Arzerra (ofatumumab) – Safety update on fatal infusion reaction reported with intravenous ofatumumab

GlaxoSmithKline would like to inform healthcare professionals of a fatal infusion reaction that was reported in a 71 year old male, with chronic lymphocytic leukaemia, receiving intravenous ofatumumab. Intravenous ofatumumab has been associated with infusion reactions. Despite premedication, infusion reactions may still occur. In cases of severe infusion reaction, infusion of ofatumumab must be interrupted immediately and symptomatic treatment instituted. In addition, ofatumumab should be administered under the supervision of a physician experienced in the use of cancer therapy and administered in an environment where facilities to adequately monitor and treat infusion reactions are available. Patients should receive premedication agents 30 minutes to 2 hours prior to each infusion in accordance to the premedication protocol as defined in the product label. The Arzerra package insert has been updated to reflect this safety information.
Healthcare professional, Therapeutic Products
Published:

Dear Healthcare Professional Letters

12 Dec 2019

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

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

Step 3: Click on the MOH Alert icon under the ‘Applications’ section.

Step 4: Click on the Drug Alert tab to view the DHCPLs.