The majority of patients with CKD will require supplemental iron during the course of ESA therapy. 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. 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). Nephrol Dial Transplant. Google Scholar. Active ingredient: methoxy polyethylene glycol-epoetin beta Inactive ingredients: mannitol, methionine, poloxamer 188, sodium phosphate monobasic monohydrate, and sodium sulfate. 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. [citation needed] Le bilan martial est dpendant de l'tat inflammatoire et la protine C ractive (CRP) est galement suivi tous les 3 mois pour cela. Adv Ther 30, 10071017 (2013). Available for Android and iOS devices. m+KqXAXOkS@,1C0VgzXzeWU},4 2). Cochrane Database Syst Rev. The geometric mean DCR was 1.17 (95% CI 1.05, 1.29). 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. before initiating Mircera [see Warnings and Precautions (5.9)]. Epoetin alfa (Eprex [JanssenCilag], Binocrit [Sandoz], and epoetin zeta (Retacrit, - Hospira UK): the initial dose is 150 IU kg-1 given subcutaneously three times per week.5 -7 Alternatively, epoetin alfa can be administered at an initial dose of 450 IU kg 1 subcutaneously once weekly.5-7 The maximum recommended dose is 900 IU kg-1 This article does not contain any studies with human or animal subjects performed by any of the authors. 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 study sample comprised adult patients (age 18years) with CKD who received maintenance hemodialysis between January 2008 and August 2011 and whose ESA treatment was switched from IV DA to IV PEG-Epo. Aranesp (darbepoetin alfa) prescribing information, Amgen. Conversion from darbepoetin or erythropoietin to Mircera 1. St. Gallen, Switzerland: Vifor (International) Inc.; June 2018. 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. Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. 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. These adverse reactions included myocardial infarction and stroke. | DOWNLOAD SIZE:
2004;19(Suppl 2):ii1631. PubMed Lancet. Horowitz J, Agarwal A, Huang F, Gitlin M, Gandra SR, Cangialose CB. 1MIRCERA [prescribing information]. Nick Manamley, MSc, is an employee of Amgen with Amgen stock ownership. The pre-transfusion Hb concentrations were similar for transfusions occurring both pre- and post-switch (Fig. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Anemia Associated with Chronic Renal Failure, Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL, Drug class: recombinant human erythropoietins. Mircera is used to treat anemia caused by chronic kidney disease in adults, or in children at least 5 years old who are on hemodialysis. A primary growth factor for erythroid development, erythropoietin is produced in the kidney and released into the bloodstream in response to hypoxia. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. -, Kazmi WH, Kausz AT, Khan S, et al. Methoxy polyethylene demonstrated that the dose efficiency after SC and IV ad- glycol-epoetin b (PEG-epoetin b; Mircera; F. Hoffmann- ministration was . Regression analysis indicated a non-linear relationship between pre- and post-switch ESA doses; DCR decreased with increasing pre-switch DA dose. 2008;23:365461. MIRCERA has an approximate molecular weight of 60 kDa. 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. 4. Methoxy polyethylene glycol-epoetin beta injection is used to treat anemia in adults with chronic kidney disease (CKD) who may or may not be on dialysis or in children with CKD who are on dialysis. 4! The remaining enrolment was at four sites divided between three other countries. Geometric mean weekly PEG-Epo dose at Month 1 post-switch was 26.7g (95% CI 24.4, 29.3), rising to 29g (95% CI 26.2, 32.2) by Month 7 post-switch. Brand: Mircera. Article Dr. Peter Choi is the guarantor for this article, and takes responsibility for the integrity of the work as a whole. For Adult Patients with CKD not on dialysis: Refer patients who self-administer Mircera to the Instructions for Use [see Patient Counseling Information (17)]. Regardless of possible differences in their clinical characteristics it should be borne in mind that patients were not selected for inclusion in the DCR analysis on the basis of their fulfilling any clinical, Hb or ESA dose requirements: all patients who had Hb measurements in both EPs, a DA dose in the pre-switch EP and a PEG-Epo dose in the post-switch EP were eligible for inclusion. PubMed 5). Mircera with 1-step decrease as soon as Hgb is < 11.8 g/dL and last dose was administered 2 weeks ago or more. CAS Logistic regression analysis showed a higher likelihood of a transfusion during the post-switch period among patients with a dose ratio at switching of <1. For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. Monitor patients closely for new-onset seizures, premonitory symptoms, or change in seizure frequency. Please know that the sponsors of this site are not responsible for content on the site you are about to enter. adult patients on dialysis and adult patients not on dialysis. 2020 Sep 29;21(1):418. doi: 10.1186/s12882-020-02078-z. For recommended dose equivalency, see Tables A and B (below). ?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`. 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. Strength: 100 mcg / 0.3ml. 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. Provided by the Springer Nature SharedIt content-sharing initiative, Over 10 million scientific documents at your fingertips, Not logged in }"nUEcJumC0ooF Initial Treatment: 0.6 mcg/kg body weight administered once every two weeks (2.2). 2.
