Tolerability and Efficacy of Multidose Formulations of Epoetin Beta

Summary

Two studies were performed to assess the tolerability of a new multidose formulation of epoetin beta that contains benzalkonium chloride 0.002% and benzyl alcohol 0.4%. In study 1,12 healthy volunteers received 2ml subcutaneous injections of placebo epoetin beta lyophilisate dissolved in either the multidose solvent or water for injections. There were no significant differences between treatments in the rating of subjective sensations (pain, itching, numbness and tenderness) and local reactions (swelling, induration, redness and heat). Study 2, a single-blind, randomised trial, compared the tolerability and clinical efficacy of multidose epoetin beta (n = 244; subcutaneous 171, intravenous 73) with that of the monodose formulation (n = 62; subcutaneous 44; intravenous 18) in patients with end-stage renal failure. Mild local reactions were experienced by 1 multidose subcutaneous recipient and 3 monodose subcutaneous recipients; no local reactions were recorded following intravenous administration of either formulation. The overall incidence of adverse events was low with both formulations, and there was no difference in clinical efficacy (assessed by haematological parameters and iron turnover) between the two formulations. These results indicate that the multidose formulation of epoetin beta is at least as well tolerated as the monodose formulation.