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Byetta is a brand name for Exenatide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Byetta is indicated for treatment of type 2 diabetes mellitus in combination with: - metformin - sulphonylureas - thiazolidinediones - metformin and a sulphonylurea - metformin and a thiazolidinedione in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.…
Verbatim from this product's EMA label. Tap a section to expand.
Posology Immediate-release exenatide (Byetta) therapy should be initiated at 5 mcg exenatide per dose administered twice daily (BID) for at least one month in order to improve tolerability. The dose of exenatide can then be increased to 10 mcg BID to further improve glycaemic control.
Doses higher than 10 mcg BID are not recommended. Immediate-release exenatide is available as either a 5 mcg or a 10 mcg exenatide per dose pre-filled pen. 3 Immediate-release exenatide can be administered at any time within the 60-minute period before the morning and evening meal (or two main meals of the day, approximately 6 hours or more apart).
Immediate-release exenatide should not be administered after a meal. If an injection is missed, the treatment should be continued with the next scheduled dose. Immediate-release exenatide is recommended for use in patients with type 2 diabetes mellitus who are already receiving metformin, a sulphonylurea, pioglitazone and/or a basal insulin.
Immediate-release exenatide use can be continued when a basal insulin is added to existing therapy. When immediate-release exenatide is added to existing metformin and/or pioglitazone therapy, the current dose of metformin and/or pioglitazone can be continued as no increased risk of hypoglycaemia is anticipated, compared to metformin or pioglitazone alone.
). When immediate-release exenatide is used in combination with basal insulin, the dose of basal insulin should be evaluated. 8). The dose of immediate-release exenatide does not need to be adjusted on a day-by-day basis depending on self-monitored glycaemia.
Blood glucose self-monitoring is necessary to adjust the dose of sulphonylurea or insulin, particularly when Byetta therapy is started and insulin is reduced. A stepwise approach to insulin dose reduction is recommended. Special populations Elderly Immediate-release exenatide should be used with caution and dose escalation from 5 mcg to 10 mcg should proceed conservatively in patients > 70 years.
The clinical experience in patients > 75 years is very limited. Renal impairment No dosage adjustment is necessary in patients with mild renal impairment (creatinine clearance 50-80 mL/min). 2). 4). 2). Paediatric population The efficacy of exenatide in children and adolescents under 18 years of age was not demonstrated.
Summary of the safety profile The most frequent adverse reactions were mainly gastrointestinal related (nausea, vomiting and diarrhoea). The most frequently reported single adverse reaction was nausea which was associated with the initiation of treatment and decreased over time.
Patients may experience hypoglycaemia when immediate-release exenatide is used with a sulphonylurea. Most adverse reactions associated with immediate-release exenatide were mild to moderate in intensity. 4). Tabulated list of adverse reactions Table 1 lists adverse reactions reported of immediate-release exenatide from clinical trials and spontaneous reports (not observed in clinical trials, frequency not known).
In clinical trials, background therapies included metformin, a sulphonylurea, a thiazolidinedione, or a combination of oral glucose-lowering medicinal products. 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).
Table 1:
Adverse reactions of immediate-release exenatide identified from clinical trials and spontaneous reports System organ class /adverse reaction terms Frequency of occurrence Very common Common Uncommon Rare Very rare Not known Blood and lymphatic system disorders Drug-induced thrombocytopenia X3 Hepatobiliary disorders Cholecystitis X1 Cholelithiasis X1 Immune system disorders Anaphylactic reaction X1 Metabolism and nutrition disorders Hypoglycaemia (with metformin and a sulphonylurea)2 X1 Hypoglycaemia (with a sulphonylurea) X1 Decreased appetite X1 Dehydration, generally associated with nausea, vomiting and/or diarrhoea.
Exenatide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Exenatide is not a substitute for insulin. 2) Immediate-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 5 mcg increased frequency and severity of gastrointestinal adverse reactions. Exenatide is not recommended for use in patients with end-stage renal disease or severe renal impairment (creatinine clearance < 30 mL/min).
