What Does “Unlicensed” or “Off-Label” Mean for Wegovy and Mounjaro?
Unlicensed Medications
A medication is considered unlicensed if:
- It has a valid license but requires modification into a formulation that is not officially approved (e.g., a different strength or dosage form).
- It is licensed in other countries but has not been approved for use in the UK.
- It has no official license at all.
Currently, both Wegovy and Mounjaro are licensed for weight management in the UK. However, there may be cases where prescribing outside of the licensed conditions is considered.
Off-Label Use of Wegovy & Mounjaro
Off-label prescribing refers to the use of a medication in a way that differs from its official licensing. This can include:
- Prescribing Wegovy or Mounjaro for a condition not explicitly stated in the license.
- Using these medications at a different dosage for maintenance than specified in the license.
- Using these medications for a different treatment duration than specified in the license.
- Prescribing to a patient group outside the licensed age range.
The licensed maintenance dose of Wegovy is 2.4mg.
The licensed maintenance doses of Mounjaro are:
- 5mg
- 10mg
- 15mg
You and your prescriber may agree to maintain on an unlicensed dose e.g. 2.5mg Mounjaro. In this case, your prescriber will inform you of off-label prescribing and the reason why they believe this particular dose is most appropriate for you.
All requests for off-label use of Wegovy and Mounjaro are carefully assessed by our prescribing team.
A clinician will review each case individually to determine whether the treatment is appropriate and safe based on medical history and current guidelines.
If you have any questions about your prescription, please don’t hesitate to contact our team.