Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
LEGAL CATEGORY

1. NAME OF THE MEDICINAL PRODUCT

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

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

 Each vial contains 2 mg of exenatide.

For a full list of excipients, see section 6.1.

3. 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.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

 BYDUREON is indicated for treatment of type 2 diabetes mellitus in combination with

• Metformin

• Sulphonylurea

• Thiazolidinedione

• Metformin and sulphonylurea

• Metformin and thiazolidinedione

in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.

4.2 Posology and method of administration

 Posology

The recommended dose is 2 mg exenatide once weekly.

Patients switching from exenatide twice daily (BYETTA) to BYDUREON may experience transient elevations in blood glucose concentrations, which generally improve within the first two weeks after initiation of therapy.

When BYDUREON is added to existing metformin and/or thiazolidinedione therapy, the current dose of metformin and/or thiazolidinedione can be continued. When BYDUREON is added to sulphonylurea therapy, a reduction in the dose of sulphonylurea should be considered to reduce the risk of hypoglycaemia (see section 4.4).

BYDUREON should be administered once a week on the same day each week. The day of weekly administration can be changed if necessary as long as the next dose is administered at least one day (24 hours) later. BYDUREON can be administered at any time of day, with or without meals.

If a dose is missed, it should be administered as soon as practical. Thereafter, patients can resume their once weekly dosing schedule. Two injections should not be given on the same day.

The use of BYDUREON does not require additional self-monitoring. Blood glucose self-monitoring may be necessary to adjust the dose of sulphonylurea.

If a different antidiabetic treatme