2). There have been uncommon, spontaneously reported events of altered renal function, including increased serum creatinine, renal impairment, worsened chronic renal failure and acute renal failure, sometimes requiring hemodialysis.
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, nonsteroidal 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. Acute pancreatitis Use of GLP-1 receptor agonists has been associated with a risk of developing acute pancreatitis.
There have been spontaneously reported events of acute pancreatitis with exenatide. Resolution of pancreatitis has been observed with supportive treatment but very rare cases of necrotising or hemorrhagic 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, exenatide should be discontinued; if acute pancreatitis is confirmed, exenatide should not be restarted.
1. 4
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2 but no recommendation on a posology can be made. Method of administration Each dose should be administered as a subcutaneous injection in the thigh, abdomen, or upper arm. Immediate-release exenatide and basal insulin must be administered as two separate injections.
6 and the user manual included with the leaflet.
4) X3 Eructation X1 Constipation X1 Flatulence X1 Delayed gastric emptying X1 Skin and subcutaneous tissue disorders Hyperhidrosis2 X1 Alopecia X1 Macular and papular rash X3 Pruritus, and/ or urticaria X1 Angioneurotic oedema X3 Renal and urinary disorders Altered renal function, including acute renal failure, worsened chronic renal failure, renal impairment, increased serum creatinine X1 General disorders and administration site conditions Feeling jittery X1 Asthenia 2 X1 Injection site reactions X1 Investigations Weight decreased X1 International normalised ratio increased with concomitant warfarin, some reports associated with bleeding X3 1 Rate based on immediate-release exenatide completed long-term efficacy and safety studies n=5763 total (patients on sulphonylurea n=2971).
2 In insulin-comparator controlled studies in which metformin and a sulphonylurea were concomitant medicinal products, the incidence for these adverse reactions was similar for insulin- and immediate-release exenatide-treated patients.
3 Spontaneous reports data (unknown denominator) 9 When immediate-release exenatide was used in combination with basal insulin therapy the incidence and types of other adverse events observed were similar to those seen in the controlled clinical trials with exenatide as monotherapy, with metformin and/or sulphonylurea or a thiazolidinedione, with or without metformin.
Description of selected adverse reactions Drug-induced thrombocytopenia Drug-induced thrombocytopenia (DITP) with exenatide-dependent anti-platelet antibodies has been reported 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. 3%) and appeared to be dependent on the doses of both immediate-release exenatide and the sulphonylurea. There were no clinically relevant differences in incidence or severity of hypoglycaemia with exenatide compared to placebo, in combination with a thiazolidinedione, with or without metformin.
Hypoglycaemia was reported in 11% and 7% of patients treated with exenatide and placebo respectively. Most episodes of hypoglycaemia were mild to moderate in intensity, and resolved with oral administration of carbohydrate. 0%, per protocol design in order to minimize the risk of hypoglycaemia.
1). There were no clinically significant differences in the incidence of hypoglycaemic episodes in the immediate-release exenatide compared to the placebo group (25% and 29% respectively). There were no episodes of major hypoglycaemia in the immediate-release exenatide arm.
In a 24-week study, where either insulin lispro protamine suspension or insulin glargine was added to existing therapy of immediate-release exenatide and metformin or metformin plus thiazolidinedione the incidence of patients with at least one minor hypoglycaemic episode was 18% and 9% respectively and one patient reported major hypoglycaemia.
In patients where existing […]
Caution should be exercised in patients with a history of pancreatitis. Severe gastrointestinal disease 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 exenatide is not recommended in patients with severe gastrointestinal disease. Hypoglycaemia When immediate-release exenatide was used in combination with a sulphonylurea, the incidence of hypoglycaemia was increased over that of placebo in combination with a sulphonylurea.
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 observed in approximately 5% of clinical trial 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.
Concomitant medicinal products The effect of immediate-release exenatide to slow gastric emptying may reduce the extent and rate of absorption of orally administered medicinal products. Immediate-release exenatide should be used 5 with caution in patients receiving oral medicinal products that require rapid gastrointestinal absorption and medicinal products with a narrow therapeutic ratio.
Specific recommendations regarding intake of such medicinal products in relation to immediate-release exenatide is given in section