Special populations

Elderly

No dose adjustment is required based on age. However, as renal function generally declines with age, consideration should be given to the patient's renal function (see patients with renal impairment). The clinical experience in patients > 75 years is very limited (see section 5.2).

Patients with renal impairment

No dose adjustment is necessary for patients with mild renal impairment (creatinine clearance 50 to 80 ml/min). Clinical experience in patients with moderate renal impairment (creatinine clearance 30 to 50 ml/min) is very limited (see section 5.2). BYDUREON is not recommended in these patients.

BYDUREON is not recommended for use in patients with endstage renal disease or severe renal impairment (creatinine clearance < 30 ml/min) (see section 4.4).

Patients with hepatic impairment

No dose adjustment is necessary for patients with hepatic impairment (see section 5.2).

Paediatric population

The safety and efficacy of BYDUREON in children and adolescents aged under 18 years have not yet been established (see section 5.2). No data are available.

Method of administration

BYDUREON is for self administration by the patient. Each kit should be used by one person only and is for single use.

Appropriate training is recommended for non-healthcare professionals administering the product. The “Instructions for the User”, provided in the carton, must be followed carefully by the patient.

Each dose should be administered in the abdomen, thigh, or the back of the upper arm as a subcutaneous injection immediately after suspension of the powder in the solvent.

For instructions on the suspension of the medicinal product before administration, see section 6.6 and the “Instructions for the User”.

4.3 Contraindications

 Hypersensitivity to the active substance or to any of the excipients.

4.4 Special warnings and precautions for use

 BYDUREON should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

BYDUREON must not be administered by intravenous or intramuscular injection.

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially “sodium-free”.

Renal impairment

In patients with endstage renal disease receiving dialysis, single doses of exenatide twice daily increased frequency and severity of gastrointestinal adverse reactions, therefore BYDUREON is not recommended for use in patients with endstage renal disease or severe renal impairment (creatinine clearance < 30 ml/min). The clinical experience in patients with moderate renal impairment is very limited and the use of BYDUREON is not recommended.

There have been rare, spontaneously reported events of altered renal function with exenatide, including increased serum creatinine, renal impairment, worsened chronic renal failure and acute renal failure, sometimes requiring haemodialysis. Some of these events occurred in patients experiencing events that may affect hydration, including nausea, vomiting, and/or diarrhoea and/or receiving medicinal products known to affect renal function/hydration status. Concomitant medicinal