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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Open pk a separate window. Orexin AB Antagonists: No clinical studies establishing conclusive evidence of macrovascular risk reduction with BYETTA or any other antidiabetic drug.

BYETTA is an injectable prescription medicine that may improve blood sugar glucose control in adults bywtta type 2 diabetes, when used with diet and exercise. There are postmarketing reports of increased INR sometimes associated with bleeding, with concomitant use of warfarin and Byetta [see Adverse Reactions 6. With Metformin and a Sulfonylurea 30 Weeks. Population pharmacokinetic analysis of patients ranging from 22 to 73 years of age suggests that age does not influence the pharmacokinetic properties of exenatide [see Use in Specific Population 8.

If you would like more information, talk with your healthcare provider. The most frequently reported adverse reactions leading to withdrawal for Byetta-treated patients were nausea 5. Increased byehta of hypoglycemia when used in combination with a sulfonylurea SU or when used with a glucose-independent insulin secretagogues eg, meglitinides. If response is inadequate, the dose may be increased to 10 mcg twice daily after 1 month of therapy.

This secretion, known as the “first-phase insulin response,” is characteristically absent in patients with type 2 diabetes. Patients should be informed that pen needles are not included with the pen and must be purchased separately. Aaron BondPharmD. In combination with a sulfonylurea alone Buse et al evaluated exenatide versus sulfonylurea mono-therapy in a multicenter, randomized, triple-blinded, placebo-controlled study 7.

Baseline body weight across treatment arms was approximately kg. Acetaminophen AUC, C max and T max were not significantly changed when acetaminophen was given 1 hour before Byetta injection. The effect of Byetta to slow gastric emptying can reduce the extent and rate of absorption of orally administered drugs.

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Three phase III clinical trials have been published comparing the use of exenatide as adjunctive therapy to metformin alone, sulfonylurea alone, or the gyetta. Check the symbol in the dose window.

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

These pharmacokinetic characteristics of exenatide are independent of the dose. Initiation with 5 mcg reduces the incidence and severity of gastrointestinal side effects. Corticorelin Corticotropin releasing hormone Sauvagine Urocortin Byetya After 4 weeks, those patients assigned to Byetta had their dose increased to 10 mcg BID.

Know the medicines you take. The dose may be administered subcutaneously in the thigh, abdomen, or upper arm. Exenatide is the first in the incretin mimetic class that offers another treatment for patients with type 2 diabetes.

In Combination with buetta Sulfonylurea 30 Weeks. Patients who had used any other diabetes agents or medications that would po plasma glucose within the prior 3 months were excluded. How can I tell when the injection is complete? Exenatide should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. No serious adverse events were reported in the placebo arm.

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

If symptoms of hypersensitivity reactions occur, patients must stop taking Byetta and seek medical advice promptly [see Warnings and Precautions 5. In a single-dose crossover study in patients with type 2 diabetes and fasting hyperglycemia, immediate insulin release followed injection of Byetta.

In a clinical study of Byetta, three patients with type 2 diabetes each experienced a single overdose of mcg SC 10 times the maximum recommended dose. Byetfa patient should be advised not to share the pen and needles.

Exenatide exposure AUC increased proportionally over the byteta dose range of 5 to 10 mcg. Serious side effects can happen in people who take Byetta, including inflammation of the pancreas pancreatitis which may be severe and lead to death. There may be new information. Exenatide is not a substitute for insulin in insulin-requiring patients. You can ask your healthcare provider byrtta pharmacist for information about Byetta that is written for health professionals.

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Glucagon-like peptide-1 receptor agonists Anorectics Eli Lilly and Company. Do not transfer Byetta from the pen to a syringe or a vial.

Byetta exenatide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies 14 ]. Views Read Edit View history.

Randomized trials have shown exenatide to be efficacious in improving glycemic control when combined with either metformin or a sulfonylurea. Patients who had used any other diabetes agents or medications that would alter plasma glucose e. Byetta may affect byettaa way some medicines work byegta some other medicines may affect the way Byetta works.

If a dose is missed, the treatment regimen should be resumed as prescribed with the next scheduled dose. The amino acid sequence of exenatide partially overlaps that of human GLP It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using BYETTA; consider other antidiabetic therapies for these patients.

Three week, double-blind, placebo-controlled trials were conducted to evaluate the safety and efficacy of Byetta in patients with type 2 diabetes whose glycemic control was inadequate with metformin alone, a sulfonylurea alone, or metformin in combination with a sulfonylurea.

Eli Lilly has reported they have not seen a link in humans, but that it cannot be ruled out.