Tolerability and Efficacy of Multidose Epoetin Beta (Reco-Pen^®) for Subcutaneous Administration in Patients with Anemia due to Renal Failure

Abstract

Aims: To assess the tolerability, safety and efficacy of the epoetin beta multidose cartridge formulation, self-administered subcutaneously via a pen device (Reco-Pen^®), in adult patients with renal anemia. Methods: Patients receiving maintenance epoetin therapy were switched to the subcutaneous (SC) multidose formulation of epoetin beta (NeoRecormon^®). The frequency of adverse events, local tolerability, and changes in blood pressure and laboratory variables were recorded. Hematologic parameters, transfusion requirements and epoetin beta dosage were also assessed. Results: A total of 406 patients were entered in the intention-to-treat analysis. Mean treatment duration was 82.3 days. Fifty patients (12.3%) withdrew from the study; 14 (3.4%) discontinued because of adverse events. Treatment was well tolerated, with adverse events considered probably related to treatment in only 5 cases, and 1 case of local intolerability. There were no clinically significant changes in blood pressure or laboratory variables, and no changes in hematologic parameters or transfusion requirements. Unexpectedly, the epoetin beta dose was reduced by almost one-third in patients previously maintained on SC epoetin. Conclusion: SC administration of this multidose epoetin beta formulation with the Reco-Pen^® device was well tolerated and effective. It is possible that the improved capacity to individualize dose may have contributed to the considerable reduction in SC epoetin beta dosage requirement.

Recombinant human epoetin beta in the treatment of renal anemia

“…This is suggested by the results of a study on hypertensive hemodialysis patients under intravenous epoetin therapy, whose pre-dialysis blood pressure levels signifi cantly decreased after switching to subcutaneous administration, so that within 6 months nearly half of them were no longer considered hypertensive (Navarro et al 1995). A larger study of 406 patients receiving maintenance intravenous or subcutaneous epoetin treatment who were switched to subcutaneous epoetin beta showed epoetin beta to be well tolerated and effective, with adverse events occurring at a very low rate during the study (Kleophas et al 2003). Finally, different studies reported that once-weekly subcutaneous epoetin beta is as well tolerated as two-or three-times-weekly regimens (Weiss et al 2000;Locatelli et al 2002).…”

Achieving therapeutic targets in renal anaemia: considering cost-efficacy

“…Studies using epoetin beta have consistently reported very good tolerability with 81% of patients rating the injection as pain-free 30,37,38 . Injection site reactions occur rarely.…”

“…Median epoetin dosage and haematocrit in patients previously maintained on subcutaneous epoetin and switched to multidose subcutaneous epoetin beta30 …”