Hypersensitivity and infusion reactions related to BenlystaTM (Belimumab)

GlaxoSmithKline would like to inform healthcare professionals on important safety information regarding the association of hypersensitivity and infusion reactions with Benlysta^TM. In clinical trials, hypersensitivity and serious infusion reactions affected approximately 0.9% of patients, and included reactions such as anaphylactic reaction, bradycardia, hypotension, angioedema and dyspnoea. Post-marketing reports concerning serious acute hypersensitivity reactions, some of which appear to have been delayed beyond the typical 1 to 2 hours seen in previous trials, have been identified. Healthcare professionals are advised to keep their patients under clinical supervision for a prolonged period of time (for several hours) following at least the first 2 infusions and to inform patients of the potential risk, the seriousness of such reactions and the importance of seeking medical attention. Please refer to the letter for details.