Drug Catalog - Product Detail
BYETTA SUBCUTANEOUS SOLUTION 250MCG/1ML 1.2ML X 1
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00310-6512-01 | ASTRAZENECA | 1 | 5MCG/0.02ML | SOLUTION |
PACKAGE FILES
Generic Name
EXENATIDE
Substance Name
EXENATIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
SUBCUTANEOUS
Application Number
NDA021773
Description
11 DESCRIPTION BYETTA (exenatide) is a synthetic peptide, glucagon-like peptide-1 (GLP-1) receptor agonist, that was originally identified in the lizard Heloderma suspectum . Exenatide is a 39-amino acid peptide amide. Exenatide has the empirical formula C 184 H 282 N 50 O 60 S and molecular weight of 4186.6 Daltons. The amino acid sequence for exenatide is shown below. H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH 2 BYETTA injection is supplied for subcutaneous administration as a sterile, preserved isotonic solution in a glass cartridge that has been assembled in a pen-injector (pen). Each milliliter (mL) contains 250 micrograms (mcg) synthetic exenatide, 2.2 mg metacresol as an antimicrobial preservative, mannitol as a tonicity-adjusting agent, and glacial acetic acid and sodium acetate trihydrate in water for injection as a buffering solution at pH 4.5. Two prefilled pens are available to deliver unit doses of 5 mcg or 10 mcg. Each prefilled pen will deliver 60 doses to provide for 30 days of twice daily administration (BID).
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied BYETTA (exenatide) 250 mcg/mL is a clear, colorless solution supplied as: • 5 mcg per dose, 60 doses, 1.2 mL prefilled pen, NDC 0310-6512-01 • 10 mcg per dose, 60 doses, 2.4 mL prefilled pen, NDC 0310-6524-01 16.2 Storage and Handling • Store BYETTA in the refrigerator at 36°F to 46°F (2°C to 8°C). • After first use, BYETTA can be kept at a temperature not to exceed 77°F (25°C). • Do not freeze. Do not use BYETTA if it has been frozen. • Protect BYETTA from light. • Discard the pen 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.
Indications & Usage
1 INDICATIONS AND USAGE BYETTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14) ] . Limitations of Use • BYETTA is not indicated for use in patients with type 1 diabetes. • BYETTA contains exenatide and should not be used with other products containing the active ingredient exenatide. • BYETTA has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis [see Warnings and Precautions (5.2) ] . BYETTA (exenatide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 , 14 ) Limitations of Use • Should not be used for the treatment of type 1 diabetes. ( 1 ) • Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION • 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). ( 2.1 ) • Initiate at 5 mcg per dose twice daily; increase to 10 mcg twice daily after 1 month based on clinical response. ( 2.1 ) 2.1 Recommended Dosing • Initiate BYETTA at 5 mcg administered subcutaneously 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). Do not administer after a meal. • Based on clinical response, the dose of BYETTA can be increased to 10 mcg twice daily after 1 month of therapy. • Administer as a subcutaneous injection in the thigh, abdomen, or upper arm. • Inspect visually for particulate matter and discoloration. Only use BYETTA if the solution appears clear, colorless, and contains no particles. • Do not mix BYETTA with insulin. Do not transfer BYETTA from the pen to a syringe or a vial. • If a dose is missed, resume the treatment regimen as prescribed with the next scheduled dose.