What is the risk associated?
The most common side effects seen with Bydureon were mainly problems affecting the stomach and gut (nausea (feeling sick), vomiting, diarrhoea and constipation). Nausea was the most common single side effect, which was mainly seen at the start of treatment and decreased over time. In addition, reactions at the site of injection (itching), low blood sugar levels (when used with a sulphonylurea) and headache occurred. Most side effects were mild to moderate in intensity. For the full list of all side effects reported with Bydureon, see the package leaflet.

Bydureon should not be used in people who may be hypersensitive (allergic) to exenatide or any of the other ingredients.

Bydureon Page

Why has it been approved?
The CHMP noted that the benefits of Bydureon, such as its effect on reducing the levels of HbA1c, compare well with those of comparator medicines and that its side effects are manageable. The CHMP therefore decided that Bydureon’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Further information
The European Commission granted a marketing authorisation valid throughout the European Union for Bydureon to Eli Lilly Nederland B.V. on 17 June 2011. The marketing authorisation is valid for five years, after which it can be renewed. europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Bydureon, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 05-2011. Bydureon Page

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Name

BYDUREON 2 mg powder and solvent for prolonged-release
suspension for injection

Composition

Each vial contains 2 mg of exenatide.

For a full list of excipients, see section 6.1.

Pharmaceutical Form

Powder and solvent for prolonged-release suspension for injection.

Powder: white to off-white powder.
Solvent: clear, colourless to pale yellow to pale brown solution.

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