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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Patients should be informed of the potential risks and benefits of Byetta and of alternative modes of therapy. In combination bydtta a sulfonylurea alone Buse et al evaluated exenatide versus sulfonylurea mono-therapy in a multicenter, randomized, triple-blinded, placebo-controlled study 7. The intention-to-treat population—that is, all patients who received one dose of medication—comprised subjects. Dasiglucagon Glucagon Oxyntomodulin Antagonists: Views Read Edit View history. These may be symptoms of pancreatitis.

Patients in the long-term uncontrolled open-label extension studies at 52 weeks reported no new types of adverse reactions than those observed in the week controlled trials. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Exenatide – Wikipedia

These instructions do not take the place of talking with your healthcare provider about your medical condition or your treatment. A small air bubble will not harm you or affect your dose. See How Supplied section for a complete list of available packages of Byetta. Based on postmarketing data, Byetta byetat been associated with acute byetat, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. The dose may be administered subcutaneously in the thigh, abdomen, or upper arm.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in the elderly based on renal function. If is in the dose window and the dose knob will not turn: Byeta and effectiveness of Byetta have not been established in pediatric patients.

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Call your healthcare provider right away if you have pain in your stomach area abdomen that is severe, and will not go away. Because exenatide is cleared primarily by the kidney, hepatic dysfunction is not expected to affect blood concentrations of exenatide [see Clinical Pharmacology However, in subjects with end-stage renal disease receiving dialysis, mean exenatide exposure increased by 3.

Exenatide should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

Based on animal data, BYETTA may cause fetal harm and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Approval History FDA approved The concurrent use of Byetta with prandial insulin has not been studied and cannot be recommended.

Exenatide is the first in the incretin mimetic class that offers another treatment for patients with type 2 diabetes. No placebo-treated patients withdrew due to nausea or vomiting.

Postprandial glucose was measured after a mixed meal betta test in 9. Byetta has not been studied in patients with a history of pancreatitis. Exenatide differs in chemical structure and pharmacological action from byeta, sulfonylureas including D-phenylalanine derivatives and meglitinidesbiguanides, thiazolidinediones, alpha-glucosidase inhibitors, amylinomimetics and dipeptidyl peptidase-4 inhibitors.

There are no adequate and well-controlled studies of Byetta use in pregnant women.

The primary endpoint was the change in HbA 1c from baseline to Week 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. Effects of 3 months of continuous subcutaneous administration of glucagon-like peptide 1 in elderly patients with type 2 diabetes. Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, byegta heartbeat, sweating, and feeling jittery.

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Five weeks after initiating randomized treatment, insulin doses were titrated with guidance from the investigator toward predefined fasting glucose targets according to the dose titration algorithm provided in Table 9.

This page was last edited on 14 Novemberat This insulin secretion subsides as blood glucose concentrations decrease and approach euglycemia.

Patients should be advised to inform their physicians if they are pregnant or intend to become pregnant. Galanin Galanin Galmic Galnon Antagonists: Randomization to Byetta or placebo was stratified based on whether the patients were receiving metformin. Byetta did not significantly alter the pharmacodynamic properties e. For oral medications that are dependent on threshold concentrations for efficacy, such as contraceptives and antibiotics, patients should be advised to take those drugs at least 1 hour before Byetta injection.

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

Buse et al evaluated exenatide versus sulfonylurea mono-therapy in a multicenter, randomized, triple-blinded, placebo-controlled study 7. See Commonly Asked Questions, number 4, in Section 4 of this user manual. Similar exposure is achieved with SC administration of Byetta in the abdomen, thigh, or upper arm.

Before byftta BYETTA, tell your healthcare provider if you have had pancreatitis, stones in your gallbladder gallstonesa history of alcoholism, or high blood triglyceride levels.