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Posology: The recommended dose is 2 mg exenatide once weekly.
Patients switching from immediate-release exenatide (Byetta) to prolonged-release exenatide (Bydureon or Bydureon BCise) may experience transient elevations in blood glucose concentrations, which generally improve within the first four weeks after initiation of therapy. Patients switching between the prolonged-release exenatide products (Bydureon or Bydureon BCise) may do so, with no expected relevant effect on blood glucose concentrations.
When prolonged-release exenatide is added to existing metformin and/or thiazolidinedione therapy, the current dose of metformin and/or thiazolidinedione can be continued. When added to sulphonylurea therapy, a reduction in the dose of sulphonylurea should be considered to reduce the risk of hypoglycaemia (see Precautions).
Prolonged-release exenatide 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 last dose was administered at least three days before. Prolonged-release exenatide 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, provided the next regularly scheduled dose is due in 3 days or more. Thereafter, patients can resume their usual once weekly dosing schedule.
If a dose is missed and the next regularly scheduled dose is due 1 or 2 days later, the patient should not administer the missed dose, but instead resume prolonged-release exenatide on the next regularly scheduled dosing day.
The use of this medicinal product does not require additional self-monitoring. Blood glucose self-monitoring is necessary to adjust the dose of sulphonylurea and of insulin, particularly when prolonged-release exenatide 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 prolonged-release exenatide, consideration should be given to the prolonged release of the product (see Pharmacology: Pharmacokinetics under Actions).
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 Renal impairment as follows) (see Pharmacology: Pharmacokinetics under Actions).
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 limited. Prolonged-release exenatide is not recommended in these patients.
Prolonged-release exenatide is not recommended for use in patients with end-stage renal disease or severe renal impairment (creatinine clearance <30 ml/min) (see Precautions).
Hepatic impairment: No dose adjustment is necessary for patients with hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of prolonged-release exenatide in children and adolescents aged under 18 years have not yet been established. Currently available data are described in Pharmacology: Pharmacokinetics under Actions but no recommendation on a posology can be made.
Method of administration: Subcutaneous use.
Prolonged-release exenatide is for self-administration by the patient. Each autoinjector can only be used by one person and is for single use.
Prior to initiation of prolonged-release exenatide, 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 the medicinal product is fully mixed.
When used with insulin, prolonged-release exenatide and insulin must be administered as two separate injections.
For instructions on the preparation of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage and the "Instructions for the User".
