Communications on the association of MabThera® (Rituximab) with Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome

Roche would like to inform healthcare professionals on post-marketing cases of severe skin reactions such as Toxic Epidermal Necrolysis (TEN) and Stevens-Johnson Syndrome (SJS) associated with the use of MabThera®. Rare post-marketing cases of TEN and SJS, with fatal outcomes, have been reported in patients with autoimmune diseases and haematological malignancies following MabThera® infusions. A total of 67 cases of TEN And SJS occurring in patients treated with MabThera® were received by Roche for the period since product approval to 11 June 2012. The package insert for MabThera® would be updated to include the safety information on the occurrence of TEN And SJS, with fatal outcomes, following MabThera® administration. Healthcare professionals are advised to discontinue MabThera® treatment in case of the occurrence of severe skin reactions and to carefully assessed the decision to re-administer MabThera® based on the individual patient's benefit-risk profile.

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 ↗ (opens in new tab) 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.