Bydureon

DRUG DESCRIPTION

BYDUREON (exenatide extended-release for injectable
suspension) is supplied as a sterile powder to be suspended in the diluent
included in the single-dose tray and administered by subcutaneous injection.
Exenatide is a 39-amino acid synthetic peptide amide with an empirical formula
of C₁₈₄H₂₈₂N₅₀O₆₀S and a 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-NH2

BYDUREON is a white to off-white powder that is available
in a dosage strength of 2 mg exenatide per vial. Exenatide is incorporated in
an extended release microsphere formulation containing the 50:50
poly(D,L-lactide-co-glycolide) polymer (37.2 mg per vial) along with sucrose
(0.8 mg per vial). The powder must be suspended in the diluent prior to
injection. The diluent is provided in a prefilled syringe. Each prefilled
syringe delivers 0.65 mL of the diluent as a clear, colorless to pale yellow
solution composed of carboxymethylcellulose sodium (23 mg), polysorbate 20
(0.77 mg), sodium phosphate monobasic monohydrate (0.74 mg), sodium phosphate
dibasic heptahydrate (0.62 mg), sodium chloride (5.0 mg), and water for
injection.