BYETTA PI PDF

Learn about BYETTA, the BYETTA Pen. Important Safety Information for BYETTA (exenatide) injection. Contraindications. BYETTA is contraindicated in. Exenatide (Byetta) is the first in a new class of incretin peptide mimetics .. Available at ; accessed October 15, 3. Meneilly. Exenatide (marketed as Byetta, Bydureon) is a glucagon-like peptide-1 receptor agonist (GLP-1 receptor agonist) medication, belonging to the group of incretin.

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If there is worsening glycemic control or failure to achieve targeted glycemic control, alternative antidiabetic therapy should be considered [see Adverse Reactions 6. In the week controlled clinical trials of Byetta, the use of Byetta in patients already receiving HMG CoA reductase inhibitors was not associated with consistent changes in lipid profiles compared to baseline.

Benign thyroid C-cell adenomas were observed in female rats at all exenatide doses.

Add BYETTA to insulin glargine as a complementary action to help improve glycemic control

In a single-dose crossover study in patients with type 2 diabetes and fasting hyperglycemia, immediate insulin release followed injection of Byetta.

The primary endpoints of the study were glycemic control measured by HbA 1C and safety.

The site you are about to visit is maintained by a third party who is solely responsible for its contents. With a Thiazolidinedione 16 Weeks. Proc Bayl Univ Med Cent.

Exenatide marketed as ByettaBydureon is a glucagon-like peptide-1 receptor agonist GLP-1 receptor agonist medication, belonging to the group of incretin mimeticsapproved in April for the treatment of diabetes mellitus type 2.

BYETTA should not be used in people with type 1 diabetes or people with diabetic ketoacidosis a condition caused by very high blood sugar.

In the week trials, after a 4-week placebo lead-in period, patients were randomly assigned to receive Byetta 5 mcg BID, Byetta 10 mcg BID, or placebo BID before the morning and evening meals, in addition to their existing oral antidiabetic agent. Bytta slows stomach emptying and can affect medicines that need to pass through the stomach quickly.

However, exenatide is present at low concentrations less than or equal to 2. No pharmacokinetic study has been performed in oi with a diagnosis of acute or chronic hepatic impairment.

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See “What is the most important information I should know about Byetta?

Official BYETTA® (exenatide) injection Healthcare Professional Website

Failure to follow these instructions completely may result in a wrong dose, a broken pen or an infection. This ppi, known as the “first-phase insulin response,” is characteristically byettw in patients with type 2 diabetes. The primary endpoint was the change in HbA 1c from baseline to Week Tell your healthcare provider if you have severe problems with your stomach, such as delayed emptying of byefta stomach gastroparesis or problems with digesting food.

Additionally, the FDA has raised concerns over the lack of data to determine if the long-acting once-weekly version of exenatide but not the twice-daily form of exenatide may increase thyroid cancer risk.

This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment. Exenatide is the synthetic version of exendin-4, an incretin hormone originally found in the saliva of the Gila monster Heloderma suspectum.

Exenatide (Byetta) as a novel treatment option for type 2 diabetes mellitus

Retrieved from ” https: Use of twice-daily exenatide in basal insulin—treated patients with type 2 diabetes: The symptoms, treatment, and conditions that predispose to development of hypoglycemia should be explained to the patient. Exenatide is a amino-acid peptide ; it is a synthetic version of Exendin-4a hormone found in the saliva of the Gila monster. The primary byettz of the study were glycemic control measured by hemoglobin A1C HbA 1C and safety.

Approval History FDA approved Patients should be informed of the potential risks and benefits of Byetta and of alternative modes of therapy. The mean apparent clearance of exenatide po humans is 9. Do not transfer Byetta from the pen to a syringe or a vial. The main side effects of exenatide use are gastrointestinal in nature, including acid or sour stomach, belching, diarrhea, heartburn, indigestion, nausea, and vomiting; exenatide is therefore not meant for people with severe gastrointestinal disease.

Byetta may affect the way some medicines work byeta some other medicines may affect the way Byetta works. Byetta should not be used for the treatment of type 1 diabetes or diabetic ketoacidosis, as bydtta would not be effective in these settings.

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Type 2 Diabetes Medication | BYETTA® (exenatide) injection

Make sure that the 5 with the line under it is in the center of the dose window. This site is intended for US Consumers. Check the symbol in the dose window. In a clinical study of Byetta, three patients with type 2 diabetes each experienced a single overdose of mcg Ppi 10 times the maximum recommended dose. We byettta you to read the privacy policy of every website you visit. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In the week trial of Byetta add-on to thiazolidinediones, with or without metformin, Byetta resulted in statistically significant reductions from baseline in HbA 1c compared with patients receiving placebo Table 7.

Views Read Edit View history. Patients assigned to placebo received placebo BID throughout the trial.

When Byetta is used in combination with insulin, the dose of insulin should be evaluated. Based on postmarketing data BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. The addition of Byetta to a regimen of metformin, a sulfonylurea, or both, resulted in statistically significant reductions from baseline in HbA 1c compared with patients receiving placebo added to these agents in the three controlled trials Table 7.

Call your healthcare provider right away if you have pain in your stomach area abdomen that is severe, and will not go away.

All studies were conducted over a week period and were placebo controlled.