MIRCERA.com

The safety profile of MIRCERA® is comparable to shorter-acting erythropoiesis-stimulating agents (ESAs). The safety database from clinical trials comprised 2737 CKD patients, including 1789 treated with MIRCERA and 948 patients treated with an ESA.¹

MIRCERA is generally well tolerated. The overall incidence of adverse events and their distribution across body systems is similar between MIRCERA and other ESAs.^2–9 The majority of adverse events reported with MIRCERA were of mild or moderate severity, with the most frequently occurring being hypertension, diarrhoea and nasopharyngitis; these three events occurred with similar frequency between patients receiving MIRCERA and those receiving a comparator treatment (see table).¹⁰ No cases of pure red cell aplasia (PRCA) were reported in clinical trials..

 

 

Adverse events occurring in ≥5% of chronic kidney disease patients.¹⁰

 

Change in haemoglobin (Hb) after withholding treatment
A pooled analysis of the MICERA Phase III maintenance studies assessed the rate of Hb decline when ESA treatment was withheld because Hb levels had exceeded 14g/dL. Following dose interruption, the time taken for Hb to reach a level below 13 g/dL was similar in the MIRCERA and comparator groups: approximately 4–5 weeks for MIRCERA and approximately 4–6 weeks for epoeitin or darbepoetin alfa (see figure).^10,11

 

 

Change in haemoglobin after withholding treatment.^10,11

 

References:

 

1. MIRCERA® Summary of Product Characteristics. F. Hoffmann-La Roche Ltd. 2007.
2. Macdougall IC, Walker R, Provenzano R, et al. C.E.R.A. corrects anaemia in patients with chronic kidney disease not on dialysis: Results of a randomized clinical trial. Clin J Am Soc Nephrol. 2007 In press.
3. Klinger M, Aria M, Vargemezis V, et al. Intravenous C.E.R.A. administered twice monthly corrects haemoglobin levels in patients with chronic kidney disease on dialysis: results of AMICUS, a randomized prospective study vs epoetin given once to three times weekly. Am J Kidney Dis. 2007 In press.
4. Sulowicz W, Locatelli F, Ryckelynck J-P, et al. Once-monthly subcutaneous continuous erythropoietin receptor activator (C.E.R.A.) maintains stable control in patients with chronic kidney disease on dialysis directly converted from epoetin one to three times weekly. Clin J Amer Soc Nephrol. 2007 doi:10.2215/CJN.03631006.
5. Canaud B, Mingardi G, Braun J, et al., on behalf of the ARCTOS Study Investigators.  Intravenous C.E.R.A. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin: results from STRIATA, a randomized phase III study. 2007 Submitted.
6. Locatelli F, Sulowicz W, Harris K, et al.SC C.E.R.A. (continuous erythropoietin receptor activator) once every 2 weeks or once monthly maintains stable Hb levels after converting directly from IV epoetin 1–3 times per week in patients with CKD on dialysis. J Am Soc Nephrol 2006;17:619A.
7. Fishbane S, Levin NW, Mann JFE, et al. IV C.E.R.A. (continuous erythropoietin receptor activator) once every 2 weeks or once monthly maintains stable Hb levels after converting directly from IV epoetin 1–3 times per week in patients with CKD on dialysis. J Am Soc Nephrol 2006;17:618A (abstract SA-PO205).
8. Ryckelynck J-P, Harris K, Selga R, et al. SC C.E.R.A. (continuous erythropoietin receptor activator) administered up to once monthly in patients with CKD on dialysis maintains adequate Hb levels regardless of age, gender or diabetic status. J Am Soc Nephrol. 2006;17:620A (abstract SA-PO210).
9. Mann J, Locatelli F, Sulowicz W, et al. C.E.R.A. provides stable haemoglobin (Hb) levels in CKD patients on dialysis with and without coronary artery disease (CAD) or diabetes mellitus (DM) when administered once monthly. Nephrol Dial Transplant. 2007 In Press (abstract Suo002).
10. Data on file. F. Hoffmann-La Roche 2007.
11. Heifets M, Dougherty FC on behalf of the PROTOS, MAXIMA, STRIATA and RUBRA study investigators. Hemoglobin (Hb) decline after withholding C.E.R.A. administration is not influenced by C.E.R.A.’s long half life. Poster presented at the World Congress of Nephrology 2007, Rio de Janeiro, Brazil.