Communication on the introduction of warnings and precautions for severe skin reactions with Xeloda® (capecitabine)

Roche would like to inform healthcare professionals of the introduction of warnings and precautions for severe skin reactions with Xeloda^®(capecitabine). A recent review of the company safety database and literatures has identified reports of severe skin reactions such as Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), in some cases with a fatal outcome, during treatment with Xeloda^®. The frequency of the severe skin reactions is estimated as very rare taking into account the exposure to Xeloda^® as per April 2013. Healthcare professionals are advised to monitor and inform their patients on the potential causality of severe skin reactions to Xeloda^® treatment. The package insert for Xeloda^® will be updated to reflect the new safety information. Please refer to the Dear Healthcare Professional Letter for more 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 ↗ (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.