BYDUREON POWDER, SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION IN PRE-FILLED PEN 2MG

Exenatide

Source of information: Drugbank (External Link). Last updated on: 3rd July 18
*Trade Name used in the content below may not be the same as the HSA-registered product.

Active Ingredient / Synonyms

AC 2993 | AC-2993 | AC002993 | AC2993 | AC2993a | Exenatide | Exenatide synthetic | Synthetic exendin-4 | Exenatide |

Description

Exenatide, derived from a compound found in the saliva of the Gila monster, a large lizard native to the southwestern US, is a functional analog of Glucagon-Like Peptide-1 (GLP-1), a naturally occuring peptide.

Indication

Indicated as adjunctive therapy to improve glycemic control in patients with Type 2 diabetes mellitus who are taking metformin, a sulfonylurea, or a combination of both, but have not achieved adequate glycemic control.

Mechanism of Action

Exenatide is a functional analog of the human incretin Glucagon-Like Peptide-1 (GLP-1). Incretins enhance glucose-dependent insulin secretion and exhibit other antihyperglycemic actions following their release into the circulation from the gut. The GLP-1 system increases insulin secretion only in the presence of elevated plasma glucose levels, avoiding inappropriately high insulin levels during fasting. The drug also moderates peak serum glucagon levels during hyperglycemic periods following meals, but does not interfere with glucagon release in response to hypoglycemia. Secondary effects of drug administration reduces the rate of gastric emptying and decreases food intake, mitigating the potential severity of hyperglycemic events after meals.

Pharmacodynamics

Exenatide is an incretin mimetic, which has glucoregulatory effects. While it is has blood-sugar lowering actions alone, it can also be combined with other medications such as pioglitazone, metformin, sulfonylureas, and/or insulin to improve glucose control. The approved use of exenatide is with either sulfonylureas, metformin and thiazolinediones. The medication is injected twice per day using a pre-filled pen device. Typical human responses to exenatide plus eating include improvements in the initial rapid release of endogenous insulin, suppression of glucagon release by the pancreas, regulation of gastric empyting and reduced appetite; all behaviors more typical of individuals without blood sugar control problems. Exenatide is self-regulating in that in lowers blood sugar when levels are elevated but does not continue to lower blood sugar when levels return to normal, unlike with sulfonylureas or insulins.

Pharmacokinetics

Absorption:

Following subcutaneous administration to patients with type 2 diabetes, exenatide reaches median peak plasma concentrations in 2.1 hours.

Distribution:

* 28.3 L

Metabolism:

Not Available

Elimination:

Nonclinical studies have shown that exenatide is predominantly eliminated by glomerular filtration with subsequent proteolytic degradation.

Half-life

Mean terminal half-life is 2.4 hours.

Clearance

* Apparent cl=9.1 L/hr

Toxicity

Effects of the overdoses included severe nausea, severe vomiting, and rapidly declining blood glucose concentrations.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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Approval Information

BYDUREON POWDER, SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION IN PRE-FILLED PEN 2MG was registered with Health Science Authority of Singapore by ASTRAZENECA SINGAPORE PTE LTD. It is marketed with the registration number of SIN15095P with effective from 2016-10-10.

This product contains 2mg of Exenatide in the form of SUBCUTANEOUS INJECTION, POWDER, FOR SUSPENSION, EXTENDED-RELEASE.

The medicine was manufactured by Amylin Ohio LLC in UNITED STATES

It is a Presciption Only Medicine which can only be obtained from a doctor or a dentist, or from a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Anatomical Therapeutic Chemical (ATC) Classification

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