NHS Greater Glasgow & Clyde Area Drug and Therapeutics Committee
Greater Glasgow and Clyde Medicines
Medicines Update

Exenatide (Bydureon®) formulation change

The Bydureon® prolonged release (exenatide 2mg) vial & syringe delivery device is being withdrawn and will change to a pre-filled pen device. Exenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist prepared as a once weekly subcutaneous injection indicated for treatment of type 2 diabetes mellitus.

 

Currently the Bydureon 2mg (vial) powder and solvent for prolonged-release suspension is still available & Astra Zeneca the manufacturer have advised that supplies of the old device will still be available in the UK until November - December 2015.

 

The new exenatide (Bydureon prolonged release) 2mg powder and solvent in prefilled pens has been introduced gradually since earlier this year. This new pen permits reconstitution of the powder more easily and is easier for patients with manual dexterity problems to use safely. 

 

The user manual provides step by step guidance on how to use the new pre-filled pen. Information on the different devices along with a patient information leaflet has been produced by the manufacturer. 

 

All new patients being initiated on Bydureon 2 mg prolonged release will now be started on the prefilled pen device.

 

Existing patients using the vial & syringe will need additional training in advance of switching to the prefilled pen before supplies of the vial are discontinued at the end of 2015. This should be provided wherever possible by the team currently managing that patient's diabetes care, which will usually be the GP and the community diabetes specialist nurse (DSN).

 

The DSN network across primary and secondary care will make arrangements to facilitate patient education and the switch of Bydureon to the new prefilled pen device.  Patients affected by this change should be encouraged to contact their usual DSN for advice in the first instance, and GP surgeries looking for advice should contact their link community DSN. Secondary care teams who are managing patients affected by this change will also make arrangements to facilitate smooth transition.

 

Caution: A few patients have received the wrong preparation.

 

Community Pharmacists

To reduce the risk that patients receive the wrong preparation:

  • Be vigilant to ensure the correct device is dispensed.
  • Confirm that what is on the prescription is what the patient is expecting, ie the vial or the new prefilled pen device.
  • Confirm with all patients expecting the new prefilled pen device they know how to use the new prefilled pen device or have arranged to be shown how to use the new prefilled pen device by a healthcare professional.

 

GP practices

To reduce the risk that patients receive the wrong preparation:

  • Be vigilant when selecting the BYDUREON prefilled pen device on EMIS or VISION to ensure the correct descriptor is selected.
  • Descriptions are very similar and the wrong one may be chosen in error. 
  • The descriptors for the prefilled pen device which should be chosen are in bold below

 

 

EMIS  

 

  • Bydureon powder and solvent for suspension for injection 2mg vial
  • Bydureon powder and solvent for suspension for injection 2mg device

 

  • Exenatide powder and solvent for suspension for injection 2mg vial
  • Exenatide powder and solvent for suspension for injection 2mg pen

 

 

 

 

Vision

  • Bydureon 2mg powder and solvent for suspension for injection vials (AstraZeneca UK Ltd)
  • Bydureon 2mg powder and solvent for suspension for injection pre-filled pen (AstraZeneca UK Ltd)

 

  • Exenatide 2mg powder and solvent for suspension for injection vials
  • Exenatide 2mg powder and solvent for suspension for injection pre-filled disposable devices