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DrugAubagio (teriflunomide) [Genzyme]

October 2013

Therapeutic area - Multiple Sclerosis

FDA approved indication

Aubagio (teriflunomide) is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS).

Aubagio contains a black box warning for Hepatotoxicity and Teratogenicity.  

Approval criteria

  • Aubagio is being used as monotherapy for relapsing forms of multiple sclerosis AND
  • After documented compliance of at least 6 months of therapy, unless contraindicated, recipient has had an inadequate response to Copaxone AND
  • Females of child bearing age must have a negative pregnancy test and be using reliable contraception

Inadequate response is defined as meeting two of the following three criteria during treatment with another Disease Modifying Drug:

  • Unchanged or increase relapse rate or ongoing severe relapses compared with the previous year despite treatment
  • The patient continues to have CNS lesion progression as measured by MRI
  • The patient continues to have worsening disability. Examples of worsening disability include, but are not limited to, decreased mobility or decreased ability to perform activities of daily living due to disease progression.

Aubagio tablets are supplied as blister card cartons containing 5 or 28 tablets.

Quantity limit

34 tablets per 34-day supply


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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