MIRCERA
Safety
The safety of MIRCERA® is comparable to shorter-acting erythropoiesis-stimulating agents (ESAs).
The observed adverse events were comparable with other ESAs and typical for this patient population (see Table).1–9 No cases of pure red cell aplasia (PRCA) were reported in clinical trials.
Adverse events occurring in ≥5% of chronic kidney disease patients.1
References
1. Data on file. F. Hoffmann-La Roche 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).
