BETA solution of subcutaneous injection of the administered 250mkg ml 1.2 ml N1
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Active ingredients
Exenatide
Release form
Solution
Composition
The solution for SC injection is colorless, transparent. 1 ml Exenatide 250 mcg Excipients: sodium acetate trihydrate - 1.59 mg, acetic acid - 1.1 mg, mannitol - 43 mg, metacresol - 2.2 mg, water d / and - q.s. to 1 ml.
Pharmacological effect
Exenatide (exendin-4) is a receptor agonist of a glucagon-like polypeptide and is a 39-amino acid amidopeptide. Incretins, such as glucagon-like peptide-1 (GLP-1), increase glucose-dependent insulin secretion, improve the function of & # 946. Cells, inhibit inadequately increased secretion of glucagon and slow down the emptying of the stomach after they enter the bloodstream from the intestine. Exenatide is a potent incretin mimetic, which causes an increase in glucose-dependent insulin secretion and has other hypoglycemic effects inherent to incretin, which allows for improved glycemic control in patients with type 2 diabetes. The amino acid sequence of exenatide partially corresponds to the sequence of human GLP-1, as a result of which it binds and activates GLP-1 receptors in humans, which leads to an increase in glucose-dependent synthesis and secretion of insulin from pancreatic cells of the pancreas with cyclic AMP and / or other intracellular signaling pathways. Exenatide stimulates the release of insulin from & # 946. Cells in the presence of elevated glucose concentrations. In terms of chemical structure and pharmacological action, exenatide differs from insulin, sulfonylurea derivatives, D-phenylalanine derivatives and meglitinides, biguanides, thiazolidinediones and alpha-glucosidase inhibitors. Exenatide improves glycemic control in patients with type 2 diabetes due to the following mechanisms. Glucose-dependent insulin secretion: in hyperglycemic conditions, exenatide enhances the glucose-dependent insulin secretion from pancreas cells & # 946. This insulin secretion stops as the concentration of glucose in the blood decreases and approaches its normality, thereby reducing the potential risk of hypoglycemia. The first phase of the insulin response: insulin secretion during the first 10 minutes, known as the “first phase of the insulin response,” is specifically absent in patients with type 2 diabetes. In addition, the loss of the first phase of the insulin response is an early dysfunction of the & # 946.-Cells in type 2 diabetes.The administration of exenatide restores or significantly enhances both the first and second phase of the insulin response in patients with type 2 diabetes. Secretion of glucagon: in patients with type 2 diabetes with hyperglycemia, administration of exenatide suppresses excessive secretion of glucagon. However, exenatide does not interfere with the normal glucagon response to hypoglycemia. Food consumption: the introduction of exenatide leads to a decrease in appetite and a decrease in food intake. inhibits gastric motility, which leads to a slowdown in its emptying. Gastric emptying: introduction of exenatide has been shown to inhibit gastric motility, which leads to a slowdown in its emptying. In patients with type 2 diabetes, treatment with exenatide in combination with metformin, thiazolidinedione and / or sulfonylurea drugs leads to a decrease in fasting blood glucose, postprandial blood glucose, and HbA1c, thereby improving glycemic control in these patients.
Indications
Monotherapy - type 2 diabetes as monotherapy in addition to diet and exercise to achieve adequate glycemic control. Combination therapy - type 2 diabetes mellitus as an adjunct to metformin, a sulfonylurea derivative, thiazolidinedione, a combination of metformin and a sulfonylurea derivative, or metformin and thiazoldinedione if the adequate glycemic control is not achieved. - Type 2 diabetes mellitus as an additional therapy to a combination of basal insulin and metformin preparations to improve glycemic control.
Use during pregnancy and lactation
The drug is contraindicated in pregnancy and lactation (breastfeeding).
