(4) For patients not currently treated with an erythropoiesis stimulating agent (ESA), the recommended starting dose is 0.6 microgram/kg body weight, administered once every two weeks as a single intravenous or subcutaneous injection in order to increase the haemoglobin to greater than 11 g/dl (6.83 mmol/l). Patients currently treated with an ESA can be converted to MIRCERA administered once a month as a single intravenous or subcutaneous injection. The starting dose of methoxy polyethylene glycol-epoetin beta is based on the calculated previous weekly dose of darbepoetin alfa or epoetin at the time of substitution. Summary of Product Characteristics for MIRCERA in the EU, http://www.emeaeuropa.eu. Darbepoetin alfa in the correction phase, the initial dose by subcutaneous or intravenous administration is 0.45 microgram/kg body weight, as a single injection once weekly. Alternatively, in patients not on dialysis, an initial dose of 0.75 microgram/kg may be administered subcutaneously as a single injection once every two weeks. In the maintenance phase, Aranesp may continue to be administered as a single injection once weekly or once every two weeks. In patients not on dialysis, once the target haemoglobin has been achieved with once every two week dosing, Aranesp may be administered subcutaneously once monthly using an initial dose equal to twice the previous once every two week dose.
(5) Machin D, Lewith GT, Wylson S. Pain measurement in randomized clinical trials. A comparison of two pain scales. Clinical Journal of Pain. 1988;4:161-168.
(6) National Kidney Foundation web site. Available at: http://www.kidney.org. Accessed August 9, 2007.
(7) Jurkovitz CT, Abramson JL, Vaccarino LV, Weintraub WS, McClellan WM. Association of high serum creatinine and anemia increases the risk of coronary events: results from the prospective community-based atherosclerosis risk in communities (ARIC) study. J Am Soc Nephrol. 2003;14:2919-2925.
(8) Pisoni RL, Bragg-Gresham JL, Young EW, et al. Anemia management and outcomes from 12 countries in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis. 2004;44:94-111.
(9) Perlman RL, Finkelstein FO, Liu L, et al. Quality of life in chronic kidney disease (CKD): a cross-sectional analysis in the Renal Research Institute-CKD study. Am J Kidney Dis. 2005;45:658-666.
(10) Evans RW, Rader B, Manninen DL. The quality of life of hemodialysis recipients treated with recombinant human erythropoietin. Cooperative Multicenter EPO Clinical Trial Group. JAMA. 1990;263:825-830.
(11) Stevens JM, Auer J, Strong CA, et al. Stepwise correction of anaemia by subcutaneous administration of human recombinant erythropoietin in patients with chronic renal failure maintained by continuous ambulatory peritoneal dialysis. Nephrol Dial Transplant. 1991;6:487-494.
(12) Brazeau GA, Cooper B, Svetic KA, Smith CL, Gupta P. Current perspectives on pain upon injection of drugs. J Pharm Sci. 1998;87:667-677.
(13) Frenken LA, van Lier HJ, Gerlag PG, den Hartog M, Koene RA. Assessment of pain after subcutaneous injection of erythropoietin in patients receiving haemodialysis. BMJj. 1991;303:288.
(14) Lui SF, Leung CB, Li PK, Lai KN. Pain after subcutaneous injection of erythropoietin. BMJ. 1991;303:856.
(15) Granolleras C, Leskopf W, Shaldon S, Fourcade J. Experience of pain after subcutaneous administration of different preparations of recombinant human erythropoietin: a randomized, double-blind crossover study. Clin Nephrol. 1991;36:294-298.
(16) Veys N, Vanholder R, Lameire N. Pain at the injection site of subcutaneously administered erythropoietin in maintenance hemodialysis patients: a comparison of two brands of erythropoietin. Am J Nephrol. 1992;12:68-72.
(17) Bommer J, Weinreich T, Ritz E, Zeier M, Bommer G. Efficacy of subcutaneous or intravenous recombinant human erythropoietin therapy in dialysis patients (Abstract). Nephrol Dial Transplant. 1989;4:471.
(18) Veys N, Dhondt A, Lameire N. Pain at the injection site of subcutaneously administered erythropoietin: phosphate-buffered epoetin alpha compared to citrate-buffered epoetin alpha and epoetin beta. Clin Nephrol. 1998;49:41-44.
(19) Yu AW, Leung CB, Li PK, Lui SF, Lai KN. Pain perception following subcutaneous injections of citrate-buffered and phosphate-buffered epoetin alpha. Int J Artif Organs. 1998;21:341-343.
(20) Frenken LA, van Lier HJ, Jordans JG, et al. Identification of the component part in an epoetin alfa preparation that causes pain after subcutaneous injection. Am J Kidney Dis. 1993;22:553-556.
(21) Frenken LA, van Lier HJ, Koene RA. Analysis of the efficacy of measures to reduce pain after subcutaneous administration of epoetin alfa. Nephrol Dial Transplant. 1994;9:1295-1298.
(22) Morris KP, Hughes C, Hardy SP, Matthews JN, Coulthard MG. Pain after subcutaneous injection of recombinant human erythropoietin: does Emla cream help? Nephrol Dial Transplant. 1994;9:1299-1301.
For further information please contact: Sheila Gies, Roche, Tel: +1-973-235-4347, Mobile:+1-973-687-0188; Diane Lorton, Galliard Healthcare, Tel: +44(0)20-7663-2265, Mobile: +44(0)7717-531-823
