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AUBAGIO FILM-COATED TABLET 14mg

Product Information

Registration Status: Active

SIN14841P

AUBAGIO FILM-COATED TABLET 14mg is approved to be sold in Singapore with effective from 2015-08-31. It is marketed by SANOFI-AVENTIS SINGAPORE PTE LTD, with the registration number of SIN14841P.

This product contains Teriflunomide 14mg in the form of TABLET, FILM-COATED. It is approved for ORAL use.

This product is manufactured by Sanofi Winthrop Industrie in FRANCE.

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

Teriflunomide is the active metabolite of leflunomide, and it acts as an immunomodulatory agent by inhibiting pyrimidine synthesis. It is marketed under the name Aubagio® and is indicated for the treatment of multiple sclerosis, specifically relapsing forms. The FDA label states an important warning about the risk of hepatoxicity and teratogenicity for patients using teriflunomide.

Indication

Used in the treatment of relapsing forms of multiple sclerosis (MS).

Mechanism of Action

The exact mechanism by which teriflunomide acts in MS is not known. What is known is that teriflunomide prevents pyrimidine synthesis by inhibiting the mitochondrial enzyme dihydroorotate dehydrogenase, and this may be involved in its immunomodulatory effect in MS.

Pharmacokinetics

Absorption
After oral administration of teriflunomide, maximum plasma concentrations are reached, on average, in 1-4 hours.
Distribution
After a single intravenous dose, the volume of distribution is 11 L.
Metabolism
Teriflunomide mainly undergoes hydrolyis to minor metabolites. Other minor metabolic pathways include oxidation, N-acetylation and sulfate conjugation. Teriflunomide is not metabolized by CYP450 or flavin monoamine oxidase.
Elimination

Clearance

After a single IV dose, teriflunomide has a total body clearance of 30.5 mL/h.

Toxicity

Teriflunomide is contraindicated in pregnant women or women of childbearing age due to the risk of teratogenicity. Teriflunomide is also contraindicated in severe hepatic impairment due to reports of hepatotoxicity, hepatic failure, and death.

Active Ingredient/Synonyms

(Z)-2-cyano-alpha,alpha,alpha-trifluoro-3-hydroxy-p-crotonotoluidide | A 77-1726 | A 771726 | A771726 | HMR 1726 | Teriflunomida | Tériflunomide | Teriflunomidum | Teriflunomide |


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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