A new formulation of Rybelsus (oral semaglutide) will be marketed in Belgium in early 2026. This formulation offers increased bioavailability compared with the initial formulation. As a result, the new formulation has a lower dosage in order to guarantee bioequivalence with the old formulation. The old and new formulations will temporarily coexist on the market, which may lead to confusion and a potential risk of overdose.
Semaglutide is a glucagon-like peptide-1 (GLP-1) analogue. Rybelsus is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an addition to diet and exercise.
Novo Nordisk, the firm that markets Rybelsus, has decided to replace the initial formulation (3 mg, 7 mg and 14 mg tablets) with a new one (1.5 mg, 4 mg and 9 mg tablets).
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Initial formulation |
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New formulation |
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3 mg (starting dose) |
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1.5 mg (starting dose) |
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7 mg (maintenance dose) |
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4 mg (maintenance dose) |
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14 mg (maintenance dose) |
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9 mg (maintenance dose) |
Compared to the original formulation, the excipients in the new formulation have been modified to increase absorption. Bioavailability has thus been increased, making it possible to reduce doses while maintaining the same exposure to the medicine. Bioequivalence has been demonstrated in a clinical trial, and doses of the new formulation have the same effectiveness and safety as doses of the initial formulation.
The coexistence of the two formulations during the transition period could lead to confusion and could pose a risk of medication errors. These errors could lead to increased exposure to semaglutide, which could cause gastrointestinal side effects such as nausea, vomiting and diarrhea.
The launch date for the new formulation will be announced as soon as it is confirmed.
The product information has already been updated and coexists in one single summary of product characteristics (SmPC) and leaflet, to explain the differences between the two formulations and to enable users to identify equivalent doses from one formulation to the other. The packaging and tablet shape of the new formulation differ from those of the initial formulation, but the colour of the different dosing steps remains similar.
Information for healthcare professionals
At its April 2024 meeting, the PRAC decided to issue a Direct Healthcare Professional Communication (DHPC) to target healthcare professionals to inform them of the new formulation and of the measures in place to avoid medication errors due to confusion between formulations. The DHPC will be available as soon as the new formulation will be launched.
Information for patients
If you have any doubts or questions, the FAMHP advises patients to speak to their pharmacist or doctor to avoid any confusion.
It is important for the patient not to take a double dose of the new formulation, as the new formulation has higher bioavailability than the initial formulation. This means that the same effectiveness and safety have been demonstrated at lower doses.
How to notify a medication error?
- Errors with no adverse reactions
Potential or actual errors with no adverse reactions can be reported to medication-errors@fagg-afmps.be. - Errors with adverse reactions
If the error led to an adverse reaction, the classic reporting system should be used and the context of the medication error should be described, via https://www.famhp.be/en/side_effect.a