Rybelsus

The most common side effects with Rybelsus (which may affect more than 1 in 10 people) are nausea (feeling sick), diarrhoea and low blood sugar levels (when used with insulin or a sulphonylurea).

For the full list of side effects and restrictions of Rybelsus, see the package leaflet.

Rybelsus is available as tablets (3, 7 and 14 mg) and can only be obtained with a prescription. The starting dose is 3 mg once daily. After one month, the dose should be increased to 7 mg once daily. If needed, the dose can be further increased up to a maximum of 14 mg once daily.

For more information about using Rybelsus, see the package leaflet or contact your doctor or pharmacist.

Type 2 diabetes is a disease in which the body does not make enough insulin to control the level of glucose in the blood or when the body cannot use insulin effectively. The result is a high level of glucose in the blood.

The active substance in Rybelsus, semaglutide, is a ‘GLP-1 receptor agonist’. It acts in the same way as GLP-1 (a hormone produced in the gut) by increasing the amount of insulin that the pancreas releases in response to food. This helps with the control of blood glucose levels.

Rybelsus was effective at controlling blood glucose levels in 7 main studies involving a total of over 5,500 patients with type 2 diabetes.

Depending on the dose, Rybelsus lowered HbA1c (showing improved blood glucose control) by between 0.6 and 1.4 percentage points. The results compared favourably with those with three other diabetes treatments empagliflozin, sitagliptin or liraglutide, which led to reductions of 0.9, 0.8, 0.9 percentage points, respectively. Rybelsus was also more effective than placebo (a dummy treatment).

In addition to better controlled blood glucose, patients taking Rybelsus had a beneficial reduction in body weight after 6 months. A further study in close to 3,200 patients suggested that Rybelsus may reduce the number of heart attacks and strokes compared to placebo, however, the difference was not statistically significant (it may be due to chance).

Rybelsus is effective at controlling blood glucose levels in patients with type 2 diabetes and can also help patients reduce their weight. The most common side effects with Rybelsus affect the digestive system; the side effects are generally manageable and similar to those with an authorised injectable form of semaglutide (Ozempic).

As with the injectable form, there is a risk that Rybelsus could worsen some patients’ diabetic retinopathy (damage to the retina in the eye). Patients with this condition will therefore be monitored carefully.

The European Medicines Agency concluded that Rybelsus’ benefits are greater than its risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rybelsus have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Rybelsus are continuously monitored. Side effects reported with Rybelsus are carefully evaluated and any necessary action taken to protect patients.

Rybelsus received a marketing authorisation valid throughout the EU on on 3 April 2020.