5) shows that most transfusions occurred in the first 4months post-switch. This study and the article processing charges were funded by Amgen Europe GmbH, Zug, Switzerland. For Adult Patients with CKD not on dialysis: Refer patients who self-administer Mircera to the Instructions for Use [see Patient Counseling Information (17)]. ?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`. The initial conversion factor was 200:1. 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. Epub 2011 Dec 2. 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. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. 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. National Library of Medicine 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. Table 1 Mircera Starting Doses for Adult Patients Currently Receiving an ESA, Table 2 Mircera Starting Doses for Pediatric Patients Currently Receiving an ESA. Nephrol Dial Transplant. Peter Choi. 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. An official website of the United States government. Mircera is administered by subcutaneous (SC) or intravenous (IV) injection (2.2). History of serious or severe allergic reactions to Mircera (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). St. Gallen, Switzerland: Vifor (International) Inc.; June 2018. 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. Section III: Treatment of renal anaemia. The remaining enrolment was at four sites divided between three other countries. 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. Dr. Gerald Diaz @GeraldMD. Epoetin beta and methoxy polyethylene glycol may increase tumor growth or decrease survival time in people with certain types of cancer. Carrera F, Lok CE, de Francisco A, et al.
PDF beta (Mircera ) Protocol - Northwest Kidney Centers Procrit dosing calculator | Math Applications 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. Kazmi WH, Kausz AT, Khan S, et al. Do not pool unused portions from the prefilled syringes. Each pre-filled syringe contains 0.3 ml or 0.6 ml. 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]. Pharmacokinetic studies have shown that the meanSD terminal half-life of DA is 217.5h when administered intravenously (IV) [7]. This was particularly evident in patients whose pre-switch EP weekly DA dose was higher than 100g. Immediately and permanently discontinue Aranesp or EPOGEN if a serious allergic
MIRCERA (methoxy polyethylene glycol-epoetin beta) is the first erythropoiesis-stimulating agent (ESA) approved by FDA for once-monthly administration. Mircera is not the same as epoetin alfa (Procrit, Epogen). Amgen Europe B.V., Breda, The Netherlands, 29 August 2013. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000332/WC500026149.pdf.
Vifor (International) Inc. MIRCERA- methoxy polyethylene glycol-epoetin Methoxy polyethylene glycol-epoetin beta - Wikipedia Strength: 100 mcg / 0.3ml. Dose Conversion Ratio in Hemodialysis Patients Switched from Darbepoetin Alfa to PEG-Epoetin Beta: AFFIRM Study. BlandAltman analysis of agreement between pre- and post-switch erythropoiesis-stimulating agent dose (n=205). The introduction of exogenous erythropoiesis-stimulating agents (ESAs) to clinical practice has transformed the care of patients with CKD, by ameliorating anemia, reducing transfusion requirements, and improving quality of life [4]. Epub 2022 Apr 22. You may also report negative side effects of prescription drugs to the Food and Drug Administration (FDA). 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. Janet Addison is an employee of Amgen with Amgen stock options. 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. Use caution in patients with coexistent cardiovascular disease and stroke.
Aranesp Dosing Calculator75 mcg/kg as an IV or SC injection once every W\iA* Please know that Amgen, the sponsor of this site, is not responsible for the content on the site you are about to enter. For recommended dose equivalency, see Tables A and B (below). Use the Previous and Next buttons to navigate the slides or the slide controller buttons at the end to navigate through each slide. 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%. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Red blood cell transfusions pre- and post-switch were quantified. [3] It is the first approved, chemically modified erythropoiesis-stimulating agent (ESA). 6); the mean (SD) Hb within 14days prior to transfusion in these periods was 8.8 (1.41) and 8.3 (1.26), respectively. The enrolling dialysis centers were situated in France, Germany, Spain and the UK, and each was expected to enroll a minimum of 20 patients into the study. 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? endobj
Aranesp Dosing and Conversion Brochure | Amgen Anemia Hub If Hgb remains >= 12 g/dL for more than 2 months, return to regular Hgb testing policy. Each dosage strength of MIRCERA is designated by a unique syringe plunger color. Hb hemoglobin. afK ] T z"$qu9H$}W//~||!+iO7^Q)|F.j+m
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Mircera (methoxy polyethylene glycol / epoetin beta) dosing - Medscape Please know that the sponsors of this site are not responsible for content on the site you are about to enter.
Amgen Wins Patent Battle Over Roche's Anemia Drug The relationship between the DA and PEG-Epo doses during the evaluation periods was explored through linear and quadratic regression. Methoxy polyethylene glycol-epoetin beta injection causes the .
