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Exenatide

GLP-1 agonist

Also known as: Byetta (immediate-release), Bydureon / Bydureon BCise (extended-release)

Tier 1, Approved, characterised

Approved by at least one major regulator for a defined indication, with published human pharmacokinetics and a prescribing label. Well-characterised does not mean risk-free, read the label warnings.

Half-life
2.40 hours · human data · subcutaneous

Byetta immediate-release: mean terminal half-life 2.4 h; median peak plasma concentration at 2.1 h. Bydureon extended-release is a different microsphere formulation dosed once weekly (2 mg) with sustained release over weeks. PubChem MW 4187 (label states 4186.6 Da).

Model a dosing schedule →
Dosing
5 - 10 mcg

Byetta IR: 5 mcg twice daily, may increase to 10 mcg twice daily after 1 month. Bydureon ER: 2 mg (2000 mcg) once weekly.

Titration
Byetta: 5 mcg twice daily for 1 month, then may increase to 10 mcg twice daily.
Frequency
Byetta: twice daily. Bydureon: once weekly.
Timing
Byetta: within the 60-minute period before the morning and evening meals; do not administer after a meal.
Regulatory status
FDA-approved for type 2 diabetes.
Evidence base
human clinical · confidence: high

FDA prescribing information (DailyMed); high quality.

Storage

Lyophilised: Not applicable, Byetta is a pre-filled solution pen (not lyophilized).

Reconstituted: Store refrigerated 2-8°C before first use; after first use keep ≤25°C; discard pen 30 days after first use.

Safety

Byetta immediate-release carries NO boxed warning. NOTE: the extended-release form (Bydureon/Bydureon BCise) DOES carry a BOXED WARNING for thyroid C-cell tumors (contraindicated with MTC/MEN 2). Both forms: pancreatitis risk, hypoglycemia with sulfonylureas, renal impairment cautions.

Sources