The Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance regarding the transition to the new formulation and risk of medication error with Rybelsus® tablets.

There is a risk of patient harm arising through medication error during a transition period where the original and new formulation of Rybelsus® tablets, which have different stated mg doses but are bioequivalent, will both be available on the market. Medication error may result in overdose if healthcare professionals prescribe more than one tablet per day of the new formulation to try to match the dose to the old strengths. This could affect disease control and increase the risk of side effects. Healthcare systems are advised that a co-ordinated response is required to manage switching patients to the new formulation. Healthcare professionals should be aware that the original formulation is anticipated to be available until approximately 31st January 2026 however, original formulation stock of imported Rybelsus® may be within supply chains beyond this date.

Advice for Healthcare Professionals:

  • The new formulation of Rybelsus® has increased bioavailability therefore lower strength tablets achieve the same drug exposure and clinical effect as the previous formulation
  • Ensure all relevant staff members are familiar with the new dosing range:
    Initial formulation (one oval tablet) Bioequivalent New formulation (one round tablet)
    3 mg (starting dose) = 1.5 mg (starting dose)
    7 mg (maintenance dose) = 4 mg (maintenance dose)
    14 mg (maintenance dose) = 9 mg (maintenance dose)
  • Details of the new formulation can be found in the Direct Healthcare Professional Communication distributed by the Marketing Authorisation Holder in September 2025
  • The two formulations will temporarily co-exist on the market until approximately 31st January 2026 however, original formulation stock of imported Rybelsus® may be within supply chains beyond this date
  • Rybelsus® should always be taken as one tablet per day. Taking more than this will result in overdosing, which affects disease control and increases the risk of adverse events
  • Prescribe patients starting Rybelsus® treatment the new formulation once it is available in your prescribing system
  • Systematically switch patients who are currently on Rybelsus® to the new formulation once it is available in your prescribing systems
  • Inform patients about the change in formulation and strength when the new formulation is prescribed or dispensed
  • Ensure that patients are aware that tablets with the new formulation and lower strengths will have the same effects as the tablets with the initial formulation and higher strengths
  • Document in the patient’s notes that the change has been undertaken and communicate to other parts of the system where required
  • Refer patients to the patient transition guide for further information
  • Report medication errors or near misses via local risk management systems and medication errors resulting in patient harm on the Yellow Card website

Advice for Healthcare Professionals to Provide to Patients:

  • Rybelsus® tablets have been modified so that the medicine is more easily absorbed by your body. The new and modified tablets are just as effective as the old tablets, but have a smaller dose. It will work the same as the old tablets even though the dose is different. The tablets will now be smaller and round in shape.
  • Continue to take one tablet per day
  • Refer to the patient transition guide for further information
  • If you are unsure about what dose you are taking, speak to your pharmacist or prescriber
  • Report suspected adverse drug reactions via the Yellow Card website

For further details, please view the full Drug Safety Update here.

The post MHRA Drug Safety Update: Rybelsus® (semaglutide tablets): transition to new formulation and risk of medication error appeared first on Community Pharmacy England.