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. 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. Unable to load your collection due to an error, Unable to load your delegates due to an error. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. 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. PEG-Epo was approved in 2009 for administration Q2W or once a month (QM) to patients on dialysis [5, 8]. 33 Dose. Individual patients could contribute multiple transfusions to these analyses. 1986;327:30710. Conversion from Another ESA: dosed once every 4 weeks based on total Studies of erythropoietin therapy in patients with chronic anemia of cancer as well as CIA document response rates ranging from ~60% to 85%.
Conversion Dosing Guide: from Epoetin Alfa to Aranesp in Patients with Revised European Best Practice Guidelines for the management of anaemia in patients with chronic renal failure. Accessed 18 October 2013. Anemia of end-stage renal disease (ESRD) Kidney Int.
Mircera Injection: Uses, Dosing & Side Effects - Drugs.com Statistical methods for assessing agreement between two methods of clinical measurement. Generic name: Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL 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. Eschbach JW, Adamson JW. 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. Before 2002;162:14018. PubMedGoogle Scholar. Arch Intern Med. Packaging Type: Injection. Do not pool unused portions from the prefilled syringes. Matsumura K, Okumiya T, Sugiura T, Takahashi N, Yamamoto Y, Kikuchi S, Fujii K, Otagaki M, Shiojima I. BMC Nephrol. Conversion Dosing Guide: From epoetin alfa to Aranesp in patients with anemia due to CKD on dialysis. The intravenous route is recommended for patients on hemodialysis because the intravenous route may be less immunogenic. Dose by Weight Chart - Resourcehub Epogen Dosage Guide - Drugs.com Epogen, Procrit (epoetin alfa) dosing, indications, interactions 2012;59:444451. 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 .
A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia 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. adult patients on dialysis and adult patients not on dialysis. 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 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. Unauthorized use of these marks is strictly prohibited. . Appropriately control hypertension prior to initiation of and during treatment with MIRCERA, Seizures have occurred in patients participating in MIRCERA, For lack or loss of hemoglobin response to MIRCERA, If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. volume30,pages 10071017 (2013)Cite this article. Mircera (methoxy polyethylene glycol-epoetin beta) is an erythropoiesis-stimulating agent (ESA). Use the lowest Mircera dose sufficient to reduce the need for red blood cell (RBC) transfusions. Drugs. Macdougall IC. %PDF-1.7
A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these
This medicine is not used to treat anemia caused by cancer medicines. 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. . Am J Nephrol. randomized patients to darbepoetin or epoetin beta once weekly after the patients had been treated with epoetin beta three times weekly. ^D[5j@%e Mean Hb was 11.5g/dL in the pre-switch EP and 11.4g/dL in the post-switch EP. Dosage form: injection, solution Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. 4 0 obj
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Mircera Dosage Guide - Drugs.com 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). Decreases in dose can occur more frequently. Excluding patients receiving a transfusion within 90days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). Epub 2014 Nov 1. However, the relationship between the pre- and post-switch ESA doses during the two evaluation periods was non-linear. I certify that I am a healthcare professional in the US. 8600 Rockville Pike 2012;59:44451. 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. Treatment for Anaemia [STRIATA] [8] and comPArator sTudy of C.E.R.A. The geometric mean weekly ESA dose for those included in the DCR analysis is shown in Fig. in the treatment of anemia due to cancer chemotherapy. 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. A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks. 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). Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 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. Disposition of patients. 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]. MIRCERA Classification: Erythropoiesis stimulating protein. 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. Please enable it to take advantage of the complete set of features!
The data from this study were analyzed using SAS Statistical Software v9.2 (SAS Institute Inc., Cary, NC, USA). The site is secure. Donck J, Gonzalez-Tabares L, Chanliau J, Martin H, Stamatelou K, Manamley N, Farouk M, Addison J. Adv Ther. 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. }"nUEcJumC0ooF Of 302 patients enrolled, 206 had data available for DCR analysis. AFFIRM demonstrated non-linearity of the dose relationship curve, with DCR decreasing as pre-switch DA dose increased. J Manag Care Pharm. Data quality and completeness were aided by automatic edit checks built into the database software. A BlandAltman analysis [10] was also performed to assess the agreement between ESA doses in the evaluation periods.
