Bydureon 2 mg powder and solvent for prolonged-release suspension for injection in pre-filled pen
Each pre-filled pen contains 2 mg of exenatide. After reconstitution, each pen delivers a dose of 2 mg in 0.65 ml.
For the full list of excipients, see section 6.1.
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.
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.
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 may be necessary to adjust the dose of sulphonylurea.
If a different antidiabetic 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 patients
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 end-stage 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 Bydureone 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
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 be trained by their healthcare professional. 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”.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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 end-stage 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 end-stage 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 products included angiotensin converting enzymes inhibitors, angiotensin-II antagonists, non-steroidal anti-inflammatory medicinal products and diuretics. Reversibility of altered renal function has been observed with supportive treatment and discontinuation of potentially causative agents, including exenatide.
Severe gastrointestinal disease
Bydureon has not been studied in patients with severe gastrointestinal disease, including gastroparesis. Its use is commonly associated with gastrointestinal adverse reactions, including nausea, vomiting, and diarrhoea. Therefore, the use of Bydureon is not recommended in patients with severe gastrointestinal disease.
Acute pancreatitis
Use of GLP-1 receptor agonists has been associated with a risk of developing acute pancreatitis. There have been rare, spontaneously reported events of acute pancreatitis with Bydureon. Resolution of pancreatitis has been observed with supportive treatment, but very rare cases of necrotising or haemorrhagic pancreatitis and/or death have been reported. Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain. If pancreatitis is suspected, Bydureon should be discontinued; if acute pancreatitis is confirmed, Bydureon should not be restarted.
