Byetta

What is Byetta?

• Byetta (Exenatide) is a glucagon-like peptide-1 (GLP-1) receptor agonist used in combination with diet and exercise in the therapy of type 2 diabetes, either alone or in combination with other antidiabetic agents.

Exenatide

Exenatide sequence

What are the uses of this medicine?

• Byetta (Exenatide) is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes mellitus, when used with a diet and exercise program.
• Byetta is not insulin.

Limitations of Use:

• You should not take Byetta instead of insulin.
• The use of Byetta with short acting insulin is not recommended.
• The use of Byetta with rapid acting insulin is not recommended.
• Byetta is not for people with type 1 diabetes or people with diabetic ketoacidosis.
• It is not known if Byetta is safe and effective in children.
• Byetta has not been studied in people who have pancreatitis.
• Byetta should not be used in people who have severe kidney problems.

How does this medicine work?

• Exenatide (ex en' a tide) is a synthetic analogue of glucagon-like peptide-1 (GLP-1) that acts like the native gastrointestinal hormone (incretin) to increase insulin secretion.
• Exenatide, like GLP-1, increases insulin secretion by the pancreas and can improve glycemic control in patients with type 2 diabetes. Exenatide is a polypeptide initially extracted from salivary glands of the Gila monster and has close homology (53%) to human GLP-1, but is resistant to DPP-4 degradation and thus has a prolonged duration of activity.
• Exenatide (also known as exendin-4) must be given parenterally.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have had an allergic reaction to exenatide or any of the other ingredients in Byetta.

What drug interactions can this medicine cause?

Byetta may affect the way some medicines work and some other medicines may affect the way Byetta works.

Especially tell your healthcare provider if you take:

• Other anti-diabetes medicines, especially sulfonylurea medicines or insulin.
• birth control pills that are taken by mouth (oral contraceptives). Byetta may lower the amount of the medicine in your blood from your birth control pills and they may not work as well to prevent pregnancy. Take your birth control pills at least one hour before your injection of Byetta. If you must take your birth control pills with food, take it with a meal or snack where you do not also take Byetta.
• an antibiotic. Take antibiotic medicines at least one hour before taking Byetta. If you must take your antibiotic with food, take it with a meal or snack where you do not also take Byetta.
• warfarin sodium (Coumadin®, Jantoven®).
• a blood pressure medicine.
• a water pill (diuretic).
• a pain medicine.
• lovastatin (Altoprev®, Mevacor®, Advicor®).

Is this medicine FDA approved?

• Exenatide was approved for use in the United States in 2005, and current indications are for the management of glycemic control in adults with type 2 diabetes used in combination with diet and exercise, with or without other oral hypoglycemic agents.

How should this medicine be used?

Recommended dosage:

• Inject subcutaneously within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart).
• Initiate at 5 mcg per dose twice daily; increase to 10 mcg twice daily after 1 month based on clinical response.

Administration:

• Byetta comes in a prefilled pen.
• Use Byetta exactly as prescribed by your healthcare provider. Do not change your dose unless your healthcare provider has told you to change your dose.
• Your healthcare provider must teach you how to inject Byetta before you use it for the first time. If you have questions or do not understand the instructions, talk to your healthcare provider or pharmacist.
• Pen needles are not included. You may need a prescription to purchase pen needles from your pharmacist. Ask your healthcare provider which needle length and gauge is best for you.
• Inject your dose of Byetta under the skin (subcutaneous injection) of your upper leg (thigh), stomach area (abdomen), or upper arm as instructed by your healthcare provider. Do not inject into a vein or muscle.
• Do not mix Byetta and insulin in the same syringe or vial even if you take them at the same time.
• Byetta is injected two times each day, at any time within the 60 minutes (1 hour) before your morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart). Do not take Byetta after your meal.
• If you miss a dose of Byetta, skip that dose and take your next dose at the next prescribed time. Do not take an extra dose or increase the amount of your next dose to make up for a missed dose.
• If you use too much Byetta, call your healthcare provider or poison control center right away. Too much Byetta can cause your blood sugar to drop quickly and you may have symptoms of low blood sugar. You may need medical treatment right away. Too much Byetta can also cause severe nausea and vomiting.
• Follow your healthcare provider's instructions for diet, exercise, and how often to test your blood sugar. If you see your blood sugar increasing during treatment with Byetta, talk to your healthcare provider because you may need to adjust your current treatment plan for your diabetes.
• Talk to your healthcare provider about how to manage high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia), and how to recognize problems that can happen with your diabetes.
• Never share your Byetta pen with another person. You may give an infection to them, or get an infection from them, and Byetta may harm them.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As 250 mcg/mL exenatide in:

• 5 mcg per dose, 60 doses, 1.2 mL prefilled pen
• 10 mcg per dose, 60 doses, 2.4 mL prefilled pen

This medicine is available in fallowing brand namesː

• Byetta

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• vomiting
• diarrhea
• feeling jittery
• dizziness
• headache
• acid stomach
• constipation
• weakness

Byetta can cause serious side effects which may include:

• pancreatitis
• hypoglycemia
• Kidney problems
• Severe allergic reactions

What special precautions should I follow?

• Postmarketing reports with exenatide, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Discontinue Byetta promptly. Byetta should not be restarted. Consider other antidiabetic therapies in patients with a history of pancreatitis.
• Increased risk when Byetta is used in combination with medications known to cause hypoglycemia (e.g. insulin or insulin secretagogue). Consider reducing the dose of insulin or insulin secretagogue.
• Postmarketing reports with exenatide, sometimes requiring hemodialysis and kidney transplantation. Byetta should not be used in patients with severe renal impairment or end-stage renal disease and should be used with caution in patients with renal transplantation. Caution should be applied when initiating Byetta or escalating the dose of Byetta in patients with moderate renal failure.
• Use of Byetta is not recommended in patients with severe gastrointestinal disease (e.g., gastroparesis).
• Postmarketing reports with exenatide of hypersensitivity reactions (e.g. anaphylaxis and angioedema). The patient should discontinue Byetta and other suspect medications and promptly seek medical advice.
• There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Byetta or any other antidiabetic drug.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• nausea
• severe vomiting
• rapidly declining blood glucose concentrations
• severe hypoglycemia

Management of overdosage:

• In the event of overdose, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies of Byetta use in pregnant women.
• Byetta should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• Safety and effectiveness of Byetta have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: exenatide
• Inactive Ingredients: metacresol, mannitol, glacial acetic acid, and sodium acetate trihydrate in water for injection.

Who manufactures and distributes this medicine?

• Manufactured for Amylin Pharmaceuticals, Inc., San Diego, CA
• Byetta is a registered trademark of Amylin Pharmaceuticals, Inc.

What should I know about storage and disposal of this medication?

• Store your new, unused Byetta Pen in the original carton in a refrigerator at 36°F to 46°F (2°C to 8ºC).
• After first use, keep your Byetta Pen at a temperature cooler than 77°F (25°C).
• Do not freeze your Byetta Pen. Do not use Byetta if it has been frozen.
• Protect Byetta from light.
• Use a Byetta Pen for only 30 days. Throw away a used Byetta Pen after 30 days, even if there is some medicine left in the pen.
• Do not use Byetta after the expiration date printed on the label.
• Do not store the Byetta Pen with the needle attached. If the needle is left on, medicine may leak from the Byetta Pen or air bubbles may form in the cartridge.
• See the Byetta Pen User Manual for instructions about the right way to throw away your Byetta Pen.
• Keep your Byetta Pen, pen needles, and all medicines out of the reach of children.

• Dailymed label info on Byetta
• FDA Byetta

Byetta Resources
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