Tolerability of the Epoetin-Beta Multidose Formulation (Reco-Pen®) in Patients with Renal Anaemia

Objective: To assess the tolerability, efficacy and ease of use of epoetin-beta in a cartridge formulation, self-administered subcutaneously via a pen injector (Reco-Pen®), in patients with end-stage renal disease. Design and Setting: This was a multinational, multicentre, open, single-group study of 12 to 16 weeks’ duration. Patients: 420 adult patients with end-stage renal disease in the maintenance phase of epoetin treatment for anaemia. Interventions: Reco-Pen® epoetin-beta multidose formulation. Patients had previously been receiving treatment with subcutaneous or intravenous epoetin at a dosage of ≥2500 IU/week. Main Outcome Measures and Results: Drug tolerability was evaluated by the frequency of adverse events (AEs), local tolerability, changes in blood pressure and laboratory variables. Efficacy was assessed using blood transfusion requirements and changes in haematological variables. The ease of use of the Reco-Pen® was also assessed. A total of 40% of evaluable patients (n = 418) reported ≥1 AE, although few AEs were considered to be drug related (5%). The incidence of serious AEs was 13%. A very small percentage of patients reported local intolerability (2%). No relevant changes in blood pressure, laboratory variables, haematocrit and haemoglobin levels were apparent during treatment with epoetin-beta. Four percent of patients required blood transfusions. Most patients (92%) found the Reco-Pen® device easy to use and 89% found it easier to use than their previous self-administration method. The majority of patients (81%) rated injections as pain free. Conclusions: Reco-Pen® appears to be as well tolerated and effective as other conventional methods of epoetin administration. However, it has the added benefits of pain reduction at the injection site and improved convenience, which can encourage patients to self-administer their medication subcutaneously.