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.