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LYXUMIA SOLUTION FOR INJECTION IN PRE-FILLED PEN 20MCG (100MCG/ML)

Product Information

Registration Status: Active

SIN14655P

LYXUMIA SOLUTION FOR INJECTION IN PRE-FILLED PEN 20MCG (100MCG/ML) is approved to be sold in Singapore with effective from 2014-10-30. It is marketed by SANOFI-AVENTIS SINGAPORE PTE LTD, with the registration number of SIN14655P.

This product contains Lixisenatide 100mcg/mL in the form of INJECTION, SOLUTION. It is approved for SUBCUTANEOUS use.

This product is manufactured by Sanofi-Aventis Deutschland GmbH in GERMANY.

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

Product Reference
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Description

Lixisenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist used in the treatment of type 2 diabetes mellitus (T2DM). It is sold under the brand name Adlyxin by Sanofi-Aventis. Adlyxin recieved FDA approval July 28, 2016 [L763].

Indication

For use as an antihyperglycemic agent in the treatment of T2DM [FDA Label].

Mechanism of Action

The activation of the GLP-1 receptor by lixisenatide results in the activation of adenylyl cyclase [19193]. This increases the concentration of cyclic adenosine monophosphate in the cell leading to the activation of protein kinase A (PKA) as well as Epac1 and Epac2. PKA, Epac1, and Epac2 are involved the in release of Ca2+ from the endoplasmic reticulum which is known as the "amplification" pathway which increases insulin release when the triggering pathway is activated. By activating this amplification pathway lixisenatide increases glucose stimulated insulin secretion.

Pharmacokinetics

Absorption
tmax of 1-3.5h when administered subcutaneously [FDA Label].
Distribution
100L [FDA Label]
Metabolism
Assumed to undergo proteolytic degradation [FDA Label].
Elimination

Clearance

35L/h [FDA Label]

Toxicity

Thyroid C-cell adenomas occurred in rats when exposed to >15 times human exposure of 20mcg/day [FDA Label]. Overdose is associated with GI side effects typical of GLP-1 receptor agonists.

Active Ingredient/Synonyms

des-38-proline-exendine-4 (Heloderma suspectum)-(1-39)-peptidylpenta-L-lysyl-L-lysinamide | DesPro38Exendin-4(1-39)-Lys6-NH2 | L-histidylglycyl-L-α-glutamylglycyl-L-threonyl-L-phenylalanyl-L-threonyl-L-seryl-L-α-aspartyl-L-leucyl-L-seryl-L-lysyl-L-glutaminyl-L-methionyl-L-α-glutamyl-L-α-glutamyl-L-α-glutamyl-L-alanyl-L-valyl-L-arginyl-L-leucyl-L-phenylalanyl-L-isoleucyl-L-α-glutamyl-L-tryptophyl-L-leucyl-L-lysyl-L-asparaginylglycylglycyl-L-prolyl-L-seryl-L-serylglycyl-L-alanyl-L-prolyl-L-prolyl-L-seryl-L-lysyl-L-lysyl-L-lysyl-L-lysyl-L-lysyl-L-lysinamide | lixisenatida | lixisénatide | Lixisenatide |


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.

References

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

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