Patient Information Leaflet. Package leaflet: Information for the patient. Byetta 5 micrograms solution for injection in pre-filled pen. Byetta 10 micrograms solution . Learn about BYETTA, the BYETTA Pen. in patients with prior severe hypersensitivity reactions to exenatide or to any of the product components. PRODUCT MONOGRAPH. BYETTA® exenatide injection. µg/mL. mL prefilled pen (60 doses of 5 µg/dose) and. mL prefilled pen.
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Go to Patient Packate. BYETTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. You are encouraged to report negative side effects of prescription drugs to the FDA.
Byetta (exenatide) dose, indications, adverse effects, interactions from
All other trademarks are property of their respective owners. Pen-sharing poses a risk for transmission of blood-borne pathogens, even if the needle is changed. Based on postmarketing data BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis.
After initiation and dose increases of BYETTA, observe patients carefully for pancreatitis including persistent severe abdominal pain, sometimes radiating to the back, with or without vomiting. If pancreatitis is suspected, BYETTA should be discontinued promptly and should not be restarted if pancreatitis is confirmed.
Increased risk of hypoglycemia when used in combination with a sulfonylurea SU or when used with a glucose-independent insulin secretagogues eg, meglitinides. When used with insulin, evaluate and consider reducing the insulin dose in patients at increased risk of hypoglycemia. Should not be used in patients with severe renal impairment or end-stage renal disease. Use with caution in patients with renal transplantation or when initiating or escalating the dose in patients with moderate renal failure.
Postmarketing reports of altered renal function, including increased serum creatinine, renal impairment, worsened chronic renal failure, and acute renal failure, sometimes requiring hemodialysis and kidney transplantation.
Type 2 Diabetes Medication | BYETTA® (exenatide) injection
Because exenatide is commonly associated with gastrointestinal adverse reactions, BYETTA is not recommended in patients with severe gastrointestinal disease eg gastroparesis. Patients may develop pakcage to exenatide. If worsening of or failure to achieve adequate glycemic control pavkage, consider alternative antidiabetic therapy. Postmarketing reports of serious hypersensitivity reactions eg anaphylaxis and angioedema.
No clinical studies establishing conclusive evidence of macrovascular risk reduction with BYETTA or any other antidiabetic drug. Drug Interactions Oral Medications: BYETTA slows gastric emptying and can reduce the extent and rate of absorption of orally administered drugs. Use with caution with medications that have a narrow therapeutic index or require inser gastrointestinal absorption. Oral medications dependent on threshold concentrations for efficacy, such as contraceptives or antibiotics, should be taken at least 1 hour before BYETTA.
Postmarketing reports of increased international normalized ratio INR sometimes associated with bleeding with concomitant use of warfarin. 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.
To report drug exposure during pregnancy call Use in pediatric patients is not recommended as safety and effectiveness pwckage not been established.
Not a substitute for insulin and should not be used in patients with type 1 diabetes or diabetic ketoacidosis. Concurrent use with prandial insulin has not been studied and cannot be recommended.
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BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing ibsert, based on postmarketing data. 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. Glucagon-like peptide-1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes.
This product information is intended for US Healthcare Professionals only.
The most frequently reported adverse reactions leading to iinsert for Byetta-treated patients were nausea 5. No placebo-treated patients withdrew due to nausea or vomiting.