aranesp to retacrit conversion When administered subcutaneously, Mircera should be injected in the abdomen, arm or thigh. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events. Cost (BNF 60, March 2013) Aranesp (darbepoetin alfa) - 14.68-220.22 (10 micrograms syringe to 150 microgram syringe) NeoRecormon Mircera (methoxy polyethylene glycol-epoetin beta) - 44.05-220.22 (30 microgram syringe to 150 microgram syringe . Conclusion: For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. 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. 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. Mircera may be used alone or with other medications. doi: 10.1038/ki.1985.109. 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 . Shortened red blood cell age in patients with end-stage renal disease who were receiving haemodialysis: a cross-sectional study. 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. 2008;23:365461. Dr. Peter Choi is the guarantor for this article, and takes responsibility for the integrity of the work as a whole. 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. 2. Reasons for exclusion of 96 enrolled patients from the DCR analysis are presented in Fig. Am J Kidney Dis. 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. 5). For lack or loss of hemoglobin response to Aranesp or EPOGEN, initiate a search for causative factors. | DOWNLOAD SIZE:
Of the 302 patients enrolled, 206 (68%) were included in the DCR analysis. Support for this assistance was funded by Amgen. Discontinue MIRCERA, When administered subcutaneously, MIRCERA. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study. Accounting for the effect of transfusion, the DCR was 1.21 (95% CI 1.09, 1.35). For Pediatric Patients with CKD on hemodialysis: Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Pediatric Patients with CKD Treated with Hemodialysis. 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. 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. Macdougall IC.
What is the practical conversion dose when changing from epoetin alfa 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.
PDF Mircera, INN: methoxy polyethylene glycol-epoetin beta Product Information and Dosing | Mircera The number of RBC transfusions and units transfused in the post-switch period was approximately threefold higher compared to the pre-switch period. 2023 Springer Nature Switzerland AG. In an additional analysis performed to assess the sensitivity of this result to the effects of transfusion by excluding those patients who received an RBC transfusion within 90days prior to or during either evaluation period, the DCR was 1.21 (95% CI 1.09, 1.35). [citation needed] The dose of Mircera, given as a single intravenous or subcutaneous injection, should be based on the m+KqXAXOkS@,1C0VgzXzeWU},4 PMC history of serious or severe allergic reactions to MIRCERA (e.g., anaphylactic reactions, angioedema, bronchospasm, pruritus, skin rash, and urticaria). 2020 Mar 26;2(3):286-296. doi: 10.1016/j.xkme.2020.01.007. 2013;73:11730. An observational cohort study of extended dosing (once every 2 weeks or once monthly) regimens with darbepoetin alfa in patients with chronic kidney disease not on dialysis: the EXTEND study. Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. 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. Months 7 to 1 constituted the pre-switch period, with switch defined as the date of first administration of PEG-Epo, and Months +1 to +7 constituted the post-switch period. Pure red cell aplasia (PRCA) that begins after treatment with Mircera or other erythropoietin protein drugs. doi: 10.1053/j.ajkd.2011.11.013. 20,000 Units/2 mL (10,000 Units/mL) and 20,000 Units/mL of RETACRIT as a clear and colorless liquid in multiple-dose vials (contains benzyl alcohol). PubMed Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Adult Patients with CKD. x]r9r}W#k
PDF Anmie chez l'insuffisant rnal : comment utiliser les agents stimulant Data on clinical and laboratory parameters relating to CKD management were abstracted from patient records and entered into an anonymized study-specific central database by study center staff. In the first month after switch, these proportions were 10.2%, 48.5% and 37.4%, respectively. The baseline (i.e., at time of switch) demographic and clinical characteristics of enrolled patients and those included in and excluded from the DCR analysis are displayed in Table1. Anemia Associated with Chronic Renal Failure, Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL, Drug class: recombinant human erythropoietins.
Epoetin zeta | Drugs | BNF | NICE 3 DOSAGE FORMS AND STRENGTHS.
Dose conversion ratio in hemodialysis patients switched from Of 302 patients enrolled, 206 had data available for DCR analysis. Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp GrepMed. _____ (if . Please click the OK button below to continue. Initial Treatment: 0.6 mcg/kg body weight administered once every two weeks (2.2).
Dose Conversion Ratio in Hemodialysis Patients Switched from 1MIRCERA [prescribing information]. For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. eCollection 2020 Jun. Nephrol Dial Transplant. Methoxy polyethylene glycol-epoetin beta, the active substance of MIRCERA, is a continuous erythropoietin receptor activator that shows a different activity at the receptor level characterized by a slower association to and faster dissociation from the receptor, a reduced specific activity in vitro with an increased activity in vivo, as well as an increased half-life, in contrast to . When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. Evaluate the iron status in all patients before and during treatment. Pure red cell aplasia (PRCA) that begins after treatment with MIRCERA, History of serious or severe allergic reactions to MIRCERA. Aranesp (darbepoetin alfa) Epogen (epoetin alfa) Mircera . Results: Conversion from Another ESA: dosed once monthly or once every two weeks based on total weekly epoetin alfa or darbepoetin alfa dose at time of conversion (2.2). 2021 Jan;26(1):46-53. doi: 10.1111/nep.13765. At the moment forecasts for Mircera are $345m in 2015 rising to $552m in 2020, reflecting sales made outside the US. Optimizing the use of erythropoietic agentspharmacokinetic and pharmacodynamic considerations. 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.