Product Information
Registration Status: ActiveAUBAGIO 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.
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.