Posology : מינונים

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. For the next injection patients can return to their chosen injection day. However, only one injection should be taken in a 24-hour period 
The use of BYDUREON does not require additional self-monitoring. Blood glucose self-monitoring is necessary to adjust the dose of sulphonylurea and of insulin, particularly when BYDUREON therapy is started and insulin is reduced. A stepwise approach to insulin dose reduction is recommended.

If a different glucose-lowering treatment is started after the discontinuation of BYDUREON, consideration should be given to the prolonged release of BYDUREON (see section 5.2).

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).

Renal impairment
No dose adjustment is necessary for patients with mild renal impairment (creatinine clearance 50 to 80 ml/min). Bydureon should be used with caution in patients with renal transplantation. Use BYDUREON with caution in patients with moderate renal impairment (creatinine clearance 30-50 mL/min).

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

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 Currently available data are described in section 5.2 but no recommendation on a posology can be made.

Method of administration
Subcutaneous use
BYDUREON is for self-administration by the patient. Each pen should be used by one person only and is for single use.

Prior to initiation of BYDUREON, it is strongly recommended that patients and caregivers be trained by their healthcare professional. The “Instructions for the User”, provided in the carton, must be followed carefully.

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.

When used with insulin, BYDUREON and insulin must be administered as two separate injections.

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