Byetta (Exenatide Injection) - Indications and Dosage

INDICATIONS AND USAGE

Type 2 Diabetes Mellitus

BYETTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Important Limitations of Use

BYETTA is not a substitute for insulin. BYETTA should not be used for the treatment of type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings.

The concurrent use of BYETTA with prandial insulin has not been studied and cannot be recommended.

Based on postmarketing data BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. BYETTA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using BYETTA. Other antidiabetic therapies should be considered in patients with a history of pancreatitis.

DOSAGE AND ADMINISTRATION

Recommended Dosing

BYETTA should be initiated at 5 mcg administered twice daily at any time within the 60-minute period before the morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart). BYETTA should not be administered after a meal. Based on clinical response, the dose of BYETTA can be increased to 10 mcg twice daily after 1 month of therapy. Initiation with 5 mcg reduces the incidence and severity of gastrointestinal side effects. Each dose should be administered as a subcutaneous (SC) injection in the thigh, abdomen, or upper arm. Do not mix BYETTA with insulin. Do not transfer BYETTA from the pen to a syringe or a vial. No data are available on the safety or efficacy of intravenous or intramuscular injection of BYETTA.

Use BYETTA only if it is clear, colorless and contains no particles.

DOSAGE FORMS AND STRENGTHS

BYETTA is supplied as a sterile solution for subcutaneous injection containing 250 mcg/mL exenatide in the following packages:

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

HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

BYETTA is supplied as a sterile solution for subcutaneous injection containing 250 mcg/mL exenatide.

The following packages are available:
5 mcg per dose, 60 doses, 1.2 mL prefilled pen, NDC 54868-5384-0
10 mcg per dose, 60 doses, 2.4 mL prefilled pen, NDC 54868-5384-1

Storage and Handling

• Prior to first use, BYETTA must be stored refrigerated at 36ºF to 46ºF (2ºC to 8ºC).
• After first use, BYETTA can be kept at a temperature not to exceed 77ºF (25ºC).
• Do not freeze. Do not use BYETTA if it has been frozen.
• BYETTA should be protected from light.
• The pen should be discarded 30 days after first use, even if some drug remains in the pen.
• Use a puncture-resistant container to discard the needles. Do not reuse or share needles.
• BYETTA should not be used past the expiration date.
• BYETTA pens are not to be shared with other patients.