamoto Y, Kikuchi S, Fujii K, Otagaki M, Shiojima I. BMC Nephrol. Nephrol Dial Transplant. Please enable it to take advantage of the complete set of features! The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Amgen's two anemia drugs, Epogen and Aranesp, had sales of $6.6 billion last year, nearly half the company's total revenue. Each pre-filled syringe contains 0.3 ml or 0.6 ml. Aranesp (darbepoetin alfa) prescribing information, Amgen. AFFIRM (Aranesp Efficiency Relative to Mircera) was a retrospective, multi-site, observational study designed to estimate the population mean maintenance dose conversion ratio [DCR; dose ratio achieving comparable hemoglobin level (Hb) between two evaluation periods] in European hemodialysis patients whose treatment was switched from DA to PEG-Epo. ?Ij{JVv:oC*#]}V#$M_T.zC>~] L%lq[Tn`QbWB./@ClVgrk)U-j#(0(D Am J Kidney Dis. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS and TUMOR PROGRESSION OR RECURRENCE. Carrera F, Lok CE, de Francisco A, et al. Composition: Methoxy Polyethylene Glycol-Epoetin Beta. Article All calculations should be confirmed before use. Low hemoglobin at hemodialysis initiation: an international study of anemia management and mortality in the early dialysis period. Individualize dosing and use the lowest dose of MIRCERA. Epoetin beta and methoxy polyethylene glycol may increase tumor growth or decrease survival time in people with certain types of cancer. New anemia therapies: translating novel strategies from bench to bedside. Epub 2011 Dec 2. Treatment: Treat to anemia in people with chronic kidney disease. 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. 2001;38:80312. Do not use Mircera after the expiration date. 2. 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). I certify that I am a healthcare professional in the US. Injection: 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, 10,000 Units/mL, and 40,000 Units/mL of RETACRIT as a clear and colorless liquid in single-dose vials. ARANESP single-dose strengths can be combined 4,* You can more . 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. For more information, please see the full Prescribing Information, including Boxed WARNING, and Medication Guide(English, Espaol) for MIRCERA. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. The relationship between the DA and PEG-Epo doses during the evaluation periods was explored through linear and quadratic regression. 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. 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. 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. and transmitted securely. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. MIRCERA is a registered trademark of F. Hoffmann-La Roche Ltd. All Vifor Pharma Groups intellectual rights, including copyright, are reserved by the Vifor Pharma Group. 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. DA, launched in 2001 [5, 7], contains 5 N-linked oligosaccharide chains, rather than the 3 contained in short-acting epoetins, which confer an approximately threefold longer serum half-life and mean residence time, allowing extended inter-dosing intervals [6]. Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. "BG0RjI G78 Secondary outcomes included Hb concentrations and ESA use during the study period, and the incidence of red blood cell (RBC) transfusions. }"nUEcJumC0ooF Kidney Int. 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 See Instructions for Use for complete instructions on the preparation and administration of Mircera. Please click to see accompanying Aranesp full prescribing information and EPOGEN full prescribing information, including Boxed WARNINGS and Medication Guide. This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited. doi: 10.1053/j.ajkd.2011.11.013. 2012 Jun;27(6):2303-11. doi: 10.1093/ndt/gfr677. 4 0 obj The data from this study were analyzed using SAS Statistical Software v9.2 (SAS Institute Inc., Cary, NC, USA). Nephrol Dial Transplant. . Peter Choi, MB BChir, PhD, FRCP (UK), has received lecturing and consulting fees from Amgen, and has participated in advisory boards for Amgen. endobj 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. More severe cases were recorded with long-acting agents (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta). 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]. Aranesp and EPOGEN increase the risk of seizures in patients with CKD. Arch Intern Med. Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Pediatric Patients with CKD Treated with Hemodialysis 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. 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. A motion conversion mechanism 123 includes a yoke 153 and a rotatable member 149, which causes the yoke 152, . 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. 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 . The odds ratio for receiving a transfusion was twice as high in patients switched at a dose ratio less than 1 when compared to those switched at 1:1 or higher. Part of Springer Nature. Department of Nephrology, John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, 2305, Australia, Amgen (Europe) GmbH, Dammstrasse 23, P.O. Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. - , . 3. 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. Statistical methods for assessing agreement between two methods of clinical measurement. 2 0 obj MIRCERA is available, for all strengths, in pack sizes of 1 and also pack size of 3 for the strengths 30, 50, 75 micrograms/0.3ml. ?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`.