There is limited availability of the medicine Ozempic (semaglutide-based solution for subcutaneous injection) due to an acute increase in demand. This limited availability will certainly last until early 2024. Rybelsus (semaglutide-based tablets) is also unavailable. The experts from the FAMHP's Unavailability Task Force adapt the recommendations.
Recommendations for medical doctors (specialists) and (hospital) pharmacists:
- As long as the availability remains limited, priority should be given to the authorised indication of Osempic. Which is the treatment of adult patients with inadequately regulated type 2 diabetes mellitus as an adjunct to diet and body exercise.
- Off-label use of Ozempic should be limited in these circumstances. Especially for use in the treatment of obesity where there is a body mass index (BMI) below 30 kg/m² or below 27 kg/m² in combination with at least one weight-related comorbidity.
- When necessary, the following alternatives can be applied to treat adult patients with type 2 diabetes mellitus:
- exenatide (Bydureon suspension for subcutaneous injection with prolonged release);
- liraglutide (Victoza solution for subcutaneous injection);
- semaglutide (Rybelsus tablets). These tablets are also currently unavailable and the period of unavailability is unknown for now.
- Since 1 September 2022, the ban on cumulation between the Ozempic speciality and the other specialities of the incretinomimetics class (A-92) was temporarily lifted by the National Institute for Health and Disability Insurance (NIHDI).
The FAMHP closely monitors the situation, both at national and European level.