This document communicates a safety update for the product Mogamulizumab, based on a reviewed safety signal (EPITT no 20113).
1. Update to the Summary of Product Characteristics (SmPC):
- Section 4.8 (Undesirable Effects):
- Colitis has been added as a common adverse reaction (frequency ‘common’) under Gastrointestinal disorders.
- A description notes that colitis was “mainly characterized by watery diarrhoea, in some cases excessive.”
2. Update to the Package Leaflet:
- Section 4 (Possible Side Effects):
- Under “Serious side effects,” the following text has been added as a common side effect (may affect up to 1 in 10 people):”Watery diarrhoea, more bowel movements than usual, severe abdominal pain or tenderness which are possible signs of inflammation of the large bowel (colitis).”
Purpose
The update informs healthcare professionals and patients of a newly recognized, common risk of colitis associated with Mogamulizumab, ensuring this risk is clearly communicated in the official product information.
