Agenzia Italiana del Farmaco
Direct Healthcare Professional Communication (DHPC) on Rybelsus (oral semaglutide) - Direct Healthcare Professional Communication (DHPC) on Rybelsus (oral semaglutide)
Direct Healthcare Professional Communication (DHPC) on Rybelsus (oral semaglutide)
A new formulation of Rybelsus® (oral semaglutide, indicated for type 2 diabetes) has been approved. It is bioequivalent to the previous one, but has increased bioavailability. The corresponding doses are:
- 1.5 mg (instead of 3 mg),
- 4 mg (instead of 7 mg),
- 9 mg (instead of 14 mg).
The dosage remains unchanged: one tablet per day.
The new formulation will replace the previous one, but during the transition period, both formulations will be available, which may lead to confusion or administration errors. Therefore, it is important that patients are informed to avoid overdosing and an increased risk of adverse events.
The new tablets are smaller and round, with more compact blister packs compared to the previous formulation.
The related document provides further information.
Healthcare professionals are reminded of the importance of reporting suspected adverse reactions in order to monitoring drug safety and protecting patient health.
Published on: 01 December 2025
