Byeta solution for subcutaneous injection 250mkg / ml 1.2 ml No. 1 syringe pen

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Byeta solution for subcutaneous injection 250mkg / ml 1.2 ml No. 1 syringe pen

Byetta
Pharmachologic effect:
Byetta is a hypoglycemic drug. Exenatide (exendin-4) is an incretin mimetic and is a 39-amino-acid amidopeptide. Incretins, such as glucagon-like peptide-1 (GLP-1), increase glucose-dependent insulin secretion, improve β-cell function, suppress inadequately increased glucagon secretion, and slow down gastric emptying 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 increased glucose-dependent synthesis and insulin secretion from β-cells of the pancreas with the participation of cyclic AMP and / or other intracellular signal ways. Exenatide stimulates insulin release from β-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.

In hyperglycemic conditions, exenatide enhances glucose-dependent insulin secretion from β-cells of the pancreas. This insulin secretion stops as the concentration of glucose in the blood decreases and approaches its normality, thereby reducing the potential risk of hypoglycemia.

Insulin secretion during the first 10 minutes (in response to an increase in glycemia), 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 β-cells in type 2 diabetes.The administration of exenatide restores or significantly enhances both the first and second phases of the insulin response in patients with type 2 diabetes.

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.

It has been shown that administration 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.

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 in case of failure to achieve adequate glycemic control.

Contraindications:

Hypersensitivity to exenatide or excipients that are part of the drug;
Type 1 diabetes mellitus or the presence of diabetic ketoacidosis;
Severe renal failure (creatinine clearance
The presence of severe diseases of the gastrointestinal tract with concomitant gastroparesis.

Side effects:

Adverse reactions occurring more often than in isolated cases are listed according to the following gradation: very often - ≥10%, often - ≥1%, but

On the part of the digestive system: very often - nausea, vomiting, diarrhea; often - loss of appetite, dyspepsia, gastroesophageal reflux; sometimes - abdominal pain, bloating, belching, constipation, a violation of taste, flatulence.

From the side of the central nervous system: often - dizziness, headache; rarely - drowsiness.

On the part of the endocrine system: very often - hypoglycemia (in combination with sulfonylurea derivatives); often - a feeling of trembling, weakness, hyperhidrosis.

Allergic reactions: rarely - rash, itching, angioedema; extremely rarely - an anaphylactic reaction.

Other: often - skin reaction at the injection site; rarely, dehydration (associated with nausea, vomiting and / or diarrhea). Several cases of increased clotting time (INR) have been reported with simultaneous use of warfarin and exenatide, sometimes accompanied by bleeding.

Due to the fact that the frequency of hypoglycemia increases with co-administration of the drug Byetta with sulfonylurea derivatives, it is necessary to provide for a reduction in the dose of sulfonylurea derivatives 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.

Special instructions:

Not recommended in / in or in / m the introduction of the drug.

Byeta's preparation should not be used if particles are detected in the solution or if the solution is cloudy or has staining.

During therapy with the drug Byetta, antibodies to exenatide may appear. However, this does not affect the frequency and types of reported side effects.

Patients should be informed that treatment with Byetta may lead to a decrease in appetite and / or body weight and that due to these effects there is no need to change the dosage regimen.

Patients before starting treatment with Byetha should familiarize themselves with the “Manual on the use of syringe pens” attached to the preparation.

Overdose:

Symptoms: severe nausea and vomiting, as well as the rapid development of hypoglycemia (when taking a dose 10 times higher than the maximum recommended).

Treatment: conduct symptomatic therapy, including parenteral administration of glucose in case of severe hypoglycemia.

Use during pregnancy and lactation:

The drug is contraindicated during pregnancy and during breastfeeding.

It is a pharmaceutical drug. Use only as directed by your doctor.

Attention! During storage must comply with the temperature regime.

Composition

Release form:
Solution for SC injection

Composition:
1 ml contains exenatide 250 mcg

Packaging:

Syringe pen 1.2 ml, 60 doses of 5mkg.

Mode of application

Dosage and administration:
P / c, in the region of the thigh, abdomen or forearm.

The initial dose is 5 mcg, which is administered 2 times / day at any time during the 60-minute period before the morning and evening meals. Do not administer the drug after a meal. In case of missing an injection, treatment continues without changing the dose.

One month after the start of treatment, the dose of the drug can be increased to 10 μg 2 times / day.

If coadministered with metformin, thiazolidinedione, or with a combination of these drugs, the initial dose of metformin and / or thiazolidinedione can not be changed. In the case of a combination of the drug Byetta with sulfonylurea derivatives, it may be necessary to reduce the dose of the sulfonylurea derivative in order to reduce the risk of hypoglycemia.