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Bydureon is a brand name for Exenatide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Bydureon is indicated in adults, adolescents and children aged 10 years and above with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose-lowering medicinal products including basal insulin, when the therapy in use, together with diet and exercise, does not provide adequate…
Verbatim from this product's EMA label. Tap a section to expand.
Posology The recommended dose is 2 mg exenatide once weekly. Patients switching from immediate-release (Byetta) to prolonged-release (Bydureon or Bydureon BCise) exenatide, may experience transient elevations in blood glucose concentrations, which generally improve within the first two 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.
4). Combination therapy with thiazolidinedione was only studied in adult patients. 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.
3 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 prolonged-release exenatide 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.
2). Special populations Elderly No dose adjustment is required based on age. 2). Renal impairment No dose adjustment is necessary for patients with mild or moderate renal impairment. 4). 2). Paediatric population No dose adjustment is required for adolescents and children aged 10 years and above.
2). Method of administration Subcutaneous use Prolonged-release exenatide is for self-administration by the patient. Each kit should be used by one person only 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.
Summary of the safety profile The most frequent adverse reactions in adults were mainly gastrointestinal related (nausea which was the most frequent reaction and associated with the initiation of treatment and decreased over time, and diarrhoea).
In addition, injection site reactions (pruritus, nodules, erythema), hypoglycaemia (with a sulphonylurea), and headache occurred. Most adverse reactions associated with prolonged-release exenatide were mild to moderate in intensity.
Tabulated list of adverse reactions The frequency of adverse reactions of prolonged-release exenatide identified from clinical studies and spontaneous reports in adults (not observed in clinical studies, frequency not known) are summarised in Table 1 below.
In the prolonged-release exenatide clinical studies in adults, background therapies included diet and exercise, metformin, a sulphonylurea, a thiazolidinedione, a combination of oral glucose-lowering medicinal products or a basal insulin.
The reactions are listed below as MedDRA preferred term by system organ class and absolute frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) very rare (< 1/10,000) and not known (cannot be estimated from the available data).
4). 4) X4 1 Rate based on twelve prolonged-release exenatide completed long-term efficacy and safety studies n = 2868 total (patients on sulphonylurea n = 1002). 9 2 Based on hypoglycaemic events that 1. Result in loss of consciousness, seizure, or coma which resolves after administration of glucagon or glucose OR 2.
Require third-party assistance to resolve because of impairment in consciousness or behaviour and has glucose value of < 54 mg/dL (3 mmol/L) OR 3. Result in symptoms consistent with hypoglycaemia with a concomitant glucose < 54 mg/dL (3 mmol/L) prior to treatment.
Prolonged-release exenatide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Prolonged-release exenatide is not a substitute for insulin. 2). Prolonged-release exenatide must not be administered by intravenous or intramuscular injection.
Renal impairment In patients with end-stage renal disease receiving dialysis, single doses of immediate-release exenatide increased frequency and severity of gastrointestinal adverse reactions; therefore, prolonged-release exenatide is not recommended for use in patients with end-stage renal disease or severe renal impairment (GFR < 30 mL/min).
There have been uncommon 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 medicinal products, including exenatide.
Severe gastrointestinal disease Prolonged-release exenatide 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 prolonged-release exenatide 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.
1. 4
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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, prolonged-release exenatide and insulin must be administered as two separate injections. 6 and the “Instructions for the User”.
3 Frequency reported from the 28-week controlled treatment period of the prolonged-release exenatide as add-on to insulin glargine study (N=231). 4 Rate based on prolonged-release exenatide spontaneous reports data (unknown denominator).
5 Rate based on sixteen prolonged-release exenatide completed long term efficacy and safety studies n = 4086 total. 6 Rate based on BYDUREON completed safety and efficacy studies (n=3560 total); includes DURATION 7 and DURATION 8 studies.
Description of selected adverse reactions Drug-induced thrombocytopenia Drug-induced thrombocytopenia (DITP) with exenatide-dependent anti-platelet antibodies has been reported in adults in the postmarketing setting. DITP is an immune-mediated reaction that is caused by drug-dependent platelet-reactive antibodies.
These antibodies cause destruction of platelets in the presence of the sensitizing drug. 4). 4). Prolonged-release exenatide was associated with a significantly lower incidence of episodes of hypoglycaemia than basal insulin in patients also receiving metformin therapy (3% versus 19%) and in patients also receiving metformin plus sulphonylurea therapy (20% versus 42%).
9% n = 649) of hypoglycaemia were minor, and resolved with oral administration of carbohydrate. 2 mmol/L) and requested assistance with oral carbohydrate treatment which resolved the event. When prolonged-release exenatide was added to basal insulin, no initial dose adjustment of insulin was required.
Prolonged-release exenatide in combination with basal insulin showed no clinically significant differences in the incidence of hypoglycaemic episodes compared to insulin. There were no episodes of major hypoglycaemia in the prolonged-release exenatide with insulin group.
Nausea The most frequently reported adverse reaction in adults was nausea. In patients treated with prolonged-release exenatide, generally 20% reported at least one episode of nausea compared to […]
3% of patients. There have been spontaneously reported events of acute pancreatitis with prolonged-release exenatide. 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, prolonged-release exenatide should be discontinued; if acute pancreatitis is confirmed, prolonged-release exenatide should not be restarted.
Caution should be exercised in patients with a history of pancreatitis. Concomitant medicinal products The concurrent use of prolonged-release exenatide with D-phenylalanine derivatives (meglitinides), alpha-glucosidase inhibitors, dipeptidyl peptidase-4 inhibitors or other GLP-1 receptor agonists has not been studied.
The concurrent use of prolonged-release and immediate-release exenatide has not been studied and is not recommended. 8). Patients with higher titre antibodies may have an attenuated HbA1c response. No commercial testing of anti-drug antibodies is available, but if targeted glycaemic control is not achieved despite confirmed patient compliance, regardless of the reason for the lack of efficacy, physicians should consider alternative antidiabetic therapy.
5). Hypoglycaemia The risk of hypoglycaemia was increased when prolonged-release exenatide was used in combination with a sulphonylurea in clinical studies. Furthermore, in the clinical studies, patients on a sulphonylurea combination, with mild renal impairment had an increased incidence of hypoglycaemia compared to patients with normal renal function.
To reduce the risk of hypoglycaemia associated with the use of a sulphonylurea, reduction in the dose of sulphonylurea should be considered. 5 kg per week has been reported in patients treated with exenatide. Weight loss of this rate may have harmful consequences.
Patients with rapid weight loss should be monitored for signs and symptoms of cholelithiasis. Discontinuation of treatment After discontinuation, the effect of prolonged-release exenatide may continue as plasma levels of exenatide decline over 10 weeks.
Choice of other medicinal products and dose selection should be considered accordingly, as adverse reactions may continue and efficacy may, at least partly, persist until exenatide levels decline. Aspiration in association with general anaesthesia or deep sedation Cases of pulmonary aspiration have been reported in patients receiving GLP-1 receptor agonists undergoing general anaesthesia or deep sedation.
8) should be considered prior to performing procedures with general anaesthesia or deep sedation. e. essentially “sodium-free”.