Side effects
Monotherapy Adverse reactions occurring more often than in isolated cases are listed according to the following gradation: very often (& # 8805 .10%), often (& # 8805 .1%, less than 10%), infrequently (> 0.1%, less than 1%), rarely (> 0.01%, less than 0.1%), very rarely (less than 0.01%). Very often - a skin reaction at the injection site (itching). Often - nausea, vomiting, diarrhea, dyspepsia, loss of appetite, dizziness. Rarely - skin reactions at the injection site (rash, redness). When using the drug Byetta as monotherapy, the incidence of cases of hypoglycemia was 5% compared with 1% placebo. Most episodes of hypoglycemia were mild or moderate in intensity.Combination therapy Adverse reactions occurring more often than in isolated cases are listed according to the following gradation: very often (& # 8805 .10%), often (& # 8805 .1%, less than 10%), infrequently (> 0.1% , less than 1%), rarely (> 0.01%, less than 0.1%), very rarely (less than 0.01%). Very often - nausea, vomiting, diarrhea, hypoglycemia (in combination with a sulfonylurea derivative), skin reaction at the injection site (itching). Often - dyspepsia, trembling, dizziness, headache, loss of appetite, weakness, gastroesophageal reflux. Infrequently - abdominal pain, bloating, belching, constipation, a violation of taste, flatulence. Rarely - drowsiness, skin reactions at the injection site (rash, redness), dehydration (in most cases associated with nausea, vomiting and / or diarrhea), angioedema, acute pancreatitis, impaired renal function (including acute renal failure, aggravation of chronic renal deficiency, increased serum creatinine concentration). Very rarely - an anaphylactic reaction. A few cases of increased clotting time have been reported with simultaneous use of warfarin and exenatide, which is infrequently accompanied by bleeding. Since the frequency of hypoglycemia increases with co-administration of Byetta with a sulfonylurea derivative; it is necessary to provide for a reduction in the dose of the sulfonylurea derivative with an increased risk of hypoglycemia. Most episodes of hypoglycemia in intensity were mild or moderate and were stopped by oral carbohydrate intake. In general, the intensity side effects were mild or moderate and did not lead to the abolition of treatment. Most commonly recorded nausea of weak or moderate intensity was dose-dependent and decreased over time without interfering with daily activity. Spontaneous (post-marketing) messages From the immune system: very rarely - an anaphylactic reaction. Eating and metabolism disorders: dehydration, usually associated with nausea, vomiting and / or diarrhea, weight loss. On the part of the nervous system: dysgeusia, drowsiness. On the part of the digestive system: belching, constipation, flatulence. rarely (including, in very rare cases - necrotizing or hemorrhagic) - acute pancreatitis. From the urinary system: changes in kidney function, incl.acute renal failure, exacerbation of chronic renal failure, impaired renal function, increased serum creatinine concentration. From the skin and subcutaneous tissue: maculae skin rashes, papular skin rashes, pruritus, urticaria, angioedema, alopecia. Abnormalities identified in laboratory studies: increased INR (when combined with warfarin), in some cases associated with the development of bleeding. in some cases associated with the development of bleeding.
special instructions
Monotherapy Adverse reactions occurring more often than in isolated cases are listed according to the following gradation: very often (& # 8805 .10%), often (& # 8805 .1%, less than 10%), infrequently (> 0.1%, less than 1%), rarely (> 0.01%, less than 0.1%), very rarely (less than 0.01%). Very often - a skin reaction at the injection site (itching). Often - nausea, vomiting, diarrhea, dyspepsia, loss of appetite, dizziness. Rarely - skin reactions at the injection site (rash, redness). When using the drug Byetta as monotherapy, the incidence of cases of hypoglycemia was 5% compared with 1% placebo. Most episodes of hypoglycemia were mild or moderate in intensity. Combination therapy Adverse reactions occurring more often than in isolated cases are listed according to the following gradation: very often (& # 8805 .10%), often (& # 8805 .1%, less than 10%), infrequently (> 0.1% , less than 1%), rarely (> 0.01%, less than 0.1%), very rarely (less than 0.01%). Very often - nausea, vomiting, diarrhea, hypoglycemia (in combination with a sulfonylurea derivative), skin reaction at the injection site (itching). Often - dyspepsia, trembling, dizziness, headache, loss of appetite, weakness, gastroesophageal reflux. Infrequently - abdominal pain, bloating, belching, constipation, a violation of taste, flatulence. Rarely - drowsiness, skin reactions at the injection site (rash, redness), dehydration (in most cases associated with nausea, vomiting and / or diarrhea), angioedema, acute pancreatitis, impaired renal function (including acute renal failure, aggravation of chronic renal deficiency, increased serum creatinine concentration). Very rarely - an anaphylactic reaction.A few cases of increased clotting time have been reported with simultaneous use of warfarin and exenatide, which is infrequently accompanied by bleeding. Since the frequency of hypoglycemia increases with co-administration of Byetta with a sulfonylurea derivative; it is necessary to provide for a reduction in the dose of the sulfonylurea derivative with an increased risk of hypoglycemia. Most episodes of hypoglycemia in intensity were mild or moderate and were stopped by oral carbohydrate intake. In general, the intensity side effects were mild or moderate and did not lead to the abolition of treatment. Most commonly recorded nausea of weak or moderate intensity was dose-dependent and decreased over time without interfering with daily activity. Spontaneous (post-marketing) messages From the immune system: very rarely - an anaphylactic reaction. Eating and metabolism disorders: dehydration, usually associated with nausea, vomiting and / or diarrhea, weight loss. On the part of the nervous system: dysgeusia, drowsiness. On the part of the digestive system: belching, constipation, flatulence. rarely (including, in very rare cases - necrotizing or hemorrhagic) - acute pancreatitis. From the urinary system: changes in kidney function, incl. acute renal failure, exacerbation of chronic renal failure, impaired renal function, increased serum creatinine concentration. From the skin and subcutaneous tissue: maculae skin rashes, papular skin rashes, pruritus, urticaria, angioedema, alopecia. Abnormalities identified in laboratory studies: increased INR (when combined with warfarin), in some cases associated with the development of bleeding. in some cases associated with the development of bleeding.