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BYETTA Solution for injection (2019)

Active ingredients: Exenatide

Product Name and Form

Byetta 5 micrograms solution for injection in pre-filled pen.

Byetta 10 micrograms solution for injection in pre-filled pen.

Pharmaceutical form

Solution for injection (injection).

Clear, colourless solution.

Qualitative and Quantitative Composition

Each dose contains 5 micrograms (mcg) of exenatide in 20 microlitres (mcl), (0.25 mg exenatide per ml).

Each dose contains 10 micrograms (mcg) of exenatide in 40 microlitres (mcl), (0.25 mg exenatide per ml).

Excipient with known effect:

Byetta 5 mcg: Each dose contains 44 mcg metacresol.

Byetta 10 mcg: Each dose contains 88 mcg metacresol.

For the full list of excipients, see section 6.1.

Chemical substance
Description

Exenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist that exhibits several antihyperglycaemic actions of glucagon-like peptide-1 (GLP-1). The amino acid sequence of exenatide partially overlaps that of human GLP-1. Exenatide has been shown to bind to and activate the known human GLP-1 receptor in vitro, its mechanism of action mediated by cyclic AMP and/or other intracellular signalling pathways. Exenatide increases, on a glucose-dependent basis, the secretion of insulin from pancreatic beta cells.

List of excipients

Metacresol
Mannitol
Glacial acetic acid
Sodium acetate trihydrate
Water for injections

Pack sizes and Marketing

Type I glass cartridge with a (bromobutyl) rubber plunger, rubber disc, and aluminium seal. Each cartridge is assembled into a disposable pen-injector (pen).

5 mcg: Each pre-filled pen contains 60 doses (approximately 1.2 ml of solution).

10 mcg: Each pre-filled pen contains 60 doses (approximately 2.4 ml of solution).

Pack size of 1 and 3 pens. Not all pack sizes may be marketed.

Injection needles are not included.

Becton, Dickinson and Company needles are suitable to use with the Byetta pen.

Marketing authorization holder
Authorization dates

AstraZeneca AB, SE-151 85 Sodertalje, Sweden

Date of first authorisation: 20 November 2006

Date of latest renewal: 22 July 2016

Marketing authorization number:

EU/1/06/362/001-4