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Health Sciences Authority
Dear Healthcare Professional Letters

Hypersensitivity and infusion reactions related to BenlystaTM (Belimumab)

Audiences

Healthcare professional

Product type

Therapeutic Products

9 January 2013

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

GlaxoSmithKline would like to inform healthcare professionals on important safety information regarding the association of hypersensitivity and infusion reactions with BenlystaTM. 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.


Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.

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