BYETTA PACKAGE INSERT PDF

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BYETTA is a non-insulin type 2 diabetes injection medication for adults. Learn about BYETTA, the BYETTA Pen. in patients with prior severe hypersensitivity reactions to exenatide or to any of the product components. Patient Information Leaflet. Package leaflet: Information for the patient. Byetta 5 micrograms solution for injection in pre-filled pen. Byetta 10 micrograms solution .

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If worsening of or failure to achieve adequate glycemic control occurs, consider alternative antidiabetic therapy. Should not be used in patients with severe renal impairment or end-stage renal disease. Because exenatide is commonly associated with gastrointestinal adverse reactions, BYETTA is not recommended in patients with severe gastrointestinal disease eg gastroparesis.

You are encouraged to report negative side effects of prescription drugs to the FDA. Call your healthcare provider right away if you have nausea, vomiting, or diarrhea that will not go away, or if you cannot take liquids by mouth. Talk to your healthcare provider first if you are breastfeeding or plan to breastfeed. Increased risk of hypoglycemia when used in combination with a sulfonylurea SU or when used with a glucose-independent insulin secretagogues eg, meglitinides.

You may give other people a serious infection, or get a serious infection from them. Patients may develop antibodies to exenatide.

BYETTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Tell your healthcare provider if you have severe problems with your stomach, such as delayed emptying of your stomach gastroparesis or problems with digesting food. Concurrent use with prandial insulin has not been studied and cannot be recommended. All other trademarks are property of their respective owners. Staying Active Learn how regular physical activity can help you manage type 2 diabetes.

Type 2 Diabetes Medication | BYETTA® (exenatide) injection

BYETTA is an injectable prescription medicine that may improve blood sugar glucose control in adults with type 2 diabetes, when used with diet and exercise.

BYETTA should not be used in people with type 1 diabetes or people with diabetic ketoacidosis a condition caused by very high blood sugar. Approved Uses BYETTA is an injectable prescription medicine that may improve blood sugar glucose control in adults with type 2 diabetes, when used with diet and exercise. Postmarketing insrt of altered renal function, including increased serum creatinine, renal impairment, worsened chronic renal failure, and acute renal failure, sometimes requiring hemodialysis and kidney transplantation.

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Postmarketing reports of serious hypersensitivity reactions eg anaphylaxis and angioedema. The Double B logo is a trademark of the AstraZeneca group of companies.

Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, and feeling jittery. AstraZeneca provides this link as a service to website visitors. 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.

These may be symptoms of pancreatitis. The most frequently reported adverse reactions leading to withdrawal for Byetta-treated patients were nausea 5.

The most common side effects with BYETTA include nausea, vomiting, diarrhea, feeling jittery, dizziness, headache, acid stomach, constipation, and weakness. Use in pediatric patients is not recommended as safety and effectiveness have not been established. This site is intended for US Consumers. BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, based on postmarketing data.

Drug Interactions Oral Medications: No clinical studies establishing conclusive evidence of macrovascular risk reduction with BYETTA or any other antidiabetic drug. Tell your healthcare provider if you are pregnant or plan to become pregnant. Use with caution in patients with renal transplantation or when initiating or escalating the dose in patients with moderate renal failure. Go to Healthcare Professional Site. 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.

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. This product information is intended for US Healthcare Professionals only.

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Symptoms of a severe allergic reaction include severe rash or itching, swelling of your face, lips, and throat that may cause difficulty breathing or swallowing, feeling faint or dizzy and very rapid heartbeat. No placebo-treated patients withdrew due to nausea or vomiting. We encourage you to read the privacy policy of every byehta you visit.

Glucagon-like peptide-1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes. Based on postmarketing data BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis.

Postmarketing reports of increased international normalized ratio INR sometimes associated with bleeding with concomitant use of warfarin. Tell your healthcare provider if you have or had kidney problems or a kidney transplant. BYETTA slows gastric emptying and can reduce the extent and rate of absorption of orally administered drugs. Not a substitute for insulin and should not be used in patients with type 1 diabetes or diabetic ketoacidosis. Use of twice-daily exenatide in basal insulin—treated patients with type 2 diabetes: Before taking BYETTA, tell your healthcare provider if you have had pancreatitis, stones in your gallbladder gallstonesa history of alcoholism, or high blood triglyceride levels.

Go to Patient Site. Stop taking BYETTA and call your healthcare provider right away if you have pain in your stomach area abdomen that is severe, and will not go away, occurs with or without vomiting or is felt going from your abdomen through to your back.

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To report drug exposure during pregnancy call If pancreatitis is suspected, BYETTA should be discontinued promptly and should not be restarted if pancreatitis is confirmed. Use with caution with medications that have a narrow therapeutic index or require rapid gastrointestinal absorption.

You may report side effects related to AstraZeneca products by clicking here.