Introduction: Eschbach JW, Adamson JW. %
A BlandAltman analysis [10] was also performed to assess the agreement between ESA doses in the evaluation periods. 10PAGE BROCHURE
Conclusion: In patients on hemodialysis receiving ESAs, conversion from epoetin alfa to darbepoetin alfa was associated with an approximate and persistent reduction of 65% of the required dose. aranesp to retacrit conversiontuto amigurumi grenouille au crochet. Kidney Med. EPOGEN from multidose vials contains benzyl alcohol and is contraindicated in neonates, infants, pregnant women, and lactating women. endobj
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. 1986;327:30710. The geometric mean DCR was 1.17 (95% CI 1.05, 1.29). Always store Mircera prefilled syringes in their original cartons. MIRCERA can be administered once every 2 weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA. Section III: Treatment of renal anaemia. 33 Dose. 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). This medicine is not used to treat anemia caused by cancer medicines. I certify that I am a healthcare professional in the US. 2 0 obj
We comply with the HONcode standard for trustworthy health information. Accessed 18 October 2013. New anemia therapies: translating novel strategies from bench to bedside. Excluding patients receiving a transfusion within 90days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35). The https:// ensures that you are connecting to the Please click to see accompanying Aranesp full prescribing information and EPOGEN full prescribing information, including Boxed WARNINGS and Medication Guide. endobj
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Canaud B, Mingardi G, Braun J, et al. Am J Kidney Dis. Mircera Injection (Methoxy Polyethylene Glycol-Epoetin Beta ) 6,610/ Piece Get Latest Price. 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. 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. Learn about Mircera, potential side effects, proper use and dosing, and popular alternatives. 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.
This article does not contain any studies with human or animal subjects performed by any of the authors. When administered subcutaneously, Mircera should be injected in the abdomen, arm or thigh. Values are means (arithmetic for hemoglobin, geometric for dose) with 95% confidence intervals. 2013;73:11730. The data from this study were analyzed using SAS Statistical Software v9.2 (SAS Institute Inc., Cary, NC, USA). In the evaluation periods, the geometric mean weekly DA dose in the pre-switch EP was 24.1g (95% CI 21.3, 27.1) while the geometric mean weekly PEG-Epo dose in the post-switch EP was 28.6g (95% CI 26.0, 31.5). Patients were then switched to fortnightly darbepoetin alfa dosing treatments; the existing weekly dose being doubled and Hb levels fell from 125 to 110 g/L (P < 0.0001), despite an increase in the mean dose from 44.9 to 47.5 . J Manag Care Pharm. 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. sharing sensitive information, make sure youre on a federal Empirical methods to calculate an erythropoiesis-stimulating agent dose conversion ratio in nondialyzed patients with chronic kidney disease. Am J Kidney Dis. Janet Addison is an employee of Amgen with Amgen stock options. Reasons for exclusion of 96 enrolled patients from the DCR analysis are presented in Fig. 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. Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Adult Patients with CKD. *Data from a multicenter, randomized, open-label study comparing epoetin, given 1, 2, or 3 times weekly IV or SC, with ARANESP , at a reduced dose frequency, in dialysis patients (N = 522).Dose adjustments were made as necessary and per study protocol to maintain individual patients' Hb within a target range of -1.0 to +1.5 g/dL of their baseline Hb and between 9 g/dL and 13 g/dL for up . What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? 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. Regression analysis indicated a non-linear relationship between pre- and post-switch ESA doses; DCR decreased with increasing pre-switch DA dose. Learn how to combine multiple dosing options for precise titration and individualize anemia management.1. 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 Hemoglobin level and weekly equivalent erythropoiesis-stimulating agent dose during the 14-month observation period. Disposition of patients. Please enable it to take advantage of the complete set of features! MIRCERA comes in pre-filled syringes with laminated plunger stopper and tip cap with one needle 27G1/2. Please know that Amgen, the sponsor of this site, is not responsible for the content on the site you are about to enter. 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. Individual patients could contribute multiple transfusions to these analyses. Eligible patients had received hemodialysis for 12 months and DA for 7 months. Dialysis centers were expected to adhere to European Best Practice Guidelines for iron repletion [9]. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. Drugs. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. Do not mix Mircera with any parenteral solution. Anemia: an early complication of chronic renal insufficiency. If severe anemia and low reticulocyte count develop during treatment with Aranesp or EPOGEN, withhold Aranesp or EPOGEN and evaluate patients for neutralizing antibodies to erythropoietin. Accounting for the effect of transfusion, the DCR was 1.21 (95% CI 1.09, 1.35). Epub 2011 Dec 2. Karaboyas A, Morgenstern H, Waechter S, Fleischer NL, Vanholder R, Jacobson SH, Sood MM, Schaubel DE, Inaba M, Pisoni RL, Robinson BM. 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. Asterisk Not all transfusions had an associated hemoglobin concentration in the 14-day period before transfusion. Administer MIRCERA intravenously once every 4 More ways to get app. Most frequent adverse reactions (5%) in adult patients with CKD treated with MIRCERA. Aranesp (darbepoetin alfa) Epogen (epoetin alfa) Mircera . The distribution of Hb values reported within the 14days prior to transfusion was described; if multiple Hb values were recorded, the value closest to the transfusion date was utilized. Read reviews from GoodRx users who have taken Mircera and find the latest news on the drug. 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 . Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. a Mutually exclusive categories; patients are censored in the following, Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. doi: 10.1053/j.ajkd.2011.11.013. 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 MIRCERA Interactions: May require increased anticoagulation (heparin) during hemodialysis. 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. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others.
Eunice News Arrests,
How To Get Archaeologist Badge Wizard101,
Articles M
